How does a health establishment get HAS certification in France?

A health establishment first holds its ARS authorisations, then its legal representative engages it with HAS through Calista, and HAS sets a visit period. Experts-visiteurs evaluate it against the référentiel, and the Commission de certification decides between four levels, the highest being Haute qualité des soins.

Who must be certified, and on what basis

Certification is a mandatory, independent evaluation of the quality and safety of care in every French health establishment, public and private, carried out every four years by experts-visiteurs mandated by HAS, under articles L.6113-3 and following of the Code de la santé publique.¹ Autonomous cosmetic surgery installations are certified too, under article L.6322-1, on a référentiel adapted to their work.² Medico-social activity is outside the procedure, even inside a hospital.⁶ The HAS certification software hub shows which providers sit where.

The ARS comes first

The ARS director general authorises the creation of any health establishment, the creation, conversion and grouping of activités de soins, the installation of heavy equipment and any change of site, under article L.6122-1. Applications are received only in windows, at least two a year per activity, and the ARS decides within six months of the window closing.⁴ The authorisation runs seven years from the declaration that the activity has started, the ARS may make a conformity visit within six months of that declaration, and an authorisation lapses if work has not started within three years or finished within four.⁵

1. Hold the ARS authorisations. For the establishment, each activité de soins and each heavy equipment, and declare each start to the ARS.
2. Engage with HAS. The legal representative applies through Calista with the name, address, FINESS juridique number, the legal representative and the person in charge of certification.
3. Name the Calista administrator. They keep the establishment's data current and give access to staff and user representatives.
4. Validate the champs d'applicabilité. Populations, care modes and sectors decide which specific criteria apply, and an activity found undeclared at the visit suspends it and is reported to the ARS.
5. Evaluate internally. Use the HAS methods and grids on every applicable criterion, the 21 impératifs first.
6. Receive the team and dates. About three months before the visit, and check each expert-visiteur within two weeks.
7. Hold the visit, then answer the report. Observations within one month of the visit report, and a recours gracieux within two months of the decision if needed.

1. Establishment ______ FINESS juridique ______
2. ARS authorisations held ______ Next renewal ______
3. Calista administrator ______ Certification lead ______
4. Champs d'applicabilité validated on ______
5. Visit period ______ Expert team checked on ______
6. Impératif criteria evaluated internally ______ Gaps and owners ______

Copy template

How the decision is made

HAS can decide certification valid four years, with or without a mention, certification under conditions with a new procedure within two years at most, or no certification with a new procedure within two years at most.³ It weighs the gap between results and a 100% target, risky practices, repeated weaknesses and the criticality of any anomaly on an impératif criterion, along with the establishment's observations.³ HAS publishes the decisions as Haute qualité des soins, Qualité des soins confirmée, Qualité des soins à améliorer and Qualité des soins insuffisante.¹

Questions

Is HAS certification optional for a private clinic?

No. Certification is mandatory for every health establishment, public and private, under the Code de la santé publique.

Who decides the certification level?

The HAS Commission de certification des établissements de santé decides, and the HAS Collège rules on any recours gracieux.

Can several sites share one certification?

Yes, on a motivated request to HAS, for establishments that share a direction, a medical body and a quality approach, or for a large entity with distant sites. One visit and one report then cover them.

Sources

1. 1Haute Autorité de santé, 2025Comprendre la certification pour la qualité des soinsRead source
2. 2Haute Autorité de santé, 2025Installation autonome de chirurgie esthétiqueRead source
3. 3Haute Autorité de santé, 2025Référentiel, Certification des établissements de santé pour la qualité des soins, version 2025Read source
4. 4ARS Île-de-France, 2025Informations générales sur les autorisations et procéduresRead source
5. 5ARS Auvergne-Rhône-Alpes, 2026Démarche relative à une autorisation détenue, déclaration de mise en oeuvre et visite de conformitéRead source
6. 6Haute Autorité de santé, 2026Guide méthodologique, Certification des établissements de santé pour la qualité des soins, version 2026Read source

Written by the wai team from Haute Autorité de santé guidance, checked on 16 October 2026. This is guidance, not legal advice. Neither HAS nor any ARS endorses wai or any software.