ISO 13485 8.2.1 and 8.2.2 - Customer Feedback and Customer Complaints

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duff999

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#1
#1
For ISO 13485 8.2.1 Customer Feedback and 8.2.2 Customer Complaints - when developing an SOP, should these standards remain separate or combined into one SOP. Currently I have these as separate SOP's, one dealing with Customer Feedback, and one dealing with Customer Complaints. Just looking for feedback as how others are handing these standards.

Thanks
 
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Tagin

Tagin

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#2
#2
I consider customer complaints a subset of customer feedback. For 9001, we just have one SOP, with different paths and escalations depending on the feedback type and severity.

Whether they are in one SOP or two is more likely determined by how complex and disparate are your two processes, formats for each process, and authorities and responsibilities.
 
atitheya

atitheya

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#3
#3
Wheras ISO 9001:2015 has a requirement of obtaining customer feedback relating to products and services, including customer complaints in clause 8.2.1 c, and monitoring customer satisfaction in clause 9.1.2 which Tagin is referring to,

ISO 13485:2016 8.2.1 is Feedback from various sources and not customer feedback alone. The clause 8.2.2 Complaint handling has a requirement b, to evaluate information to determine if feedback constitutes a complaint.

Thus feedback and complaint handling are two distinct processes with different purposes. A part of feedback may be an input to complaint handling.
 
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twanmul

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#5
#5
atitheya said:
Wheras ISO 9001:2015 has a requirement of obtaining customer feedback relating to products and services, including customer complaints in clause 8.2.1 c, and monitoring customer satisfaction in clause 9.1.2 which Tagin is referring to,

ISO 13485:2016 8.2.1 is Feedback from various sources and not customer feedback alone. The clause 8.2.2 Complaint handling has a requirement b, to evaluate information to determine if feedback constitutes a complaint.

Thus feedback and complaint handling are two distinct processes with different purposes. A part of feedback may be an input to complaint handling.
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Very good point. We've fallen foul of this and had to amend our QMS accordingly. Do ensure that your feedback includes production and post-production feedback, otherwise you'll end up having to retrofit things into your QMS.
 
T

ThatSinc

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#6
#6
twanmul said:
Very good point. We've fallen foul of this and had to amend our QMS accordingly. Do ensure that your feedback includes production and post-production feedback, otherwise you'll end up having to retrofit things into your QMS.
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what additional feedback sources from production did you feel were necessary to include in a feedback procedure?
Procedures exist for the feedback process from production with regards to NCs, Deviations, Dispatch timeliness, as well as post production in the form of the customer complaints procedure and post market surveillance procedure which solicits direct feedback from customers as well as a broader review of device performance, equivalent device performance, changes in standards etc. etc.

I'm looking to avoid having a specific feedback procedure in itself, and reference the various other procedures and how they function to provide feedback in the QM under this requirement.
 
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