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How to mark and identify Company Policies?

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Guest user Created:   Aug 15, 2019 Last commented:   Aug 15, 2019

How to mark and identify Company Policies?

New to QA Manager. Previous QA Manager made it mandatory for Position Descriptions in HR department, as well as Company Policies i.e Health & Safety, Social Media Policy to be version & document ID controlled. It is mandatory for those types of documents to have a document ID, version number and review date?
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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 Aug 15, 2019

Answer:

It is not mandatory for these documents to have document ID, version number and review date. In ISO 13485:2016, in point 4.2.4 it is stated that Organization must ensure that documents are identified according to the current revision status, must prevent the unintended use of obsolete documents and must apply suitable identification to them. Therefore, how you will identify them and how you differentiate them is absolutely up to you, but you must ensure that the above requirements are secured.

According to the ISO 13485:2016, for Quality Policy it is not mandatory to have document ID and version number. However, in requirement 5.3 Quality policy, in subsection e) it is stated that Top management must ensure that it is re viewed for continuing suitability. Therefore, you have to have a date on it to know when it was last reviewed.

For more about common mistakes in document control, please read 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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Aug 15, 2019

Aug 15, 2019

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