Abstract

Quality records are evidence of product quality. A professional records management program (RMP) supports all aspects of ISO (International Standards Organization) 9000. However, some areas of the ISO 9000 standards only imply their requirements. For example, standards on reworking and reinspection do not explicitly note the existence of records for these processes. More explicit is Section 4.16 of ANSI/ASQC (American National Standards Institute/American Society for Quality Control) 9001. This Section lists components of RMP, including: records creation, records retention, and indexing. It is best that RMP be centralized in a quality records department. The department ensures that the organization's records are the fourth tier of a quality records system. Traditionally, this model consists of the three document tiers of: quality manual, departmental procedures, and work instructions. When records are added to the model, they become the base upon which the whole pyramid rests. Successful RMP requires understanding of terms like "records," "documents," "documentation," and "document control."