ISO 14001 Environmental Aspects And Impacts
The fundamental purpose of the EMS is to control and reduce the environmental impacts of your facility’s processes and products. For this reason, a critical element of the EMS involves identifying and prioritizing the environmental aspects and impacts associated with your facility. An environmental aspect is an element of an organizations activities, products, or services that can interact with the environment. For example, chrome plating is a metal finishing activity and an associated aspect is chrome air emissions.
This aspect may have an impact on the environment in several ways, for example, ambient air quality degradation.
The environmental aspects and impacts of your metal finishing operations can be identified, prioritized, and documented in several ways. This Template includes two approaches, either of which can be used during EMS implementation. Use the approach that works best for your circumstances. This process is important because high-priority environmental aspects and impacts will be considered when environmental objectives and targets are established.
Aspects and Impacts Form A -- The first approach uses the experience and judgment of
employees familiar with facility processes to identify the top five environmental issues
currently facing the facility. These issues and their specific aspects and impacts should
be summarized using Aspects and Impacts Form A.
Aspects and Impacts Form B -- The second approach uses detailed, structured matrices
to list and prioritize environmental aspects and impacts according to the following
categories:
• Environmental Aspects and Impacts: Wastewater
• Environmental Aspects and Impacts: Air Emissions
• Environmental Aspects and Impacts: Hazardous and Solid Waste
• Environmental Aspects and Impacts: Raw Materials
• Environmental Aspects and Impacts: Water and Energy
The matrices that comprise Form B will help facility staff identify and document environmental aspects and impacts. The matrices also provide criteria for prioritizing environmental aspects and impacts; this process is important because high-priority environmental aspects and impacts will be considered when environmental objectives and targets are established. One possible way to prioritize environmental aspects and impacts using Form B is described as follows:
Step 1:
For each aspect and impact, score each prioritization criterion on a scale from 1 to 5, where 1 indicates the criterion is very important or relevant to that aspect (for example, the aspect is strictly regulated, is the subject of compliance violations, or is a waste generated in large uantities), and 5 indicates the criterion is relatively unimportant or irrelevant to that aspect (for example, the aspect is an unregulated waste, is generated infrequently, and is inexpensive to manage).
Step 2:
Add the scores of all criteria for each aspect and write the total in the right-most column of the form.
This number indicates the relative priority of the aspect compared to other aspects and impacts in the same category. The lower the total score, the higher the priority.
Purpose Of This procedure is used to identify, document, and update the environmental aspects and impacts of facility processes and operations.
Step 1 The environmental manager and other facility personnel selected by the environmental manager are responsible for identifying and prioritizing the environmental aspects and impacts of facility operations during EMS planning and development.
Environmental aspects are characteristics of facility processes and products that interact with the environment. Only environmental aspects the company can control or influence will be considered. Environmental impacts are the effects of an organization's activitie , products or services on the environment.
Step 2 Environmental aspects and impacts will be documented and prioritized.
Environmental aspects and impacts will be associated with the following categories:
• Wastewater
• Air emissions
• Hazardous and solid waste
• Raw materials
• Water and energy
High-priority environmental aspects and impacts will be considered when environmental
objectives and targets are set.
Step 3 The environmental manager and other facility personnel will review and update
the environmental aspects and impacts documentation annually.
Step 4 Environmental aspects and impacts documentation will be retained at the facility
for at least 2 years.
Responsible Person: _____________________________________
Signature and Date: ______________________________________
Monday, September 21, 2009
ISO 14001 ENVIRONMENTAL POLICY
ISO 14001 ENVIRONMENTAL POLICY
The intent of an environmental policy is to state the organization’s commitment to continuous improvement in environmental performance. A strong, clear environmental policy can serve as both a starting point for developing the EMS and a reference point for maintaining continuous improvement.
The policy should be evaluated regularly and modified, as necessary, to reflect changing environmental priorities.
The policy should function in two ways: (1) within the company, the policy should focus attention on environmental issues associated with company activities, products, and services; and (2) outside the company, the policy is a public commitment to addressing environmental issues and continuously improving environmental performance.
The environmental policy must address:
• Commitment to compliance with relevant environmental legislation and
regulations
• Pollution prevention
• Continuous improvement
Tips for Developing an Environmental Policy:
1. Develop a policy that reflects perspectives of various employees within the company (for example, line worker, owner, wastewater treatment operator, quality inspector, compliance/legal manager, production manager).
2. Display the policy statement in view of all employees; the policy should be available to the public and customers if requested and be printed in languages other than English, as appropriate.
3. Include top management signatures on the policy to demonstrate understanding and commitment.
Purpose This procedure is used to develop and write the company’s environmental policy.
Step 1 The environmental manager will form a policy development team responsible for developing and writing the environmental policy. The policy will address, at a minimum, compliance, pollution prevention, and continuous improvement.
Step 2 The policy development team will review other relevant documents to ensure consistency with other company policies and guide the content and phrasing of the policy. Example documents include the company mission statement and the example environmental policies included in this EMS element.
Step 3 The policy will be displayed in view of all employees and introduced to new employees; the policy will be available in languages other than English, as appropriate, and to the public (on request) and customers (as appropriate).
Step 4 The environmental manager will review the environmental policy at least annually, and update it if needed.
Responsible Person: _____________________________________
Signature and Date: ______________________________________
Environmental Policy Example 1
It is the policy of COMPANY NAME to conduct its operations in a manner that is environmentally responsible and befitting a good corporate neighbor and citizen.
In accordance with this policy, COMPANY NAME complies with all environmental laws and manages all phases of its business in a manner that minimizes the impact of its operations on the environment.
To further this policy, COMPANY NAME shall:
1. Include environmental requirements in planning and design activities
2. Comply with applicable environmental laws and regulations
3. Eliminate, or reduce to the maximum practical extent, the release of contaminants into the environment, first through pollution prevention (material substitution and source reduction), then recycling, and finally through treatment and control technologies
4. Effectively communicate with company employees, suppliers, regulators, and customers, as well as the surrounding community, regarding the environmental impact of company operations
5. Periodically review and demonstrate continuous improvement in the company’s environmental management system
SIGNATURE___________________
Responsible Person
______________________
Environmental Policy Sample 2
Effective Date
ENVIRONMENTAL POLICY
_________________________ IS COMMITTED TO IMPROVE THE HEALTH, SAFETY AND ENVIRONMENT FOR OUR EMPLOYEES, NEIGHBORS, AND FAMILIES.
WE WILL MEET AND OR EXCEED LAWFUL COMPLIANCE THROUGH POLLUTION PREVENTION PRACTICES AND CONTINUOUS IMPROVEMENT.
TO IMPLEMENT THIS POLICY WE WILL CREATE AN ENVIRONMENTAL MANAGEMENT SYSTEM TO IDENTIFY GOALS, SYSTEMS, MEASUREMENTS AND SAMPLING METHODS.
TO SUPPLEMENT THIS POLICY WE WILL INCORPORATE SOURCE REDUCTION THROUGH REUSE, RECYCLING, MATERIAL SUBSTITUTION, NEW AND IMPROVED TECHNOLOGIES, CREATIVE MANAGEMENT AND OPERATIONAL PRACTICES.
TO MAINTAIN THIS POLICY WE WILL PERFORM MANAGEMENT REVIEW, REVENTATIVE MAINTENANCE, EMPLOYEE TRAINING, AND A COMMITMENT AND INVOLVEMENT FROM OUR EMPLOYEES AND MANAGEMENT TO SUPPORT THIS POLICY.
The intent of an environmental policy is to state the organization’s commitment to continuous improvement in environmental performance. A strong, clear environmental policy can serve as both a starting point for developing the EMS and a reference point for maintaining continuous improvement.
The policy should be evaluated regularly and modified, as necessary, to reflect changing environmental priorities.
The policy should function in two ways: (1) within the company, the policy should focus attention on environmental issues associated with company activities, products, and services; and (2) outside the company, the policy is a public commitment to addressing environmental issues and continuously improving environmental performance.
The environmental policy must address:
• Commitment to compliance with relevant environmental legislation and
regulations
• Pollution prevention
• Continuous improvement
Tips for Developing an Environmental Policy:
1. Develop a policy that reflects perspectives of various employees within the company (for example, line worker, owner, wastewater treatment operator, quality inspector, compliance/legal manager, production manager).
2. Display the policy statement in view of all employees; the policy should be available to the public and customers if requested and be printed in languages other than English, as appropriate.
3. Include top management signatures on the policy to demonstrate understanding and commitment.
Purpose This procedure is used to develop and write the company’s environmental policy.
Step 1 The environmental manager will form a policy development team responsible for developing and writing the environmental policy. The policy will address, at a minimum, compliance, pollution prevention, and continuous improvement.
Step 2 The policy development team will review other relevant documents to ensure consistency with other company policies and guide the content and phrasing of the policy. Example documents include the company mission statement and the example environmental policies included in this EMS element.
Step 3 The policy will be displayed in view of all employees and introduced to new employees; the policy will be available in languages other than English, as appropriate, and to the public (on request) and customers (as appropriate).
Step 4 The environmental manager will review the environmental policy at least annually, and update it if needed.
Responsible Person: _____________________________________
Signature and Date: ______________________________________
Environmental Policy Example 1
It is the policy of COMPANY NAME to conduct its operations in a manner that is environmentally responsible and befitting a good corporate neighbor and citizen.
In accordance with this policy, COMPANY NAME complies with all environmental laws and manages all phases of its business in a manner that minimizes the impact of its operations on the environment.
To further this policy, COMPANY NAME shall:
1. Include environmental requirements in planning and design activities
2. Comply with applicable environmental laws and regulations
3. Eliminate, or reduce to the maximum practical extent, the release of contaminants into the environment, first through pollution prevention (material substitution and source reduction), then recycling, and finally through treatment and control technologies
4. Effectively communicate with company employees, suppliers, regulators, and customers, as well as the surrounding community, regarding the environmental impact of company operations
5. Periodically review and demonstrate continuous improvement in the company’s environmental management system
SIGNATURE___________________
Responsible Person
______________________
Environmental Policy Sample 2
Effective Date
ENVIRONMENTAL POLICY
_________________________ IS COMMITTED TO IMPROVE THE HEALTH, SAFETY AND ENVIRONMENT FOR OUR EMPLOYEES, NEIGHBORS, AND FAMILIES.
WE WILL MEET AND OR EXCEED LAWFUL COMPLIANCE THROUGH POLLUTION PREVENTION PRACTICES AND CONTINUOUS IMPROVEMENT.
TO IMPLEMENT THIS POLICY WE WILL CREATE AN ENVIRONMENTAL MANAGEMENT SYSTEM TO IDENTIFY GOALS, SYSTEMS, MEASUREMENTS AND SAMPLING METHODS.
TO SUPPLEMENT THIS POLICY WE WILL INCORPORATE SOURCE REDUCTION THROUGH REUSE, RECYCLING, MATERIAL SUBSTITUTION, NEW AND IMPROVED TECHNOLOGIES, CREATIVE MANAGEMENT AND OPERATIONAL PRACTICES.
TO MAINTAIN THIS POLICY WE WILL PERFORM MANAGEMENT REVIEW, REVENTATIVE MAINTENANCE, EMPLOYEE TRAINING, AND A COMMITMENT AND INVOLVEMENT FROM OUR EMPLOYEES AND MANAGEMENT TO SUPPORT THIS POLICY.
ISO 9001 Standards In General
ISO 9001 Standards In General
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization’s quality management system is influenced by— its business environment, changes in that environment, or risks associated with that environment,— its varying needs,— its particular objectives,— the products it provides,— the processes it employs,— its size and organizational structure.It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying theassociated requirement.This International Standard can be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer, statutory and regulatory requirements applicable to theproduct, and the organization’s own requirements.The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization’s quality management system is influenced by— its business environment, changes in that environment, or risks associated with that environment,— its varying needs,— its particular objectives,— the products it provides,— the processes it employs,— its size and organizational structure.It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying theassociated requirement.This International Standard can be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer, statutory and regulatory requirements applicable to theproduct, and the organization’s own requirements.The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.
ISO 9001 – Compatibility with other management systems
ISO 9001 – Compatibility with other management systems
ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independently.ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, for certification, or for contractual purposes. It focuses on the effectiveness of the qualitymanagement system in meeting customer requirements.ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organizations overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.
During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community.This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financialmanagement or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible foran organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard
ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independently.ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, for certification, or for contractual purposes. It focuses on the effectiveness of the qualitymanagement system in meeting customer requirements.ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organizations overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.
During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community.This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financialmanagement or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible foran organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard
Certification In ISO 9001 Standards
Certification In ISO 9001 Standards
Certification involves an independent assessment of your quality system to confirm that it meets the requirements of ISO 9001. You will need to design, document and implement your own quality system. The system will need to cover all the requirements of the ISO 9001 standard. Many certification bodies will not conduct a formal assessment until the system has been operating for at least three months. Your quality system cannot be audited until you have generated documentary evidence to show that you are meeting the standard. To find a certification body with relevant experience in your sector and accreditation from the United Kingdom Accreditation Service (UKAS). Certification by a non-UKAS accredited body is likely to lead to credibility problems with your customers. Arrange a visit from the certification body’s auditors. UKAS prohibits auditors from acting as consultants. They will not tell you how to meet the standard but can offer advice. They will seek objective evidence that you are complying with each of the clauses of the ISO 9001 standard. The auditors will tell you of any shortcomings in your system. If you satisfy the standard, the auditors put your name forward for certification. You will be required to correct these problems within a specified timeframe. You can also be certificated if the auditors only identify a small number of ‘minor’ problems. Once you are certificated, you can display the certification body’s logo, and if the body is UKAS-accredited, the UKAS ‘tick and crown’ symbol (consult UKAS about exceptions to this rule). If the auditors identify more serious ‘major’ problems, you will be required to correct these before certification. These surveillance visits normally take place twice a year at agreed dates. All certification bodies are required to revisit registered companies to ensure they still meet the requirements of the standard. You will be given time to deal with any minor or major problems which are identified before any action is taken to withdraw your certificate.
Certification involves an independent assessment of your quality system to confirm that it meets the requirements of ISO 9001. You will need to design, document and implement your own quality system. The system will need to cover all the requirements of the ISO 9001 standard. Many certification bodies will not conduct a formal assessment until the system has been operating for at least three months. Your quality system cannot be audited until you have generated documentary evidence to show that you are meeting the standard. To find a certification body with relevant experience in your sector and accreditation from the United Kingdom Accreditation Service (UKAS). Certification by a non-UKAS accredited body is likely to lead to credibility problems with your customers. Arrange a visit from the certification body’s auditors. UKAS prohibits auditors from acting as consultants. They will not tell you how to meet the standard but can offer advice. They will seek objective evidence that you are complying with each of the clauses of the ISO 9001 standard. The auditors will tell you of any shortcomings in your system. If you satisfy the standard, the auditors put your name forward for certification. You will be required to correct these problems within a specified timeframe. You can also be certificated if the auditors only identify a small number of ‘minor’ problems. Once you are certificated, you can display the certification body’s logo, and if the body is UKAS-accredited, the UKAS ‘tick and crown’ symbol (consult UKAS about exceptions to this rule). If the auditors identify more serious ‘major’ problems, you will be required to correct these before certification. These surveillance visits normally take place twice a year at agreed dates. All certification bodies are required to revisit registered companies to ensure they still meet the requirements of the standard. You will be given time to deal with any minor or major problems which are identified before any action is taken to withdraw your certificate.
