ISO/IEC 17025 for medical devices

ISO/IEC 17025 sets out what a testing or calibration laboratory must be able to do for its results to be reliable: impartial work, validated methods, traceable measurements, demonstrated staff competence and statement of measurement uncertainty. Unlike ISO 9001 or ISO 13485, this is not certification but accreditation — in Germany by DAkkS, in Austria by Akkreditierung Austria, in Switzerland by SAS. Accreditation does not cover the laboratory as a whole but the individual methods listed in the annex to the accreditation certificate.

In medical technology this matters above all for tests whose results feed into the technical documentation: biocompatibility to ISO 10993, sterility and endotoxin testing, testing of sterile barrier systems, electrical safety, materials testing and calibration. Notified bodies also accept results from non-accredited laboratories, but as a rule look more closely at how they were obtained.

For buyers this means: do not just ask whether a laboratory is accredited, but whether the method required is listed in the annex to the certificate. Certificate and annex are publicly available from the accreditation bodies.