6 mandatory documents for ISO13485

[dubagent]

What are the 6 mandatory documents/procedures required for ISO13485?

 

[shimonv]

Don't know where you got that number... I've never seen a QMS with only 6 procedures.
For a starters you cans each for the keyword "procedure" in ISO 13485. Keep in mind that there are other applicable standards you should follow, like risk management, software development ect. They too have a requirement for documented procedure.

 

[dubagent]

Thanks for the input. I came across an ISO13485 checklist that calls out checking that the “6 mandatory procedures” are documented. I have not come across this anywhere else!

 

[Sidney Vianna]

Probably an old checklist reflecting the older (OBSOLETE) version of ISO 13485 which was based on ISO 9001:1994.

 

[LUFAN]

Technically you could have 1 insanely long manual with nested procedures and meet all the documentation requirements. Not sure what that accomplishes, but any X number of procedures is just arbitrary.

 

[chris1price]

Once upon a time............... ISO9001 (2000 I think) required 6 procedures, I have an old document from 13485:2003 which lists 32 required procedures. I think I gave up counting after that. But Lufan is correct, you could combine them all-togther in one quality manual.

 

[Jen Kirley]

Thanks for the input. I came across an ISO13485 chent cklist that calls out checking that the “6 mandatory procedures” are documented. I have not come across this anywhere else!

Hello dubagent, if you don't yet have a copy of the current version of ISO 13485, I suggest this is a good time to purchase one. It is no good to guess at things like what procedures to have for what - besides, of course, what would help your organization function effectively and fulfill interested party requirements.

 

[DutchMarten]

Hello dubagent, if you don't yet have a copy of the current version of ISO 13485, I suggest this is a good time to purchase one. It is no good to guess at things like what procedures to have for what - besides, of course, what would help your organization function effectively and fulfill interested party requirements.

And if it is price that is holding you back, then I would try to google on "estonian standards". I have no affiliation but it's the same standards for less than anywhere.