Costs and resources Of ISO 9001 Standards
Costs and resources Of ISO 9001 Standards
The largest cost of ISO 9001 is the involvement of company
employees. The ‘ownership’ created by involving employees in designing the quality system maximises the chances of them accepting it. Reducing this cost by minimising employee involvement is a false economy. The next largest cost will be for designing and developing the system. This needs to be led by someone with experience in this particular field. You may have someone within your own organisation who has carried out this role, perhaps with a former employer. Your Business Link may offer free or subsidised advice and training, and will be able to provide names of approved consultants. Grants for work in this area tend to be directed through Business Links. Different areas have different grants, which depend on local conditions. A typical grant may cover up to 50 per cent of the cost of an approved consultant. Certification fees are around £800 for the smallest companies. Overall costs depend upon company size and the number of locations involved. Ask certification bodies for quotes for initial audits and surveillance visits. Many will give an all-inclusive price, including surveillance visits for three years. Typically, special rates will depend on how long the assessment is likely to take and what the company’s turnover is. Ask your certification body if it offers special rates for small companies. The standard requires that companies have trained internal auditors to conduct audits on the system. An internal audit can provide an effective means of monitoring the system and identifying areas for improvement. For further details, contact the International Register of Certificated Auditors.
The largest cost of ISO 9001 is the involvement of company
employees. The ‘ownership’ created by involving employees in designing the quality system maximises the chances of them accepting it. Reducing this cost by minimising employee involvement is a false economy. The next largest cost will be for designing and developing the system. This needs to be led by someone with experience in this particular field. You may have someone within your own organisation who has carried out this role, perhaps with a former employer. Your Business Link may offer free or subsidised advice and training, and will be able to provide names of approved consultants. Grants for work in this area tend to be directed through Business Links. Different areas have different grants, which depend on local conditions. A typical grant may cover up to 50 per cent of the cost of an approved consultant. Certification fees are around £800 for the smallest companies. Overall costs depend upon company size and the number of locations involved. Ask certification bodies for quotes for initial audits and surveillance visits. Many will give an all-inclusive price, including surveillance visits for three years. Typically, special rates will depend on how long the assessment is likely to take and what the company’s turnover is. Ask your certification body if it offers special rates for small companies. The standard requires that companies have trained internal auditors to conduct audits on the system. An internal audit can provide an effective means of monitoring the system and identifying areas for improvement. For further details, contact the International Register of Certificated Auditors.
ISO 9000 family of standards and SMEs
ISO 9000 family of standards and SMEs
The ISO 9000 quality management system is generic in nature and applicable to all companies, regardless of the type and size of the business, including small and medium enterprises (SMEs), and they are applicable to all categories of products, whether hardware, software, processed materials or services. ISO 9001:2008 specifies what is required to be done by an organization but does not indicate how it should be done, thus giving the enterprise a lot of flexibility to run its business.
It is simple to use, clear in language and easily understandable. The new standard is also appropriate for small companies, as it does not demand the type of paper bureaucracy needed for the implementation of the 1994 version. Only six documented procedures are now required and need for other procedures/documents can be decided by the company. Companies will, however, be required to provide objective evidence that the QMS has been effectively implemented. A small company may find it appropriate to include the description of its entire QMS within a single Quality Manual, including all the documented procedures required by the standard.
The process-based approach given in the new standard will tend to ensure that systems are documented and implemented in a manner that suits a SME’s own way of doing business. This approach makes it easier for SMEs to implement, instead of just taking over an artificial structure of QMS imposed from outside. It will also be easier for SMEs managed by their owners to demonstrate “top management commitment” towards QMS. Furthermore, in a SME, it is easier to ensure effective internal communication, better utilization of resources, people clearly understanding their roles and responsibilities, etc.
The new standard has included a provision for deciding on the applicability of
certain product realization processes included in section 7 of the standard. For example, if the SME has no responsibility for the design and development of the product it provides, the SME may say so, giving the reasoning behind it, in the Quality Manual; the certification body, being satisfied that this corresponds, would then award it certification to ISO 9001:2008. Similarly, other product realization processes such as purchasing, product identification and traceability, control of measuring devices may also be excluded if these are not applicable for the type of products or services being provided by the company.
It is also possible that SMEs may not have adequate in-house expertise or there may be other constraints to perform all processes on their own. In such cases, the new standard also permits the outsourcing of any of the QMS processes, providing the company has control over such processes. The nature of this control will depend on the nature of the outsourced or subcontracted processes and the risk involved. For example, the design and development process may be subcontracted to an expert or a specialized agency, inspection/verification of goods purchased may be subcontracted to an inspection agency, internal audit of QMS can be outsourced, etc. However, overall responsibility for ensuring control on all outsourced processes as per requirements of the standard would remain with the company’s management.
The ISO 9000 quality management system is generic in nature and applicable to all companies, regardless of the type and size of the business, including small and medium enterprises (SMEs), and they are applicable to all categories of products, whether hardware, software, processed materials or services. ISO 9001:2008 specifies what is required to be done by an organization but does not indicate how it should be done, thus giving the enterprise a lot of flexibility to run its business.
It is simple to use, clear in language and easily understandable. The new standard is also appropriate for small companies, as it does not demand the type of paper bureaucracy needed for the implementation of the 1994 version. Only six documented procedures are now required and need for other procedures/documents can be decided by the company. Companies will, however, be required to provide objective evidence that the QMS has been effectively implemented. A small company may find it appropriate to include the description of its entire QMS within a single Quality Manual, including all the documented procedures required by the standard.
The process-based approach given in the new standard will tend to ensure that systems are documented and implemented in a manner that suits a SME’s own way of doing business. This approach makes it easier for SMEs to implement, instead of just taking over an artificial structure of QMS imposed from outside. It will also be easier for SMEs managed by their owners to demonstrate “top management commitment” towards QMS. Furthermore, in a SME, it is easier to ensure effective internal communication, better utilization of resources, people clearly understanding their roles and responsibilities, etc.
The new standard has included a provision for deciding on the applicability of
certain product realization processes included in section 7 of the standard. For example, if the SME has no responsibility for the design and development of the product it provides, the SME may say so, giving the reasoning behind it, in the Quality Manual; the certification body, being satisfied that this corresponds, would then award it certification to ISO 9001:2008. Similarly, other product realization processes such as purchasing, product identification and traceability, control of measuring devices may also be excluded if these are not applicable for the type of products or services being provided by the company.
It is also possible that SMEs may not have adequate in-house expertise or there may be other constraints to perform all processes on their own. In such cases, the new standard also permits the outsourcing of any of the QMS processes, providing the company has control over such processes. The nature of this control will depend on the nature of the outsourced or subcontracted processes and the risk involved. For example, the design and development process may be subcontracted to an expert or a specialized agency, inspection/verification of goods purchased may be subcontracted to an inspection agency, internal audit of QMS can be outsourced, etc. However, overall responsibility for ensuring control on all outsourced processes as per requirements of the standard would remain with the company’s management.
Management Principles Of ISO 9001 Standards
Management Principles Of ISO 9001 Standards
ISO 9000 is based on eight management principles:
• Customer focus, resulting in meeting customer requirements and striving to exceed them;
• Leadership, aiming to create an internal environment in which people are fully involved;
• Involvement of people who are the essence of an organization;
• Process approach, resulting in improved efficiency to obtain desired results;
• System approach to management, leading to improved effectiveness and efficiency through identification, understanding and management of interrelated processes;
• Continual improvement, which becomes a permanent objective of the organization;
• Factual approach to decision-making, based on the analysis of data and information; and
• Mutually beneficial supplier relationships, based on an understanding of their interdependence.
ISO 9000 encourages the adoption of the process approach to manage an organization. There are five main areas considered for the revised process model in ISO 9000:
• Quality management system
• Management responsibility
• Resource management
• Product realization
• Measurement, analysis and improvement.
ISO 9000 is based on eight management principles:
• Customer focus, resulting in meeting customer requirements and striving to exceed them;
• Leadership, aiming to create an internal environment in which people are fully involved;
• Involvement of people who are the essence of an organization;
• Process approach, resulting in improved efficiency to obtain desired results;
• System approach to management, leading to improved effectiveness and efficiency through identification, understanding and management of interrelated processes;
• Continual improvement, which becomes a permanent objective of the organization;
• Factual approach to decision-making, based on the analysis of data and information; and
• Mutually beneficial supplier relationships, based on an understanding of their interdependence.
ISO 9000 encourages the adoption of the process approach to manage an organization. There are five main areas considered for the revised process model in ISO 9000:
• Quality management system
• Management responsibility
• Resource management
• Product realization
• Measurement, analysis and improvement.
Costs Of Setting Up A Quality Management System
Costs Of Setting Up A Quality Management System
Common implementation costs that companies incur can be broken down into direct and indirect costs.
The direct costs include, inter alia, the following:
• hiring consultants or external trainers, if required;
• sending personnel for external training;
• acquiring relevant national and international standards of the ISO 9000 family and other related books and publications; and
• acquiring additional equipment, instruments and other resources as identified by the company.
The indirect costs include, inter alia, the following:
• time spent by the management and other staff in developing the system;
• reorganization of the processes, including improvements in the house-keeping, if required;
• external calibration charges for equipment to ensure national and/or international measurement traceability;
• organizing in-house training;
• time spent by internal auditors for periodic internal audits;
• corrective actions, including revision of manuals and procedures, if required; and
• expenditure on word-processing, stationery and other consumables required for the preparation of manuals and documenting procedures, etc.
Some factors can help to lower the above costs. They include:
• having people in the company already conversant with QMS requirements;
• having documented system-related activities such as work instructions, quality plans, procedures, etc. already in place;
• using consultants only for specific activities like gap analysis, training of
auditors, pre-assessment audits, etc., and having in-house staff oversee the remaining activities.
On the other hand, there are factors that can mean higher implementation costs for the company. For example, if your company carries out activities at different locations, or if your company is involved in product design and development, this may increase costs.
Common implementation costs that companies incur can be broken down into direct and indirect costs.
The direct costs include, inter alia, the following:
• hiring consultants or external trainers, if required;
• sending personnel for external training;
• acquiring relevant national and international standards of the ISO 9000 family and other related books and publications; and
• acquiring additional equipment, instruments and other resources as identified by the company.
The indirect costs include, inter alia, the following:
• time spent by the management and other staff in developing the system;
• reorganization of the processes, including improvements in the house-keeping, if required;
• external calibration charges for equipment to ensure national and/or international measurement traceability;
• organizing in-house training;
• time spent by internal auditors for periodic internal audits;
• corrective actions, including revision of manuals and procedures, if required; and
• expenditure on word-processing, stationery and other consumables required for the preparation of manuals and documenting procedures, etc.
Some factors can help to lower the above costs. They include:
• having people in the company already conversant with QMS requirements;
• having documented system-related activities such as work instructions, quality plans, procedures, etc. already in place;
• using consultants only for specific activities like gap analysis, training of
auditors, pre-assessment audits, etc., and having in-house staff oversee the remaining activities.
On the other hand, there are factors that can mean higher implementation costs for the company. For example, if your company carries out activities at different locations, or if your company is involved in product design and development, this may increase costs.
Benefits Of Obtaining ISO 9000 Certification
Benefits Of Obtaining ISO 9000 Certification
Implementing a quality management system brings internal benefits to most organizations, as well as opening up opportunities vis-Ã -vis the outside world.
Internal benefits to the company include:
• improved customer focus and process orientation within the company;
• improved management commitment and decision-making;
• better working conditions for employees;
• increased motivation of employees;
• reduced cost of internal failures (lower rates of rework, rejection, etc.) and external failures (fewer customer returns, replacements, etc.); and last but not least,
• continual improvement of the quality management system.
The following external benefits are generated:
• customers are more confident that they will receive products conforming to their requirements, which in turn results in higher customer satisfaction;
• an improved image of the company;
• more aggressive publicity, as customers can be informed of the benefits of their doing business with a company that manages the quality of its outputs;
• more confidence that the company’s products meet relevant regulatory
requirements;
• better objective evidence to defend product liability charges if such are brought by customers.
Refer http://www.iso9001-standard.us for more information.
Implementing a quality management system brings internal benefits to most organizations, as well as opening up opportunities vis-Ã -vis the outside world.
Internal benefits to the company include:
• improved customer focus and process orientation within the company;
• improved management commitment and decision-making;
• better working conditions for employees;
• increased motivation of employees;
• reduced cost of internal failures (lower rates of rework, rejection, etc.) and external failures (fewer customer returns, replacements, etc.); and last but not least,
• continual improvement of the quality management system.
The following external benefits are generated:
• customers are more confident that they will receive products conforming to their requirements, which in turn results in higher customer satisfaction;
• an improved image of the company;
• more aggressive publicity, as customers can be informed of the benefits of their doing business with a company that manages the quality of its outputs;
• more confidence that the company’s products meet relevant regulatory
requirements;
• better objective evidence to defend product liability charges if such are brought by customers.
Refer http://www.iso9001-standard.us for more information.
Implementing A Quality Management System
Implementing A Quality Management System
An ISO 9000:2008 quality management system can be implemented by following the steps detailed as follows:
1. Evaluate the organization’s need/goals for implementing a QMS Need may arise from repeated customer complaints; frequent warranty returns; delayed deliveries; high inventories; frequent production hold-ups; and high level of rework or rejection of products or services.
At this stage, identify the goals which you would like to achieve through a QMS, such as customer satisfaction, increased market share, improved communications and morale in the organization, greater efficiency and profitability, etc. Another objective in implementing a QMS may be a demonstration of compliance through third party certification, which may be requested by an important client or required for enlisting as a supplier to large companies, e.g., original equipment manufacturers (OEMs).
2. Obtain information about the ISO 9000 family
The persons identified for initiating the development of an ISO 9000 QMS need tounderstand the requirements of ISO 9001:2008 as read with ISO 9000:2000 and ISO 9001:2008.
Supporting information such as quality management principles, frequently asked questions (FAQs), guidance on clause 1.2 (application) of ISO 9001:2008, guidance on documentation requirements of ISO 9001:2008 and other brochures are available free of charge on the ISO web site;
3. Appoint a consultant, if necessary
If, within the organization, you do not have adequate competence to develop a QMS, you may appoint a consultant. Before doing so, it is good to check his/her background; knowledge about the product realization processes of your organization; and experience in helping other organizations to achieve their stated goals, including certification.
