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

[Sebastian]

Availability depends on request. If requested by organization from automotive industry, laboratory has to follow, or organization has to get waiver from customer side. So there is an option and we have to use it, as backup.

If your, my auditors did not ask about it for years, it does not mean interpretation of auditor quoted in this topic is wrong. He is absolutely right. Doing whole life mistakes does not transform these mistakes into good actions.

In ISO 17025 draft I've found two options. One of them is to establish management system in accordance with the requirements of ISO 9001, so certification with accreditation is possible. Second option results only in accreditation. I do not know what states final edition, but laboratory with ISO 9001 could be available.

After all, it is good point for next SI or ISO/IATF official statement, that ISO 17025:2017 accreditation can be used interchangeably with ISO 9001:2015 certification.

 

[Golfman25]

Well looking deeper into the standard, there is a difference between 8.4.1.1 and 8.4.2.3. 8.4.1.1 applies to "externally provided products, processes, and services." 8.4.2.2 applies specifically to to "suppliers of automotive products and services."

I don't think 8.4.2.2 applies to calibration labs. That's my out until further guidance.

 

[Golfman25]

Availability depends on request. If requested by organization from automotive industry, laboratory has to follow, or organization has to get waiver from customer side. So there is an option and we have to use it, as backup.

Sorry, but the laboratory doesn't have to do jack squat. I can guarantee you if I asked our laboratory provider to do ISO 9000, they would laugh at me. And getting several customer waivers wouldn't be fun neither.

 

[Sebastian]

There is a logic flow in 8.4 section, and even we have also "calibration" mentioned in 8.4.1.1, although some say its place should be only somewhere in 7.1.5.3.

Product or service coming from external source become "automotive" when they are connected with product we supply to automotive customer.
Stamping plate can be automotive or non-automotive, nevertheless it comes from a same manufacturing process. Destination makes a difference and one time ISO 9001 is enough and other time IATF 16949 is required.

 

[Sidney Vianna]

What a reasonable IATF 16949 auditor should think, in my estimation:

Would an ISO 9001 certificate enhance confidence in the laboratory's capabilities, if they are already properly accredited to ISO 17025?

Would the lack of an ISO 9001 certificate for that laboratory represent a higher risk for the automotive supply chain?

I would say no to both counts and not expect the lab to have an ISO 9001 certificate.

We ALWAYS HAVE TO remember what is the end goal with these certificate mandates. Confidence build up. If compliance to a standard and independent certification does not enhance confidence to stakeholders, it is just an added cost with no return; in other words, a bad business decision.

 

[dwperron]

When I worked in the "third party" world our labs went through the effort, and expense, to maintain both ISO 17025 accreditation and ISO 9001 certification.

Why? Just because of a situation like this. A customer requires 9001 certification, we can make their life easier.

We also spent more time dealing with Purchasing than technical leads, so if the selection process for a calibration provider requires 9001 certification it is much easier to show them the certificate than to try to explain why they don't need it.

All in the name of customer satisfaction.

 

[Sidney Vianna]

When I worked in the "third party" world our labs went through the effort, and expense, to maintain both ISO 17025 accreditation and ISO 9001 certification.

Why? Just because of a situation like this. A customer requires 9001 certification, we can make their life easier.

We also spent more time dealing with Purchasing than technical leads, so if the selection process for a calibration provider requires 9001 certification it is much easier to show them the certificate than to try to explain why they don't need it.

All in the name of customer satisfaction.

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?

 

[dwperron]

It is typical far a company put out requests for a calibration quotation.
Then you need to be placed on the approved vendor list.
A lot of 9001 companies wrote boilerplate documents requiring that suppliers be 9001 certified.
So you get a communication from someone in purchasing to fill out their vendor survey. One of the questions asks you to provide your ISO 9001 certificate.
If you don't supply it there is a high probability that you will be disqualified as a supplier. They will simply go with the company that provided the certificate. That makes their life easier.

There is no shortage of companies out there that are 9001 certified. It is a cost of business than can be recovered in a single customer who otherwise would have gone with a company that provided their certificate.

And the cost of recovering a lost customer? Priceless.

 

[Hendor]

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?

 

[AndyN]

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?

2 things, both driven by your PO requirements: On time and right first time (to spec)?