ISO13485 7.2.1 (d) User Training

[April H]

I work for a company that is a contract manufacturer for class 1 medical devices. We have a NA for clause 7.2.1 d in our Quality Manual since the device designs are owned by our customers and they are responsible for determining what user training is required. An auditor wants to give us a nonconformance since we add IFUs to cartons and some cartons are printed with instructions for the consumer.

We do conduct incoming inspection on the IFUs and preprinted cartons. How can we be responsible for this clause?

Has anyone else encountered this issue and what have you done?


Thank you!

 

[yodon]

That does seem odd. Can you post the exact statement of the nonconformity?

 

[April H]

Requirement:
ISO 13485:2016 Clause 4.2.2 Quality manual

The organization shall document a quality manual that includes:

a) the scope of the quality management system, including details of and justification for any exclusion

or non-application;

Objective Evidence: Quality manual version 24 lists clause 7.2.1(d) as not applicable. ****** does provide user training with the product per customer requirements.

 

[DanMann]

Requirement:
ISO 13485:2016 Clause 4.2.2 Quality manual

The organization shall document a quality manual that includes:

a) the scope of the quality management system, including details of and justification for any exclusion

or non-application;

Objective Evidence: Quality manual version 24 lists clause 7.2.1(d) as not applicable. ****** does provide user training with the product per customer requirements.

Does your Quality Manual include the justification for exclusion you've given here? If so, I don't understand this finding.
The only reading I can make kind of fit this (although I don't agree and it doesn't fit the ISO definition of "determine") is that the auditor is thinking of you making the right IFU (part number, version) go with the right medical device, so maybe point 7.5.1d to that process and put it down as a strange NC with a quick fix?
What did you put in your corrective action plan in the end?