Document Control in an ISO Environment

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Kristian Parks
8 years ago
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1 AN INTRODUCTORY GUIDE: Document Control in an ISO Environment How to maintain an up-to-date Quality System

2 Why is Document Control Important? Document control has the ability to ensure that all end users are in possession of the latest version of a document and that the document will be accurate prior to release and up to date during its life cycle. Document control within the ISO environment means that documents are retained for evidence thus giving great accountability. Every section of ISO involves document control in some form and from an audit point of view this is the most common area where issues are found.

3 ISO Standards Relating to Document Control. There are several document control issues that relate to all ISO standards. Firstly, documents always need to be reviewed and approved prior to issue. A list of all documents is required with current revision and distribution list. This ensures only current versions are available at point of use. Also, documents need to be periodically reviewed and revised as necessary. Invalid or obsolete documents are removed from points of use and retained, superseded documents are clearly marked. Hand amendment is possible with suitable controls. Each document requires unique identifiers: Title Current Revision Number of Pages Authority to Issue Source Identification

4 Document Life Cycle Document Development Phase There are various phases during the initial development of any document or information package. Though they are are shown below as progressive steps, they may be repeated based on feedback from various reviews. 1. The document required needs to be identified. 2. The stakeholders and authorities of the document need to be identified. 3. A draft document needs to be produced and circulated for initial review. 4. The document is then modified based on feedback and circulated for official review. 5. Once reviewed it can be forwarded for approval and released as current.

5 Document Release Phase There are various phases following a documents release for use including the monitoring of the applicability of the document to reflect current practice within the facility. 1. The document should be monitored to ensure it is still applicable. 2. If not, changes to process should be identified. 3. The document should be modified to reflect the changes to the program. 4. The document is then submitted to reviewers. 5. The next step is to forward to approvers. 6. The history of the document and the details of the change should be recorded. 7. Amended document is then released as current.

6 Document Life Cycle Completed Methods to ensure that documents are removed from the available information system when their usefulness has been reached will enable the system to be current and relevant. 1. Monitor to ensure documents are relevant. 2. Any documents that are identified as obsolete should be deleted or archived as necessary. Documented Evidence Required Record of sign offs of reviews Record of requested changes and evidence of re-review Record of sign off for release History of changes Revision update log Record of sign off the end users have received document and read it and agree to comply Records of periodic review Records of review approval and distribution for any documents that are modified either from review or changes to the process

7 Conclusion: Make sure you really need a policy or procedure before you write it! Gary Halford is a quality control expert at Paradigm 3 document and compliance management software. For more information on developing procedures and for automating your document control system please feel free to contact an Interax Group representative. REQUEST A DEMO x 2 or sales@interaxgrp.com