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Requirements for analytical laboratories under 16949 designation

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Guest user Created:   Sep 17, 2020 Last commented:   Jul 13, 2022

Requirements for analytical laboratories under 16949 designation

Can you tell me analytical lab requirements for the 16949 standard?
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IATF 16949 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

IATF 16949 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Fırat İnceli Sep 18, 2020

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.

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Steph Jul 12, 2022

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?

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Fırat İnceli Jul 13, 2022

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.

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Steph Jul 13, 2022

@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.

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