Defining Document Review and Approval responsibilities - ISO 13485 - Medical Device

S

s.parakos

Hi all,

Do the Author, Reviewer and Approver of a Controlled Document have do be different people to meet the requirements of the standard? Or is it enough to have and record the Author, Reviewer and Approver functions, even if the same person is responsible for them.

My example is:
I am the Quality manager. I modify a Work Instruction to do with the quality system. It is only a minor change in terms of amount of content, but is necessary none the less. I am also responsible for approving the release of the document. Can I also be the Reviewer, as the size of the change does not warrant sending the document to a third party for review? It would in my opinion be bureaucratic overkill.

thanks
Simon
 
G

Gert Sorensen

Re: Defining Document Review and Approval responsibilities

Do the Author, Reviewer and Approver of a Controlled Document have do be different people to meet the requirements of the standard?
That depends on the document :)


Or is it enough to have and record the Author, Reviewer and Approver functions, even if the same person is responsible for them.
Sometimes :)


My example is:
I am the Quality manager. I modify a Work Instruction to do with the quality system. It is only a minor change in terms of amount of content, but is necessary none the less. I am also responsible for approving the release of the document. Can I also be the Reviewer, as the size of the change does not warrant sending the document to a third party for review? It would in my opinion be bureaucratic overkill.
Normally, no. Politics, procedures, and work instructions is - in my experience - normally required to be signed by your superior. So, how to avoid bureaucracy? If one of your staff makes the changes to the document then you are their superior, and you approve it. However, keep in mind that there is a reason that one wants an independent reviewer ;)
 

Al Rosen

Leader
Super Moderator
Re: Defining Document Review and Approval responsibilities - ISO 13485 - Medical Devi

My interpretation of the standard would allow you to make the change without additional review.

The organization shall ensure that changes to documents are reviewed and approved either by the original approving function or by another designated function that has access to pertinent background information upon
which to base its decisions
.
 

DannyK

Trusted Information Resource
Re: Defining Document Review and Approval responsibilities - ISO 13485 - Medical Devi

No need to have a different reviewer and approver unless your quality management system says otherwise. You have to define this in clause 4.2.3, Document Control

Danny
 
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