Is Design and Development needed to be in the quality manual if excluded from scope in ISO 13485?

[StephenE]

I am the only quality engineer for my company and we are ISO 13485 & ISO 9001 certified. I have just recently went through my first surveillance audit and I am trying to clean up the company's quality manual and make it sound more professional by removing all personal pronouns in it (a carry-over from the last quality engineer). I came across a section of the manual that describes the design and development process, but since we are excluded from the clause (we do not design or manufacture medical devices) is this something that needs to have a whole section written out for it or can I just put in wording that this process is excluded per our excluded and non-applicable clauses section of our quality manual?

 

[Nichole F]

For ISO 13485, generally companies have a section in their QM that is for exclusions and non-applications. If it is an exclusion or non-application, you wouldn't have a section for it in the QM. You will of course need to justify your selected exclusions or non-applications. I don't know about ISO 9001 though.

 

[DannyK]

Keeping the excluded clause in the manual and providing the justification for the exclusion is a good practice.
It helps align the manual to the standard and makes it easier to read for anyone outside the organization.

 

[LUFAN]

You'll have a scope section of the QMS that says something like Section 7.3 is excluded and 7.5.10 is Not Applicable.

Then in the manual text you'll have something like the following. You'll want to keep the section numbers but the section is replaced with a generic statement like below

7.2: Blah Blah Blah
7.3 Design and Development is excluded from the QMS per scope section listed in section 1.0
...
7.5.10 Customer Property is Not Applicable to the QMS per scope section listed in section 1.0

 

[ChrisM]

ISO13485 does require you to identify all clauses of the Standard and give justifiable reasons for any that you are are excluding, or classifying as "non-applicable" .
Therefore the responses above, notably that by Lufan, offer you good advice.

 

[Ed Panek]

Our auditors request our QM first thing. I think putting a page on exclusions is proper and helps set the scope from the get go. If there are discrepancies in scope you need that resolved before beginning the audit and the QM seems a good place.