The quality assurance standards ISO 9001, 9002 and 9003 specify three sets of quality system requirements that can be used for external quality assurance purposes. The requirements in these standards are viewed as minimum good business practices for a supplier company in any industry/economic sector. ISO 9004-1 however, goes beyond the requirements of ISO 9001, 2, and 3 and helps organisations design and implement a quality system to enable them to meet their market- place needs and achieve overall success.

When the first edition of the three quality assurance models was adopted worldwide, some difficulties in their interpretation and implementation ere reported. These standards have been recently revised to address the difficulties report earlier.

In the revised ISO 9001 standards, the structure remains the same. However, changes were made to a number of clauses to either clarify, enhance or expand specific requirements. The following are some f the more significant changes,

Subclause 4.1.1: Quality policy - has been enhanced with respect to its relevance to customer’s expectations and needs and the suppliers' internal organization’s goals for meeting policy requirement.

Subclause 4.1.2.2: Resources - has been expanded to include management and work performance.

Subclause 4.2.1: Quality system - General - includes a requirement for a quality manual that defines the documentation structure of the quality system.

Subclause 4.2.2: Quality system procedures - has been enhanced to clarify the degree of documentation required for the quality system.

Subclause 4.2.3: Quality planning - is a new addition. It covers quality planning and product quality plans.

Subclause 4.3: Contract review - now includes precontract tender arrangements as ,ell as contact and ordering requirements.

Subclause 4.4: Design control - has been expanded to include design validation, and separate requirements for design review and design verification.

Subclaute 4.9: Process control - includes- additional requirements for maintaining process equipment to ensure continuing process capability.

Subclause 4.14: Corrective and prevention action - now requires separate corrective and preventive actions.

Changes in the revised ISO 9002 standard are similar to those for ISO 9001 except for the following:

Subclause 4.19: Servicing - is a new addition. It is applicable if servicing is a specified requirement.

The revised ISO 9003 stricture has been changed by the addition of headings that act as "place keepers" for four subclauses that do not contain requirements i.e. (subclauses 4.4, 4.6, 4.9 and 4.19).

Additional requirements in the revised ISO 9003 include:

Subclause 4.3: Contract review

Subclause 4.7: Control of customer supplied product

Subclause 4.14: Corrective action

Subclause 4.17: Internal quality audit

These additional requirements ensure that all three quality assurance models embrace. a ore set of quality system elements (within their defined scopes) that address customer requirement evaluation and adequate demonstration of product conformity.

The revised version of the ISO 9004-1, like its 1987 version, is intended as a separate standard that organizations could use internally to improve their quality management practices. As a guidance. document, it identifies more thoroughly, effective quality management practices without imposing mandatory requirements.

The changes in the revised standard include the following:

Subclause 5.6: Quality improvement - has been added t. coordinate with the -newly developed ISO 9004-4.

Clause 6: Financial considerations of quality systems - This clause draws on the content of a new standard developed or, the economics of quality.

Contents relating to configuration management have been revised t. be consistent with another new standard that is at draft International Standard stage.

Additional references have also been made to environmental considerations as well as to market-place input and feedback as a means of improving quality system.

In addition to content enhancements, virtually every clause of ISO 9004-1 contains some change in wording for clarification or consistency with other standards in the ISO 9000 family.


by Phua Kim Chua, SISIR, Singapore