External lab not accredited, or its accreditation unknown
IATF 16949 7.1.5.3.2 asks for an external laboratory to hold ISO/IEC 17025 accreditation (or the national equivalent) covering the service, or else to be shown acceptable to the customer, with the equipment maker as a stated alternative where no qualified laboratory exists. ISO 9001 does not ask for an accredited laboratory, so without the IATF 16949 tick this is a question with no clause: your customer, a contract or your own supplier procedure may ask for an accredited lab.
When the finder raises it
Fires for an instrument calibrated externally when the accreditation column is blank, "no" or "unknown". With IATF 16949 ticked it is a finding under 7.1.5.3.2, the only clause here that asks for an accredited laboratory. Without it, a question with no clause: ISO 9001 does not ask for an accredited lab, but your customer, a contract or your supplier procedure may. Read only when the register has an accreditation column.
A question for the quality manager
Is the service inside an accreditation scope, or is there customer acceptance or a stated alternative on file? Without IATF 16949: does a customer, a contract or your supplier procedure ask for an accredited lab?
Clauses behind it
1 across the standards| Standard | Clause | Applies to |
|---|---|---|
| IATF 16949 | IATF 16949 7.1.5.3.2 External laboratory | an automotive supplier holding IATF 16949 certification |
IATF 16949 7.1.5.3.2External laboratoryExternal laboratories used for inspection, calibration or test work have a defined scope that includes the service needed. Each one either holds ISO/IEC 17025 accreditation (or the national equivalent), with the service inside the accreditation scope and the accreditation body's mark on the certificate or report, or else it is shown to be acceptable to the customer, for example by a customer assessment or by a second-party assessment the customer has approved. Where no qualified laboratory exists for a piece of equipment, the equipment's manufacturer may calibrate it, as long as the organization makes sure the internal laboratory requirements of 7.1.5.3.1 are satisfied; using other calibration services may require confirmation by a regulator. As revised: SI 10 (April 2018, revised June 2018, April 2021, July 2021): accreditation is by a body that signs the ILAC MRA, against ISO/IEC 17025 or the national equivalent, with the accreditation mark on the certificate or report; the SI also lists when a laboratory without accreditation may be used (specialist or integrated equipment, parameters for which no traceable standard exists, the equipment's manufacturer) and what the organization then has to ensure.