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Scope of stage 1 certification audit

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Guest user Created:   May 11, 2017 Last commented:   May 11, 2017

Scope of stage 1 certification audit

I would just like to know what the Stage 1 Audit will entail in ISO 9001? We have a lot of standard operating procedures. Is it necessary to have quality objectives for all of them? Are they all suppose to form part of the operational and control clause? Is monitoring and measuring required for all these procedures?
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Strahinja Stojanovic May 11, 2017

Can they ask you many questions?

Answer:

The purpose of the Stage 1 audit is to review the QMS documentation and determine whether it is compliant with requirements of the standard. There is no requirement to have quality objectives for every procedure. All process procedures are part of operational controls, different processes need to meet requirements of different clauses, for example, production process need to meet requirements of cause 8.5, purchasing process needs to meet requirements of clause 8.4, etc. I noticed that you are mixing processes and procedures and this is not the same thing, here is an article that might be interesting to you: ISO 9001:2015 process vs. procedure – Some practical examples https://adv isera.com/9001academy/blog/2016/01/19/iso-90012015-process-vs-procedure-some-practical-examples/

The organization needs to determine what should be monitored and measured, as well as the methods and frequency of monitoring and measuring activities. The standard does not explicitly requires that every process has monitoring and measuring but it can be beneficial in order to monitor performance of the processes. For more information, see: Analysis of measuring and monitoring requirements in ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/analysis-of-measuring-and-monitoring-requirements-in-iso-90012015/

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May 11, 2017

May 11, 2017

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