[Recommendations for the control of documents and the establishment of a documentary system]

Abstract

The quality management system that must be implemented in a MBL to meet the requirements of the standard NF EN ISO 15189 is based, among other things, on the creation and use by staff of a documentary system approved and updated. This documentary system is constituted by external documents (standards, suppliers' documents...) and internal documents (quality manual, procedures, instructions, technical and quality recordings...). A procedure of the documentary system control must be formalized. The documentary system should be modeled in order to identify the various procedures to be drafted and the incurred risks in the case a document would be missing in this system. Each document must be indexed in a unique way and document management must be carried out rigorously. The use of document management software is a great help to manage the life cycle of documents.

Keywords: ISO 15189; accreditation; document management; documentary system; procedures.