NF EN ISO 20387 Standard V2020 (September 2020)

NF EN ISO 20387 Standard V2020 (September 2020)

We support you in your transition to the NF EN ISO 20387 V2020 standard (September 2020).

Why?

Obtaining the NF EN ISO 20387 certification

Biological Resource Centers (or biobanks) must demonstrate exemplary services to scientific researchers and may also obtain financial support.

The NF EN ISO 20387 standard enables you to control your risks through reliable processes, demonstrate the traceability and quality of your samples to research stakeholders, and facilitate exchanges with other BRCs using the same methods.

The NF EN ISO 20387 standard offers several advantages:

  • Having the reliability of processes and the quality of biological resources recognized by stakeholders in research, the pharmaceutical sector, or education
  • Being part of the network of BRCs certified by a recognized and independent body
  • Facilitating exchanges with other BRCs

We offer tailor-made support to help you transition from the NF S 96-900 standard to the NF EN ISO 20387 V2020 standard (September 2020).

How?

Our support methodology

• Initial diagnosis

During this first phase, we review the overall context of the organization (interested parties, policy, scope, challenges, etc.) and analyze the company’s existing documentation. We also meet with members of senior management.

This phase concludes with a report and the drafting of a personalized action plan.

• Definition of an operational schedule

Definition and implementation of an operational schedule.

• Training

Training for all individuals concerned by the NF EN ISO 20387 standard.

• Audit

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

• Feasibility study

Following the initial diagnosis, VISKALI UBILAB will provide you with a report including an assessment of the feasibility of your certification project.

• Support for biological resource centers

Support is an essential element of your improvement approach and change management process. Our consultants help you design, deploy, and improve your quality management system. Their interventions are tailored to your needs.
Our consultants support you throughout your project, from the initial diagnosis to the implementation of your management system and the achievement of your accreditation. The action plan is updated throughout the process.

• Implementation

Implementation of the actions defined during the establishment of the operational schedule.

• Planning

Scheduling of the audit with a certification body.

Who is this certification intended for?

Certification according to the NF EN ISO 20387 standard is intended for biological resource centers (or biobanks) that wish to ensure the appropriate quality of collections of biological materials and associated data for research and development.

It concerns biological resources such as tissues and cells of human and microbial origin.

How long does the support process last?

The duration of quality support may vary from 6 to 18 months. This variation depends on your situation (initial diagnosis report), your size, and the resources allocated.

You will be supported by an NF EN ISO 20387 expert consultant.

You will be supported by an NF EN ISO 20387 expert consultant.

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