NF EN ISO 15189 Accreditation

NF EN ISO 15189 Accreditation

Why seek accreditation?

In France, accreditation of medical biology laboratories — whether private or hospital-based — has been a legal requirement since Ordinance No. 2010-49 of January 13, 2010 on the reform of medical biology, which established a national accreditation timetable.

This timetable was subsequently amended by:
• Law No. 2013-442 of May 30, 2013
• Law No. 2020-734 of June 17, 2020

Since November 1, 2021, a medical biology laboratory may no longer perform examinations within defined scope areas unless it is accredited for those specific areas.

A scope area refers to a group of medical laboratory examinations sharing common characteristics and assessed under a common accreditation methodology.

We provide tailored support throughout your accreditation process

Our methodology

• Initial assessment

We begin by reviewing your organization’s overall context (stakeholders, policy, scope of application, strategic challenges, etc.) and analyzing your existing documentation. Meetings are held with senior management.

This phase concludes with a detailed report and a customized action plan.

• Operational planning

Definition and implementation of a structured operational timeline.

• Training

Training of all personnel involved in the NF EN ISO 15189 standard.

• Internal audit

Conducting a mock (internal) audit to ensure optimal preparation for the COFRAC audit.

• Feasibility study

Following the initial assessment, VISKALI UBILAB issues a report including a formal feasibility opinion regarding your accreditation project.

• Laboratory support

Support is a key component of your continuous improvement and change management strategy. Our consultants assist you in designing, implementing, and enhancing your quality management system. Their interventions are fully tailored to your needs.
They remain at your side from the initial assessment through full system implementation and achievement of accreditation. The action plan is updated as the project progresses.

• Implementation

Execution of the actions defined in the operational plan.

• Audit scheduling

Coordination and scheduling of the accreditation audit with COFRAC.

Who is this accreditation for?

Accreditation under NF EN ISO 15189 is intended for medical biology laboratories (private or hospital-based) and pathology laboratories.

Duration of support

The duration of quality support typically ranges from 6 to 18 months, depending on your initial situation (as identified during the initial assessment), your organization’s size, and allocated resources. You will be supported by an expert NF EN ISO 15189 consultant.

Tailored support for every organization

Do you have questions?
Please do not hesitate to contact us.

20 Boulevard Eugène Deruelle
Building A
69003, Lyon
France

04 78 38 94 10

ventes@inlog.fr