How to Accredit a Laboratory to ISO/IEC 17025
Earn competence recognition that is granted per method and per matrix, not per building.
What a how-to is not
A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.
Accreditation to the testing and calibration competence standard is widely misunderstood in one specific way: it is granted against a defined scope, method by method and matrix by matrix. A laboratory is not accredited in general. The schedule attached to the certificate is the document that says what was actually assessed, and reading the certificate instead of the schedule is the most common error made by the people relying on it.
- 1
Define the scope you will apply for
List each method, the matrices it covers, and the measurement ranges. Scope drives cost, assessment effort and what you may then claim, and a scope drafted aspirationally rather than to what you can demonstrate will fail at assessment.
- 2
Demonstrate impartiality and competence structurally
Show that commercial or managerial pressure cannot influence a result, and that personnel are competent for the specific activities they perform. Impartiality is assessed as an arrangement, not accepted as a policy statement.
- 3
Validate methods and establish measurement uncertainty
Standard methods are verified as implemented by you; non-standard methods are validated. Measurement uncertainty is estimated for each, and a laboratory that cannot state the uncertainty of a result cannot support a decision made at a specification limit.
- 4
Establish metrological traceability
Results trace to the appropriate reference through an unbroken calibration chain with stated uncertainty. A calibration certificate that does not itself trace is a break in the chain, and it invalidates everything measured on that instrument.
- 5
Run proficiency testing and act on the outcomes
Participate in interlaboratory comparison where available for your scope, and treat an unsatisfactory result as an investigation with a cause, not a data point to note. A poor result acted on is evidence the system works; one merely recorded is evidence it does not.
- 6
Maintain the scope through surveillance, and state it accurately
Accreditation is maintained through periodic assessment, and adding a method means extending the scope. Never describe the laboratory as accredited without qualification — the correct claim names the methods, and a laboratory is never accredited by the mutual recognition arrangement, which recognises accreditation bodies rather than laboratories.
- !The laboratory described as accredited without reference to the scope that defines what is covered.
- !A method added to the service offering without extending the accredited scope to cover it.
- !Measurement uncertainty omitted, leaving results that cannot support a decision at a specification limit.
- !A proficiency testing outlier recorded as a data point rather than investigated to a cause.
How to Accredit a Laboratory to ISO/IEC 17025: frequently asked questions
Common questions on accredit a laboratory to iso/iec 17025.
What does the accreditation actually cover?
The methods and matrices listed on the schedule, within the stated ranges — nothing more. The certificate identifies the laboratory; the schedule identifies the competence that was assessed. Anyone relying on the accreditation should be reading the schedule, and most read the certificate.
Is a laboratory ever accredited by the international recognition arrangement?
No, and this is a persistent error. The arrangement provides mutual recognition between accreditation bodies, so recognition is a property of the body that granted the accreditation, not of the laboratory. A laboratory is accredited by its accreditation body; that body may be a signatory.
How does this relate to the medical and trial laboratory standards?
It addresses competence in testing and calibration generally. Medical laboratories work to the standard written for diagnostic testing, and laboratories analysing clinical trial samples work to clinical laboratory practice for trials. The three overlap in technique and differ in purpose, and one does not substitute for another.