Showing posts with label quality management system. Show all posts
Showing posts with label quality management system. Show all posts

Wednesday, June 22, 2011

Management Review IN ISO 9001 Standard

One of the most important factors in determining the success of an ISO 9001 implementation is management commitment and management understanding of what makes a good quality systems. Our turnkey Quality Management System (QMS) gives you everything you need to educate your entire company from top to bottom.

Management review is one of the key elements to building a sustainable quality system. To do this, management must be committed. This means that the management must do more than just say they are committed, they must allocate the resources to make sure that the company can continuously improve quality. Most quality systems fail from the top down! That is why external auditor almost always review the management review documentation every audit. External ISO 9001 auditors look for this commitment by evaluating the management review records. Management reviews should focus on both the quality of the products and the quality of the QMS. In general, it is very simple to maintain compliance of the management review portion of the standard. It can be done with a simple notebook that is maintained as a quality record. The Management review procedure includes a list of documentation that should be included in management review meeting. Management reviews should be done a least once per year and auditors like to see them quarterly.

Under ISO 9001, executive management has defined responsibilities. Although most of the work required to implement and maintain ISO certification is done below the executive level, ISO requires involve of personnel at the top of the organization.

It is the leader of an organization that set the goals and objectives for the quality of the company. It is also the leader that assigns resources (responsibility and authority) throughout the organization. Because of this, the leaders must be kept aware of the status of the quality system and product/service quality so they make good decision.
Much of how the company accomplishes these tasks is covered in the quality manual. Here are the 8 areas that should be address in the quality system to assure compliance to the ISO standard.

Top Management must:

Show A Commitment To The Customer

This requirement includes maintain records showing their commitment to the a customer focus, the quality system and the continuous improvement system. The use of a customer survey program is an excellent way to meet the ISO requirements for a customer focus. It is also an excellent way to keep in touch with your customers.

Make Quality Important

This includes communicating to the organization the importance of meeting the customer regulatory, legal needs as well as their produce or service needs (customer focus). Training and posting quality information around the building can do this.

Establish A Quality Policy

This should include a concise quality statement in conjunction with quality goals and a quality manual. The policy verbiage should include a commitment to continuous improvement. This information must be communicated to and understood by the entire organization.

Establish, Monitor And Update Quality objectives

These objectives should be measurable and should be relevant to all levels of the company. I recommend that they be publicly posted where everyone can see them and their status may also be posted.

Assign Resources

Ensure that resources are available to achieve the quality goals. This is the area where many companies do not meet the requirements but it is very hard to audit this general statement. Resources should be identified and planned. Planning includes manuals, procedure, work instructions and quality plans.

Assign Responsibility And Authority

Ensure that responsibilities and authorities are assigned and communicated to individuals. Responsibilities can be assigned as part of the personnel records ( see training summary sheet). Having authority means that the individual must be empowered to make changes.

Designate A Management Representative

This person will report the QMS status at periodic management reviews and promote awareness of the importance of meeting the customers needs. This is usually the quality, engineering or production manager.

Conduct Periodic Management Reviews

Management review meetings should include inputs from audits, customer feedback, process performance analysis, preventive and corrective actions system, follow-up from previous management meetings and areas for improvement. The output from the management reviews should include resource assignments, action targeting improvement of the products, processes and QMS.

The records for the management review are frequently audited so I recommend keeping a organized notebook with tabs for each management review. The creation of a check sheet (listing all the reports to be shown to top management) will make this periodic task simple to maintain. The check sheet can also be used to keep track of attendance and log feedback that is generated during the meeting.

Read more on ISO 9001 Standards at http://www.iso9001store.com

Monday, September 21, 2009

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.

Thursday, September 3, 2009

ISO 9001 Management Representative

The ISO 9001 Management Representative is appointed by the top management of an organization. Irrespective of other responsibilities, he/she is responsible and has the authority in
ensuring that processes needed for the quality management system are established, implemented and maintained,
reporting to top management on the performance of the quality management system and any need for improvement, and
ensuring the promotion of awareness of customer requirements throughout the organization.
The responsibility of the Management Representative also includes liaison with external parties on matters relating to the quality management system.
The Management Representative is usually assisted at the departmental level by Quality Representatives. This position is assumed by the respective Department Managers. The Quality Representatives are responsible for the quality processes which are applicable to their respective departments.
The Quality Representatives head their respective Quality Improvement Teams which are established for the purpose of monitoring processes and identifying opportunities for improvements. Members of the Quality Improvement Teams comprise of key personnel within the departments/process areas who are appointed by the Quality Representative to assist him/her at the process-level.
The Management Representative is also assisted by an appointed Document Controller whose responsibility is to implement the Control of Documents and Control of records procedures.
Collectively, the Management Representative, Quality Representatives and the Document Controller make up the Quality Management System Committee. This committee meets regularly to provide relevant inputs and resolutions for the quality management system. The structure of the Quality Management System Committee is as follows:
Management Representative – Chairman
Document Controller – Secretary
Quality Representatives – Members
[Note: The above is just an example. If you are a small organization, a QMS Committee and Quality Improvement Teams may not be necessary]
To facilitate effecetive communications, the Quality Management System Committee and the Quality Improvement Teams, respectively, meet regularly in order to ensure that communication regarding the effectiveness of the quality management system takes place. Pertinent information regarding the quality management system is then posted by the Management Representative on the Bulletin Board for the benefit of all employees. Employees are generally encouraged to provide their inputs towards the quality management system through suggestion boxes which are located at strategic locations within the organization’s premises.
Note: Some organizations employ this method but results may vary among other organizations. The key is to continually improve on these methods/processes.