Validation Requirements: ISO 9001 vs. ISO 13485?

T

treesei

#1
My employer is 13485 certified. However, lots of our suppliers (providers of parts and/or raws) are only 9001 certified. There are validation requirements in both 13485 and 9001. The wording in 9001 is "weak" but the basics seems the same. What would be the reasonable requirement to these 9001 suppliers in process/equipment validation? Thanks! (We make cable assemblies for medical devices).
 
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G

Gert Sorensen

#2
Re: validation requirement: 9001 vs 13485?

My employer is 13485 certified. However, lots of our suppliers (providers of parts and/or raws) are only 9001 certified. There are validation requirements in both 13485 and 9001. The wording in 9001 is "weak" but the basics seems the same. What would be the reasonable requirement to these 9001 suppliers in process/equipment validation? Thanks! (We make cable assemblies for medical devices).
The requirement to validate a process is usually:

*That you cannot verify the quality afterwards.
*That the process is considered critical
*That you want to use the validated state for marketing purposes.

IMO you only validate processes where there is a very good reason to do it. Validation is an expensive and tiresome process, and you can practically break a company if you want to validate everything.

If your suppliers provide you with 1 or 2 of the above you should require validation, if not you should have a good description of the quality that you expect. :bigwave:
 
Last edited by a moderator:
M

maxwell

#4
As long as you can verify the resulting output by measurement thier is no need to validate. For cables I would think physical measurements and functional testing would suffice.
 

RCW

Quite Involved in Discussions
#5
(We make cable assemblies for medical devices).
Do you perform any soldering functions during the manufacturing of your cable assemblies? Many companies consider soldering a special process which would fall under the validation umbrella.

Just providing food for thought.
 
T

treesei

#6
RCW,

Yes we do.

But is soldering a process that I can verify the quality afterwords?

Thanks, the food being delicious.:)
 

RCW

Quite Involved in Discussions
#7
But is soldering a process that I can verify the quality afterwords?
I have had to debate this one before from both sides of the fence.

Yes, you can visually inspect for the contour of the solder fillet and for any solder defects such as voids or blow-holes. This is usually a good indication of a proper solder joint.

No, you cannot visually inspect the intermetallic bond, where the true solder bond occurs. You could do destructive testing by cutting open a solder joint to visually inspect it but is there really a need to go that far? (I vote no.)

That's probably why some (but not all) customer companies want you to validate your soldering processes. It really depends on your customer(s) and how you want to handle it.
 
D

DRDDO

#8
Dear Friend,
I recommend you read: GHTF/SG3?N99-1-: 2004, QMS -process validation Guidance,
By Google, type: GHTF/SG3?N99-1-: 2004
or Type GHTF-Process validation,
Very good Document,
:thanx:
DRDDO
 
P

phenol

#9
RCW,

Yes we do.

But is soldering a process that I can verify the quality afterwords?

Thanks, the food being delicious.:)

Hi,

Some throughts on verifying the quality afterwords.

Just give you an example for products like cosmetics and toiletries in which a critical process (Mixing- e.g. time & temperature controlled) is involved will serious affect the stablility of the products, in this case it is difficult to measure the safety level & quality of product immediately until after certain period of time, there's a need to validate the critical process.

To decide whether process validation is needed it's depending on those processes are seriously affecting customer or product requirements.

Phenol
 

harry

Super Moderator
#10
My employer is 13485 certified. However, lots of our suppliers (providers of parts and/or raws) are only 9001 certified. There are validation requirements in both 13485 and 9001. The wording in 9001 is "weak" but the basics seems the same. What would be the reasonable requirement to these 9001 suppliers in process/equipment validation? Thanks! (We make cable assemblies for medical devices).
You can't really compare the two. ISO 13485 is industry specific whereas as ISO 9001 is purposely being vague because it has to cater to industries ranging from high tech and complex to low tech and simple ones.

Then there are product certifications to consider also. An ISO 9001 certified manufacturer of cables would have different processes, validation methods and testing methods for the different type of 'certified' cables it produce. Thus, 'VDE' certified cables had different testing and validation requirements than say a 'JIS' certified cable.
 
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