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Related Topic Tags
rework, definitions, repair and or overhaul
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  #1  
Old 30th December 2008, 03:43 PM
Arie0712 - 2010 Arie0712 - 2010 is offline
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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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  #2  
Old 30th December 2008, 03:51 PM
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Coury Ferguson Coury Ferguson is offline
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Re: Rework Vs Repair

See here: Repair

Here for: Rework

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Old 30th December 2008, 03:59 PM
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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.

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Old 30th December 2008, 04:14 PM
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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.

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Old 30th December 2008, 04:50 PM
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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.

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Old 30th December 2008, 05:53 PM
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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.
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Old 30th December 2008, 06:18 PM
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Re: Definition of Rework Vs Repair-ISO 13485

Thanks Gumaer - what you wrote looks very reasonable.
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Old 30th December 2008, 06:32 PM
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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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