Carry out a cost-benefit analysis of hiring a consultant and agree the scope of his/her work in writing. It is also possible to appoint a consultant only for the training of key staff; the latter can then carry out further training and development of the system.
4. Awareness and training
Raise awareness about QMS requirements amongst all personnel performing activities that affect quality. Plan for and provide specific training on how to develop Quality Manuals; on procedures; on QMS planning; on how to identify and implement improvement processes; and on how to audit compliance with the QMS, etc.
The Institute of Quality Assurance (IQA), the American Society for Quality (ASQ)and the International Auditor and Training Certification Association (IATCA) can provide lists of training organizations.
5. Gap analysis
Evaluate gaps between your existing quality management system and the QMS requirements of ISO 9001. Prepare how to bridge these gaps, including by planning for any additional resources required. Gap analysis may be carried out through selfassessment or by the external consultant.
6. Product realization processes
Review clause 7 of ISO 9001:2008 relating to “Product realization” to determine how the requirements apply or do not apply to your company’s QMS.
The processes covered by this clause include:
• Customer-related processes
• Design and development
• Purchasing
• Production and service provision
• Control of measuring and monitoring devices
Note that if your company is not responsible for preparing the design of your product, you can exclude the requirement for “design and development” from your QMS and explain the reasons for doing so in your Quality Manual.
7. Staffing
Decide on the responsibilities of the persons who will be involved in developing and documenting the QMS, including the appointment of a management representative who will oversee the implementation of the QMS. Establishing a project Steering Committee may also prove useful to oversee progress and provide resources wherever required.
8. Planning a time frame
Prepare a complete plan to close the gaps identified in Step 5 to develop the QMS processes. In the plan, include activities to be performed, resources required, responsibilities and an estimated completion time for each activity. Clauses 4.1 and
7.1 of ISO 9001:2008 provide information that should be used when developing the plan. The total time required for each phase (planning, documentation, implementation and evaluation) depends on the extent of the gaps in your existing QMS.
9. Draft a Quality Manual
In your Quality Manual;
• Include how the QMS applies to the products, processes, locations and departments of the organization;
• Exclude any requirement with justification for doing so as decided in step 6
above;
• Refer to or include documented procedures for QMS;
• Describe the interaction between the processes of the QMS, e.g., the interaction between product realization processes and other management, measurement and improvement processes; and
• Draft the quality policy and quality objectives for the organization.
The staff concerned in the organization should review the Quality Manual and the documented procedures so that their comments and suggestions can be taken into account before the Quality Manual and procedures are approved for issue and use.
The effective date of implementation should also be decided.
10. Carry out internal audits
During the phase of implementation of some three to six months after the documentation has been written, the trained auditors should carry out one or two internal audits covering all activities for the QMS, and concerned management should take corrective action on the audit findings without delay. Wherever required, revise the manuals, procedures and objectives. After each internal audit, the top management should review the effectiveness of the system and provide necessary resources for corrective actions and improvements.
11. Apply for certification
On satisfactory completion of Step 10, and if your company decides to obtain third party certification, you can make an application for certification to an accredited certification body. The certification audit process is explained section VII.
12. Conduct periodic evaluations
After certification, the organization should periodically conduct internal audits to review the effectiveness of the QMS and see how it can be “continually improved”. The organization should evaluate periodically if the purpose and goals (see Step 1) for which the QMS was developed are being achieved, including its continual improvement.
An ISO 9000:2008 quality management system can be implemented by following the steps detailed as follows:
1. Evaluate the organization’s need/goals for implementing a QMS Need may arise from repeated customer complaints; frequent warranty returns; delayed deliveries; high inventories; frequent production hold-ups; and high level of rework or rejection of products or services.
At this stage, identify the goals which you would like to achieve through a QMS, such as customer satisfaction, increased market share, improved communications and morale in the organization, greater efficiency and profitability, etc. Another objective in implementing a QMS may be a demonstration of compliance through third party certification, which may be requested by an important client or required for enlisting as a supplier to large companies, e.g., original equipment manufacturers (OEMs).
2. Obtain information about the ISO 9000 family
The persons identified for initiating the development of an ISO 9000 QMS need tounderstand the requirements of ISO 9001:2008 as read with ISO 9000:2000 and ISO 9001:2008.
Supporting information such as quality management principles, frequently asked questions (FAQs), guidance on clause 1.2 (application) of ISO 9001:2008, guidance on documentation requirements of ISO 9001:2008 and other brochures are available free of charge on the ISO web site;
3. Appoint a consultant, if necessary
If, within the organization, you do not have adequate competence to develop a QMS, you may appoint a consultant. Before doing so, it is good to check his/her background; knowledge about the product realization processes of your organization; and experience in helping other organizations to achieve their stated goals, including certification.
Carry out a cost-benefit analysis of hiring a consultant and agree the scope of his/her work in writing. It is also possible to appoint a consultant only for the training of key staff; the latter can then carry out further training and development of the system.
4. Awareness and training
Raise awareness about QMS requirements amongst all personnel performing activities that affect quality. Plan for and provide specific training on how to develop Quality Manuals; on procedures; on QMS planning; on how to identify and implement improvement processes; and on how to audit compliance with the QMS, etc.
The Institute of Quality Assurance (IQA), the American Society for Quality (ASQ)and the International Auditor and Training Certification Association (IATCA) can provide lists of training organizations.
5. Gap analysis
Evaluate gaps between your existing quality management system and the QMS requirements of ISO 9001. Prepare how to bridge these gaps, including by planning for any additional resources required. Gap analysis may be carried out through selfassessment or by the external consultant.
6. Product realization processes
Review clause 7 of ISO 9001:2008 relating to “Product realization” to determine how the requirements apply or do not apply to your company’s QMS.
The processes covered by this clause include:
• Customer-related processes
• Design and development
• Purchasing
• Production and service provision
• Control of measuring and monitoring devices
Note that if your company is not responsible for preparing the design of your product, you can exclude the requirement for “design and development” from your QMS and explain the reasons for doing so in your Quality Manual.
7. Staffing
Decide on the responsibilities of the persons who will be involved in developing and documenting the QMS, including the appointment of a management representative who will oversee the implementation of the QMS. Establishing a project Steering Committee may also prove useful to oversee progress and provide resources wherever required.
8. Planning a time frame
Prepare a complete plan to close the gaps identified in Step 5 to develop the QMS processes. In the plan, include activities to be performed, resources required, responsibilities and an estimated completion time for each activity. Clauses 4.1 and
7.1 of ISO 9001:2008 provide information that should be used when developing the plan. The total time required for each phase (planning, documentation, implementation and evaluation) depends on the extent of the gaps in your existing QMS.
9. Draft a Quality Manual
In your Quality Manual;
• Include how the QMS applies to the products, processes, locations and departments of the organization;
• Exclude any requirement with justification for doing so as decided in step 6
above;
• Refer to or include documented procedures for QMS;
• Describe the interaction between the processes of the QMS, e.g., the interaction between product realization processes and other management, measurement and improvement processes; and
• Draft the quality policy and quality objectives for the organization.
The staff concerned in the organization should review the Quality Manual and the documented procedures so that their comments and suggestions can be taken into account before the Quality Manual and procedures are approved for issue and use.
The effective date of implementation should also be decided.
10. Carry out internal audits
During the phase of implementation of some three to six months after the documentation has been written, the trained auditors should carry out one or two internal audits covering all activities for the QMS, and concerned management should take corrective action on the audit findings without delay. Wherever required, revise the manuals, procedures and objectives. After each internal audit, the top management should review the effectiveness of the system and provide necessary resources for corrective actions and improvements.
11. Apply for certification
On satisfactory completion of Step 10, and if your company decides to obtain third party certification, you can make an application for certification to an accredited certification body. The certification audit process is explained section VII.
12. Conduct periodic evaluations
After certification, the organization should periodically conduct internal audits to review the effectiveness of the QMS and see how it can be “continually improved”. The organization should evaluate periodically if the purpose and goals (see Step 1) for which the QMS was developed are being achieved, including its continual improvement.
ISO 9001 Standards – Management Review
ISO 9001 Standards – Management Review
Review the quality management system at planned intervals to:- Assess possible opportunities for improvementEnsure a suitable, adequate, and effective system
- Evaluate the need for any changes to the system
- Consider the need for changes to the quality policy and objectives
Maintain records of the management reviews.
Inputs for management review must include information on:
- Results of audits
- Customer feedback
- Process performance and product conformity
- Status of preventive and corrective actions
- Follow-up actions from earlier reviews
- Changes that could affect the quality system
- Recommendations for improvement
Outputs from the management review must include any decisions and actions related to:
- Improvement of the effectiveness of the quality management system and its processes
- Improvement of product related to customer requirements
- Resource needs
Review the quality management system at planned intervals to:- Assess possible opportunities for improvementEnsure a suitable, adequate, and effective system
- Evaluate the need for any changes to the system
- Consider the need for changes to the quality policy and objectives
Maintain records of the management reviews.
Inputs for management review must include information on:
- Results of audits
- Customer feedback
- Process performance and product conformity
- Status of preventive and corrective actions
- Follow-up actions from earlier reviews
- Changes that could affect the quality system
- Recommendations for improvement
Outputs from the management review must include any decisions and actions related to:
- Improvement of the effectiveness of the quality management system and its processes
- Improvement of product related to customer requirements
- Resource needs
ISO 9001 Standards – Design and Development
ISO 9001 Standards - Design and Development
Plan and control the product design and development. This planning must determine the:Identify problems and propose any necessary actions
- Stages of design and development
- Appropriate review, verification, and validation activities for each stage
- Responsibility and authority for design and development
The interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.
NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.
Determine product requirement inputs and maintain records. The inputs must include:
- Functional and performance requirements
- Applicable statutory and regulatory requirements
- Applicable information derived from similar designs
- Requirements essential for design and development
Review these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.
Document the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:
- Meet design and development input requirements
- Provide information for purchasing, production, and service
- Contain or reference product acceptance criteria
- Define essential characteristics for safe and proper use
- Be approved before their release
Perform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:
- Evaluate the ability of the results to meet requirements
- The reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.
Plan and control the product design and development. This planning must determine the:Identify problems and propose any necessary actions
- Stages of design and development
- Appropriate review, verification, and validation activities for each stage
- Responsibility and authority for design and development
The interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.
NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.
Determine product requirement inputs and maintain records. The inputs must include:
- Functional and performance requirements
- Applicable statutory and regulatory requirements
- Applicable information derived from similar designs
- Requirements essential for design and development
Review these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.
Document the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:
- Meet design and development input requirements
- Provide information for purchasing, production, and service
- Contain or reference product acceptance criteria
- Define essential characteristics for safe and proper use
- Be approved before their release
Perform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:
- Evaluate the ability of the results to meet requirements
- The reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.
ISO 9001 Standards – Control of Measuring and Monitoring Equipment
ISO 9001 Standards - Control of Measuring and Monitoring Equipment
Determine the monitoring and measurements to be made, and the required equipment, to provide evidence of product conformity. Use and control the monitoring and measuring devices to ensure that measurement capability is consistent with monitoring and measurement requirements.
Where necessary to ensure valid results:
- Calibrate and/or verify the measuring equipment at specified intervals or prior to use
- Calibrate the equipment to national or international standards (or record other basis)
- Adjust or re-adjust as necessary
- Identify the measuring equipment in order to determine its calibration status
- Safeguard them from improper adjustments
- Protect them from damage and deterioration
Assess and record the validity of prior results if the device is found to not conform to requirements. Maintain records of the calibration and verification results.
Confirm the ability of software used for monitoring and measuring for the intended application before its initial use (and reconfirmed as necessary).
NOTE: Confirming the ability of software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.
For More Information Please Visit http://www.iso9001-standard.us
Determine the monitoring and measurements to be made, and the required equipment, to provide evidence of product conformity. Use and control the monitoring and measuring devices to ensure that measurement capability is consistent with monitoring and measurement requirements.
Where necessary to ensure valid results:
- Calibrate and/or verify the measuring equipment at specified intervals or prior to use
- Calibrate the equipment to national or international standards (or record other basis)
- Adjust or re-adjust as necessary
- Identify the measuring equipment in order to determine its calibration status
- Safeguard them from improper adjustments
- Protect them from damage and deterioration
Assess and record the validity of prior results if the device is found to not conform to requirements. Maintain records of the calibration and verification results.
Confirm the ability of software used for monitoring and measuring for the intended application before its initial use (and reconfirmed as necessary).
NOTE: Confirming the ability of software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.
For More Information Please Visit http://www.iso9001-standard.us
ISO 14001:2004 Standards Contents
ISO 14000 is a series of international standards on environmental management. It provides a framework for the development of an environmental management system and the supporting audit programme.
The main thrust for its development came as a result of the Rio Summit on the Environment held in 1992.
ISO 14000 is an Environmental Management System (EMS), which requires that an organization consider the environmental aspects of its products and services.
Iso14000 approach forces you to take a hard look at all areas of your business that has an environmental impact.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
ISO 14000 is an Environmental Management System (EMS) who’s purpose is:
· A management commitment to pollution prevention.
· An understanding of the environmental impacts (reducing) of an organization’s activities.
A commitment (pollution prevention) to employees, neighbors and customers
ISO 14001 is the corner stone standard of the ISO 14000 series. It specifies a framework of control for an Environmental Management System against which an organization can be certified by a third party.
The environment cannot be protected by our convictions or goodwill alone. Efforts to protect the environment must be planned, coordinated and organized into a system, such as ISO 14001.
ISO14001 requires an Environmental Policy to be in existence within the organisation, fully supported by senior management, and outlining the policies of the company, not only to the staff but to the public. The policy needs to clarify compliance with Environmental Legislation that may effect the organization and stress a commitment to continuous improvement. Emphasis has been placed on policy as this provides the direction for the remainder of the Management System.
Those companies who have witnessed ISO9000 Assessments will know that the policy is frequently discussed during the assessment, many staff are asked if they understand or are aware of the policy, and any problems associated with the policy are seldom serious. The Environmental Policy is different, this provides the initial foundation and direction for the Management System and will be more stringently reviewed than a similar ISO9000 policy. The statement must be publicised in non-technical language so that it can be understood by the majority of readers. It should relate to the sites within the organisation encompassed by the Management System, it should provide an overview of the company’s activities on the site and a description of those activities. A clear picture of the company’s operations.
The preparatory review and definition of the organization’s environmental effects is not part of a ISO14001 Assessment, however examination of this data will provide an external audit with a wealth of information on the methods adopted by the company. The preparatory review itself should be comprehensive in consideration of input processes and output at the site. This review should be designed to identify all relevant environmental aspects that may arise from existence on the site. These may relate to current operations, they may relate to future, perhaps even unplanned future activities, and they will certainly relate to the activities performed on site in the past (i.e. contamination of land).
