Internal laboratories to be accredited to ISO 17025?

D

David Bear - 2010

#11
What is an internal lab?

I am trying to determine if my facility needs a 17025 certification from the people testing our parts. Our parts are tested in two separate facilities.

The first facility is a central testing location within our company in a different state.

The second facility is our customer/designer. Our customer designed the parts and we fabricate them. The parts are shipped to their customer, our customer has nothing to do with our daily operations. We originally tested the parts at our facility, then moved the test equipment to their facility.
 
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B

Bigfoot

#12
David Bear said:
I am trying to determine if my facility needs a 17025 certification from the people testing our parts. Our parts are tested in two separate facilities.

The first facility is a central testing location within our company in a different state.

The second facility is our customer/designer. Our customer designed the parts and we fabricate them. The parts are shipped to their customer, our customer has nothing to do with our daily operations. We originally tested the parts at our facility, then moved the test equipment to their facility.
David - Could you provide a bit more detail about the testing of the part? What type of testing? What is the application the part is going into? Is there a potential for product liability to be concerned about?

Based on what you have provided here "Your" facility (where the part is made) isn't doing the testing so there isn't a need for a 17025 certification. The Central facility where the testing is being done (off site) may need to look into 17025 and determine the need depending on the product, the type of testing, & your customers requirements.

Your customer or their customer would be the best source of information regarding the need to be 17025 certified.
 

Miner

Forum Moderator
Staff member
Admin
#13
David Bear said:
I am trying to determine if my facility needs a 17025 certification from the people testing our parts. Our parts are tested in two separate facilities.

The first facility is a central testing location within our company in a different state.

The second facility is our customer/designer. Our customer designed the parts and we fabricate them. The parts are shipped to their customer, our customer has nothing to do with our daily operations. We originally tested the parts at our facility, then moved the test equipment to their facility.
First of all, ISO 17025 only applies to companies that offer calibration (not testing) services. Your scenario does not seem to involve calibration, but does seem to involve product testing done outside of your facility.

This would fall under ISO 9001 or TS16949. You did not state whether you were registered to either of these, but I will assume ISO 9001.

The outside testing could fall under 7.4, Purchasing, for your central testing location, definitely under 8.2.4, Monitoring and measurement of product. You would need to demonstrate that they are qualified to perform the testing, have the current requirements, provide test records that comply with all ISO 9001 requirements, etc.

The customer facility will depend on the contract and how the testing is used. If the customer is using your equipment to perform receiving inspection, the only issue that you need to concern yourself with is who is responsible for calibration of the equipment. If you are responsible, do you calibrate the equipment yourself or use an external calibration lab. If the external lab, the external lab should be registered to ISO 17025. If you do it, you must comply under ISO 9001, 7.6, Control of monitoring and measurement devices.

If the customer tests, then provides results back to you to take action on, a number of ISO 9001 clauses may apply.

Bottom line is:
  • Your company's test facility does not need ISO 17025
  • Your customer does not need ISO 17025
  • An external calibration company should be ISO 17025 registered.
 
D

David Bear - 2010

#14
Bigfoot said:
David - Could you provide a bit more detail about the testing of the part? What type of testing? What is the application the part is going into? Is there a potential for product liability to be concerned about? QUOTE]

The testing includes endurance, strength, durability, fatigue, rigidity, etc. (generally life cycle, strength and environmental testing). There would be a potential for product liability as some of these tests include safety and significant characteristics. The facilities doing the testing are very knowledgeable concerning the tests, but are not certified to 17025 (our Central facility may be certified, but I have not received verification of this, our customer's lab is not certified).
 
B

Bigfoot

#15
David Bear said:
Bigfoot said:
David - Could you provide a bit more detail about the testing of the part? What type of testing? What is the application the part is going into? Is there a potential for product liability to be concerned about? QUOTE]

The testing includes endurance, strength, durability, fatigue, rigidity, etc. (generally life cycle, strength and environmental testing). There would be a potential for product liability as some of these tests include safety and significant characteristics. The facilities doing the testing are very knowledgeable concerning the tests, but are not certified to 17025 (our Central facility may be certified, but I have not received verification of this, our customer's lab is not certified).
From the sound of things it would appear that this would be mostly Mechanical Testing to determine the performance characteristics of the part. You also mention that safety & significant characteristics are involved and there is potential for product liability. I know that some industries conduct ongoing Mechanical testing as a means of Certifying their product in meeting the specifications that are applicable (example would be fasteners). Where this type of testing is being done for this purpose it is very common for the Internal Testing lab to be accredited by an external source, ala A2LA, which if they pass results in their being issued a certificate to ISO 17025. I hope this helps. There are many in these forums with far greater experience in this than I and hopefully they will provide their input to this. ;) Good luck.
 
B

Bigfoot

#16
Miner said:
First of all, ISO 17025 only applies to companies that offer calibration (not testing) services. Your scenario does not seem to involve calibration, but does seem to involve product testing done outside of your facility.

This would fall under ISO 9001 or TS16949. You did not state whether you were registered to either of these, but I will assume ISO 9001.

The outside testing could fall under 7.4, Purchasing, for your central testing location, definitely under 8.2.4, Monitoring and measurement of product. You would need to demonstrate that they are qualified to perform the testing, have the current requirements, provide test records that comply with all ISO 9001 requirements, etc.

The customer facility will depend on the contract and how the testing is used. If the customer is using your equipment to perform receiving inspection, the only issue that you need to concern yourself with is who is responsible for calibration of the equipment. If you are responsible, do you calibrate the equipment yourself or use an external calibration lab. If the external lab, the external lab should be registered to ISO 17025. If you do it, you must comply under ISO 9001, 7.6, Control of monitoring and measurement devices.

If the customer tests, then provides results back to you to take action on, a number of ISO 9001 clauses may apply.

Bottom line is:
  • Your company's test facility does not need ISO 17025
  • Your customer does not need ISO 17025
  • An external calibration company should be ISO 17025 registered.
I believe there are provisions for Mechanical Testing in 17025 as well as calibration, otherwise there are an awful lot of Testing labs that have gone through a very extensive / expensive process for no reason. ;)
 

Helmut Jilling

Auditor / Consultant
#17
Miner said:
First of all, ISO 17025 only applies to companies that offer calibration (not testing) services. Your scenario does not seem to involve calibration, but does seem to involve product testing done outside of your facility.

This would fall under ISO 9001 or TS16949. You did not state whether you were registered to either of these, but I will assume ISO 9001.


I believe ISO 17025 applies to testing and calibration labs. It is not limited to calibration.

Internal labs in TS-16949 or ISO 9001 certified companies are not required to be accredited to ISO 17025, but it is permitted.
 

Miner

Forum Moderator
Staff member
Admin
#18
hjilling said:
I believe ISO 17025 applies to testing and calibration labs. It is not limited to calibration.

Internal labs in TS-16949 or ISO 9001 certified companies are not required to be accredited to ISO 17025, but it is permitted.
I stand corrected. Thanks to Bigfoot and hjilling for the catch.

In any case, if your customer contract does not require these labs to be registered to ISO 17025, then the rest of what I said still holds true.

Given the additional information about product liability, it may be desireable for you to seek registration. In the event of litigation, it would help show that the company took every possible measure to protect against defectives. But it is not a requirement.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#19
If your internal lab is in fact performing tests that include:

"The testing includes endurance, strength, durability, fatigue, rigidity, etc. (generally life cycle, strength and environmental testing). There would be a potential for product liability as some of these tests include safety and significant characteristics."

Then an accreditation under ISO/IEC 17025 is certainly a good thing. Your lab would not be anywhere even close to the first internal lab to be accredited.....it is not terribly uncommon.

Also, for your accrediting body, do NOT center on one accrediting body until you have talked to ALL SIX operating in North America that are recognized under the Mutual Recognition Arrangements (MRAs).....they are IAS, A2LA, NVLAP, SCC, L-A-B, ACLASS.

Hope this helps.

Hershal
 
D

David Bear - 2010

#20
Thank all of you for your help! :thanks:

I will suggest to my company that it would be beneficial if our testing facility was certified to ISO/IEC 17025 (if they are not already certified). All of our manufacturing facilities in North America are currently certified to either QS9000 or TS16949.

I am not aware that our customer doing the testing has been certified to anything yet. They are a new Tier 2 facility that is only just beginning to ramp up production. (They only test our parts - they do not use them and rarely ever see our regular production parts - we ship our parts directly to other Tier 1 facilities).

We are paying both facilities to do the testing.

I apologize to all if I am vague in my postings. I have recently began auditing our processes and I am still at the beginning of a big learning curve.
 
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