ISO 13485 - Advisory Notice Requirements

[RM1967]

My company is 13485 Certified. We do not have a "product" as we are an engineering service company. Recently we had an audit that identified the need for a process for issuing advisory notices.

However, being that our clients are typically the ones who handle this clause, we are uncertain as to how to apply "Advisory Notices" into our QMS. Any insight as to how we could apply this when there is no "actual product" made by our company? Thank you for any thoughts in advance.

 

[ScottK]

Was it a finding or an OFI?
If it's a finding - Can you provide the wording of the finding from the auditor?

 

[Ajit Basrur]

Welcome to the Cove, RM1967

You will find an example SOP here: https://elsmar.com/Forums/329957-post2.html

and what is required for from a contractor manufacturer here: https://elsmar.com/Forums/330362-post4.html

Please note the SOP is mainly from an European perspective.

 

[QuinnM]

Hi RM1967,

First look at the scope consider the definition of “advisory notice” in section 3.1. Would anything in this definition apply to your supplied component/part?

Then consider this:
ISO 13485:2016, Section 1 Scope: “ If any requirement in Clauses 6, 7, or 8 of this International Standard is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system.”

Quinn

 

[Edward Reesor]

Here's a way of looking at it...say your company hired someone and 5 years later it was found that they had falsified their credentials or that their degree didn't come from an accredited school. You would have to deal with somehow in the terms of looking into the projects they were associated with, and how would you notify your clients and the regulatory groups responsible for the project.

So the question is..."What is your process?".

 

[Talja]

I am facing with the same question now in my company, can you tell me if it is enough to have an escalation procedure to our customers only in this case?