It is required that External labs be also certified to ISO 9001?

[Golfman25]

I just had a question on this topic about external laboratory.

8.4.2.4 Monitoring of the external provider.
Should I have your performance in the same way as other providers?
In current practice we use the score card for our suppliers.
But taking a look, I'm not evaluating the performance of the external laboratory.:mg:

What practice do you recommend?
What do you use?

Unless they are a regular vendor, I am not sure how you really "monitor" a lab. Ours does its work once a year for calibrations. They either do a good job or they don't.

 

[mwohlg]

Sometimes suppliers have to educate customers who don’t know what they want or need. What if explaining the issue to the buyer who has no idea of what 9001 or 17025 is, saves your company/lab $2 to $5 thousand a year and, more, avoid the disruption of another audit? Wouldn’t that be worth explaining it to the non technical buyer you are dealing with?

Perhaps. I can also foresee where non-technical buyers don't want to hear explanations, it just sounds like excuses. When looking at 3 quotes from 3 different labs, and 2 of the 3 have both ISO9001 AND ISO17025, the third only has 17025 and a long detailed explanation as to why it is acceptable according to the standard blah blah blah blah, well the third lab is just not gonna get that job. So the business decision to save $2 to $5 thousand a year might cost the lab tens of thousands of $$ in lost business.

 

[Golfman25]

Perhaps. I can also foresee where non-technical buyers don't want to hear explanations, it just sounds like excuses. When looking at 3 quotes from 3 different labs, and 2 of the 3 have both ISO9001 AND ISO17025, the third only has 17025 and a long detailed explanation as to why it is acceptable according to the standard blah blah blah blah, well the third lab is just not gonna get that job. So the business decision to save $2 to $5 thousand a year might cost the lab tens of thousands of $$ in lost business.

In my world, that would be fine. I'm too old to tolerate incompetence any longer.

 

[Sidney Vianna]

Perhaps. I can also foresee where non-technical buyers don't want to hear explanations, it just sounds like excuses. When looking at 3 quotes from 3 different labs, and 2 of the 3 have both ISO9001 AND ISO17025, the third only has 17025 and a long detailed explanation as to why it is acceptable according to the standard blah blah blah blah, well the third lab is just not gonna get that job. So the business decision to save $2 to $5 thousand a year might cost the lab tens of thousands of $$ in lost business.

Maybe, just maybe, it is a blessing in disguise to avoid doing business with a customer that forces a lab to attain a totally irrelevant approval, costing them money along the way, just to send them a request for cost cutting, a month later.

Not everyone is in a position to stop doing business with dysfunctional customers, but, if you are, good for you.

 

[Sebastian]

Our opinions are irrelevant until there is Si issued stating clearly that external laboratory supplying us with measurement, calibration services shall not be ISO 9001 certified. It is good that still we have such auditors who see more in standard than we do.

 

[Golfman25]

Our opinions are irrelevant until there is Si issued stating clearly that external laboratory supplying us with measurement, calibration services shall not be ISO 9001 certified. It is good that still we have such auditors who see more in standard than we do.

No it is not. Auditors shouldn't make stuff up that is not there or that is counter intuitive. If it isn't a clear requirement it's up,to the drafters to correct it, not for auditors to interpret it.

 

[dwperron]

Maybe, just maybe, it is a blessing in disguise to avoid doing business with a customer that forces a lab to attain a totally irrelevant approval, costing them money along the way, just to send them a request for cost cutting, a month later.

Not everyone is in a position to stop doing business with dysfunctional customers, but, if you are, good for you.

Back in my third party days I would love to have a competitor with that mindset. And I would probably enjoy the customers I took from them.

Companies that don't pay in a timely fashion, that demand expedited services, that don't cooperate with you on onsites, those are the customers that you don't mind losing. But a customer that asks that you maintain a basic quality program... that's no reason to lose them.

 

[Sidney Vianna]

But a customer that asks that you maintain a basic quality program... that's no reason to lose them.

ISO 17025 is basically that. A QMS for the lab. With the 2017 edition, even more explicitly.

In my opinion, this is akin to ask a Medical Device Manufacturer that is certified to ISO 13485 to also maintain an ISO 9001 certificate. Valueless in my estimation.

 

[Sebastian]

Common sense is a variable thing. It depends on knowledge.
Latest ISO 9001 edition is 2015, latest ISO 17025 edition most (all) laboratories are certified is 2005. Edition years are mismatching, so there is no chance 17025 was aligned to latest 9001.
ISO 9001 is management standard, while ISO 17025 is not. It is focused on laboratory core activity only.

In edition 2017 as I see from draft, it was finally recognized and laboratory has two options: establish management system according to option A, where some of ISO 9001 elements are mentioned or option B where fully ISO 9001 compliance can be claimed. I do not have final edition, so I can't say more.

I would be happy to see IATF 16949 SI stating I am wrong, or even I am right, IATF in case of laboratories accepts ISO 17025 accreditation only instead of ISO 9001 certification.
Still I am very happy, that there are auditors who consider something unconsidered so far. It bring us further, even some say it wont.

Best regards and end of comments from my side in this topic.

 

[Sidney Vianna]

What you might fail to realize that many people in policy-setting positions in the IATF peruse this Forum and use the information and opinions provided here to decide on issues related to their standards.

Although, they will never admit to it, the ISO TC 176 decision to "delete" preventive actions from the 2015 Edition of the ISO 9001 standard was due, in great part, to numerous discussions we've had here at The Cove. Ditto for the requirement added to ISO 9001:2015 about ensuring that the QMS requirements are embedded in the organization's business process. So, this space is, indirectly, an influencing force in the development of global standards and conformity assessment policies.

Soon, it should be announced a very important chairmanship to a Cover contributor.

As for the rationale to require calibration labs, which already have a proper accreditation to ISO 17025, to also attain certification to ISO 9001, we have to return to basics:

What is the purpose of requiring such certifications? The answer is: to increase confidence in the supplier's capabilities to fulfill orders and add trustworthiness in the supply chain.

Would an ISO 9001 certificate bring enhanced confidence to a (properly accredited) calibration/test lab? The answer is NO.

So, in the spirit of getting rid of non value added activities, when the IATF comes up with an official position, they should clarify as such. Keep in mind that, just like in the ISO 9001 world, there are bogus (non accredited and pseudo accredited) ISO 17025 certificates of accreditation. So, buyer be ware still applies.

PS. As evidence of the IATF paying attention to what this Forum offers, check the development of the IATF Definitions - Reworked product (8.7.1.4) vs Repaired product (8.7.1.5) thread.