The initial or preparatory review will also include a wide-ranging consideration of the legislation which may effect the site, whether it is currently being complied with, and perhaps even whether copies of the legislation are available. Many of the environmental assessments undertaken already have highlighted that companies are often unaware of ALL of the legislation that affects them, and being unaware, are often not meeting the requirements of that legislation.
The company will declare its primary environmental objectives, those that can have most environmental impact. In order to gain most benefit these will become the primary areas of consideration within the improvement process, and the company’s environmental program. The program will be the plan to achieve specific goals or targets along the route to a specific goal and describe the means to reach those objectives such that they are real and achievable. The Environmental Management System provides further detail on the environmental program. The EMS establishes procedures, work instructions and controls to ensure that implementation of the policy and achievement of the targets can become a reality. Communication is a vital factor, enabling people in the organisation to be aware of their responsibilities, aware of the objectives of the scheme, and able to contribute to its success.
As with ISO9000 the Environmental Management System requires a planned comprehensive periodic audit of the Environmental Management System to ensure that it is effective in operation, is meeting specified goals, and the system continues to perform in accordance with relevant regulations and standards. The audits are designed to provide additional information in order to exercise effective management of the system, providing information on practices which differ to the current procedures or offer an opportunity for improvement.
In addition to audit, there is a requirement for Management Review of the system to ensure that it is suitable (for the organization and the objectives) and effective in operation. The management review is the ideal forum to make decisions on howe to improve for the future.
The newly revised ISO 14001:2004 specifies the requirements for an environmental management system (EMS), which provides a framework for an organization to control the environmental impacts of its activities, products and services, and to continually improve its environmental performance. It applies to those environmental aspects which the organization can control and over which it can be expected to have an influence. It does not itself state specific environmental performance criteria. ISO 14001:2004 is applicable to any organization that wishes to:
· implement, maintain and improve an environmental management system
· assure itself of its conformance with its stated environmental policy
· demonstrate such conformance to others
· seek certification/registration of its environmental management system by an external organization
· make a self-determination and self-declaration of conformance with this international standard.
All the requirements in this standard can be incorporated into any environmental management system. Having been revised, the improved ISO 14001 is now expected to bring the benefits of implementing an EMS to more businesses than ever. The standard is now easier to understand and use and has more detailed checklists for inputs and outputs from the management review and has increased compatibility to ISO 9001. Organizations who are currently registered to ISO 14001:1996 will have an 18-month transition period to register to ISO 14001:2004.
The main thrust for its development came as a result of the Rio Summit on the Environment held in 1992.
ISO 14000 is an Environmental Management System (EMS), which requires that an organization consider the environmental aspects of its products and services.
Iso14000 approach forces you to take a hard look at all areas of your business that has an environmental impact.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
ISO 14000 is an Environmental Management System (EMS) who’s purpose is:
· A management commitment to pollution prevention.
· An understanding of the environmental impacts (reducing) of an organization’s activities.
A commitment (pollution prevention) to employees, neighbors and customers
ISO 14001 is the corner stone standard of the ISO 14000 series. It specifies a framework of control for an Environmental Management System against which an organization can be certified by a third party.
The environment cannot be protected by our convictions or goodwill alone. Efforts to protect the environment must be planned, coordinated and organized into a system, such as ISO 14001.
ISO14001 requires an Environmental Policy to be in existence within the organisation, fully supported by senior management, and outlining the policies of the company, not only to the staff but to the public. The policy needs to clarify compliance with Environmental Legislation that may effect the organization and stress a commitment to continuous improvement. Emphasis has been placed on policy as this provides the direction for the remainder of the Management System.
Those companies who have witnessed ISO9000 Assessments will know that the policy is frequently discussed during the assessment, many staff are asked if they understand or are aware of the policy, and any problems associated with the policy are seldom serious. The Environmental Policy is different, this provides the initial foundation and direction for the Management System and will be more stringently reviewed than a similar ISO9000 policy. The statement must be publicised in non-technical language so that it can be understood by the majority of readers. It should relate to the sites within the organisation encompassed by the Management System, it should provide an overview of the company’s activities on the site and a description of those activities. A clear picture of the company’s operations.
The preparatory review and definition of the organization’s environmental effects is not part of a ISO14001 Assessment, however examination of this data will provide an external audit with a wealth of information on the methods adopted by the company. The preparatory review itself should be comprehensive in consideration of input processes and output at the site. This review should be designed to identify all relevant environmental aspects that may arise from existence on the site. These may relate to current operations, they may relate to future, perhaps even unplanned future activities, and they will certainly relate to the activities performed on site in the past (i.e. contamination of land).
The initial or preparatory review will also include a wide-ranging consideration of the legislation which may effect the site, whether it is currently being complied with, and perhaps even whether copies of the legislation are available. Many of the environmental assessments undertaken already have highlighted that companies are often unaware of ALL of the legislation that affects them, and being unaware, are often not meeting the requirements of that legislation.
The company will declare its primary environmental objectives, those that can have most environmental impact. In order to gain most benefit these will become the primary areas of consideration within the improvement process, and the company’s environmental program. The program will be the plan to achieve specific goals or targets along the route to a specific goal and describe the means to reach those objectives such that they are real and achievable. The Environmental Management System provides further detail on the environmental program. The EMS establishes procedures, work instructions and controls to ensure that implementation of the policy and achievement of the targets can become a reality. Communication is a vital factor, enabling people in the organisation to be aware of their responsibilities, aware of the objectives of the scheme, and able to contribute to its success.
As with ISO9000 the Environmental Management System requires a planned comprehensive periodic audit of the Environmental Management System to ensure that it is effective in operation, is meeting specified goals, and the system continues to perform in accordance with relevant regulations and standards. The audits are designed to provide additional information in order to exercise effective management of the system, providing information on practices which differ to the current procedures or offer an opportunity for improvement.
In addition to audit, there is a requirement for Management Review of the system to ensure that it is suitable (for the organization and the objectives) and effective in operation. The management review is the ideal forum to make decisions on howe to improve for the future.
The newly revised ISO 14001:2004 specifies the requirements for an environmental management system (EMS), which provides a framework for an organization to control the environmental impacts of its activities, products and services, and to continually improve its environmental performance. It applies to those environmental aspects which the organization can control and over which it can be expected to have an influence. It does not itself state specific environmental performance criteria. ISO 14001:2004 is applicable to any organization that wishes to:
· implement, maintain and improve an environmental management system
· assure itself of its conformance with its stated environmental policy
· demonstrate such conformance to others
· seek certification/registration of its environmental management system by an external organization
· make a self-determination and self-declaration of conformance with this international standard.
All the requirements in this standard can be incorporated into any environmental management system. Having been revised, the improved ISO 14001 is now expected to bring the benefits of implementing an EMS to more businesses than ever. The standard is now easier to understand and use and has more detailed checklists for inputs and outputs from the management review and has increased compatibility to ISO 9001. Organizations who are currently registered to ISO 14001:1996 will have an 18-month transition period to register to ISO 14001:2004.
ISO 9001 Standards New Blogs
Some of the new blogs on ISO 9001 Standards & ISO 14001 standards was found as below:
http://iso14000standards.blogspot.com/
http://iso-9001-standards.blogspot.com/
http://iso14001environmentmanagementsystem.blogspot.com/
http://iso9001qualitymanagementsystem.blogspot.com/
http://iso9001qualitymanual.blogspot.com/
http://iso9000standards.blogspot.com/
http://iso9001-standards.blogspot.com/
http://iso14001standards.blogspot.com/
http://iso14000standards.blogspot.com/
http://iso-9001-standards.blogspot.com/
http://iso14001environmentmanagementsystem.blogspot.com/
http://iso9001qualitymanagementsystem.blogspot.com/
http://iso9001qualitymanual.blogspot.com/
http://iso9000standards.blogspot.com/
http://iso9001-standards.blogspot.com/
http://iso14001standards.blogspot.com/
ADVANTAGES ACHIEVED BY THE IMPLEMENTATION OF Quality Management System
ADVANTAGES ACHIEVED BY THE IMPLEMENTATION OF Quality Management System (QMS)
- An Romania Perspective
The assurance of quality of the delivered products and services has always represented the main goal of any organisation which wants to be on the market. The concept of „quality” is larger than in the past, referring also to management aspects. Thus, the quality of products and services does not represent only a goal, but a consequence of the quality of the whole managerial activities, workers, and even a quality of partnerships. Modern industrial reorganisations are usually realised through the strategies of quality management, due to the fact that these are able to release the continuous and substantial improvements of the economical agents’ performances.
Within such a frame, one possibility for an organisation to maintain and to gain new positions on a market is to design, to implement and to certificate a Quality Management System (QMS), system through which all processes are controlled.
The Romanian pharmaceutical market is currently restricted as volume and value compared to other countries in the region. Joining the European Union and future improvement of living conditions will mean increase of pharmaceutical expenses per person, considering the fact that the demand for pharmaceutical products (medication) is not influenced by the evolution of prices. After 1990, foreign manufacturers have become interested in the increasing potential of Romania, a country of 22 million inhabitants with a very low intake of drugs per person, due to the low living standard. They have penetrated the market through direct import companies, through license agreements, acquisitions and privatizations.
Romanian manufacturers have tried to shift their direction towards export, but the barrier represented by the Good Manufacturing Practice (GMP – for production) and ISO 9001:2000 standards (for distribution) has stopped their penetration of new markets. Their exports mainly targeted Russia, Moldova and former socialist countries. Without norms of this kind, also known as standards, today’s international trade would be inconceivable because every product would have to be checked in keeping with individual criteria. Norms, therefore, create comparability.
Nowadays, the external market has, for several companies, the same importance as the domestic one. The conquest of external market is essential because it brings currency, improves commercial balance, creates new working places and promotes the managerial or technological know-how transfer.
ISO 9000 is a generic name given to a family of standards developed to provide a framework around which a quality management system can be effectively implemented. These standards were developed mainly to facilitate commercial relationships and to increase the confidence of consumers in the capability of a supplier to constantly satisfy the requirements of products and services quality.
The paper presents some advantages achieved by implementation of Quality Management System in pharmaceutical industry, namely S.C. X Company S.A from Tirgu-Mures, one of the most important producer and distributor of pharmaceutical products in Romania.
Using a proven management system combined with ongoing external validation, enables the X Company to continually renew its strategies, domestic and external operations and service level. To this respect, the paper presents the main steps in implementing the Quality Management System within this organisation and some benefits of the registration such as increasing domestic sales, but most off all, the penetration and increasing sales on external markets.
The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines related to quality management systems and related supporting standards.
ISO 9001:2000 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified – although certification is not a compulsory requirement of the standard.
The other standards in the family cover specific aspects such as fundamentals and vocabulary, performance improvements, documentation, training, and financial and economic aspects. Implementing a Quality Management System within an organisation needs to be a decision of top management. The objective of the quality system needs to be clearly defined so that the system can be effective. The design and implementation of quality management system will vary depending on the type, size and products of the organisation and should be used in conjunction with the ISO 9000:2000 standards. Implementing a Quality Management System is not that difficult as it seems, the key is planning and commitment. How complex or simple the QMS is depends entirely on the organisation and what the objectives are. It can be a simple guide to the organisation policy and procedures, or it can document every task and procedure. It really depends on how much risk is involved and how much control is required.
The documentation of QMS involves:
1. The policy to refer to quality, the objectives of quality and the book of quality (Quality Management System)
2. Management Responsibility
3. Resource Management
4. Product Realisation
5. Measurements, Analysis and Improvement
A well managed quality system will have impact on:
1. customer loyalty and repeat business
2. market share
3. operational efficiencies
4. flexibility and ability to respond to market opportunities
5. effective and efficient use of resources
6. cost reductions
7. competitive advantages
- An Romania Perspective
The assurance of quality of the delivered products and services has always represented the main goal of any organisation which wants to be on the market. The concept of „quality” is larger than in the past, referring also to management aspects. Thus, the quality of products and services does not represent only a goal, but a consequence of the quality of the whole managerial activities, workers, and even a quality of partnerships. Modern industrial reorganisations are usually realised through the strategies of quality management, due to the fact that these are able to release the continuous and substantial improvements of the economical agents’ performances.
Within such a frame, one possibility for an organisation to maintain and to gain new positions on a market is to design, to implement and to certificate a Quality Management System (QMS), system through which all processes are controlled.
The Romanian pharmaceutical market is currently restricted as volume and value compared to other countries in the region. Joining the European Union and future improvement of living conditions will mean increase of pharmaceutical expenses per person, considering the fact that the demand for pharmaceutical products (medication) is not influenced by the evolution of prices. After 1990, foreign manufacturers have become interested in the increasing potential of Romania, a country of 22 million inhabitants with a very low intake of drugs per person, due to the low living standard. They have penetrated the market through direct import companies, through license agreements, acquisitions and privatizations.
Romanian manufacturers have tried to shift their direction towards export, but the barrier represented by the Good Manufacturing Practice (GMP – for production) and ISO 9001:2000 standards (for distribution) has stopped their penetration of new markets. Their exports mainly targeted Russia, Moldova and former socialist countries. Without norms of this kind, also known as standards, today’s international trade would be inconceivable because every product would have to be checked in keeping with individual criteria. Norms, therefore, create comparability.
Nowadays, the external market has, for several companies, the same importance as the domestic one. The conquest of external market is essential because it brings currency, improves commercial balance, creates new working places and promotes the managerial or technological know-how transfer.
ISO 9000 is a generic name given to a family of standards developed to provide a framework around which a quality management system can be effectively implemented. These standards were developed mainly to facilitate commercial relationships and to increase the confidence of consumers in the capability of a supplier to constantly satisfy the requirements of products and services quality.
The paper presents some advantages achieved by implementation of Quality Management System in pharmaceutical industry, namely S.C. X Company S.A from Tirgu-Mures, one of the most important producer and distributor of pharmaceutical products in Romania.
Using a proven management system combined with ongoing external validation, enables the X Company to continually renew its strategies, domestic and external operations and service level. To this respect, the paper presents the main steps in implementing the Quality Management System within this organisation and some benefits of the registration such as increasing domestic sales, but most off all, the penetration and increasing sales on external markets.
The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines related to quality management systems and related supporting standards.
ISO 9001:2000 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified – although certification is not a compulsory requirement of the standard.
The other standards in the family cover specific aspects such as fundamentals and vocabulary, performance improvements, documentation, training, and financial and economic aspects. Implementing a Quality Management System within an organisation needs to be a decision of top management. The objective of the quality system needs to be clearly defined so that the system can be effective. The design and implementation of quality management system will vary depending on the type, size and products of the organisation and should be used in conjunction with the ISO 9000:2000 standards. Implementing a Quality Management System is not that difficult as it seems, the key is planning and commitment. How complex or simple the QMS is depends entirely on the organisation and what the objectives are. It can be a simple guide to the organisation policy and procedures, or it can document every task and procedure. It really depends on how much risk is involved and how much control is required.
