Hello,

I am a junior in the quality field and I really wish I could contribute to this forum because I so appreciate the wealth of information I found here.

My question is which standards such as: ISO9001, TS16949, Z299 series, N285 and N286 series: require that the outsource, in-house or original equipment manufacturer calibration labs are 17025 certified? Correction: accredited... I just learned another thing browsing through here :)

 ............... Outsource(If yes, which?).......... In house(If yes, which?)........... OEM(If yes, which?)
ISO9001
TS16949 ........... YES ...................................... no ............................................. ?
Z299.1
Z299.2
Z299.3
Z299.4
N285.X
N286.X
AS? (aerospace)
other
other
other


Was trying to post the table to reiterate my question.
Is there an official source on the internet that I may quote in my audits?

Thanks in advance for the help, which I'm sure will be pouring :D

Welcome to the Cove!

Lots of folks here have a wide range of experience with Standards and should able to help quite a bit.

I am given to understand that TS-16949 does require cal labs and test labs to be accredited. Some of the others I am not quite as sure, but regulators in various areas and fields may also require accreditation.

Welcome to the Cove!

Lots of folks here have a wide range of experience with Standards and should able to help quite a bit.

I am given to understand that TS-16949 does require cal labs and test labs to be accredited. Some of the others I am not quite as sure, but regulators in various areas and fields may also require accreditation.

Hershal,

Maybe this helps.

From ISO/TS 16949:2002:

7.6.3.2 External laboratory

External/commercial/independent laboratory facilities used for inspection, test or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test or calibration, and either
- there shall be evidence that the external laboratory is acceptable to the customer, or
- the laboratory shall be accredited to ISO/IEC 17025 or national equivalent.

NOTE 1 Such evidence may be demonstrated by customer assessment, for example, or by customer-approved second-party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent.

NOTE 2 When a qualified laboratory is not available for a given piece of equipment, calibration services may be performed by the equipment manufacturer. In such cases, the organization should ensure that the requirements listed in 7.6.3.1 have been met.

Stijloor.

Besides TS16949, I know that UL (Underwriter's Laboratories) requires ISO 17025 accredited calibration for measurment equipment used by clients looking to have their products UL listed.

UL allows various companies to perform their own testing when getting a product approved. The company submits test results to UL or does the testing with a UL auditor. Any test equipment used has to be done by an ISO 17025 accredited calibration lab.

Note that there is another difference between the requirements of these two standards. I know QS9000 (the predecessor to TS16949) did list that the lab had to be accredited by A2LA, NVLAP, or other 3rd party approved accrediteing body (or some similar wording). There was a list of companies like Perry Johnson, LAB, ACLASS and others who are acceptable to GM and therefore acceptable under QS9000 (I think the same requirement might have been in TS16949).

This being said, UL says an accrediting body who accredits a cal lab to 17025must be a signatory to the ILAC mututal recognition agreement. This would mean that (in the US as of today), A2LA, IAS, ACLASS, LAB and NVLAP would be the only people acceptable to accredit people to ISO 17025.

This is an important distinction becuase as each of these standards points out that calibration needs to be done by an accrdited lab, they define further who may accredit people to 17025 This puts on the end user the requirement to not only find someone who can send them a 17025 accrditation certificate, but someone who can provide them a certificate from the right accrediting body.

This helps avoid no name accrediting bodies to pop up and "accredit" people. It helps establish consistency within the measurement community.

I do not know much about ,any of the standards that you have listed. I hope some if this is useful to you.

A pedantic answer to this question of standards requiring ISO 17025 accreditation follows:

I am fairly sure from personal experience that ISO (and also CEN) drafting rules at least, do not allow the drafting group to absolutely require ISO 17025 accreditation in a "shall" clause. There will always be options such as the ones quoted by Stijloor - "or equivalent" , "acceptable to the customer" etc.

Hi, Merit

There is a difference between ISO 17025 and ISO 9000 in the way of getting this 3rd party recognition. First the term as you have observed: you don't get CERTIFIED with 17025. You get ACCREDITED.

The second difference with these is that the assessment and accreditation is done only by the accreditation bodies (actually the same ones that accredit the certifying bodies). In Canada I believe it is the Standards Council of Canada (SCC) which grants accreditation to ISO/IEC 17025 for qualified calibration laboratories. UK, go see: www.ukas.com , International: www.ilac.org .

The third difference (and this is the most important one) to ISO 9000 is that the assessment is much much deeper in technical aspects. They are using real experts (e.g. from the national laboratories) who really know everything about calibration to a couple of decimals better than you, not just someone with general knowledge. Of course you need to have the quality system too.

Purpose is that the millimeter would be the same everywhere.

