ISO 9001: 2000 Quality Management System Design

Chapter 8: Forms and the Control of Records

8.1 Forms Versus Records

8.1.1 Formats

Forms/formats represent tier IV of the documentation pyramid. They are essentially templates within which data/information is deposited for analytical or informational purposes. When a form is filled in with data and signed and dated by the observer and filed away for a specific period, it is termed a record. The format is controlled by any number of methods. The most common control method is to assign a control number to the form. For example, a form used for internal audit reports might be labeled, F-8.2.2-002, with a revision level, Rev. 3. The form is maintained within the engineering change order (ECO) or document change order (DCO) system used to control higher tier documents.

It is also customary to include more complex formats, such as schematics and assembly prints, into tier IV, although such documents, when they are archived, are actually records because they are signed off and dated. Because the documents contain information and usually state specific work instructions, they could just as easily be classified as tier III documents. Consistency is more important than which tier is chosen for a specific document. The development of a master forms list is the most important element so that users can quickly find an appropriate form, and effective audits can be performed.

8.1.2 Analytical Linkage

Records are basically historical documents and are not part of the operational linkage. They are certainly part of the analytical linkage that forms an information context in parallel with the...

UNLIMITED FREE
ACCESS
TO THE WORLD'S BEST IDEAS

SUBMIT
Already a GlobalSpec user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your GlobalSpec Experience

Category: Document Management Software
Finish!
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.