ISO 13485 - List of required / needed procedures and records attached

Marcelo

Inactive Registered Visitor
#51
What I provided was in relation to requirements in ISO 13485:2016 for "documented procedures", not documentation in general.
Sure, but "documentation"in 4.2.1 d) includes, between other documents, any documented procedure that the organizations needs or is required to have, beyond the explicitly XX documented procedures that ISO 13485 formally requires, and these, most of the time, are in high numbers.

So, when you say "For example, I cover all of 13485:2016 and every other med device QMS regulation/standard in the world with a Quality Manual and 21 SOPs", I understand that you mean that those 21 SOPS would cover only the documented procedures explicitly required by ISO 13485,not any other documented procedure "determined by the organization to be necessary to ensure the effective planning, operation, and control of its processes".
 
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Sam Lazzara

Trusted Information Resource
#52
For me, the 21 procedures (SOP) cover all the procedures needed to effectively manage the quality system in accordance with 13485 and the regulatory requirements. I put all of the regulatory requirements into a single SOP for example, so as we add countries we just revise that SOP.

And I am only talking about "Level 2" procedures, not "Level 3" work instructions which tend to be product-specific and numerous.
 
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