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Making it work
Table 6.9 Summary of the procedural requirements of ISO 15189:2003 for a Document Control System Clause
Part
Requirement
4.3.2
(a)
All documents must be reviewed and approved by authorized personnel prior to issue. A list or “document control log” that identifies the current valid versions of all documents, as well as their distribution, must be maintained. Only currently authorized versions of appropriate documents can be available for active use. Documents must be reviewed periodically, revised when necessary, and approved by authorized personnel before reissue. Invalid or obsolete documents must be removed promptly from all points of use (or other steps taken to ensure they cannot be used inadvertently). Superseded documents must be appropriately identified to prevent their inadvertent use. If the laboratory’s document control system allows for the amendment of documents by hand pending their reissue, then procedures and authorities for making any such amendments must be defined. Amendments must be clearly marked, initialled and dated, and a revised document reissued formally as soon as practicable. There must be procedures in place to describe how changes to documents that are maintained electronically are made and controlled. All documents must be identified uniquely, including the following information: the title of the document the edition or current revision date, or revision number, or all these the number of pages the authority for issue references for relevant source materials
(b) (c) (d) (e)
(f) (g)
(h) 4.3.3 (a) (b) (c) (d) (e)
15189:2003 has been summarized in Table 6.9. Under this Standard, all documents are considered to comprise part of the organization’s quality management system, and a “document” is considered to be “any information or instructions, including policy statements, text books, procedures, specifications, calibration tables, biological reference intervals and their origins, charts, posters, notices, memoranda, software, drawings, plans, and documents of external origin such as regulations, standards or examination procedures.”