If your SOPs meet the requirements, then a pointer is fine. However, I recommend you do an analysis to demonstrate you meet all of the attributes.
Your SOPs must be effective meaning "planned activities are realized and planned results are achieved". [ISO 9000:2015, 3.7.11]
What tools and methods do you use to investigate complaints and how do you know they are appropriate? I would expect a description of the tools and methods.
What tools and methods do you use to analyze market related experience and how do you know they are appropriate? I would expect a description of the tools and methods.
The PMS doesn't anticipate that you have any data. It anticipates that, should data show up on your doorstep, you are ready to deal with.
Don't think of this as strange requirements that fell from the sky. Instead think of this as the things you would probably do anyway. It is now more formal and less (considerably less) and hoc.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 24-Jul-2019 11:19
From: Anonymous Member
Subject: Post-Market Surveillance Plan - Requirements outlined in Annex III (1.1b)
This message was posted by a user wishing to remain anonymous
Greetings,
I know the forum has had a few discussions regarding the post-market surveillance plan under the new MDR, however, I'm still confused regarding the requirements outlined in Annex III(1.1b).
A few of the requirements appear to be redundant as our PMS SOP linkages to risk management, design, complaints, CAPA, etc. For example, the plan shall cover "effective and appropriate methods and tools to investigate complaint and analyze market-related experience collected in the field." This would be covered in our SOPs. Is it sufficient to simply point to procedures for certain items listed within this section? If not, any suggestions?
This section of the MDR is really throwing me for a loop. We have a class I, low risk device, and we generate very little data. This requirement for us (the small guy) is onerous. If anyone has any general suggestions regarding how to handle this section of the MDR in our PMS Plan, I'm all ears because I am stuck!