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ISO9001:2015 Clause 9.1 - What the external auditor will look at?

Golfman25

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#11
Whether you have a quality manual or not, it is helpful to have a cross reference between the standard and your system. For us, that is the "quality manual."
 
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Tagin

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#12
1) clause9.1.1 (The organization shall evaluate the performance and the effectiveness of the quality management system)
~the question form (internal/external auditor may sound like;
-show me how you evaluate the quality performance and the effectiveness of the quality management system?

2) clause9.1.3c (the performance and effectiveness of the quality management system)
~the question form (internal/external auditor may sound like;
-How to prove/ensure conformity and effectiveness of the QMS?

based on the clause above; actually what the external auditor will look on?

p/s advise

thanks in advance :) !
9.1.1 says you are going to determine how you will mon/meas/analyze/eval.
9.1.3c says you are going to use the results of analysis to evaluate the perf/eff of the QMS.

So, in the first case, they might ask to see some evidence you have indeed identified what you are going to mon/meas and how you are going to analyze that tracked data.
E.g., do you have a list of KPIs, process control monitoring/measurements (as needed), etc.? Where is the data stored? What kind of analysis do you perform on the data?

In the second case, they might ask you to show how you are applying these results to the perf/eff of the QMS.
E.g., show me how your KPIs are they being used (by the appropriate people) to evaluate the perf/eff of the QMS? If the KPIs are not being met, are actions being taken to correct that?

In reality, the likelihood is the questions will be combined into a general one: E.g., "show me your KPIs, etc., how/where you track them, and how they are being used in evaluating the QMS, and actions arising therefrom."
 
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