ISO/IEC 17025 – Accreditation for testing and calibration laboratories
The standard sets out the requirements a laboratory has to meet for its results to count as competent, impartial and dependable. It is the basis of every accreditation granted by the German national accreditation body (DAkkS).
Unlike ISO 9001, this is not only about organisation and processes but about the technical correctness of the results, and that is exactly where accreditations come unstuck in practice.
Who it applies to
- Testing and calibration laboratories whose results have to be recognised by third parties
- In-house works laboratories that test for customers or authorities
- Laboratories working around medical devices, food, mineral oil processing or materials testing
- The most common trigger: a customer or an authority no longer accepts results without accreditation
Where accreditations come unstuck in practice
1. Measurement uncertainty is underestimated
The most frequent point, and at the same time the most underrated. Many laboratories determine a measurement uncertainty but cannot set out without gaps how it comes about and which influence quantities were taken into account. In the assessment interview that quickly leads to follow-up requirements. Build the uncertainty budget properly from the start and you save yourself considerable rework later, and as a side effect you gain a tool that lets you improve test procedures in a targeted way.
2. Method validation is confused with method description
A documented work instruction is not a validation. What is required is evidence that the method is fit for its intended purpose – with data. For standardised procedures the effort is smaller, but it does not disappear: even then the laboratory has to show that it has mastered the method under its own conditions.
3. Traceability stops too early
The chain from your own measurement to the national standard has to be complete and unbroken. In practice it often stops at a service provider's calibration certificate, without anyone having checked whether that provider's accreditation actually covers the measuring range required.
And a fourth point that is rarely named
Software. Where spreadsheets calculate test results or keep records, the standard requires evidence that they do so reliably. Home-grown Excel solutions are a regular finding here. See Software validation.
How we support you
A position check with the assessment in mind, building or reworking the technical evidence, an internal audit before the assessment, support during the procedure. Details under Internal audits & gap analyses and Building a management system.
For laboratories already working to ISO 9001 or ISO 13485, a great deal can be integrated instead of building a second system.
Who handles this at our end
Michael Bremer – specialist for laboratory accreditation, medical devices and measurement uncertainty. Honorary member of the DKD expert committees Chemische Messgrößen und Stoffeigenschaften (chemical measurands and material properties) and Flüssigkeitsvolumen und Dichte (liquid volume and density).
Marion Rammé and Rüdiger Rammé – both IRCA registered Lead Auditors with ISO/IEC 17025 in their competence profile. Cover is therefore assured even during absences.
Related standards
- ISO 13485 – Medical devices (a common combination for testing laboratories)
- ISO 9001 – Quality management (shared foundation)
- ISO 22000 – Food safety (for food laboratories)
Frequently asked questions
How long does it take to get accredited?
From the start, expect around twelve to eighteen months. The time-critical part is rarely the documentation, it is the data: validation data, proficiency testing results and uncertainty budgets need a lead time that cannot be shortened.
What does the preparation cost?
That depends above all on how many test procedures are to be in the scope and how good the technical evidence already is. A laboratory with three procedures and clean documentation is in a completely different order of magnitude from a multi-discipline laboratory with no uncertainty budget. The accreditation body's fees are charged separately.
Is our existing ISO 9001 system enough as a basis?
As a basis yes, as a substitute no. The organisational requirements largely overlap. The technical part – measurement uncertainty, validation, traceability, competence of personnel – is added in full, and it is the more demanding one.
Do all our test procedures have to be accredited?
No. You set the scope yourselves. A narrow, well-evidenced scope is almost always the better start than a broad one in which individual procedures hold up the assessment. You can extend it later.
What happens during the assessment?
Alongside the examination of the system you are questioned on technical matters, and tests are observed in the laboratory. That is why we do not only prepare the documents, we go through the technical questions with everyone involved.
We only have a small works laboratory. Is it worth it?
It depends on who needs the results. If a customer or an authority requires the accreditation, there is no alternative. If not, a laboratory run to ISO 9001 with clean traceability is sometimes the more economical route. We will tell you that honestly in the first conversation.