Return information production and post production

A

amira2018

#1
Hello;

how can I make a production and production feedback procedure in accordance with ISO 13485 version 2016, to show that every negative feedback will be treated as a complaint;

Thank you in advance
 
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yodon

Leader
Super Moderator
#2
By and large, this will depend, I believe, on what your current systems are.

Probably the least 'technical' solution might be to have spreadsheet logs for feedback and complaints. Each entry in each log would get a unique number. If you determine, indeed, the feedback is a complaint, you can then cross-reference the unique numbers in each spreadsheet.

Most all of the 'QMS automation' tools will facilitate this for you.

Oh, and not all negative feedback will necessarily be a complaint. Feedback would only be considered a complaint if it (per the definition in 13485) "alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization’s control or related to a service that affects the performance of such medical devices"

If someone gave ('negative') feedback that the box contained too much padding, that would not qualify as a complaint since there's no allegation of any of the indicated issues.
 
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