ISO/IEC 17025 — Lab Accreditation

What does ISO/IEC 17025:2017 require?

The standard has two halves. Clauses 4 to 7 cover the technical and structural requirements that make a result trustworthy, and clause 8 covers the management system. Clause 8.1 lets a laboratory meet the management system requirements either directly (Option A) or through a management system that already meets ISO 9001 (Option B).

Assessors spend most of their time on the technical clauses. They pick results from your reports and trace each one back to the method, the analyst, the equipment and the calibration behind it. The requirements below are the ones that take the most preparation.

Is ISO/IEC 17025 accreditation or certification?

It is accreditation. A certification body can certify a laboratory to ISO 9001, but that certificate says the quality management system is in place. It says nothing about whether a particular test or calibration is done competently. ISO/IEC 17025 accreditation is a statement of technical competence for specific tests or calibrations, granted by an accreditation body after its assessors, including technical experts in the methods, have reviewed the work.

Accreditation is tied to a scope. The scope of accreditation lists the tests or calibrations covered, the methods used and, for calibration laboratories, the measurement ranges and capabilities. A result outside that scope is not an accredited result, even when it comes from an accredited laboratory.

Many laboratories hold both. A plant already certified to ISO 9001 can use Option B, so the existing document control, internal audit and management review carry the management system half of ISO/IEC 17025, and the project concentrates on the technical requirements.

Who needs ISO/IEC 17025 accreditation in Canada?

Commercial testing and calibration laboratories pursue accreditation because their customers, and in some sectors their regulators, accept only accredited results. Environmental, food, materials, mineral and petroleum testing are areas where accreditation is commonly expected.

In-house laboratories at manufacturing plants have a different reason. When a lab issues results that a customer relies on for product release, or calibrates the gauges used for final inspection, accreditation gives that customer confidence in the numbers without a separate lab audit. Automotive suppliers should also note that IATF 16949:2016 expects the external laboratories they use for inspection, test or calibration to be accredited to ISO/IEC 17025, so labs serving that supply chain are often asked for it.

Accreditation is not required for every lab. A lab whose results are used only for internal process control may be better served by tight calibration and method control under ISO 9001. The right answer depends on who relies on the results and what they have written into contracts.

How long does accreditation take, and what drives the cost?

A laboratory with established methods and calibrated equipment typically needs nine to eighteen months to reach accreditation, including the time the accreditation body takes to schedule and complete its assessment. A lab that must validate methods or build measurement uncertainty estimates from the start should plan for the longer end.

The size of the scope is the biggest cost driver, because each method in it needs verification or validation evidence, an uncertainty estimate and competence records for every analyst who performs it. Starting with a narrow scope of the methods customers ask about most, then extending it after accreditation, is a common approach.

Other factors are the availability of suitable proficiency testing for your methods, the state of equipment calibration records, and how much internal audit and management review history exists. The compliance software keeps the equipment register, calibration intervals and certificates in Assets, so traceability evidence is ready when assessors ask; the calibration and maintenance module shows how. To scope your project, talk to ISO Certification Consultants.