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  • 1.  ISO 9001:2015 Clause 8.3 (Process Design not Product Design)

    Posted 05/06/22 10:18 AM

    We exclude Clause 8.3 in our QM and Scope however we do have a Quality Procedure titled: 830 Process Design and Development. (written for process design not product design)

    During our last audit the auditor recommended removing this procedure from our ‘QP’ section or renaming it. We would like to keep this procedure as it is.

    Has anyone else had this issue and if so how was it resolved.



  • 2.  RE: ISO 9001:2015 Clause 8.3 (Process Design not Product Design)

    Posted 05/06/22 04:11 PM

    Not that exact one, but know that your registrar’s opinion on what you should name procedures is just that - an opinion. He/she is trying to make his/her job easier. I would politely decline and explain it works well for you as it is.



  • 3.  RE: ISO 9001:2015 Clause 8.3 (Process Design not Product Design)

    Posted 09/03/22 03:34 PM

    @Jerri Alexander

    1. Auditors are not supposed to make recommendations.
    2. Ask him/her how it would improve the QMS, product/service quality, and/or organizational performance