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Documents within the Quality Manual Handbook

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Guest user Created:   Aug 02, 2019 Last commented:   Aug 02, 2019

Documents within the Quality Manual Handbook

Hi may I ask you for advice, is it possible and wise to have all documents related to system in Quality manual handbook?
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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.

Expert
Chany Runnels Aug 02, 2019

Answer: 

According to the ISO 13485 Standard, the quality manual must have your documents within it or you must make a reference to the documents applicable to your QMS.

Your final decision should take a few things into consideration: 

Deciding to include all of your documents within the manual, you want to ensure every time a document is revised, updated, and/or expired that the quality manual is also updated to ensure there are no inconsistencies in your documents. Pros: Creates a centralized location where staff can always find documents related to your QMS. Cons: Any inconsistencies with documents within the Quality Manual could result in a nonconformance. Also the size of the quality manual grows resulting in longer review time, approval time and training by employees.

Providing a reference to your documents could be accomplished by including a list of document names and numbers. Pros: A list of document names a nd numbers covers future revision changes. Also prevents staff from having to sort through information not relevant to their job duties.Cons: Updates to a reference of documents would still include document retirement, new documents issued, title changes or number scheme changes.

The key here is to determine what will work best for your Quality Management System.
 
For more information, please read articles: 
How to structure Quality Management System documentation according to ISO 13485
https://advisera.com/13485academy/knowledgebase/how-to-structure-quality-management-system-documentation-according-to-iso-13485/

How to manage the Quality Manual according to ISO 13485:2016 requirements
https://advisera.com/13485academy/knowledgebase/how-to-manage-the-quality-manual-according-to-iso-13485-requirements/
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Aug 02, 2019

Aug 02, 2019