The documentation of QMS involves:
1. The policy to refer to quality, the objectives of quality and the book of quality (Quality Management System)
2. Management Responsibility
3. Resource Management
4. Product Realisation
5. Measurements, Analysis and Improvement
A well managed quality system will have impact on:
1. customer loyalty and repeat business
2. market share
3. operational efficiencies
4. flexibility and ability to respond to market opportunities
5. effective and efficient use of resources
6. cost reductions
7. competitive advantages
Thursday, September 17, 2009
ISO 14001 Standards - Contents
ISO 14001 Standards - Contents
ISO 14000 is a series of international standards on environmental management. It provides a framework for the development of an environmental management system and the supporting audit programme.
The main thrust for its development came as a result of the Rio Summit on the Environment held in 1992.
ISO 14000 is an Environmental Management System (EMS), which requires that an organization consider the environmental aspects of its products and services.
Iso14000 approach forces you to take a hard look at all areas of your business that has an environmental impact.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
ISO 14000 is an Environmental Management System (EMS) who’s purpose is:
· A management commitment to pollution prevention.
· An understanding of the environmental impacts (reducing) of an organization’s activities.
A commitment (pollution prevention) to employees, neighbors and customers
ISO 14001 is the corner stone standard of the ISO 14000 series. It specifies a framework of control for an Environmental Management System against which an organization can be certified by a third party.
The environment cannot be protected by our convictions or goodwill alone. Efforts to protect the environment must be planned, coordinated and organized into a system, such as ISO 14001.
ISO14001 requires an Environmental Policy to be in existence within the organisation, fully supported by senior management, and outlining the policies of the company, not only to the staff but to the public. The policy needs to clarify compliance with Environmental Legislation that may effect the organization and stress a commitment to continuous improvement. Emphasis has been placed on policy as this provides the direction for the remainder of the Management System.
Those companies who have witnessed ISO9000 Assessments will know that the policy is frequently discussed during the assessment, many staff are asked if they understand or are aware of the policy, and any problems associated with the policy are seldom serious. The Environmental Policy is different, this provides the initial foundation and direction for the Management System and will be more stringently reviewed than a similar ISO9000 policy. The statement must be publicised in non-technical language so that it can be understood by the majority of readers. It should relate to the sites within the organisation encompassed by the Management System, it should provide an overview of the company’s activities on the site and a description of those activities. A clear picture of the company’s operations.
The preparatory review and definition of the organization’s environmental effects is not part of a ISO14001 Assessment, however examination of this data will provide an external audit with a wealth of information on the methods adopted by the company. The preparatory review itself should be comprehensive in consideration of input processes and output at the site. This review should be designed to identify all relevant environmental aspects that may arise from existence on the site. These may relate to current operations, they may relate to future, perhaps even unplanned future activities, and they will certainly relate to the activities performed on site in the past (i.e. contamination of land).
The initial or preparatory review will also include a wide-ranging consideration of the legislation which may effect the site, whether it is currently being complied with, and perhaps even whether copies of the legislation are available. Many of the environmental assessments undertaken already have highlighted that companies are often unaware of ALL of the legislation that affects them, and being unaware, are often not meeting the requirements of that legislation.
The company will declare its primary environmental objectives, those that can have most environmental impact. In order to gain most benefit these will become the primary areas of consideration within the improvement process, and the company’s environmental program. The program will be the plan to achieve specific goals or targets along the route to a specific goal and describe the means to reach those objectives such that they are real and achievable. The Environmental Management System provides further detail on the environmental program. The EMS establishes procedures, work instructions and controls to ensure that implementation of the policy and achievement of the targets can become a reality. Communication is a vital factor, enabling people in the organisation to be aware of their responsibilities, aware of the objectives of the scheme, and able to contribute to its success.
As with ISO9000 the Environmental Management System requires a planned comprehensive periodic audit of the Environmental Management System to ensure that it is effective in operation, is meeting specified goals, and the system continues to perform in accordance with relevant regulations and standards. The audits are designed to provide additional information in order to exercise effective management of the system, providing information on practices which differ to the current procedures or offer an opportunity for improvement.
In addition to audit, there is a requirement for Management Review of the system to ensure that it is suitable (for the organization and the objectives) and effective in operation. The management review is the ideal forum to make decisions on howe to improve for the future.
The newly revised ISO 14001:2004 specifies the requirements for an environmental management system (EMS), which provides a framework for an organization to control the environmental impacts of its activities, products and services, and to continually improve its environmental performance. It applies to those environmental aspects which the organization can control and over which it can be expected to have an influence. It does not itself state specific environmental performance criteria. ISO 14001:2004 is applicable to any organization that wishes to:
· implement, maintain and improve an environmental management system
· assure itself of its conformance with its stated environmental policy
· demonstrate such conformance to others
· seek certification/registration of its environmental management system by an external organization
· make a self-determination and self-declaration of conformance with this international standard.
All the requirements in this standard can be incorporated into any environmental management system. Having been revised, the improved ISO 14001 is now expected to bring the benefits of implementing an EMS to more businesses than ever. The standard is now easier to understand and use and has more detailed checklists for inputs and outputs from the management review and has increased compatibility to ISO 9001. Organizations who are currently registered to ISO 14001:1996 will have an 18-month transition period to register to ISO 14001:2004.
ISO 14000 is a series of international standards on environmental management. It provides a framework for the development of an environmental management system and the supporting audit programme.
The main thrust for its development came as a result of the Rio Summit on the Environment held in 1992.
ISO 14000 is an Environmental Management System (EMS), which requires that an organization consider the environmental aspects of its products and services.
Iso14000 approach forces you to take a hard look at all areas of your business that has an environmental impact.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
ISO 14000 is an Environmental Management System (EMS) who’s purpose is:
· A management commitment to pollution prevention.
· An understanding of the environmental impacts (reducing) of an organization’s activities.
A commitment (pollution prevention) to employees, neighbors and customers
ISO 14001 is the corner stone standard of the ISO 14000 series. It specifies a framework of control for an Environmental Management System against which an organization can be certified by a third party.
The environment cannot be protected by our convictions or goodwill alone. Efforts to protect the environment must be planned, coordinated and organized into a system, such as ISO 14001.
ISO14001 requires an Environmental Policy to be in existence within the organisation, fully supported by senior management, and outlining the policies of the company, not only to the staff but to the public. The policy needs to clarify compliance with Environmental Legislation that may effect the organization and stress a commitment to continuous improvement. Emphasis has been placed on policy as this provides the direction for the remainder of the Management System.
Those companies who have witnessed ISO9000 Assessments will know that the policy is frequently discussed during the assessment, many staff are asked if they understand or are aware of the policy, and any problems associated with the policy are seldom serious. The Environmental Policy is different, this provides the initial foundation and direction for the Management System and will be more stringently reviewed than a similar ISO9000 policy. The statement must be publicised in non-technical language so that it can be understood by the majority of readers. It should relate to the sites within the organisation encompassed by the Management System, it should provide an overview of the company’s activities on the site and a description of those activities. A clear picture of the company’s operations.
The preparatory review and definition of the organization’s environmental effects is not part of a ISO14001 Assessment, however examination of this data will provide an external audit with a wealth of information on the methods adopted by the company. The preparatory review itself should be comprehensive in consideration of input processes and output at the site. This review should be designed to identify all relevant environmental aspects that may arise from existence on the site. These may relate to current operations, they may relate to future, perhaps even unplanned future activities, and they will certainly relate to the activities performed on site in the past (i.e. contamination of land).
The initial or preparatory review will also include a wide-ranging consideration of the legislation which may effect the site, whether it is currently being complied with, and perhaps even whether copies of the legislation are available. Many of the environmental assessments undertaken already have highlighted that companies are often unaware of ALL of the legislation that affects them, and being unaware, are often not meeting the requirements of that legislation.
The company will declare its primary environmental objectives, those that can have most environmental impact. In order to gain most benefit these will become the primary areas of consideration within the improvement process, and the company’s environmental program. The program will be the plan to achieve specific goals or targets along the route to a specific goal and describe the means to reach those objectives such that they are real and achievable. The Environmental Management System provides further detail on the environmental program. The EMS establishes procedures, work instructions and controls to ensure that implementation of the policy and achievement of the targets can become a reality. Communication is a vital factor, enabling people in the organisation to be aware of their responsibilities, aware of the objectives of the scheme, and able to contribute to its success.
As with ISO9000 the Environmental Management System requires a planned comprehensive periodic audit of the Environmental Management System to ensure that it is effective in operation, is meeting specified goals, and the system continues to perform in accordance with relevant regulations and standards. The audits are designed to provide additional information in order to exercise effective management of the system, providing information on practices which differ to the current procedures or offer an opportunity for improvement.
In addition to audit, there is a requirement for Management Review of the system to ensure that it is suitable (for the organization and the objectives) and effective in operation. The management review is the ideal forum to make decisions on howe to improve for the future.
The newly revised ISO 14001:2004 specifies the requirements for an environmental management system (EMS), which provides a framework for an organization to control the environmental impacts of its activities, products and services, and to continually improve its environmental performance. It applies to those environmental aspects which the organization can control and over which it can be expected to have an influence. It does not itself state specific environmental performance criteria. ISO 14001:2004 is applicable to any organization that wishes to:
· implement, maintain and improve an environmental management system
· assure itself of its conformance with its stated environmental policy
· demonstrate such conformance to others
· seek certification/registration of its environmental management system by an external organization
· make a self-determination and self-declaration of conformance with this international standard.
All the requirements in this standard can be incorporated into any environmental management system. Having been revised, the improved ISO 14001 is now expected to bring the benefits of implementing an EMS to more businesses than ever. The standard is now easier to understand and use and has more detailed checklists for inputs and outputs from the management review and has increased compatibility to ISO 9001. Organizations who are currently registered to ISO 14001:1996 will have an 18-month transition period to register to ISO 14001:2004.
Implementing A Quality Management System
Implementing A Quality Management System
An ISO 9000:2008 quality management system can be implemented by following the steps detailed as follows:
1. Evaluate the organization’s need/goals for implementing a QMS Need may arise from repeated customer complaints; frequent warranty returns; delayed deliveries; high inventories; frequent production hold-ups; and high level of rework or rejection of products or services.
At this stage, identify the goals which you would like to achieve through a QMS, such as customer satisfaction, increased market share, improved communications and morale in the organization, greater efficiency and profitability, etc. Another objective in implementing a QMS may be a demonstration of compliance through third party certification, which may be requested by an important client or required for enlisting as a supplier to large companies, e.g., original equipment manufacturers (OEMs).
2. Obtain information about the ISO 9000 family
The persons identified for initiating the development of an ISO 9000 QMS need tounderstand the requirements of ISO 9001:2008 as read with ISO 9000:2000 and ISO 9001:2008.
Supporting information such as quality management principles, frequently asked questions (FAQs), guidance on clause 1.2 (application) of ISO 9001:2008, guidance on documentation requirements of ISO 9001:2008 and other brochures are available free of charge on the ISO web site;
3. Appoint a consultant, if necessary
If, within the organization, you do not have adequate competence to develop a QMS, you may appoint a consultant. Before doing so, it is good to check his/her background; knowledge about the product realization processes of your organization; and experience in helping other organizations to achieve their stated goals, including certification.
Carry out a cost-benefit analysis of hiring a consultant and agree the scope of his/her work in writing. It is also possible to appoint a consultant only for the training of key staff; the latter can then carry out further training and development of the system.
4. Awareness and training
Raise awareness about QMS requirements amongst all personnel performing activities that affect quality. Plan for and provide specific training on how to develop Quality Manuals; on procedures; on QMS planning; on how to identify and implement improvement processes; and on how to audit compliance with the QMS, etc.
The Institute of Quality Assurance (IQA), the American Society for Quality (ASQ)and the International Auditor and Training Certification Association (IATCA) can provide lists of training organizations.
5. Gap analysis
Evaluate gaps between your existing quality management system and the QMS requirements of ISO 9001. Prepare how to bridge these gaps, including by planning for any additional resources required. Gap analysis may be carried out through selfassessment or by the external consultant.
6. Product realization processes
Review clause 7 of ISO 9001:2008 relating to “Product realization” to determine how the requirements apply or do not apply to your company’s QMS.
The processes covered by this clause include:
• Customer-related processes
• Design and development
• Purchasing
• Production and service provision
• Control of measuring and monitoring devices
Note that if your company is not responsible for preparing the design of your product, you can exclude the requirement for “design and development” from your QMS and explain the reasons for doing so in your Quality Manual.
7. Staffing
Decide on the responsibilities of the persons who will be involved in developing and documenting the QMS, including the appointment of a management representative who will oversee the implementation of the QMS. Establishing a project Steering Committee may also prove useful to oversee progress and provide resources wherever required.
8. Planning a time frame
Prepare a complete plan to close the gaps identified in Step 5 to develop the QMS processes. In the plan, include activities to be performed, resources required, responsibilities and an estimated completion time for each activity. Clauses 4.1 and
7.1 of ISO 9001:2008 provide information that should be used when developing the plan. The total time required for each phase (planning, documentation, implementation and evaluation) depends on the extent of the gaps in your existing QMS.
9. Draft a Quality Manual
In your Quality Manual;
• Include how the QMS applies to the products, processes, locations and departments of the organization;
• Exclude any requirement with justification for doing so as decided in step 6
above;
• Refer to or include documented procedures for QMS;
• Describe the interaction between the processes of the QMS, e.g., the interaction between product realization processes and other management, measurement and improvement processes; and
• Draft the quality policy and quality objectives for the organization.
The staff concerned in the organization should review the Quality Manual and the documented procedures so that their comments and suggestions can be taken into account before the Quality Manual and procedures are approved for issue and use.
The effective date of implementation should also be decided.
10. Carry out internal audits
During the phase of implementation of some three to six months after the documentation has been written, the trained auditors should carry out one or two internal audits covering all activities for the QMS, and concerned management should take corrective action on the audit findings without delay. Wherever required, revise the manuals, procedures and objectives. After each internal audit, the top management should review the effectiveness of the system and provide necessary resources for corrective actions and improvements.
11. Apply for certification
On satisfactory completion of Step 10, and if your company decides to obtain third party certification, you can make an application for certification to an accredited certification body. The certification audit process is explained section VII.
12. Conduct periodic evaluations
After certification, the organization should periodically conduct internal audits to review the effectiveness of the QMS and see how it can be “continually improved”. The organization should evaluate periodically if the purpose and goals (see Step 1) for which the QMS was developed are being achieved, including its continual improvement.
An ISO 9000:2008 quality management system can be implemented by following the steps detailed as follows:
1. Evaluate the organization’s need/goals for implementing a QMS Need may arise from repeated customer complaints; frequent warranty returns; delayed deliveries; high inventories; frequent production hold-ups; and high level of rework or rejection of products or services.
