Healthcare and social work

Certification de produits et de services

NF EN ISO/IEC 17065

Améliorer la santé des personnes les plus fragiles passe par la mise en place de services d’action sociale et d’outils de prescription adaptés et performants.

En France, le Code de la consommation rend obligatoire l’accréditation des organismes réalisant la certification de produits ou de services afin de disposer de garanties sur leur impartialité et leur compétence.

Cette mesure permet de donner confiance dans les prestations délivrées par des entreprises ou des organismes certifiés aux plus fragiles, qu’il s’agisse de personnes âgées, malades, en situation de handicap ou de dépendance, de personnes à mobilité réduite ou de jeunes enfants.

Comparaisons interlaboratoires

NF EN ISO/IEC 17043

Les laboratoires accrédités ou candidats à l’accréditation se doivent d’assurer la validité des résultats qu’ils rendent. Cette obligation passe par la mise en œuvre de contrôles externes permettant de s’assurer de la performance de leurs activités de laboratoires, tels que des comparaisons interlaboratoires par exemple.

Les campagnes proposées par les organisateurs de comparaisons interlaboratoires (OCIL) permettent aux laboratoires participant de démontrer leur aptitude à réaliser des analyses. Afin de renforcer leur crédibilité sur le marché et d’assurer leur développement, certains organisateurs font le choix d’avoir recours à l’accréditation pour cette activité spécifique.

En garantissant la compétence des OCIL, l’accréditation renforce encore un peu plus la confiance dans les résultats délivrés par les laboratoires d’analyse accrédités.

Certification of management systems

NF EN ISO/IEC 17021-1

Certification of such systems by a third party is a means of getting their conformity with international standards recognised, and in this way certifying that the organisation in place meets precise requirements.
The manufacturers of medical devices therefore deploy management systems to satisfy the European regulatory requirements applicable to their activity, particularly in terms of risk management.
Accreditation of the certification bodies constitutes an undeniable advantage for companies benefiting from the certification for their international development, for bidding for RFPs, and for consolidating their skills and technical competence.

Medical examinations

NF EN ISO 15189

Use of accreditation for medical examinations helps improve the quality of service rendered to the patient. Accreditation contributes to the efficiency of the healthcare system by ensuring the reliability of results.
It concerns many medical-technical procedures used for the purposes of prevention, screening and diagnosis.
In this way, accreditation guarantees the harmonised and optimum quality of the biomedical examinations conducted throughout the country by public or private laboratories. It also helps reinforce the confidence of patients and clinicians in the examinations carried out by the anatomy and cytopathology structures.

Inspection

NF EN ISO/IEC 17020

Medical installations and facilities used to care for patients are subject to regular inspections to ensure that they remain compliant with the applicable requirements. To reinforce confidence in their daily use, these inspections are carried out by accredited inspection bodies.
By providing guarantees about the competence and impartiality of these bodies, accreditation limits the risk of using a failing installation or facility, which could have serious consequences for patient health.
Certain aesthetic procedures also require accredited inspection of the installations or equipment used.

Tests

NF EN ISO/IEC 17025

Prevention is essential in matters of public health. It involves strict and regular health checks for protecting the population. Policies based on accreditation are implemented to ensure the efficiency of these checks.
In this way, accreditation helps prevent health risks. By guaranteeing the reliability of the analyses and tests carried out, it allows the competent authorities to make the necessary decisions when warning levels are reached.
Accredited tests are also widely used for checking that the equipment used for patient healthcare actually achieves the expected performance and safety levels.