Post Market Surveillance SOP - ISO 13485 Audit Nonconformance

Q

QACen

Hello - We just completed our ISO audit yesterday and the auditor issued a nonconformance for not having a procedure for post market surveillance, 8.2.1. Does someone have a sample SOP that they can share with us? We embedded this requirement throughout several procedures and apparently that was not good enough. We are not CE. Just certified for ISO/CMDR.
 
Q

QACen

Can anyone tell me who is responsible for implementing the PMS SOP (ultimately management)? QA Person?

Also, can anyone recommend to me a webinar training for PMS program? I can read all requirements and implement SOPs easily, but my understanding may not always represent the intention.
 
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Ronen E

Problem Solver
Moderator
Can anyone tell me who is responsible for implementing the PMS SOP (ultimately management)? QA Person?

Also, can anyone recommend to me a webinar training for PMS program? I can read all requirements and implement SOPs easily, but my understanding may not always represent the intention.

Hi,

Implementation responsibility lies with whoever you specify in your own SOP. I'd tend to say that it would be a collaborative effort taken by the QA, marketing, sales and customer service teams. QA could be orchestrating but not necessarily -- depends on your org.

If you feel comfortable with the written guidance and implementation, I'd give it a go -- your ISO 13485 registrar (auditor) will help you complete the fine tuning. I hold the opinion that minor audit NCs are not necessarily a bad thing -- it's a tool for improvement (no, the sky won't fall if you have >0 NCs). There's an abundance of written material for PMS, so make sure to study multiple sources and you'll be fine. I can't recommend a specific webinar but maybe others will.
 
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