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Definition Rework vs. Repair - ISO 13485 definition

Tagin

Quite Involved in Discussions
#11
Hi

I'm working in a medical device company.
I would like to add a repair/rework SOP to our quality system.
"Rework" is mentioned in ISO 13485 on section 8.3 (Control of Non-Conforming Product) - yet its not sufficient."Repair" is not mentioned at all.
Would you kindly help me with the following:
- Defining "Rework" and "Repair" and the differences between them.
- Are thay any guidelines for this specific SOP?
- Do you have an example of such SOP which you can attached?

Thanks
Arie
Rework and Repair are defined in 9000:2015, which is the reference used by 13485:2016:
3.12.8
rework
action on a nonconforming (3.6.9) product (3.7.6) or service (3.7.7) to make it conform to the requirements (3.6.4)
Note 1 to entry: Rework can affect or change parts of the nonconforming product or service.

3.12.9
repair
action on a nonconforming (3.6.9) product (3.7.6) or service (3.7.7) to make it acceptable for the intended use
Note 1 to entry: A successful repair of a nonconforming product or service does not necessarily make the product or service conform to the requirements (3.6.4). It can be that in conjunction with a repair a concession (3.12.5) is required.
Note 2 to entry: Repair includes remedial action taken on a previously conforming product or service to restore it for use, for example as part of maintenance.
Note 3 to entry: Repair can affect or change parts of the nonconforming product or service.
 
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