What is meant by the term “legally responsible?”


The laboratory may be a public or private entity, an established business or corporation, or an identifiable division or in-house activity of a business or corporation, which meets the applicable legal requirements of the governmental jurisdiction in which it conducts business. Legal responsibility aids in addressing issues of liability/accountability, uniqueness, and independence of operation.

ISO/IEC 17025 often uses the words “calibration and testing” in describing requirements. How do laboratories that only perform one or the other interpret those requirements?


ISO/IEC 17025 covers both calibration and testing laboratories, so the pairing of “calibration and test” is frequently repeated. In this context, test laboratories should ignore the word “calibration” (with the exception of Sections 5.4.6.1 and 5.6.2.2) and calibration laboratories should ignore the word “test”.

Do laboratories accredited to ISO/IEC 17025 also meet ISO 9000?

According to the 2005 version of the Standard (within the Introduction), “Care has been taken…to incorporate all those requirements of ISO 9001 that are relevant to the scope of testing and calibration services that are covered by the laboratory’s management system.” In addition, “Testing and calibration laboratories that comply with this International Standard will therefore also operate in accordance with ISO 9001.” However, laboratories may not claim ISO 9000 registration based solely on their ISO/IEC 17025 accreditation, though additional evaluation against ISO 9001/9002 should not be necessary for laboratories accredited to ISO/IEC 17025. It is also noted in the Introduction to ISO/IEC 17025 that conformity of a laboratory’s quality management system to the requirements of ISO 9001 does not of itself demonstrate the competence of the lab to produce technically valid data and results.