Mandatory documents
!Quick question: certain of the documents do not appear to apply to me but they are marked as mandatory – for example, #12 re: sterilization. Of course, as a software company, I am not involved in any such activity, so I presume it is mandatory for audit if you are involved in sterilizing MDs? Or is it that I need to have such a document in my company repertoire, even if I don’t use it (to meet the standard)?!
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
No, you do not need those documents. It is just necessary to state in the Quality manual which requirements are not applicable for you and why. For example, you will state in your Quality manual that requirement 7.5.5 Particular requirements for sterile medical device is not applicable for you because you do not produce sterile medical devices.
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Oct 13, 2019