ISO 9000

ISO 9000 - Paraphrased from Total Improvement Management, by H. James Harrington, McGraw-Hill, Inc., 1995.

The ISO 9000 series is a set of five documents that define international standards for Quality Management Systems (QMS). ISO 9000 provides guidelines for the selection and use of the other standards in the series. ISO 9004 establishes guidelines for the implementation and auditing of the QMS. ISO 9001, 9002, and 9003 are quality system models for external quality assurance. ISO 9001 is the most comprehensive and includes the following requirements related to records management (pp. 174-177):

Sec. 4.8, Product Identification and Traceability - identifying product during all stages of production, delivery, and installation.

Sec. 4.9, Process Control - ensuring that production and installation processes are carried out under controlled conditions, which include documentation, monitoring, and control.

Sec. 4.10, Inspection and Testing - inspection and testing as documented in the quality plan, including inspection of maintenance records.

Sec. 4.15, Handling, Storage, Packaging, and Delivery - procedures for those stages of the product life cycle.

Sec. 4.16, Quality Records - identification, collection, indexing, filing, and storage of records.

Sec. 4.17, Internal Quality Audits - a system to verify based upon the records whether the other processes comply with the plan and, thus, the effectiveness of the QMS.

The "core system" of ISO 9000 includes Documentation Control, Training, Records, and Corrective Action. One of the basic premises of ISO 9000 is that consistency of results starts with consistency of process execution, which can be achieved through documentation, training, and automation. The requirement for documentation permeates the standard. There must be a way of measuring and verifying the efficiency and effectiveness of the process, both in terms of customer requirements and internal needs. Internal needs commonly exceed customer requirements. (pp. 177 - 179)

Harrington notes, "Records tend to be event-driven." In other words, they should result as a byproduct of the routine work processes, rather than as a separate, make-work, after-the-fact reporting activity. He also notes: "processes are not ... stagnant... documents ... may no longer be accurate ... the cycle of updating may never end." (pp. 182 & 184)

He suggests, "it [is] most useful to begin the process with procedures which are closest to the customer ..." but "there is one absolute necessity. The Document Control system absolutely must be developed and functioning before any other procedure is implemented." (p. 185)

Harrington also notes:

The major problem with most processes is that performance is measured only at the end. In most cases, this provides little relative feedback about individual activities within the process or, when it does, it is too late... (p. 421)

Even though most people are against objective measurement, they still want to be rewarded for good work. So bite the bullet. Every manager, every team, every person can be and should be objectively, equitably, and quantitatively measured. (p. 421)