A
Arie0712 - 2010
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
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