INTERNATIONAL STANDARD ISO/IEC 17025:2017(E)
General requirements for the competence of testing and
calibration laboratories
1 Scope
This document specifies the general requirements for the competence, impartiality and consistent
operation of laboratories.
This document is applicable to all organizations performing laboratory activities, regardless of the
number of personnel.
Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment,
accreditation bodies, and others use this document in confirming or recognizing the competence of
laboratories.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated
terms (VIM)1)
ISO/IEC 17000, Conformity assessment — Vocabulary and general principles
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99 and
ISO/IEC 17000 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://w w w.iso.org/obp
— IEC Electropedia: available at http://ww w.electropedia.org/
3.1
impartiality
presence of objectivity
Note 1 to entry: Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely
influence subsequent activities of the laboratory (3.6).
Note 2 to entry: Other terms that are useful in conveying the element of impartiality include “freedom from
conflict of interests”, “freedom from bias”, “lack of prejudice”, “neutrality”, “fairness”, “open-mindedness”, “even-
handedness”, “detachment”, “balance”.
[SOURCE: ISO/IEC 17021-1:2015, 3.2, modified — The words “the certification body” have been replaced
by “the laboratory” in Note 1 to entry, and the word “independence” has been deleted from the list in
Note 2 to entry.]
1) Also known as JCGM 200.
1
ISO/IEC 17025:2017(E)
3.2
complaint
expression of dissatisfaction by any person or organization to a laboratory (3.6), relating to the activities
or results of that laboratory, where a response is expected
[SOURCE: ISO/IEC 17000:2004, 6.5, modified — The words “other than appeal” have been deleted, and
the words “a conformity assessment body or accreditation body, relating to the activities of that body”
have been replaced by “a laboratory, relating to the activities or results of that laboratory”.]
3.3
interlaboratory comparison
organization, performance and evaluation of measurements or tests on the same or similar items by
two or more laboratories in accordance with predetermined conditions
[SOURCE: ISO/IEC 17043:2010, 3.4]
3.4
intralaboratory comparison
organization, performance and evaluation of measurements or tests on the same or similar items
within the same laboratory (3.6) in accordance with predetermined conditions
3.5
proficiency testing
evaluation of participant performance against pre-established criteria by means of interlaboratory
comparisons (3.3)
[SOURCE: ISO/IEC 17043:2010, 3.7, modified — Notes to entry have been deleted.]
3.6
laboratory
body that performs one or more of the following activities:
— testing;
— calibration;
— sampling, associated with subsequent testing or calibration
Note 1 to entry: In the context of this document, “laboratory activities” refer to the three above-mentioned
activities.
3.7
decision rule
rule that describes how measurement uncertainty is accounted for when stating conformity with a
specified requirement
3.8
verification
provision of objective evidence that a given item fulfils specified requirements
EXAMPLE 1 Confirmation that a given reference material as claimed is homogeneous for the quantity value
and measurement procedure concerned, down to a measurement portion having a mass of 10 mg.
EXAMPLE 2 Confirmation that performance properties or legal requirements of a measuring system are
achieved.
EXAMPLE 3 Confirmation that a target measurement uncertainty can be met.
Note 1 to entry: When applicable, measurement uncertainty should be taken into consideration.
Note 2 to entry: The item may be, for example, a process, measurement procedure, material, compound, or
measuring system.
