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Rework vs. Repair - ISO 13485 definition


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rework, definitions, repair and or overhaul
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  Post Number #1  
Old 30th December 2008, 04:43 PM
Arie0712 - 2010

 
 
Total Posts: 21
Question Rework vs. Repair - ISO 13485 definition

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

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  Post Number #2  
Old 30th December 2008, 04:51 PM
Coury Ferguson's Avatar
Coury Ferguson

 
 
Total Posts: 4,322
Re: Rework Vs Repair

See here: Repair

Here for: Rework
Thank You to Coury Ferguson for your informative Post and/or Attachment!
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  Post Number #3  
Old 30th December 2008, 04:59 PM
Miner's Avatar
Miner

 
 
Total Posts: 3,597
Re: Rework Vs Repair

Hopefully someone familiar with ISO 13485 will chime in on this. In the ISO 9001 environment, there is a clear distinction between repair and rework.

Rework = Work done to correct defects that bring a product back into 100% conformance to requirements.

Repair = Work done to make a product functional, but not 100% conforming to requirements.

Given the distinction and the nature of the medical device industry, I would not be surprised that repair is not addressed. It is probably assumed to be disallowed.
Thank You to Miner for your informative Post and/or Attachment!
  Post Number #4  
Old 30th December 2008, 05:14 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,101
Re: Rework Vs Repair

Quote:
In Reply to Parent Post by Miner View Post

Hopefully someone familiar with ISO 13485 will chime in on this. In the ISO 9001 environment, there is a clear distinction between repair and rework.
ISO 13485 has no specific definitions for the terms rework nor repair. It invokes ISO 9000 for definitions. So, in the context of ISO 13485, your cited definitions will also work.

And I don't see anywhere in ISO 13485 that repair would not be allowed.
Thanks to Sidney Vianna for your informative Post and/or Attachment!
  Post Number #5  
Old 30th December 2008, 05:50 PM
Doug Tropf

 
 
Total Posts: 388
Re: Definition of Rework Vs Repair-ISO 13485

I don't know if this helps but 8.3.3 of ISO/TR 14969:2004 (Guidance on the application of 13485) offers the following:

"Correction" refers to repair, rework, or adjustment and relates to the disposition of an existing nonconformity, whereas the "Corrective Action" relates to the elimination of the causes of nonconformity.
Thanks to Doug Tropf for your informative Post and/or Attachment!
  Post Number #6  
Old 30th December 2008, 06:53 PM
Gumaer

 
 
Total Posts: 10
Re: Definition of Rework Vs Repair-ISO 13485

Define each in your procedure utilizing the 9001 defs. This will satisfy 99% of auditors. The other 1% may list it as an observation and offer a suggestion on bringing it to THEIR satisfaction.
  Post Number #7  
Old 30th December 2008, 07:18 PM
Arie0712 - 2010

 
 
Total Posts: 21
Re: Definition of Rework Vs Repair-ISO 13485

Thanks Gumaer - what you wrote looks very reasonable.
  Post Number #8  
Old 30th December 2008, 07:32 PM
DannyK

 
 
Total Posts: 626
Re: Definition of Rework Vs Repair-ISO 13485

Ensure that a technical authority has authorized the repair and since the product does not meet the fit, form and function, you may have to ask for a concession.

I perform audits to ISO 13485 and it is very rare that I see the repair disposition since most companies do not find it worthwhile to repair a medical device since the repair may affect the reliability and functionality of the device and they do not want to ask for a concession from their clients.
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