Management of documents and records is one of the pillars of a quality management system (QMS).
Several chapters of the ISO/IEC 17025 4.2 Management system, 4.3 Document control, 4.13 Control of records and 5.4.7 Control of data are dedicated to these topics.
This document replaces Guideline PA/PH/OMCL (97) 5 and the part of Guideline PA/PH/OMCL (07) 105 DEF related to the archiving of records.
The purpose of this guideline is to help OMCLs in establishing and maintaining procedures :
– to control internal documents: generate, identify, approve, issue, review, revise and archive
– to control external documents: access, distribute, ensure availability and implementation of current versions and track/archive previous versions
– to identify, collect, index, access, file, store, maintain and dispose of quality and technical records in order to guarantee the legibility, traceability and durability of documents and records.