Title

Create a Document Retention List: determine the storage time and location for all types of documents used

Why

In a quality management system a lot of documents will be produced. Each document contains information that needs to be stored for a certain period of time so that it can be consulted at a later stage. However, not all types of documents need to be stored at the same place and for the same period of time. Some documents contain information that must never be destroyed. Others contain information that has lost its value after a period of 5 years. To prevent the archive from becoming too full and too messy it must be decided how long each type of record is archived.

What

Make a Document Retention List that defines how long each type of document must be stored and where each type of document is archived. In the right-hand column an example document retention list is given showing most types of documents normally created and used in a quality management system with the advised storage time for each record. This can be used as a basis.


This list, called the Document Retention List, will be an appendix to the SOP for Document Control that has to be developed later in this phase. Using this list each staff member knows which document should be archived and which not, where each type of document should be archived and for how long.


In the right-hand column background information from the WHO Laboratory Quality Management System (LQMS) handbook on storing of documents and records is provided.

How & who

Quality Officer:

  1. Make a list of documents routinely being archived in the laboratory. You can use the Example Document Retention List in the right-hand column as a basis. Add documents that are not listed in this table but used by your laboratory.
  2. Decide for each document how long it should be archived and indicate this in the list (beware of national or organizational regulations; if present take these into account).
  3. Decide for each document where it should be archived and indicate this in the list.
  4. Later in phase 2 the SOP for Document Control will be developed. The Document Retention List will be an appendix of this SOP. Up to that moment store the Document Retention List at a save location so that it will not get lost.

Back to Roadmap Activity Overview
This activity belongs to the QSE Documents & Records
ISO15189:2007: 4.3.1 4.13.3 5.8.6
ISO15189:2012: 4.3 4.13
ISO15190:2003: