Is a Manufacturer's Certification good enough or is ISO 17025 Certification required

Wayne

Gage Crib Worldwide
#1
So here is the situation; in selling new testing tools; GO/NOGO Gages; Reference Connectors; specialized machines...

Is the certification of the original manufacturer acceptable; or is the certification only acceptable if it is ISO 17025 registered?

It seems to me that ISO 17025 is a certification level achieved by calibration laboratories, not manufacturers.

Is there a provision in some specification (ISO 9000 or ISO 17025) which allows an ISO 9000 manufacturer to issue a certification acceptable to ISO 17025 minded people without the manufacturer also becoming ISO 17025 registered?
 
Elsmar Forum Sponsor
#2
Re: Is a Manufactur's certification good enough or is an ISO 17025 certification requ

Wayne: It's going to depend on what the manufacturer understands by calibration! I once encountered a brake test unit which, when asked, the manufacturer said "It self calibrates"...

Well, maybe, but when we put on on the brake pedal and it's supposed to push 50# for 5 mins without any reduction (a brake leak) then it had better read accurately!

So, if the supplier can give you the "right numbers", they may not have to be accredited to ISO/IEC 17025. If they can, however, you might question, why aren't they?
 

Rustedamy

Starting to get Involved
#3
Re: Is a Manufactur's certification good enough or is an ISO 17025 certification requ

Wayne: The level of acceptable calibration depends on to what standard the purchaser is being held.
For example, we are an ISO/IEC 17025 accredited laboratory so our external calibrations must be performed by an ISO/IEC 17025 accredited calibration laboratory. This is a requirement of our accreditation body.
If a manufacturer can offer me a product with an ISO/IEC 17025 accredited calibration certificate at point of sale it saves me from having to purchase the product then send it immediately out for an ISO/IEC 17025 accredited calibration.
Any provisions for the acceptability of an ISO 9000 certified manufacturer's ISO/IEC 17025 "compliant" calibration would come from the certifying/ accrediting body rules governing acceptable calibration and traceability.
 
#4
Re: Is a Manufacturer's Certification good enough or is ISO 17025 Certification requi

The ISO 9001 (not ISO 9000) requires that the calibration be done against a standard that is traceable to an international or national standard (usually NIST in the United States). The calibration company does not need to be accredited to ISO 17025, which goes above and beyond what ISO 9001 requires.

The automotive standard (ISO/TS 16949) does require that an ISO 17025 calibration company be used. AS9100 does not.

There are many good reasons to use a calibration company that is accredited to ISO 17025 though. I would consider it to be a best practice even when not required.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#5
Re: Is a Manufacturer's Certification good enough or is ISO 17025 Certification requi

Sorry if this is a stupid question, but I have to ask: Do you manufacture the tools or are you a reseller?

If you are a reseller, the External Laboratory sub-element 7.6.3.2 does not apply because the responsibility is placed upon the manufacturer.

7.6.3.2 of TS 16949 requires 17025 for external/commercial/independent laboratories, so if you are performing calibrations for tools you manufacture then yes your laboratory needs to be accredited to 17025 or its equivalent. I would like to add that I have seen very few certificates with new tools that would pass an audit under 7.6 because the traceability was almost always missing. Sometimes the little certificates say "certificate of accuracy" but specify they are not evidence of calibration. Other people's experiences may vary. Anyway, this tends to indicate to me the internal laboratory at the manufacturer may not be 17025 accredited so the buyer is responsible to have the tools verified by a qualified lab before they are used to evaluate product acceptance.

However, there is a clause that says you can have evidence your customer accepts the laboratory instead of 17025 accreditation. This is not practical for a manufacturer of inspection equipment who sells to resellers, who then sell to whomever without having the chance to approve your laboratory.

I hope this helps!
 

cferrer

Involved In Discussions
#6
Let us bring this clarification up to date.

There is a position statement from the National Metrological Institute of Germany from 2018 that states that they DO NOT see in clause 7 of ISO/TS 16949 an implicit requirement for manufacturers of measurement or test equipment to have accreditation according to ISO 17025 as a Calibration Lab.

It is however, expected that the traceability and integrity requirements are met, which in turn, kind of means (or I interpret) that the manufacturer must anyway meet the requirements to the caliber of ISO 17025 regardless of whether they have accreditation or not under ISO 17025.

In view of this, and assuming that Wayne's firm is the manufacturer, then the answer to the question of whether it is sufficient for a manufacturer to deliver an in-house factory calibration certificate that lives up to the caliber of an ISO 17025 Calibration Certificate would have to be YES. This is of course assuming that the factory calibration certificate is made "in the image of" an ISO 17025 calibration certificate. The implicit risk here is that there is no third party involved and the one is essentially trusting the manufacturer. However, this risk can be offset if the manufacturer can show evidence of measurement integrity and traceability and even more if the customer can audit the manufacturer themselves.

Can anyone either challenge or confirm this information?
 
#7
I would agree. Be careful though that it is an actual certificate of calibration showing traceability to national or international standards. Some manufactures provide a statement of manufacturing stating that traceable standards were used, but don't provide that traceability. That will not meet ISO 9001 and related quality management systems requirements because the traceability is not provided.
 

dwperron

Trusted Information Resource
#8
Can anyone either challenge or confirm this information?


In 16949, Laboratory Requirements External Laboratory covers calibrations performed by an outside source. The OEM would fall into this category. It contains two methods to determine whether a calibration provided will be considered adequate by 16949. The second is the easy way - the lab is 17025 accredited. The other method is that "there shall be evidence that the external laboratory is acceptable to the customer". Note 1 continues that "Such evidence may be demonstrated by customer assessment..." This means that you can determine that the calibration provided is adequate for your purposes, 17025 accreditation is not required. You should be prepared to present your "evidence" of this assessment.
 
#9
people that need 17025 certs (17025 test and cal labs) will have to send the tool out to a calibration lab to get a 17025 cert. There are manufacturers with 17025 certs.
 
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