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Slide 88 of 262


8.1 General
The company shall plan and implement the monitoring, measurement, analysis and improvement processes needed....

This shall include determination of applicable methods, including statistical techniques, and the extent of their use.

Your company must plan, define and implement the activities (inspection and testing/measurement and monitoring) to assure conformity and achieve improvement throughout your company. Processes are now subject to the same inspection and test requirements as products and services. Any process that is deemed to have an impact on conformity is subject to verification. However, not only do products, processes and services have to conform, they must improve.

Inspection and Test Plans will have to be set up for critical processes. Acceptance criteria, as part of your procedure for the old 4.10, or its reference documents (i.e.: Inspection and Test Instructions) will also have to include improvement specifications.

Element 8.1 also states that your company shall determine the need for, and use of, applicable methodologies including statistical techniques. In comparison to the old standard, statistical techniques are no longer a separate element. But the significance of this requirement is its application to improvement and non-product/service related process. Companies still only require techniques that are appropriate. If there are not techniques that are appropriate to your company, then no techniques are required. Statistical tools such as chart and table analysis should be used as a minimum to measure the achievement of quality objective and goals. Your procedure should reference the procedures that use statistical tools or it could reference a list that identifies the tool and the person responsible for its implementation.

This activity can be developed in conjunction with the operations control activity and will generally be started quite early in the development and implementation of an ISO system.

Key Components
A. Receiving inspection and testing
B. In process inspection and testing
C. Final inspection and testing
D. Inspection and testing records

Note in all of the above, the reference back to the actual process involved - especially the integration of the "in process" area of inspection and testing.

This area is normally the responsibility of the quality assurance manager, however in many cases actual implementation will fall into the production or operations management role.

Potential Audit Questions

1. What verification activities are in place to ensure processes that effect quality are in conformity? Please explain the verification processes.

2. How does your company define and measure "improvement"? Please include details regarding your improvement specifications.

3. What statistical tools are used within your company to ensure conformity of processes? How does your company utilize statistical techniques (or any other methodologies) to improve quality?


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