At this stage, identify the goals which you would like to achieve through a QMS, such as customer satisfaction, increased market share, improved communications and morale in the organization, greater efficiency and profitability, etc. Another objective in implementing a QMS may be a demonstration of compliance through third party certification, which may be requested by an important client or required for enlisting as a supplier to large companies, e.g., original equipment manufacturers (OEMs).
2. Obtain information about the ISO 9000 family
The persons identified for initiating the development of an ISO 9000 QMS need tounderstand the requirements of ISO 9001:2008 as read with ISO 9000:2000 and ISO 9001:2008.
Supporting information such as quality management principles, frequently asked questions (FAQs), guidance on clause 1.2 (application) of ISO 9001:2008, guidance on documentation requirements of ISO 9001:2008 and other brochures are available free of charge on the ISO web site;
3. Appoint a consultant, if necessary
If, within the organization, you do not have adequate competence to develop a QMS, you may appoint a consultant. Before doing so, it is good to check his/her background; knowledge about the product realization processes of your organization; and experience in helping other organizations to achieve their stated goals, including certification.
Carry out a cost-benefit analysis of hiring a consultant and agree the scope of his/her work in writing. It is also possible to appoint a consultant only for the training of key staff; the latter can then carry out further training and development of the system.
4. Awareness and training
Raise awareness about QMS requirements amongst all personnel performing activities that affect quality. Plan for and provide specific training on how to develop Quality Manuals; on procedures; on QMS planning; on how to identify and implement improvement processes; and on how to audit compliance with the QMS, etc.
The Institute of Quality Assurance (IQA), the American Society for Quality (ASQ)and the International Auditor and Training Certification Association (IATCA) can provide lists of training organizations.
5. Gap analysis
Evaluate gaps between your existing quality management system and the QMS requirements of ISO 9001. Prepare how to bridge these gaps, including by planning for any additional resources required. Gap analysis may be carried out through selfassessment or by the external consultant.
6. Product realization processes
Review clause 7 of ISO 9001:2008 relating to “Product realization” to determine how the requirements apply or do not apply to your company’s QMS.
The processes covered by this clause include:
• Customer-related processes
• Design and development
• Purchasing
• Production and service provision
• Control of measuring and monitoring devices
Note that if your company is not responsible for preparing the design of your product, you can exclude the requirement for “design and development” from your QMS and explain the reasons for doing so in your Quality Manual.
7. Staffing
Decide on the responsibilities of the persons who will be involved in developing and documenting the QMS, including the appointment of a management representative who will oversee the implementation of the QMS. Establishing a project Steering Committee may also prove useful to oversee progress and provide resources wherever required.
8. Planning a time frame
Prepare a complete plan to close the gaps identified in Step 5 to develop the QMS processes. In the plan, include activities to be performed, resources required, responsibilities and an estimated completion time for each activity. Clauses 4.1 and
7.1 of ISO 9001:2008 provide information that should be used when developing the plan. The total time required for each phase (planning, documentation, implementation and evaluation) depends on the extent of the gaps in your existing QMS.
9. Draft a Quality Manual
In your Quality Manual;
• Include how the QMS applies to the products, processes, locations and departments of the organization;
• Exclude any requirement with justification for doing so as decided in step 6
above;
• Refer to or include documented procedures for QMS;
• Describe the interaction between the processes of the QMS, e.g., the interaction between product realization processes and other management, measurement and improvement processes; and
• Draft the quality policy and quality objectives for the organization.
The staff concerned in the organization should review the Quality Manual and the documented procedures so that their comments and suggestions can be taken into account before the Quality Manual and procedures are approved for issue and use.
The effective date of implementation should also be decided.
10. Carry out internal audits
During the phase of implementation of some three to six months after the documentation has been written, the trained auditors should carry out one or two internal audits covering all activities for the QMS, and concerned management should take corrective action on the audit findings without delay. Wherever required, revise the manuals, procedures and objectives. After each internal audit, the top management should review the effectiveness of the system and provide necessary resources for corrective actions and improvements.
11. Apply for certification
On satisfactory completion of Step 10, and if your company decides to obtain third party certification, you can make an application for certification to an accredited certification body. The certification audit process is explained section VII.
12. Conduct periodic evaluations
After certification, the organization should periodically conduct internal audits to review the effectiveness of the QMS and see how it can be “continually improved”. The organization should evaluate periodically if the purpose and goals (see Step 1) for which the QMS was developed are being achieved, including its continual improvement.
Saturday, September 12, 2009
Business benefits of ISO 14000
Business Benefits Of ISO 14001
Any manager will try to avoid pollution that could cost the company a fine for infringing environmental legislation. But better managers will agree that doing only just enough to keep the company out of trouble with government inspectors is a rather weak and reactive approach to business in today’s increasingly environment-conscious world.
There is a better way. The ISO 14000 way. The ISO 14000 standards are practical tools for the manager who is not satisfied with mere compliance with legislation – which may be perceived as a cost of doing business. They’re for the proactive manager with the breadth of vision to understand that implementing a strategic approach can bring return on investment in environmentrelated measures. Implementing an ISO 14000-basedenvironmental management system, and using other tools from the ISO 14000 family, will give you far more than just confidence that you are complying with legislation.
The ISO 14000 approach forces you to take a hard look at all areas where your business has an environmental impact. And this systematic approach can lead to benefits like the following:
a. Reduced cost of waste managementb. Savings in consumption of energy and materialsc. Lower distribution costsd. Improved corporate image among regulators, customers and the publice. Framework for continuous improvement of your environmental performance.
The manager who is “too busy managing the business” to listen to good senseabout environmental management could actually be costing the business plenty. Just think, for example, of the lost opportunities for achieving benefits like those above.
The ISO 14000 standards are management tools that will help your businessachieve environmental goals that go way beyond acquiring a mere “green sheen”.
Any manager will try to avoid pollution that could cost the company a fine for infringing environmental legislation. But better managers will agree that doing only just enough to keep the company out of trouble with government inspectors is a rather weak and reactive approach to business in today’s increasingly environment-conscious world.
There is a better way. The ISO 14000 way. The ISO 14000 standards are practical tools for the manager who is not satisfied with mere compliance with legislation – which may be perceived as a cost of doing business. They’re for the proactive manager with the breadth of vision to understand that implementing a strategic approach can bring return on investment in environmentrelated measures. Implementing an ISO 14000-basedenvironmental management system, and using other tools from the ISO 14000 family, will give you far more than just confidence that you are complying with legislation.
The ISO 14000 approach forces you to take a hard look at all areas where your business has an environmental impact. And this systematic approach can lead to benefits like the following:
a. Reduced cost of waste managementb. Savings in consumption of energy and materialsc. Lower distribution costsd. Improved corporate image among regulators, customers and the publice. Framework for continuous improvement of your environmental performance.
The manager who is “too busy managing the business” to listen to good senseabout environmental management could actually be costing the business plenty. Just think, for example, of the lost opportunities for achieving benefits like those above.
The ISO 14000 standards are management tools that will help your businessachieve environmental goals that go way beyond acquiring a mere “green sheen”.
Requirements for Product Environmental Quality Assurance
All Mandatory Requirements for Product Environmental Quality Assurance need to be carried out in the following manner1. Establish a system that meets all requirements2. Ensure the system is stable and efficient.3. Document the processes and procedures4. Keep records of the system’s performance.
The assigned management of the supplier shall establish a system to prevent BannedSubstances from being used in the products and packaging.(1) To determine policies and methods for ensuring Product Environment Quality.(2) To assign a person to be in charge of managing Product Environment Quality(“Product Environmental Quality Management Representative”)(3) To establish an organization in managing Product Environment Quality,determine responsibilities, authorities, roles of each department and familiarize allmembers in each department with the importance of Product Environment Quality.(4) To establish a “Cadmium-Free Factory”(5) To review the adequacy and efficiency of the system.
Maintenance of the SystemThe supplier shall maintain the system in a condition to be able to respond to therequests for Product Environment Quality and instruction letters to suppliers),ensure the system is properly functioning.(1) Plan and carry out an internal audit at least once a year.(2) When Non-conforming Products or defects are found in the system, the suppliershall conduct an internal audit immediately.(3) The assigned management for Product Environment Products at the suppliershall revise the system according to the results of the internal audit if necessary.
Documents, Data and RecordsThe supplier should manage documents, verification data related to ProductEnvironment Quality.(1) Keep documents, verification data for three years or longer, if required by law.(2) Provide documents and verification data when requested.(3) Review the documents regularly and keep them updated instructions
Selection of Materials and PartsThe supplier has to comply with the following request when selecting material and parts.(1) “No Use of Banned Substances Allowed” (or equal) must be mentioned in allrelevant documents (specifications, blueprints, purchase orders, etc)(2) Materials must not contain any Banned Substances.(3) Only purchase Designated Raw Materials from Green Partners.
The assigned management of the supplier shall establish a system to prevent BannedSubstances from being used in the products and packaging.(1) To determine policies and methods for ensuring Product Environment Quality.(2) To assign a person to be in charge of managing Product Environment Quality(“Product Environmental Quality Management Representative”)(3) To establish an organization in managing Product Environment Quality,determine responsibilities, authorities, roles of each department and familiarize allmembers in each department with the importance of Product Environment Quality.(4) To establish a “Cadmium-Free Factory”(5) To review the adequacy and efficiency of the system.
Maintenance of the SystemThe supplier shall maintain the system in a condition to be able to respond to therequests for Product Environment Quality and instruction letters to suppliers),ensure the system is properly functioning.(1) Plan and carry out an internal audit at least once a year.(2) When Non-conforming Products or defects are found in the system, the suppliershall conduct an internal audit immediately.(3) The assigned management for Product Environment Products at the suppliershall revise the system according to the results of the internal audit if necessary.
Documents, Data and RecordsThe supplier should manage documents, verification data related to ProductEnvironment Quality.(1) Keep documents, verification data for three years or longer, if required by law.(2) Provide documents and verification data when requested.(3) Review the documents regularly and keep them updated instructions
Selection of Materials and PartsThe supplier has to comply with the following request when selecting material and parts.(1) “No Use of Banned Substances Allowed” (or equal) must be mentioned in allrelevant documents (specifications, blueprints, purchase orders, etc)(2) Materials must not contain any Banned Substances.(3) Only purchase Designated Raw Materials from Green Partners.
ISO 9000 Standards
ISO 9000 Standards
ISO 9000 is a written set of rules (a “Standard”) published by an internationalstandards writing body (International Organization for Standardization. The rules define practices that are universally recognized and accepted for assuring that organizations consistently understand and meet the needs of their customers.ISO 9000 is also highly generic. Its principles can be applied to any organization providing any product or service anywhere in the world.Since meeting customer needs is one of the (many) definitions of quality, ISO 9000 is often called a quality system or a quality management system. But the rules, referred to as requirements, go beyond quality matters as they are traditionally understood. The requirements fall roughly into the following types:
a. Requirements that help assure that the organization’s output (whether product, service, or both) meets customer specifications. (Making, and keeping, them happy.)
b. Requirements that assure that the quality system is consistently implemented and verifiable. (We must actually do what we say we are supposed to do. This must be verifiable via independent, objectiveaudit.)
c. Requirements for practices that measure the effectiveness of variousaspects of the system. (In God we trust; all others bring data.)
d. Requirements that support continuous improvement of the company’sability to meet customer needs. (We cannot sit still. We must strive to get better all the time, because customers change, and competitors gain strength.)
Nothing in ISO 9000 is new. The first edition, published by ISO in 1987, was drawn almost word for word from a British quality system standard. It in turn evolved from a long succession of written quality system specifications that had their ultimate origin in the defense and arms industries. Most of the practices required by ISO 9000 have been in use in industries of various kinds for decades. One intent of ISO 9000 is to simplify things for organizations. ISO 9000 strives to harmonize the sometimes conflicting, sometimes redundant quality programs that have traditionally been imposed by major corporations on their suppliers. (Note, however, that ISO 9000 is not meant to supersede customer, legal, or regulatory requirements.)
Very often, major customers require or strongly “suggest” that their suppliers implement ISO 9000 systems. Equally often, such customers require independent verification that suppliers are meeting the equirements.
So third-party registration bodies audit suppliers, confirm compliance to the ISO 9000 standard, and register the suppliers. It does not stop there. To stay registered, suppliers must undergo periodic (often semi-annual) surveillance audits, also carried out by their registration body.
Implementing an ISO 9000 quality system is neither cheap, nor easy. How costly and difficult it can be depends on:
a. The level of commitment of senior management. (The single most important factor.)
b. Where you are when you start. If you have already implemented a disciplined, documented quality system, you will have a less difficult time migrating to ISO 9000. (But that does not mean you will waltz to registration, either.)
c. Whether your company (or any part of it) is “design responsible” or not.
d. How much time you have. If you are under the customer’s gun and have merely months to get the job done, the process will be highly stressful.
e. The physical size and configuration of your company.
The bottom line is this. ISO 9000 is a comprehensive set of rules—a business system, really—that can cause the way your organization runs to profoundly change, almost always for the better. Yet, because it is often customer-mandated, many suppliers regard ISO 9000 as “just another hoop to jump through to keep our customers happy.”
They see their choice as swallow hard, pony up, and jump through the hoops; or walk away from the customer. What many do not fully appreciate is that implementing ISO 9000—expensive, exhausting, and annoying as it can be—can also have the salutary effect of improving the performance of your organization. Not just at first, but on an ongoing basis.
ISO 9000 is a written set of rules (a “Standard”) published by an internationalstandards writing body (International Organization for Standardization. The rules define practices that are universally recognized and accepted for assuring that organizations consistently understand and meet the needs of their customers.ISO 9000 is also highly generic. Its principles can be applied to any organization providing any product or service anywhere in the world.Since meeting customer needs is one of the (many) definitions of quality, ISO 9000 is often called a quality system or a quality management system. But the rules, referred to as requirements, go beyond quality matters as they are traditionally understood. The requirements fall roughly into the following types:
a. Requirements that help assure that the organization’s output (whether product, service, or both) meets customer specifications. (Making, and keeping, them happy.)
b. Requirements that assure that the quality system is consistently implemented and verifiable. (We must actually do what we say we are supposed to do. This must be verifiable via independent, objectiveaudit.)
c. Requirements for practices that measure the effectiveness of variousaspects of the system. (In God we trust; all others bring data.)
d. Requirements that support continuous improvement of the company’sability to meet customer needs. (We cannot sit still. We must strive to get better all the time, because customers change, and competitors gain strength.)
Nothing in ISO 9000 is new. The first edition, published by ISO in 1987, was drawn almost word for word from a British quality system standard. It in turn evolved from a long succession of written quality system specifications that had their ultimate origin in the defense and arms industries. Most of the practices required by ISO 9000 have been in use in industries of various kinds for decades. One intent of ISO 9000 is to simplify things for organizations. ISO 9000 strives to harmonize the sometimes conflicting, sometimes redundant quality programs that have traditionally been imposed by major corporations on their suppliers. (Note, however, that ISO 9000 is not meant to supersede customer, legal, or regulatory requirements.)
