The revised version of ISO 9001:2015 requirements sometimes are confusing, especially regarding the 'documented information'.
What is documented information? What documented information is mandatory to keep - and what is optional?
New article by JP Russell and Denis J. Devos 'An ISO 9001:2015 Catch 22: Documenting Pans' explores this topic focusing on clause 6.1.2 requirements - plans to address risks and opportunities.
On one hand a plan is not classified as documented information and moreover the organization determines what documented information they need to maintain. On the other, when an organization documents their plans, an auditor expects the plans to be controlled and maintained as documented information and be available in some form or media. So the organization could be subject to plans being audited against documented information controls.
More on Control of Documented information
ISO 9001:2015 Quality System Procedure - Control of Documented Information
- Describes Criteria and Risks of ‘Control of Documented Information’ Process
- Contains Process Model diagram with detailed inputs and output
- User-friendly format and professional layout - reviewed and approved by experienced ISO 9001 quality auditors.
- Lists Documented Information requirements referencing the clauses of ISO 9001:2015
- Provides recommendations for Documented information maintenance for each clause.
Control of Documented Information QnA
This post first appeared on CBG Inc. - Management System Professionals Support, please read the originial post: here