Document control of ISO 17025
Document control of ISO 17025
Clause 4.3
4.3.1 General
The laboratory shall establish and maintain procedures to control all documents that form part of its management system (internally generated or from external sources), such as regulations, standards, other normative documents, test and/or calibration methods, as well as drawings, software, specifications, instructions and manuals.
NOTE 1: In this context “document” could be policy statements, procedures, specifications, calibration tables, charts, text books, posters, notices, memoranda, software, drawings, plans, etc. These may be on various media, whether hard copy or electronic, and they may be digital, analog, photographic or written.
NOTE 2: The control of data related to testing and calibration is covered in 5.4.7. The control of records is covered in 4.13.
4.3.2 Document approval and issue
4.3.2.1 All documents issued to personnel in the laboratory as part of the management system shall be reviewed and approved for use by authorized personnel prior to issue. A master list or an equivalent document control procedure identifying the current revision status and distribution of documents in the management system shall be established and shall be readily available to preclude the use of invalid and/or obsolete documents.
4.3.2.2 The procedure(s) adopted shall ensure that:
a) authorized editions of appropriate documents are available at all locations where operations essential to the effective functioning of the laboratory are performed;
b) documents are periodically reviewed and, where necessary, revised to ensure continuing suitability and compliance with applicable requirements;
c) invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use;
d) obsolete documents retained for either legal or knowledge preservation purposes are suitably marked.
4.3.2.3 Management system documents generated by the laboratory shall be uniquely identified. Such identification shall include the date of issue and/or revision identification, page numbering, the total number of pages or a mark to signify the end of the document, and the issuing authority (ies).
4.3.3 Document changes
4.3.3.1 Changes to documents shall be reviewed and approved by the same function that performed the original review unless specifically designated otherwise. The designated personnel shall have access to pertinent background information upon which to base their review and approval.
4.3.3.2 Where practicable, the altered or new text shall be identified in the document or the appropriate attachments.
4.3.3.3 If the laboratory’s document control system allows for the amendment of documents by hand pending the re-issue of the documents, the procedures and authorities for such amendments shall be defined.
Amendments shall be clearly marked, initialed and dated. A revised document shall be formally re-issued as soon as practicable.
4.3.3.4 Procedures shall be established to describe how changes in documents maintained in
computerized systems are made and controlled.
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on Tuesday, November 24th, 2009 at 12:35 pm and is filed under ISO 17025 standard.
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