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Guest user Created:   Mar 04, 2020 Last commented:   Mar 04, 2020

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Are the procedure numbers cross-linked in the documents-kit? For example, the product validation document will refer to several documents, e.g. product development plan, risk management, verification & validation procedures, etc.  Do all these procedures have numbers/codes already implemented and cross-referenced or do I have to do the work?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Mar 04, 2020

No, since each company has its own coding system, we have left our clients to insert their own codes into the documents. Of course, the policies and procedures in our toolkit make cross references to other documents using their names, but you can insert also the codes as well if you see this as necessary.

For more details please read the following article: Common mistakes with ISO 13485:2016 documentation control and how to avoid them https://advisera.com/13485academy/blog/2018/03/14/common-mistakes-with-iso-134852016-documentation-control-and-how-to-avoid-them/

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Mar 04, 2020

Mar 04, 2020

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