201919th International Congress of Metrology
|Number of page(s)
|Biology - Health / Biologie-Santé
|23 September 2019
Comprendre et surveiller la portée d’accréditation grâce à l’ISO 9001
Indépendant, 101 Quartier de la Haute Folie, 14200 Hérouville Saint Clair, France
2 Centre de Lutte Contre le Cancer François Baclesse, 3 avenue du Général Harris 14000 Caen, France
As it is said in ILAC G18 requirements, accredited laboratories according to ISO 15189 or ISO 17025 should describe and manage their scope of accreditation. Whether its description is quite understood and well conducted, the management of the scope, even if there are written procedures, is much fuzzier, especially the audit of the scope or its potential redesign. In 2018, ISO 17025 has been revised and allowed now laboratories to supervise and monitor their system of management according to ISO 9001. The main benefit of this is to increase efficiency thanks to these two concepts: the risk-based and the process-based approaches. The chapter 8.3 of ISO 9001 in particular can also help: “Design and development of products and services”. Moreover, at the time of writing, a new project ISO 15189 is in progress and there is every reason to believe that this new version will embrace ISO 17025 scheme for the system of management. The aim of this publication is to mix the “scope management” requirements with those of ISO 9001 and monitor the scope of accreditation as a full-fledged process and more, include it in the process mapping; this will help laboratories to supervise their scope of accreditation with more serenity.
© The Authors, published by EDP Sciences, 2019
This is an Open Access article distributed under the terms of the Creative Commons Attribution License 4.0, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.