Laboratory requirements (IATF only)
Plain-language summary
Internal labs need a defined scope and demonstrated competence for every test they perform; external labs must be accredited (ISO/IEC 17025 or national equivalent) or specifically customer-approved.
What the clause is really asking
Your internal lab (even 'just' the gauge room or test bench) must have a documented scope, adequate procedures, competent staff, traceable standards, and capability for each inspection or calibration it performs. Commercial labs you use must hold accreditation covering the relevant test, or be acceptable to the customer.
What auditors look for
Auditors ask for the internal lab scope document and sample a test against it: procedure, competence record, standard used. For external labs they check the accreditation certificate AND its scope annex — accredited, but not for that test, is a finding.
Typical evidence
Internal laboratory scope; test procedures; analyst competence records; external lab 17025 certificates with scope annexes checked against tests purchased.
How to comply — recommendations
Write the internal lab scope as a simple table: test/calibration, method, equipment, who is competent. File each external lab's accreditation scope and diarise expiry. Check the scope line before sending a new test type out.
Common nonconformities
No documented internal lab scope; external lab accredited for chemistry but used for mechanicals; accreditation certificates expired; no competence evidence for the person running the bench.
Related clauses
Builds on ISO 9001 7.1.5 (see Example row)
Qlause provides interpretive guidance only and is not a substitute for the standard. Refer to your licensed copy of ISO 9001 / IATF 16949 for the authoritative text.