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ISO 9001 9.2.1 - Customer File Review For Artwork and Labelling Issues

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    Grade - AIFSQN

  • IFSQN Associate
  • 33 posts
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  • Australia

Posted 05 May 2022 - 12:32 AM



We received a minor non-conformance  under Clause 9.2.1 of ISO 9001: 2015 standard for not being able to provide evidence of internal auditing of  Quality Program Elements listed below:

1) Context of organization

2) Customer File review for Artwork & Labelling issues

3) Customer Specific requirements


Can anyone provide any templates/ questionnaires etc that can be used in the internal audit of these elements to help us?


Thanks so much


Best regards




    Grade - MIFSQN

  • IFSQN Member
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  • Vietnam
  • Gender:Male

Posted 05 May 2022 - 01:24 AM

Does each of your audit questions indicate the relevant clauses?

My method is

1. Listing up applicable operation procedures and matching them with all standard clauses. (compliance by documentation)

2. Conducting "internal audits" against procedures at departments (compliance by implementation)

3. Concluding that the procedures are effective and the system complies all ISO9001 clauses.

The first step takes time and the matching is never perfect, but at least I know I have not missed any clauses.

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Also tagged with one or more of these keywords: FILE REVIEW, ARTWORK, LABELLING ISSUES

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