External Laboratory Approval

This is a one-off, then periodically reviewed, approval of a specific laboratory — not a record of an individual sample sent to it or a result it returned. Logging a single test result here instead of the correct result template makes both records harder to find.

ISO/IEC 17025:2017 clause 6.6 covers externally provided products and services, which is where a subcontracted or referral laboratory sits — the clause map below shows where each section of the assessment earns its place.

Where the laboratory is accredited, and by whom, decides how much weight its certificate actually carries — the frameworks below are the ones that matter most in practice.

Every field can be answered without the assessment actually protecting anything. The judgement calls below are what decide whether the approval would hold up if the laboratory's result were ever challenged.

The findings that recur are not laboratories failing outright — they are approvals that stopped checking after the first pass.

A manufacturer approved a contract laboratory for allergen testing on the strength of a current ISO/IEC 17025 certificate, checked once at onboarding. The certificate was real. The laboratory's accredited scope, when eventually requested two years later during a customer audit, covered a related but different allergen method to the one actually being run against their product.

Every result in between had been reported on the accredited laboratory's letterhead and none of its accredited assurance. The fix was procedural, not technical: request the schedule at approval and at every yearly review, and match it against the test being placed by name, not by category.

The form is the easy part. Checking a schedule actually covers the test being placed, and catching a review that has quietly gone overdue, is the work that actually slips.

KnowQuality

Holds the external laboratory approval against the supplier register, flags a yearly review before it lapses, and keeps the schedule check linked to the sample log entries it protects.

KnowContractor

Treats the contract laboratory as a managed external provider alongside other contractors, so an approval condition or a capacity gap surfaces in the same place as the rest of your third-party risk.

KnowLogistics

Picks up the sample transport and turnaround commitments recorded here, so a laboratory that misses its committed turnaround shows up as a logistics exception, not just a quality note.

Ella

Coordinates the crew across quality, contractor and logistics views, rolls approval status and exceptions into one place, and holds every write for your approval before it touches a record.

Accreditation schedule

The specific list of methods, matrices and parameters an accreditation body has assessed a laboratory for; the certificate confirms accreditation exists, the schedule confirms what it actually covers.

Subcontracting (laboratory)

Work a laboratory places with a third, often unnamed, laboratory rather than performing itself; undisclosed subcontracting means the buyer's approval never reached the laboratory actually doing the work.

Proficiency testing

An external scheme that sends a laboratory blind samples to check its results against a known reference, used here as evidence of ongoing competence rather than a one-off assessment.

Out-of-specification result

A test result falling outside the agreed acceptance criteria; how and when the laboratory notifies this result is treated as part of its approval, not just its technical output.

Limit of detection

The lowest concentration or level a method can reliably distinguish from zero; a laboratory's limit of detection must meet the buyer's own specification, not just be technically non-zero.