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Can the preparer be the reviewer and approver for clause 4.2.3?

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Guest user Created:   Feb 26, 2019 Last commented:   Feb 26, 2019

Can the preparer be the reviewer and approver for clause 4.2.3?

Per ISO 13485 clause 4.2.3 requirement, shall the document preparer, reviewer and approver are the different people?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Verlene Law Feb 26, 2019

Answer:

With regards to clause 4.2.3 Medical Device File, ISO 13485 did not state that the document preparer, reviewer and approver shall be a different person. However, in most practices, it is best that the preparer does not review and approve his or her own work so as to be objective. But the reviewer and the approver can be the same person.

If the same preparer&reviewer or same reviewer&approver is acceptable?

Answer:

In this case, the same reviewer and approver are acceptable.
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Feb 26, 2019

Feb 26, 2019

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