MODULE TWO - WRITERS AND ISO 9000 IMPLEMENTATION

The Recommended Documentation Structure (continued)

Records

While not an actual level of documentation, per se, Records are a critical element within the ISO 9000 standard. In many cases these records are Quality Records, but not all records fall into this category. The others are, what I refer to as VIRs - Very Important Records. Quality Records must be controlled as you will see later on in the course, while VIRs are maintained within the functional department where they are used and are vital to the department's internal operations. Quality Records are identified in quality system documentation as such, while VIRs are usually not specifically identified.

Characteristics of Records

Records are completed forms, and should be tied to specific procedures. They provide proof that a procedure has been followed and usually document the resulting outcome. While some Quality Records are identified in Level II documentation, the usual place for identifying them is in Level III.

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