Sunday, January 17, 2010

Document Review In ISO 9001 Standards

Document Review In ISO 9001 Standards
The ISO 9001 Standard requires that documents be reviewed.
Previously the implication was that the review was a check by potential users that the document was fit for purpose before it was offered for approval. It could be construed that for a document to receive approval it must be checked and therefore review and approval in this context are one and the same and the requirement is in this instance enhanced rather than relaxed.
A review is another look at something. Therefore document review is a task that is carried out at any time following the issue of a document.
This requirement responds to the Continual Improvement principle.
Reviews may be necessary when:
- Taking remedial action (i.e. Correcting an error)
- Taking corrective action (i.e. Preventing an error recurring)
- Taking preventive action (i.e. Preventing the occurrence of an error)
- Taking maintenance action (i.e. Keeping information current)
- Validating a document for use (i.e. When selecting documents for use in connection with a project, product, contract or other application)
- Taking improvement action (i.e. Making beneficial change to the information)
Reviews may be random or periodic. Random reviews are reactive and arise from an error or a change that is either planned or unplanned. Periodic reviews are proactive and could be scheduled once each year to review the policies, processes, products, procedures, specification etc. for continued suitability. In this way obsolete documents are culled from the system. However, if the system is being properly maintained there should be no outdated information
available in the user domain. Whenever a new process or a modified process in installed the redundant elements including documentation and equipment should be disposed of.

Why Is ISO 9001 Important?


ISO 9001 is important because of its orientation. While the content itself is useful and important, the content alone does not account for its widespread appeal.
ISO 9001 is important because of its international orientation. Currently, ISO 9001 is supported by national standards bodies from more than 150 countries. This makes it the logical choice for any organization that does business internationally or that serves customers who demand an international standard of excellence.
ISO is also important because of its systemic orientation. We think this is crucial. Many people wrongly emphasize motivational and attitudinal factors. The assumption is that quality can only be created if workers are motivated and have the right attitude. This is fine, but it doesnt go far enough. Unless you institutionalize the right attitude by supporting it with the right policies, procedures, records, technologies, resources, and structures, you will never achieve the standards of quality that other organizations seem to be able to achieve. Unless you establish a quality attitude by creating a quality management system, you will never achieve a world-class standard of quality.
Simply put, if you want to have a quality attitude you must have a quality system. This is what ISO recognizes, and this is why ISO 9001 is important.