TS 16949:2009:PROCESS AUDITING GUIDEBOOK

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The new revision requires the creation of plans for achieving the objectives, as well as the definition, establishment, and maintenance of quality objectives to meet customer requirements. The transition is a good time to make improvements to your existing documentation while you work on realigning your existing procedures with the new clause numbers. For more information, see: List of mandatory documents required by IATF In addition, confidentiality requirements have been increased, along with expansion of operational planning and control obligations. The definition of your design and development process needs to be expanded to include inputs, outputs, controls, and responsibilities; as well as how changes to the design and development process will be managed — like who is authorized to make changes, who will review results of any changes, and what will be done to avoid negative impacts.

This can be achieved through verifying that processes, services, and products supplied by external providers comply with your requirements.

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You are required to evaluate your QMS with regards to its performance, effectiveness, and efficiency. You may already be familiar with KPIs Key Performance Indicators — you just need to figure out what needs to be monitored, how it should be monitored, and how often. Measuring and reporting are assigned greater importance in the new standard, particularly when it comes to the performance evaluation mentioned previously.

Likewise, management review and the internal audit process must be aligned with the new standard.

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One person found this helpful. Most helpful customer reviews on Amazon. Kindle Edition Verified Purchase. Excellent tool to assist organizations trying to get the most out of the new requirements. Good book Really useful audit questions. Well written and helpful, but, get ISO Helped me understand the changes.

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