Document Record/Template Minimum Requirements

#1
What formal requirements apply to any quality related documentation like processes, templates and records. What are the requirements related to for example document history, header/footer, status, distribution etc. My intention is to find out what minimum elements should be included in any kind of document to comply with any kind of standards. like QMS (13485, 9001), ISMS (27001) or similar. This is probably a standardized set of requirements.
 
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#2
I don't think ISO13485 nor ISO9001 ever list minimum elements for your template. That said, the following should be a good starting point for you.

- Title of Document
- Document Reference Number
- Document Version Number
- Document Change Record Reference Number
- Document Effective Date
- Page Number with Total Number of Pages
- Company Name
- Disclaimers
 

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#4
What formal requirements apply to any quality related documentation like processes, templates and records. What are the requirements related to for example document history, header/footer, status, distribution etc. My intention is to find out what minimum elements should be included in any kind of document to comply with any kind of standards. like QMS (13485, 9001), ISMS (27001) or similar. This is probably a standardized set of requirements.
You should become familiar with ISO 10013:2021

https://www.iso.org/obp/ui/#iso:std:iso:10013:ed-1:v1:en
 
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