Very often, major customers require or strongly “suggest” that their suppliers implement ISO 9000 systems. Equally often, such customers require independent verification that suppliers are meeting the equirements.
So third-party registration bodies audit suppliers, confirm compliance to the ISO 9000 standard, and register the suppliers. It does not stop there. To stay registered, suppliers must undergo periodic (often semi-annual) surveillance audits, also carried out by their registration body.
Implementing an ISO 9000 quality system is neither cheap, nor easy. How costly and difficult it can be depends on:
a. The level of commitment of senior management. (The single most important factor.)
b. Where you are when you start. If you have already implemented a disciplined, documented quality system, you will have a less difficult time migrating to ISO 9000. (But that does not mean you will waltz to registration, either.)
c. Whether your company (or any part of it) is “design responsible” or not.
d. How much time you have. If you are under the customer’s gun and have merely months to get the job done, the process will be highly stressful.
e. The physical size and configuration of your company.
The bottom line is this. ISO 9000 is a comprehensive set of rules—a business system, really—that can cause the way your organization runs to profoundly change, almost always for the better. Yet, because it is often customer-mandated, many suppliers regard ISO 9000 as “just another hoop to jump through to keep our customers happy.”
They see their choice as swallow hard, pony up, and jump through the hoops; or walk away from the customer. What many do not fully appreciate is that implementing ISO 9000—expensive, exhausting, and annoying as it can be—can also have the salutary effect of improving the performance of your organization. Not just at first, but on an ongoing basis.
Goal and Scope of an ISO 9000 quality system
Goal and Scope of an ISO 9000 quality system
The ISO 9000 Standard states its goal in two blunt words: customer satisfaction.How do we achieve customer satisfaction? By meeting customer requirements.The quality management system (QMS) helps us to dothis by:
a. Applying the system. Actually using it. Putting it at the heart ofour organization.b. Continually improving the system. The QMS is never done. Afterall, customer requirements do not stand still—they evolve and grow tougher.So we have to improve continually in order to survive.
(The guidance document, ISO 9004: 2000, sets a compatibleand in some respects more ambitious goal: “improving theprocesses of an organization to enhance performance.”) Prevention of nonconformity. Prevention is the key term here: prevention,rather than detection. Quality management has longsince evolved away from the old “inspect quality in” approach.Prevention is cheaper, more effective, and more protective of thecustomer. Detection is also a different mindset. It requires a veryhigh degree of process orientation, upstream thinking, and relentlessanalysis.To what types of organizations does the Standard apply? Alltypes. The requirements “are generic and applicable to all organizations,regardless of type and size.” A compliant QMS can be implementedby any organization, producing any product or service,anywhere in the world.Within the organization, the impact of the requirements and theQMS are similarly broad. The Standard “applies to the activities of organizationsfrom the identification of customer requirements, throughall quality management system processes, to the achievement of customersatisfaction.” Every activity within the organization that impactsthe process of creating customer satisfaction is affected by therequirements of the Standard.
The ISO 9000 Standard states its goal in two blunt words: customer satisfaction.How do we achieve customer satisfaction? By meeting customer requirements.The quality management system (QMS) helps us to dothis by:
a. Applying the system. Actually using it. Putting it at the heart ofour organization.b. Continually improving the system. The QMS is never done. Afterall, customer requirements do not stand still—they evolve and grow tougher.So we have to improve continually in order to survive.
(The guidance document, ISO 9004: 2000, sets a compatibleand in some respects more ambitious goal: “improving theprocesses of an organization to enhance performance.”) Prevention of nonconformity. Prevention is the key term here: prevention,rather than detection. Quality management has longsince evolved away from the old “inspect quality in” approach.Prevention is cheaper, more effective, and more protective of thecustomer. Detection is also a different mindset. It requires a veryhigh degree of process orientation, upstream thinking, and relentlessanalysis.To what types of organizations does the Standard apply? Alltypes. The requirements “are generic and applicable to all organizations,regardless of type and size.” A compliant QMS can be implementedby any organization, producing any product or service,anywhere in the world.Within the organization, the impact of the requirements and theQMS are similarly broad. The Standard “applies to the activities of organizationsfrom the identification of customer requirements, throughall quality management system processes, to the achievement of customersatisfaction.” Every activity within the organization that impactsthe process of creating customer satisfaction is affected by therequirements of the Standard.
ISO 9000 registration or certification
ISO 9000 registration or certification
Registration is documented and objective evidence that an organization’squality system meets the requirements of ISO 9000.
Certification is a term often used interchangeably with registration.
In the context of ISO 9000, they mean the same thing. Registration isthe technically correct term for verification of compliance to standardsof quality systems. Certification usually applies to verification of thequality of products (as opposed to quality systems).
Registration is carried out by independent companies called registrars.These companies are:- Wholly independent.- Accredited by a recognized international accreditation body.- Selected, and paid, by you.
Registration can cover:- The sole location of a single-location organization.- Multiple locations of a multilocation organization.- Only certain parts of a multilocation organization (under certain conditions).- Separate locations under separate certificates. (This is a more costlyapproach.)The registration body audits your quality system against the requirementsof ISO 9000. It reports its findings in writing. These findings may (and usually do) include noncompliances (Question 96). Major noncompliances must be closed out prior to official registration.
When this has been done, the registration body:- Lists the organization’s name in its book of registered companies—in effect, registers the organization in its book.- Issues a certificate to the registered organization. This registrationincludes:— Identity of the organization.— Location(s) covered by the registration.— A list of products/services supplied by the registered locations.— Revision date of the Standard.— Registration effective dates.— Name and location of registrar.
Most registrars limit registrations to three years. After that, youmust renew your registration by undergoing another complete systemsaudit. Some registrars do not use the renewal approach. They simplykeep checking the system via surveillance audits.
Whichever the scheme, the organization, to keep registration, mustundergo a surveillance assessment every so often. Six months is the typicalinterval. Some registrars offer annual surveillance schemes (notrecommended except for firms with exceptionally well-implementedquality management systems). Surveillance assessments are scheduledevents (there is no such thing as a “surprise” surveillance audit). Onlypart of the quality system is checked at each surveillance. Usually, theregistrar does not disclose what part will be assessed until the day of theassessment, although some registrars will tell you everything up front.The entire quality system is usually checked via surveillance audits overthe course of three years.
There is no way to “fail” a surveillance assessment, just as there isno way to “fail” a registration audit—except by refusingto implement corrective action required by the registrar. Normally,registrars allow adequate time, but corrective actions must be done ina timely and agreed upon manner to keep registration.One final note: As mentioned, each registrar publishes a list ofthe firms it has registered to ISO 9000.
Registration is documented and objective evidence that an organization’squality system meets the requirements of ISO 9000.
Certification is a term often used interchangeably with registration.
In the context of ISO 9000, they mean the same thing. Registration isthe technically correct term for verification of compliance to standardsof quality systems. Certification usually applies to verification of thequality of products (as opposed to quality systems).
Registration is carried out by independent companies called registrars.These companies are:- Wholly independent.- Accredited by a recognized international accreditation body.- Selected, and paid, by you.
Registration can cover:- The sole location of a single-location organization.- Multiple locations of a multilocation organization.- Only certain parts of a multilocation organization (under certain conditions).- Separate locations under separate certificates. (This is a more costlyapproach.)The registration body audits your quality system against the requirementsof ISO 9000. It reports its findings in writing. These findings may (and usually do) include noncompliances (Question 96). Major noncompliances must be closed out prior to official registration.
When this has been done, the registration body:- Lists the organization’s name in its book of registered companies—in effect, registers the organization in its book.- Issues a certificate to the registered organization. This registrationincludes:— Identity of the organization.— Location(s) covered by the registration.— A list of products/services supplied by the registered locations.— Revision date of the Standard.— Registration effective dates.— Name and location of registrar.
Most registrars limit registrations to three years. After that, youmust renew your registration by undergoing another complete systemsaudit. Some registrars do not use the renewal approach. They simplykeep checking the system via surveillance audits.
Whichever the scheme, the organization, to keep registration, mustundergo a surveillance assessment every so often. Six months is the typicalinterval. Some registrars offer annual surveillance schemes (notrecommended except for firms with exceptionally well-implementedquality management systems). Surveillance assessments are scheduledevents (there is no such thing as a “surprise” surveillance audit). Onlypart of the quality system is checked at each surveillance. Usually, theregistrar does not disclose what part will be assessed until the day of theassessment, although some registrars will tell you everything up front.The entire quality system is usually checked via surveillance audits overthe course of three years.
There is no way to “fail” a surveillance assessment, just as there isno way to “fail” a registration audit—except by refusingto implement corrective action required by the registrar. Normally,registrars allow adequate time, but corrective actions must be done ina timely and agreed upon manner to keep registration.One final note: As mentioned, each registrar publishes a list ofthe firms it has registered to ISO 9000.
What is a quality systems registrar
What is a quality systems registrar
A registrar, or registration body (the preferred term), is sometimes called a certification body. (Accreditation bodies are entirely different—they are the entities that audit/approve registration bodies.)
There are some 573 registration bodies in operation worldwide, including52 in the United States.
The registrar is the organization that checks your quality system and confirms that it meets ISO 9000 requirements for a prescribed and agreed period of time.
To do this, the registrar:a. Audits your organization’s quality system to determine the degree of conformity to ISO 9000 standards. The audit is carried out:— On paper (desktop study).— On site (throughout your facility).b. Registers your quality system, assuming it conforms, to ISO 9000.c. Monitors conformity on an ongoing basis by means of regular reauditsand other methods.All quality system registrars perform these functions, with certainvariations. Registrars differ in two principal ways:a. Accreditation status.b. Scope of accreditation
Reputable ISO 9000 registrars are accredited by international accreditationbodies. These enforce a standard, EN 45012 (European Standard for Bodies Certificating Suppliers’ Quality Systems), that governs the processes that registrars follow. This standard is quite strict:a. Registrars must make their services available to all qualified supplierswithout imposing undue financial or other conditions, andmust administer their regulations in a nondiscriminatory manner.b. The registrar’s organization must not engage in activities that mayaffect its impartiality. For example:— It must not provide consulting services “on matters to whichits certificates are related” (i.e., quality systems). This requirementis superseded by the ISO 9000 restriction noted earlier.— It must not directly engage in commerce with firms that it hasassessed and/or registered.— Individuals involved in the registration process must not haveprovided consulting services to registration clients, or any relatedfirms, within the previous two years.— Its employees and agents must not engage in business activitiesthat would cause others to question the firm’s impartiality.— The registrar may not market consultancy and registrationservices together, and may not recommend consulting servicesto clients.— Auditors may not give advice as part of registration audits.— The registrar must provide the accreditation body with documentationof its employees’ qualifications.— The registrar must have appropriate facilities for carrying outits activities.— The registrar must have a quality manual and documentedprocedures. (Curiously, EN 45012 does not require that registrarsregister to ISO 9000!)— Registrars may not grant or renew certificates of registration until all major noncompliances are eliminated.
Another point of differentiation is scope of accreditation. All registrarsare not accredited, or approved, to register firms in any line of business. Each registrar is accredited to operate within the business or industrial sectors about which it has documented expertise. This is generically referred to as the registrar’s scope.
A registrar, or registration body (the preferred term), is sometimes called a certification body. (Accreditation bodies are entirely different—they are the entities that audit/approve registration bodies.)
There are some 573 registration bodies in operation worldwide, including52 in the United States.
The registrar is the organization that checks your quality system and confirms that it meets ISO 9000 requirements for a prescribed and agreed period of time.
To do this, the registrar:a. Audits your organization’s quality system to determine the degree of conformity to ISO 9000 standards. The audit is carried out:— On paper (desktop study).— On site (throughout your facility).b. Registers your quality system, assuming it conforms, to ISO 9000.c. Monitors conformity on an ongoing basis by means of regular reauditsand other methods.All quality system registrars perform these functions, with certainvariations. Registrars differ in two principal ways:a. Accreditation status.b. Scope of accreditation
Reputable ISO 9000 registrars are accredited by international accreditationbodies. These enforce a standard, EN 45012 (European Standard for Bodies Certificating Suppliers’ Quality Systems), that governs the processes that registrars follow. This standard is quite strict:a. Registrars must make their services available to all qualified supplierswithout imposing undue financial or other conditions, andmust administer their regulations in a nondiscriminatory manner.b. The registrar’s organization must not engage in activities that mayaffect its impartiality. For example:— It must not provide consulting services “on matters to whichits certificates are related” (i.e., quality systems). This requirementis superseded by the ISO 9000 restriction noted earlier.— It must not directly engage in commerce with firms that it hasassessed and/or registered.— Individuals involved in the registration process must not haveprovided consulting services to registration clients, or any relatedfirms, within the previous two years.— Its employees and agents must not engage in business activitiesthat would cause others to question the firm’s impartiality.— The registrar may not market consultancy and registrationservices together, and may not recommend consulting servicesto clients.— Auditors may not give advice as part of registration audits.— The registrar must provide the accreditation body with documentationof its employees’ qualifications.— The registrar must have appropriate facilities for carrying outits activities.— The registrar must have a quality manual and documentedprocedures. (Curiously, EN 45012 does not require that registrarsregister to ISO 9000!)— Registrars may not grant or renew certificates of registration until all major noncompliances are eliminated.
Another point of differentiation is scope of accreditation. All registrarsare not accredited, or approved, to register firms in any line of business. Each registrar is accredited to operate within the business or industrial sectors about which it has documented expertise. This is generically referred to as the registrar’s scope.
How long does it take to register to ISO 9000?
The time it takes to get ISO 9001 registered are varies. But it is talkingmonths here, not weeks. For one thing, you have to keep running yourbusiness. You cannot simply shut down while getting registered.The entire process can be broken down into the following generalphases:a. Implementing the ISO 9000 system.b. Operating it for the minimum time. (A minimum of three, andpreferably six, months before registration audit.)c. Selecting a registrar. This can be done during the registrationprocess, to save time.d. Interval between application and registration audit. This dependson the registrar’s backlog.
The time it takes to implement the ISO 9000 system depends in largepart on where you are when you start. If you already have any of thefollowing, implementation time should be relatively short:a. A documented quality system of any kind that is active, meaningful,but not necessarily compliant with any particular standard.b. Resources temporarily dedicated solely to implementing the system.c. The guidance of a good consultant
If you are starting from square one, implementation can take a longtime. (Unless you can shut down operations while implementing—butwho can do that?) Here are some other factors that can extend thetime it takes:a. Multiple locations.b. Head count.c. Whether or not you are design responsible.d. Corporate turmoil.e. Lack of ongoing, consistent, persistent top management commitment.This exhibits itself in a host of symptoms, including lack ofsufficient resources, other issues taking priority, vacillation, failureto pay attention, failure to learn and understand, and failureto lead.All that being said, experience has shown the following:a. On average, the shortest interval for the entire process—fromlaunch through registration audit—seems to be around 6 to 9months.b. At the other extreme, it’s been known to take 18 to 24 to 36months, even with significant resources and full managementcommitment.On average, for the typical organization (whatever that is), you arelooking at 10 to 18 months to get the job done.
