Requirements for analytical laboratories under 16949 designation

As you know, the laboratory; all kinds of mechanical, chemical, dimensional, performance, metallurgical, etc. is a center that provides measurement, testing, and calibration services. We must consider two types of laboratories, internal and external laboratories.  The internal laboratory is the laboratory inside the building that belongs to the organization, that is, your company.   The external laboratory is the laboratory where you receive support and service from outside.

Requirements for the laboratory within the organization according to the IATF 16949: 2016 standard are given below.

7.1.5.3.1 lnternal laboratory

An organization's internal laboratory facility shall have a defined scope that includes its capability to perform the required inspection, test, or calibration services. This laboratory scope shall be included in the quality management system documentation.

The laboratory shall specify and implement, as a minimum, requirements for:

• adequacy of the laboratory technical procedures;
• competency of the laboratory personnel;
• testing of the product:
•  capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN, etc.); when no national or International standard(s) ls available, the organization shall define and implement a methodology to verify measurement system capability;
• customer requirements if any;
• review of the related records.NOTE Third-party accreditation to ISO/IEC 17025 (or equivalent) may be used to demonstrate the organization's in-house laboratory conformity to this requirement.

Requirements for the external laboratory according to the IATF 16949: 2016 standard are given below.

7.1.5.3.2 External laboratory

ExtemaI/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:

• the laboratory shall be accredited to ISO/IEC 17025 or national equivalent and include the relevant inspection, test, or calibration service in the scope of the accreditation (certificate); the certificate of calibration or test report shall include the mark of a national accreditation body; or
• there shall be evidence that the external laboratory is acceptable to the customer.

NOTE Such evidence may be demonstrated by customer assessment, for example, or by the customer-approved second-party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent. The second-party assessment may be performed by the organization assessing the laboratory using a customer-approved method of assessment. 

Calibration services may be performed by the equipment manufacturer when a qualified laboratory is not available for a given piece of equipment. ln such cases the organization shall ensure that the requirements listed in Section 7.1.5.3.1 have been met. Use of calibration services, other than by qualified (or customer accepted) laboratories, may be subject to government regulatory confirmation if required.

Hello Firat, how does your response change based on the newest 2021 Sanctioned Interpretations about this? Is 17025 no longer an absolute requirement for external calibration labs?

ISO 17025 is always the first requirement. This change is for the calibration of a measuring instrument; valid if an accredited laboratory cannot be found.

@Fırat İnceli

That's what confuses me because the wording was changed from "where an accredited laboratory is not available..." to "where a non-accredited laboratory is utilized..." It seems that everyone I ask is split between saying '17025 is a must' and '17025 is not a requirement as long as the external lab follows 7.1.5.3.1'.

I understand it as the latter, which is what I'm hoping for because 17025 calibrations will be too expensive.

Dear Firat,

Could you please help us understand the requirements for laboratory accreditation based on ISO/IEC 17025 in the case of qualified & approved suppliers for our company, who supply control gauges as part of PPAP requirements for their parts?

We have considered that if the suppliers use their internal laboratory for measuring the control gauges (two gauges, one provided to us), they don't need this accreditation. However, if they measure those gauges externally, for instance at their gauge maker, they need to provide us with a laboratory certificate.

Now, it has been implied to us that if we procure not only parts but also control gauges (measurement devices), even our qualified and approved supplier needs to be accredited according to ISO/IEC 17025.

Could you please help us understand whether this is really the case, and/or what suggestions you might have for handling this topic?

Thank you very much in advance,

Dita Dumele

@Fırat İnceli Dear Firat,

Could you please help us understand the requirements for laboratory accreditation based on ISO/IEC 17025 in the case of qualified & approved suppliers for our company, who supply control gauges as part of PPAP requirements for their parts?

We have considered that if the suppliers use their internal laboratory for measuring the control gauges (two gauges, one provided to us), they don't need this accreditation. However, if they measure those gauges externally, for instance at their gauge maker, they need to provide us with a laboratory certificate.

Now, it has been implied to us that if we procure not only parts but also control gauges (measurement devices), even our qualified and approved supplier needs to be accredited according to ISO/IEC 17025.

Could you please help us understand whether this is really the case, and/or what suggestions you might have for handling this topic?

Thank you very much in advance,

Dita Dumele

According to the IATF 16949 standard 7.1.5.3.1 requirement, the organization shall create its own internal laboratory scope. The internal laboratory does not have to be ISO 17025 accreidation. However, if there is a special customer requirement, this issue may be valid. 

You can perform product measurement, testing and measurement instrument verification process in your internal laboratory. For this, it is sufficient to fulfil the requirements of the standard 7.1.5.3.1.

However, if you use an external commercial laboratory and it is related to product measurement, testing or calibration of measuring instruments, it shall be ISO 17025 accredited according to the 7.1.5.3.2 requirement of the IATF 16949 standard.

The measuring instruments that need to be calibrated can be measuring instruments such as callipers, micrometers, CMMs, temperature indicators, scales, etc., that affect the product and manufacturing processes.

Therefore, when you provide information about measuring instruments related to PPAP, you can present the verification report you made in your own laboratory. However, as you know, you need to use a calibrated device when making verification, and the calibration report of this device shall be accredited according to ISO 17025.

Dear Firat, thank you very much for your feedback, really appreciated. Frankly, we are several seinor quality people looking to this topic and we are still a bit lost. If I summarize: following 7.1.5.3.1 - OUR qualified supplier use their internal laboratory to measure the gauge (one for us and one for them) which is part of PPAP. = they dont need to be accredited. 

However, I need to use a calibrated device when making verification, and the calibration report of this device shall be accredited according to ISO 17025.

To summarize, all our suppliers have to be accredited according to ISO 17025 if they want to submit PPAP (parts, gauges) measured in their internal laboratory. 

Is that correct ?

Thank you again,

Sincerely Dita Dumele

Dear Firat, thank you very much for your feedback, really appreciated. Frankly, we are several seinor quality people looking to this topic and we are still a bit lost. If I summarize: following 7.1.5.3.1 - OUR qualified supplier use their internal laboratory to measure the gauge (one for us and one for them) which is part of PPAP. = they dont need to be accredited. 

However, I need to use a calibrated device when making verification, and the calibration report of this device shall be accredited according to ISO 17025.

To summarize, all our suppliers have to be accredited according to ISO 17025 if they want to submit PPAP (parts, gauges) measured in their internal laboratory. 

Is that correct ?

Thank you again,

Sincerely Dita Dumele

Dear Firat, thank you very much for your feedback, really appreciated. Frankly, we are several seinor quality people looking to this topic and we are still a bit lost. If I summarize: following 7.1.5.3.1 - OUR qualified supplier use their internal laboratory to measure the gauge (one for us and one for them) which is part of PPAP. = they dont need to be accredited. 

However, I need to use a calibrated device when making verification, and the calibration report of this device shall be accredited according to ISO 17025.

To summarize, all our suppliers have to be accredited according to ISO 17025 if they want to submit PPAP (parts, gauges) measured in their internal laboratory. 

Is that correct ?

Thank you again,

Sincerely Dita Dumele

When you use an external laboratory, ISO 17025 accreditation is a must.

If your supplier who produces the product performs the tests in his own laboratory, I think that if he provides you with evidence that he is in compliance with the 7.1.5.3.1 requirements of the standard, that is, that his internal laboratory is in compliance, it will be sufficient with PPAP. ​​

But again, to be safe, it would be better if you have the tests that are legally required on the product done by an accredited laboratory.