The Marriage of Quality Standards and Records Management

Article excerpt

The ISO 9000 standards are not new. They were first published in 1987 by the International Organization for Standardization, developed from elements of existing standards such as military (MIL-Q-9858A and MIL-1-45208), nuclear power plant regulations (Appendix B to 10CFR50), medical device manufacturer regulations (The FDA's Good Manufacturing Practices), British and Canadian standards and other regulations. In 1994, the standards were revised and reissued.[1]

Five standards comprise the basic ISO 9000 series:

ISO 9000-1-1994

Titled Quality Management and Quality Assurance Standards - Guidelines for Selection and Use [17 pages] This is referred to as a "guidance standard" since it does not contain any requirements. It defines some terms used in the three compliance standards (9001, 9002 and 9003) and it provides guidance on which of the three compliance standards an organization should select in order to become registered.

ISO 9001, 9002 and 9003 are the three compliance standards. They contain the requirements - those elements that organizations must implement in their quality operations in order to become registered.

ISO 9001-1994

Titled Quality Systems - Model for Quality Assurance in Design, Development, Production, Installation and Servicing [9 pages], this is the most comprehensive compliance standard. It includes requirements for all quality-related operations from the development of a quality system plan and the acceptance of a customer contract, to the design of the product or service and includes all processing activities right through shipment, delivery and after-product maintenance.

ISO 9002-1994

Called Quality Systems - Model for Quality Assurance in Production, Installation and Servicing [8 pages], this compliance standard is a subset of 9001. It includes the same requirements for all activities as 9001 except for the design function. This standard would be applicable to those organizations that do not design products, but either process or assemble items that have been designed elsewhere.

ISO 9003-1994

Titled Quality Systems - Model for Quality Assurance in Final Inspection and Test [6 pages] is the least comprehensive of the compliance standards and is applicable to those organizations who wish to be registered only on their final inspection and test activities.

ISO 9004-1-1994

Titled Quality Management and Quality System Elements - Guidelines [20 pages], this is not a compliance standard, but rather a guidance standard. It contains no requirements. Instead, it elaborates on many of the required elements in 9001, 9002 and 9003 and provides more detailed information about these requirements.

MISSION-CRITICAL RECORDS

Designing a complete quality records system assumes proficiency not only in records management, but, equally important, in the business operations and activities that comprise the mission of the organization. The so-called quality activities are those that manufacture the product and/or perform the service of the organization - the main reason why the organization exists. Because they perform the main mission of the organization, they are mission-critical activities. The standards require that records relating to the main mission be managed, and thus, they provide the opportunity for the records management function to be considered "mission critical," thereby expanding opportunities for elevated stature and increased respect. This cannot occur, however, unless records managers understand the operational activities - the manufacturing and quality activities - that comprise the standards.

The ISO 9000 standards delineate the activities almost in a strict chronological order in which they would occur in a theoretical manufacturing organization. First, the standards require that the organization establish a quality system that is audited and registered under ISO 9000. An organization does this by writing and distributing a quality manual that includes the company's philosophy and its planning for quality. …