When is accreditation compulsory in France?

Accreditation is sometimes presented as a universal guarantee, sometimes as an optional formality. The reality is more precise: it is compulsory wherever a legal text imposes it, and voluntary everywhere else. Knowing which side your activity — or your provider’s — sits on changes the legal weight of the documents you handle. Here is a tour of the cases where French law makes accreditation unavoidable.

The principle: a requirement set text by text

Since Decree no. 2008-1401 of 19 December 2008, adopted under European Regulation (EC) No 765/2008, Cofrac has been France’s sole national accreditation body. But that designation does not in itself make accreditation compulsory: it only says that, when you get accredited in France, you do so with Cofrac.

The obligation comes from sectoral texts. The mechanism is always the same: a decree or order organises a control scheme — analyses, inspections, certifications — and provides that the bodies performing it must be accredited against a named standard. The text then makes accreditation the entry filter.

Two practical consequences. First, the obligation is verified by going back to the text, not by reading a provider’s marketing vocabulary. Second, outside those cases accreditation stays voluntary — which in no way prevents clients from requiring it contractually, exactly as others require voluntary certifications.

Medical biology: the most advanced case

This is where accreditation has gone furthest in France. The Public Health Code requires medical laboratories to be accredited for the activities they perform, on the basis of NF EN ISO 15189. The scheme was set up by Ordinance no. 2010-49 of 13 January 2010 on medical biology, with a phased timetable for scaling up the share of accredited examinations.

The structuring effect has been considerable: reorganisation of the sector, systematic internal and external quality controls, traceability of the pre-analytical and post-analytical phases. It is also the field that best illustrates the limit of the “accreditation equals automatic quality” reasoning. A systematic review by Nina Brubakk and co-authors, published in 2015 in BMC Health Services Research, examined studies evaluating the effect of hospital accreditation and concluded that the available evidence remained limited and hard to interpret, accreditation being a complex intervention whose effects are poorly captured by classic study designs. The lesson is not that accreditation is useless, but that it works through the discipline it installs, not through the seal it applies.

Vocational training: the certifier is the one accredited

The training sector offers a particularly clear example of the mechanism, because the obligation does not fall on the entity you would expect.

A training provider is never accredited for its training activity: it is certified. It is its certification bodies that must be accredited against the national quality standard (Référentiel national qualité) under NF EN ISO/IEC 17065, by Cofrac or by a European peer signed up to the recognition arrangements. The framework was set by Decrees no. 2019-564 and no. 2019-565 of 6 June 2019. The Labour Code also provides a separate route: authorisation, by France compétences, of labelling bodies whose labels are recognised.

For a training provider, the consequence is very concrete: choosing a certifier means checking that it appears on the official list of authorised bodies and that its accreditation scope covers the categories of activity it delivers — training actions, skills assessments, validation of prior experiential learning, apprenticeship. The checking method is set out in our article on reading a scope of accreditation, and the vocabulary to use in the one on the differences between accreditation, certification and qualification.

Other French schemes built on accreditation

The same mechanism recurs in many fields where the State has delegated a control function to private operators. A few telling examples:

• Property surveys. French property surveyors (diagnostiqueurs immobiliers) must hold a personnel certification issued by an accredited certification body — NF EN ISO/IEC 17024 governs that type of certification. See our page on property surveyor certification.
• Vehicle roadworthiness testing. Testing centres are approved and the control bodies fall under a scheme built on accreditation. See approval of vehicle testing centres.
• Asbestos removal. Companies working in sub-section 3 must be certified by an accredited certification body, as detailed on our page on asbestos SS3 certification.
• Environment and energy. Many regulatory controls — emission measurements, periodic equipment checks — rely on laboratories or inspection bodies accredited to NF EN ISO/IEC 17025 and NF EN ISO/IEC 17020.

This list is not exhaustive, and that is exactly the point: each scheme has its own text, standard and programme. There is no single list valid everywhere, which makes case-by-case verification essential.

Where accreditation stays voluntary

Outside regulated schemes, a body may perfectly well operate without accreditation. A private analysis laboratory, an in-house control unit, a certifier of sectoral labels can all work unaccredited — provided they do not let anyone believe otherwise.

Why then take on a costly, lengthy process? Generally for three reasons:

1. Market access. Many clients, public and private, require reports covered by an accreditation.
2. International recognition. Cofrac is a signatory to the multilateral arrangements run by European Accreditation, ILAC and IAF, which get its accredited bodies’ results accepted abroad.
3. Internal discipline. Periodic assessments impose a rhythm of internal audits, reviews and treatment of findings that no amount of goodwill replaces over time.

How to tell which side you are on

Three questions suffice:

1. Is there a text organising your control activity? Decree, order, sectoral code. If there is, read it: it usually names the applicable accreditation standard.

2. Does the text require accreditation, or only competence? Some schemes stop at qualification requirements without going through accreditation. The nuance changes everything.

3. Do your clients require it contractually? If so, the obligation is commercial rather than legal — but just as binding in practice.

Take action

Identify the text framing your activity, or that of the provider whose reports you rely on, and check exactly what it requires: accreditation, certification or simple qualification. Then, if accreditation is required, check the scope and its validity before contracting — that is the only check that really commits. To understand the role and workings of France’s national accreditation body, see our page on Cofrac accreditation.