The medical biology laboratory (MBL) or medical analyzes (MAL) is accredited according to the Article 23 of the law of June 17th 2020 and its application texts, when it is accredited for all the staff lines in which the analyzes he performs are linked under conditions defined by the decree of July 16th 2020 defining the framework of accreditation mentioned in Article L. 6221-1 of the public health code and by the decree of March 8th 2021 fixing the representative exams and the associated skills for the accreditation of staff lines in medical biology exams.

To approach this accreditation process, you can choose a partner who accompanies you in its preperation, while auditing each of the critical processes – pre analytic, transportation, quality, metrology – which will allow your laboratory to be as close as possible to the accreditation standards.

Preparation of the accreditation for your laboratory : choose a partner who audits effectively your processes

The ideal partner will audit your pre-analytical processes and in particular the critical stages of collection, transportation and samples’ preparation and put at your service its perfect knowledge of your job.

First, he will audit your transportation chain because itis a recurring problem reinforced by the concentration of laboratories, and a critical phase in obtaining reliable exam results. It is its perfect knowledge of the ADR that he will put at your disposal.

Then, he will audit your quality processes. With a great independance of evaluation, armed with a perfect knowledge of (numerous) standards, he will facilitate this essential and difficult step to be implemented internally thanks to a team of trained and qualified auditors, intervening for acceditation bodies.

Finally, he will evaluate the conformity of the provisions and the staff skill towards different standards linked to metrology. For that, he will combine culture, quality and metrology, as well as a good knowledge of the functioning of a laboratory and the requirements linked to the accreditation.

The effective support in the accreditation in practice

Focus on your job

The audits of your partner can replace the internal audits of your laboratory especially if they are made by a trained team, qualified on the standards ISO15189 / ISO22870 / ISO17025 / ISO 9001.
Make sure you have access to all the certificates/qualifications of the listeners before any contracting and to the last audits carried out.

Ensure a tailor-made service

The audits of your partner need to focus on the obligatory standards without over-quality. Before every audit, the audit program is defined with you and must be made à la carte.
The audits need to be done according to the laboratory standards and the deviations eventually noted always rely on the standards – there is no “over-quality”.

Treat yourself with a complete service offer

Efficient audits processes are built upon custom support at each step. From preparation phase ( documentation, custom audit template, …) to the final report, and the support in action plan rolling out, your partner stays at your side. With the exact right quality level appreciation.

You are now aware of all qualities that the one who will support you through your certification process must have. It’s maybe the right time to touch base with LABELIANS ? It’s only one click away !