The time it takes to implement the ISO 9000 system depends in largepart on where you are when you start. If you already have any of thefollowing, implementation time should be relatively short:a. A documented quality system of any kind that is active, meaningful,but not necessarily compliant with any particular standard.b. Resources temporarily dedicated solely to implementing the system.c. The guidance of a good consultant
If you are starting from square one, implementation can take a longtime. (Unless you can shut down operations while implementing—butwho can do that?) Here are some other factors that can extend thetime it takes:a. Multiple locations.b. Head count.c. Whether or not you are design responsible.d. Corporate turmoil.e. Lack of ongoing, consistent, persistent top management commitment.This exhibits itself in a host of symptoms, including lack ofsufficient resources, other issues taking priority, vacillation, failureto pay attention, failure to learn and understand, and failureto lead.All that being said, experience has shown the following:a. On average, the shortest interval for the entire process—fromlaunch through registration audit—seems to be around 6 to 9months.b. At the other extreme, it’s been known to take 18 to 24 to 36months, even with significant resources and full managementcommitment.On average, for the typical organization (whatever that is), you arelooking at 10 to 18 months to get the job done.
What does ISO 9000 offer?
What does ISO 9000 offer? For one thing, it offers you continuedbusiness with customers who may be requiring you to register. That isa pretty strong benefit right there.These customers may never question your quality, but these customersdepend heavily on their main suppliers. They know they canimprove their quality and through-put, if you improve yours. Just because you are great does not mean you are as great as you couldbe. ISO 9000 mandates a continuous improvement system. Youcan wriggle and fudge, but if you implement that system and workit conscientiously, you cannot help but improve. Continuous improvementis not just a buzz term. It is an imperative. Just because you are great today does not mean you will be great tomorrow.Has your industry changed? Has your organizationchanged? A well-implemented ISO 9000 helps your organizationadapt to change. It brings independence of individuals and consistencyof practices—two features that tend to resist declines inperformance.
What else does ISO 9000 bring you? When well implemented, anISO 9000 quality system improves organization performance. That is,after all, the whole point. In cases where it does not, the fault tendsnot to be in the ISO 9000 process (its inherent deficiencies notwithstanding).When an ISO 9000 system does not provide substantial benefits andimprovement in performance, it is usually because managementhas consciously chosen to cut corners, blowsmoke,stay uninvolved, and starve the system of all but the most essentialresources. “We’ll do this stupid thing, but we’re sure not goingto change the way we operate.”ISO 9000 registration brings you one more thing that your organizationmay not have today: International credibility. ISO 9000 is deployedand practiced in nearly 100 countries around the world. Intoday’s ever-growing international economic climate, this is not a bademblem to have, however narrow the scope of your market today.
What else does ISO 9000 bring you? When well implemented, anISO 9000 quality system improves organization performance. That is,after all, the whole point. In cases where it does not, the fault tendsnot to be in the ISO 9000 process (its inherent deficiencies notwithstanding).When an ISO 9000 system does not provide substantial benefits andimprovement in performance, it is usually because managementhas consciously chosen to cut corners, blowsmoke,stay uninvolved, and starve the system of all but the most essentialresources. “We’ll do this stupid thing, but we’re sure not goingto change the way we operate.”ISO 9000 registration brings you one more thing that your organizationmay not have today: International credibility. ISO 9000 is deployedand practiced in nearly 100 countries around the world. Intoday’s ever-growing international economic climate, this is not a bademblem to have, however narrow the scope of your market today.
Friday, September 11, 2009
ISO 9001 – Compatibility with other management systems
ISO 9001 Standards– Compatibility with other management systems
ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independently.
ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, for certification, or for contractual purposes. It focuses on the effectiveness of the quality
management system in meeting customer requirements.
ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organizations overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.
During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community.
This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial
management or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for
an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard.
ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independently.
ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, for certification, or for contractual purposes. It focuses on the effectiveness of the quality
management system in meeting customer requirements.
ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organizations overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.
During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community.
This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial
management or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for
an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard.
Wednesday, September 9, 2009
Tuesday, September 8, 2009
Five Steps to Implementing ISO 14001:2004
Five Steps to Implementing ISO 14001:2004
ISO 14001 provides a logical, common-sense approach for
businesses to adopt. To start it is recommended to carry out an
environmental review of the business and the Annex to the Standard
provides guidance on the approach required. The Standard then
requires a management system to be developed that addresses the
key environmental issues that were identified by the review as being
relevant to the business, through a rational programme of control and
continual improvement.
There are five key steps to ISO 14001 EMS implementation, and
subsequent operation which are clearly laid out in just three pages of
text.
The five key steps are:
1. Environmental Policy
2. Planning
3. Implementation and Operation
4. Checking and Corrective Action
5. Management Review
Step 1. Environmental Policy
The company or organisation must write an environmental policy
statement which is relevant to the business activities and approved by
top management. Their full commitment is essential if environmental
management is to work. The ISO 14001 Standard clearly sets out
what to cover in the policy. Often a one page document is sufficient.
Produce a first issue and expect to amend it several times before
assessment and registration as knowledge grows in the company.
Step 2. Planning
Plan what the EMS is to address.
Environmental aspects
First make lists of the environmental aspects (issues) that are relevant
to the business. The environmental review mentioned earlier should
provide most of this information and the Annex to ISO 14001 provides
guidance on the format for doing this.
Consider the inputs, outputs and processes/activities of the business in
relation to;
a) emissions to air
b) releases to water
c) waste management
d) contamination of land
e) use of raw materials and natural resources
f) other local environmental and community issues
Consider both site (direct) and offsite (ie. indirect) aspects that you
control or have influence over (such as suppliers) and in relation to
normal operations, shut-down and start-up conditions and reasonably
foreseeable and emergencies situations.
A simple written procedure is then required to determine which of the
aspects identified are really or probably significant (important) and
training needs, outline the key stages of the project and dates that will
lead to the target achievement).
Gradually apply environmental management programme thinking to
such things as the introduction of new products, new or improved
processes and other key activities of the business. In particular,
ensure existing projects become environmental management projects
where there is a significant environmental impact involved, so that the
EMS becomes company wide. This is a frequent oversight found
during ISO 14001 assessments. The EMS must cover the whole
business – like a net thrown over the whole business and for example
including such things as engineering and maintenance
Step 3. Implementation and Operation
Structure and responsibility
Appoint one or more people, depending on the size of the business, to
have authority and responsibility for implementing and maintaining the
EMS and provide sufficient resources. (It’s worth monitoring costs
carefully and benchmarking these against key consumption figures so
that improvements delivered by the EMS become apparent).
Training, awareness and competence
Implement a procedure to provide environmental training appropriate
to identified needs for management, the general workforce, project
teams and key plant operators. This can have far reaching benefits
on employee motivation. The workforce is usually very supportive of
moves to achieve genuine environmental improvement. Every
company has its share of cynics but even some of these can be won
over with time. Training will vary from a general briefing for the
workforce to detailed environmental auditor training.
Communication
Implement procedures to establish a system of internal and external
communication to receive environmental information and respond to it
and to circulate new information to people that need to know. This will
include: new legislation, information from suppliers, customers and
neighbours and communications both with employees and for
employees about progress with the EMS. This process can often
generate worthwhile ideas from employees themselves for future
environmental improvements.
Environmental management system documentation
The EMS itself needs to be documented with a manual, procedures
and work instructions but keep it brief and simple. The Standard
clearly states where procedures are required. Eleven system
procedures are required to maintain the EMS, plus operating work
instructions but if you already have ISO 9000, this will cover most of six
of the procedures required and a quality system can certainly be
expanded to cover ISO 14001 as well. Cross reference the EMS
manual to other environmental and quality documents to link the EMS
and to integrate it with existing business practices.
Operational control
Implement additional operating procedures (work instructions) to
control the identified significant (important) aspects of production
processes and other activities. Some of these will already exist but
may need a ‘bit of polish’. Don’t forget significant aspects that relate to
goods and services from suppliers and contractors.
Emergency preparedness and response
Implement procedures to address reasonably foreseeable
emergencies and to minimise their impact should they occur. (eg. Fire,
major spillages of hazardous materials, explosion risks etc.)
Step 4. Checking and Corrective Action
Monitoring and measurement
Implement procedures to monitor and measure the progress of
projects against the targets which have been set, the performance of
processes against the written criteria using calibrated equipment (verify
monitoring records) and regularly check (audit) the company’s
compliance with legislation that has been identified as relevant to your
business. The most effective way of doing this is through regular
progress meetings.
Nonconformance and corrective and preventive action
Implement procedures to enable appropriate corrective and
subsequent preventive action to be taken where breaches of the EMS
occur (eg. process control problems, delays in project process, noncompliance
with legislation, incidents etc.).
Records
Implement procedures to keep records generated by the
environmental management system. The Annex to the Standard
suggests those that are likely to be required.
Environmental management system audit
Implement a procedure to carry out audits of each part of the EMS and
company activities and operations to verify both compliance with the
EMS and with ISO 14001. Audit results must be reported to top
management . A typical audit cycle is one year but more critical
activities will require auditing more frequently.
Step 5. Management Review
At regular intervals (typically annual), top management must conduct
through meetings and record minutes of a review of the EMS, to
determine that it is still appropriate and effective or to make changes
where necessary. Top management will need to consider audit
results, project progress, changing circumstances and the requirement
of ISO 14001 for continual improvement, through setting and achieving
further environmental targets.
ISO 14001 provides a logical, common-sense approach for
businesses to adopt. To start it is recommended to carry out an
environmental review of the business and the Annex to the Standard
provides guidance on the approach required. The Standard then
requires a management system to be developed that addresses the
key environmental issues that were identified by the review as being
relevant to the business, through a rational programme of control and
continual improvement.
There are five key steps to ISO 14001 EMS implementation, and
subsequent operation which are clearly laid out in just three pages of
text.
The five key steps are:
1. Environmental Policy
2. Planning
3. Implementation and Operation
4. Checking and Corrective Action
5. Management Review
Step 1. Environmental Policy
The company or organisation must write an environmental policy
statement which is relevant to the business activities and approved by
top management. Their full commitment is essential if environmental
management is to work. The ISO 14001 Standard clearly sets out
what to cover in the policy. Often a one page document is sufficient.
Produce a first issue and expect to amend it several times before
assessment and registration as knowledge grows in the company.
Step 2. Planning
Plan what the EMS is to address.
Environmental aspects
First make lists of the environmental aspects (issues) that are relevant
to the business. The environmental review mentioned earlier should
provide most of this information and the Annex to ISO 14001 provides
guidance on the format for doing this.
Consider the inputs, outputs and processes/activities of the business in
relation to;
a) emissions to air
b) releases to water
c) waste management
d) contamination of land
e) use of raw materials and natural resources
f) other local environmental and community issues
Consider both site (direct) and offsite (ie. indirect) aspects that you
control or have influence over (such as suppliers) and in relation to
normal operations, shut-down and start-up conditions and reasonably
foreseeable and emergencies situations.
A simple written procedure is then required to determine which of the
aspects identified are really or probably significant (important) and
training needs, outline the key stages of the project and dates that will
lead to the target achievement).
Gradually apply environmental management programme thinking to
such things as the introduction of new products, new or improved
processes and other key activities of the business. In particular,
ensure existing projects become environmental management projects
where there is a significant environmental impact involved, so that the
EMS becomes company wide. This is a frequent oversight found
during ISO 14001 assessments. The EMS must cover the whole
business – like a net thrown over the whole business and for example
including such things as engineering and maintenance
Step 3. Implementation and Operation
Structure and responsibility
Appoint one or more people, depending on the size of the business, to
have authority and responsibility for implementing and maintaining the
EMS and provide sufficient resources. (It’s worth monitoring costs
carefully and benchmarking these against key consumption figures so
that improvements delivered by the EMS become apparent).
Training, awareness and competence
Implement a procedure to provide environmental training appropriate
to identified needs for management, the general workforce, project
teams and key plant operators. This can have far reaching benefits
on employee motivation. The workforce is usually very supportive of
moves to achieve genuine environmental improvement. Every
company has its share of cynics but even some of these can be won
over with time. Training will vary from a general briefing for the
workforce to detailed environmental auditor training.
Communication
Implement procedures to establish a system of internal and external
communication to receive environmental information and respond to it
and to circulate new information to people that need to know. This will
include: new legislation, information from suppliers, customers and
neighbours and communications both with employees and for
employees about progress with the EMS. This process can often
generate worthwhile ideas from employees themselves for future
environmental improvements.
Environmental management system documentation
The EMS itself needs to be documented with a manual, procedures
and work instructions but keep it brief and simple. The Standard
clearly states where procedures are required. Eleven system
procedures are required to maintain the EMS, plus operating work
instructions but if you already have ISO 9000, this will cover most of six
of the procedures required and a quality system can certainly be
expanded to cover ISO 14001 as well. Cross reference the EMS
manual to other environmental and quality documents to link the EMS
and to integrate it with existing business practices.
Operational control
Implement additional operating procedures (work instructions) to
control the identified significant (important) aspects of production
processes and other activities. Some of these will already exist but
may need a ‘bit of polish’. Don’t forget significant aspects that relate to
goods and services from suppliers and contractors.
Emergency preparedness and response
Implement procedures to address reasonably foreseeable
emergencies and to minimise their impact should they occur. (eg. Fire,
major spillages of hazardous materials, explosion risks etc.)
Step 4. Checking and Corrective Action
Monitoring and measurement
Implement procedures to monitor and measure the progress of
projects against the targets which have been set, the performance of
processes against the written criteria using calibrated equipment (verify
monitoring records) and regularly check (audit) the company’s
compliance with legislation that has been identified as relevant to your
business. The most effective way of doing this is through regular
progress meetings.
Nonconformance and corrective and preventive action
Implement procedures to enable appropriate corrective and
subsequent preventive action to be taken where breaches of the EMS
occur (eg. process control problems, delays in project process, noncompliance
with legislation, incidents etc.).
Records
Implement procedures to keep records generated by the
environmental management system. The Annex to the Standard
suggests those that are likely to be required.
Environmental management system audit
Implement a procedure to carry out audits of each part of the EMS and
company activities and operations to verify both compliance with the
EMS and with ISO 14001. Audit results must be reported to top
management . A typical audit cycle is one year but more critical
activities will require auditing more frequently.
Step 5. Management Review
At regular intervals (typically annual), top management must conduct
through meetings and record minutes of a review of the EMS, to
determine that it is still appropriate and effective or to make changes
where necessary. Top management will need to consider audit
results, project progress, changing circumstances and the requirement
of ISO 14001 for continual improvement, through setting and achieving
further environmental targets.
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