BS EN ISO 9001 is the standard for a quality management system, regardless of the nature of user organization. Customer satisfaction is the key to a good organization so to keep customers satisfied, the organization needs to meet their requirements. The ISO 9001 standard provides a tried and tested framework for taking a systematic approach to managing the organization's processes so that they consistently turn out products that satisfies customers' expectations.

The foundation of a quality management system is the control of documentation. While not a particularly glamorous activity, document control is an essential preventive measure ensuring that to ensure that only approved, current documentation is used throughout the organization. Inadvertent use of out-of-date documents can have significant negative consequences on quality, costs and customer satisfaction.

The standard requires that you must define how you approve all documents prior to use. Approvals may be in the form of a written signature or a password-protected electronic approval record. Also any temporary documents must be clearly identified, signed and dated.

For operating procedures, the standrad requires that all documents must be reviewed periodically, and updated and re-approved if needed. A record of such reviews must be kept.

All changes and current revision status of documents must be identified, by keeping records of the reasons for, and the nature of, every change. In addition, current revision status must be maintained. This includes the current development stage (draft, review, approval, etc.) and the date or revision level (number or letter) identifying the current version of the document.

The unintended use of obsolete documents must be prevented, and suitable identification must be applied to obsolete documents if they are retained for any purpose.

Lastly, the standard requires any organization to audit its ISO 9001 system: this may be done independently to obtain an ISO 9001 certificate of conformity. This option has proved extremely popular in the market-place because of the perceived credibility of an independent assessment.

Please refer to the White Paper on Meeting the requirements of ISO 9001 for more information.


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