ISO/IEC 17025, 17020, 17065, 17024: which standard for which body

“We work with an accredited body.” Reassuring — but accredited against which standard? The question is not academic: the ISO/IEC 17000 family of standards gives each conformity assessment trade its own accreditation reference, with different requirements on impartiality, competence and traceability. Knowing which one applies to your provider means knowing what was actually verified. Here is the full map.

One family of standards, one trade per standard

The founding principle is simple: you do not assess a laboratory that measures, an inspector who observes and a certifier who decides in the same way. The ISO/IEC 17000 family therefore sets out one standard per activity.

Activity of the body	Accreditation standard
Testing and calibration	NF EN ISO/IEC 17025
Medical laboratory examinations	NF EN ISO 15189
Inspection	NF EN ISO/IEC 17020
Certification of products, services and processes	NF EN ISO/IEC 17065
Certification of management systems	NF EN ISO/IEC 17021-1
Certification of persons	NF EN ISO/IEC 17024
Proficiency testing schemes	NF EN ISO/IEC 17043
Reference material production	NF EN ISO 17034
Validation and verification	NF EN ISO/IEC 17029

These standards are not interchangeable. A body exercising two of these trades holds two accreditations, assessed separately.

The three big blocks, in practice

Measuring: laboratories

NF EN ISO/IEC 17025 is the standard for testing and calibration laboratories. It centres on the validity of the result: method validation, metrological traceability of measurements, uncertainty estimation, control of equipment and ambient conditions, participation in interlaboratory comparisons to benchmark against peers.

NF EN ISO 15189 is its counterpart for medical laboratories. It adds the clinical dimension: relevance of the examination requested, pre-analytical and post-analytical phases, interpretation, turnaround time. This is where accreditation has gone furthest in France, the Public Health Code having made it compulsory for the activities of medical laboratories, following a phased timetable begun by Ordinance no. 2010-49 of 13 January 2010.

NF EN ISO/IEC 17043 and NF EN ISO 17034 complete the metrological ecosystem: the first governs those who organise interlaboratory comparisons, the second those who produce the reference materials everyone calibrates against.

Observing: inspection

NF EN ISO/IEC 17020 governs inspection bodies: control of installations, vehicles, equipment, structures. The standard distinguishes three types of body by degree of independence — type A being the strictest, reserved for independent third parties with no link to the parties involved. That typology is a valuable reading key: it tells you whether the inspector may be a stakeholder in what it inspects.

Requirements cover inspector qualification, standardised inspection methods, traceability of findings and organisational impartiality.

Deciding: certification

Three standards, three objects.

NF EN ISO/IEC 17065 covers bodies certifying products, services and processes. The logic is that of a certification scheme: a standard, evaluation arrangements, a decision taken by a function distinct from the one that evaluated, and surveillance. It is the standard applicable to certification bodies for the French quality certification of providers of skills-development activities, as set out in Decrees no. 2019-564 and no. 2019-565 of 6 June 2019.

NF EN ISO/IEC 17021-1 covers bodies certifying management systems: ISO 9001, ISO 14001, ISO 45001, ISO 27001, ISO 50001. Its requirements focus heavily on auditor competence, audit-time calculation, the certification cycle and impartiality — a body cannot advise and then certify the same organisation. Our comparison of Qualiopi and ISO 9001 shows concretely what that distinction changes for the audited organisation.

NF EN ISO/IEC 17024 covers bodies certifying persons. It insists on separating training from certification: whoever trains the candidates cannot be the one deciding on their certification, or the examination loses its meaning. This is a major point for training providers who also wish to award individual certifications.

What these standards have in common

Despite their differences, all share three structuring requirements — which are also the three subjects on which findings are most often raised.

Impartiality. Each standard requires identifying risks to impartiality — financial, personal or commercial links, advice and assessment provided to the same client — and treating them. This is not a statement of principle: it takes a documented analysis and concrete measures.

Competence. Recruitment, training, authorisation to practise, field monitoring, periodic requalification: the standards require competence management traced end to end, for every function.

Control of records and decisions. A result, a finding, a certification decision must be reconstructible after the fact: on what evidence, by whom, under which rule.

The effect of this discipline is measurable. Mercy Okezue and co-authors, in a study published in 2020 in BMC Health Services Research, compared the audits of a Nigerian quality control laboratory before and after its ISO/IEC 17025 accreditation and documented a significant fall in the number of non-conformities across cycles (see the study). It is not the certificate that produces the improvement, but the assessment cycle it imposes.

How to identify the right standard for your need

Ask the question the other way round: what kind of verdict are you expecting?

• A figure, a measurement, an analysis → laboratory, ISO/IEC 17025 (or ISO 15189 in medical biology).
• A finding about a state, an installation, a piece of equipment → inspection, ISO/IEC 17020.
• A certificate on a product, a service or a delivery process → certification, ISO/IEC 17065.
• A certificate on a management system → certification, ISO/IEC 17021-1.
• A certificate on a person → certification, ISO/IEC 17024.

Once the standard is identified, the scope remains to be checked: it is the scope, not the standard alone, that tells you whether your precise need is covered. The method is set out in our article on reading a scope of accreditation.

Take action

List your conformity assessment providers — laboratory, inspection body, certifier — and note, for each, the accreditation standard it falls under. You will immediately see which ones you had never really checked, and which exercise several trades with a single accreditation in mind. To place these standards within the French scheme as a whole, see our page on Cofrac accreditation.