Document paper

Supporting information to the suppliers’ charter on clinical laboratories seeking accreditation to EN ISO 15189 2012

For IVD suppliers
This document is a training tool intended to ensure that laboratories understand the application of EN ISO 15189:2012 standard. It also provides support in drawing up and substantiating the responses given to laboratories. Each company will be able to transpose it into its own organisation.

For medical laboratories
This document explains to laboratories what contribution the suppliers can make to assist them with their procedure. Suppliers meet quality and regulatory requirements on a daily basis. They can therefore share their experience with laboratories as they engage in the procedure.

For participants in the accreditation procedure
This document can be used to explain to those involved in the accreditation process (national accreditation bodies, auditors, etc.) which resources are available from IVD suppliers in terms of their specific regulations and quality practices; this will ultimately allow to take part in the harmonisation of the auditing practices.

This document is available for EDMA members with the agreement of SIDIV, the French IVD association.

Posted on 07.10.2014