Raimo
"used to be ISO 17025 assessor"

Thanks to all!

I'll have to dig deeper to find more info or maybe rephrase my question... From an auditor's point of view, auditing to any of the above mentioned standards and codes, should I be asking to see the 17025 accreditation for outsource, OEM and in house calibration laboratories?

Cheers!

The accreditation body allows the accredited laboratory to use its accreditation mark or accreditation logo on the reports given by the laboratory. That is how an auditor can simply check that accreditation. Of course, if you are very suspicious, you go to the accreditation body's pages and look whether they have listed the laboratory. And while doing that, you may also check the "scope" of the laboratory. They may be restricted to e.g. calibration of length only up to 1000 mm. That means that the accreditation has not checked the ability to calibrate long tape measures. Only calipers.

Here is a link to a page at my former employer explaining the logo thing. You can probably find similar at every accreditation body. The ILAC pages have an extensive list of all accreditation bodies.

http://www.finas.fi/page.aspx?pageID=226&contentID=10

And by the way, laboratories don't get accredited only for calibration. Testing all kinds of equipment is equally accreditable. With appropriate technical experts (of course), I've been involved in assessing testing of speed radars, alcometers, mobile phones, HV electrical equipment....

Welcome, merit.

Good thing you picked up on "certification" vs. "accreditation" because the Accreditation manager for my country would have kittens if she heard someone saying "ISO 17025 certified".

I've been using the ISO 9001:2000 since 2001 and am not aware of any *requirement* in the standard that an outsourced service be done at an accredited lab.

If there is a requirement in the company's QMS that they use accredited labs for particular activities (i.e., testing and/or calibration) then its auditable (provided that's within your/the auditor's scope).

And, as you have not mentioned it, I hope you are aware that clinical labs are accredited to the ISO 15189 standard, not (normally) the ISO 17025.

Can't help with the other standards, sorry.

What an auditor can require is one thing, the other is what quality you need?

Accreditation is same kind of assurance that a subcontractor (in this case calibration laboratory) has a proper quality system than ISO 9001 is for other suppliers. Actually it is a much better one, since the laboratory is also "technically" inspected, not only for quality system.

What kind of quality control do you use for other subcontractors? I suggest to select the same level for your metrology subcontractor, especially if your own competence in that area is not strong. What is your risk if your measurements are off tolerance? How soon will you start getting parts back from your customer?

So, if you generally require certification from your suppliers, then require accreditation for your calibrations.

Thanks to all!

From an auditor's point of view, auditing to any of the above mentioned standards and codes, should I be asking to see the 17025 accreditation for outsource, OEM and in house calibration laboratories?



Correct me if I am wrong...
If auditing an ISO 17025 accredited Lab, there is definitely a need to check if the Lab is engaging a 3rd party (Outsource, OEM), which is ISO 17025 certified depends on the Lab as specified in the QM. If otherwise, some assessment and records must be review.

For those standards and codes, it should be specify somehow in the requirements if ISO 17025 accreditation is required for engaging outsource vendors, suppliers, OEM and Cal Labs.

Correct me if I am wrong...
If auditing an ISO 17025 accredited Lab, there is definitely a need to check if the Lab is engaging a 3rd party ...

I think there might be only two possibilities to add value by doing supplier audit at an accredited laboratory, since the accreditation body has already done it thoroughly. If your supplier uses a subcontractor, then the accreditation has most likely checked that too, if it is in the accreditation scope.

1) You learn some tricks of the calibration which you may not have known.

2) If the calibration that you need is NOT in the accredited scope of the laboratory. It may be that the laboratory is good in calibrating for linear measurements up to 50 mm but has not for some reason acquired accreditation for longer lengths. (And this may be essential).

there is a clause in iso 17025 about subcontracting. usually, all subcontracted work that is accredited to the lab, whenever outsourced, must be sent to another equivalently accredited laboratory that has the scope covered or more superior than the laboratory itself (maybe because the reference standard broke down etc.)

just to add, I think RoHS requirement for certain companies require the chemical testing/analysis to be performed by an accredited laboratory..

Thanks to all!

I'll have to dig deeper to find more info or maybe rephrase my question... From an auditor's point of view, auditing to any of the above mentioned standards and codes, should I be asking to see the 17025 accreditation for outsource, OEM and in house calibration laboratories?

Cheers!

I think your question was clear, and so far, the answers seemed to be clear, as well.

TS-16949 clearly requires it.

Apparently UL also requires it for companies requesting products to be approved.

Companies may choose to voluntarily require it under their own supplier control systems.

The other standards you cite did not draw any response. They are not very familiar to me. If you audit to these other standards, it should be clear by reading their requirements, whether there are any lab requirements.