EDQM Management of Documents and Records

Management of documents and records is one of the pillars of a quality management system (QMS).

Several chapters of the 17025 4.2 Management System, 4.3 Document Control, and 4.13 Control of Data are dedicated to these topics.

This document replaces PA / PH / OMCL Guideline (97) 5 and the part of PA / PH / OMCL (07) Guideline 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, 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.


EDQM Management of Documents and Records