The precise ISO 9001 requirement states, "A documented procedure shall be established to define the controls needed...a) to approve documents for adequacy prior to issue..."

The two most important aspects of the requirements boil down to:

1. The methods for document approval must be described in a documented procedure;
2. The approval process must determine if the documents are adequate prior to issuing them for use.

ISO 9001 has been around long enough for folk tales and legends to be generated. The old adage about, "All documentation must be signed by management," is one of those legends.

While a signature of a person in authority would satisfy the requirement (and provide a record of approval, which interestingly is NOT a requirements of ISO 9001), the standard does not prescribe how the approval process must operate.

(Signature approval is a specific requirement of some regulated industries. For example, medical device manufacturers must maintain signature approvals of specific documents to satisfy the requirements of 21CFR820 in the United States.)

A closer examination of the requirements indicates ISO 9001 is more interested in when the documents are approved (prior to issue) rather than who approves them, and what records are left behind after approval is granted. Auditors who understand the standard will focus their questions on how the process approves documents prior to issue. If the process is sound is demonstrated as consistent and reliable, not a word should be spoken regarding signatures or records of approval.

Persons responsible for implementing ISO 9001 can find similar situations where typical practices have evolved to address ISO 9001 requirements that don't really exist. It is important to closely evaluate all of the requirements, and determine what methods will address ISO 9001 without limiting the performance of the organization.

It is equally important to select a registrar that audits to the precise requirements of ISO 9001, rather than the tomes of folk tales and legends that have evolved around ISO 9001 over the years.

If you have any ideas or illustrations of new and better ways to satisfy ISO 9001 requirements, we would like to hear from you, so we can share your ideas with others on the Platinum Registration web site.