ISO 9000 - QUALITY MANAGEMENT STANDARDS

ISO 9000 - Quality Management Standards



ISO 9000 - Quality Management Standards

Introduction

The ISO 9000 standards were first published in 1987, revised for the first time in 1994, and revised for the second time in 2000. Standards are re-evaluated every five years to ensure that they are current and satisfy the needs of users. The ISO 9000 + 14000 News magazine enables you to keep abreast of information about standards (a bimonthly publication which provides comprehensive coverage of international developments relating to ISO's management system standards, obtainable from ISO) (ISO, 2003).

ISO 9000 is a starting point for understanding the standards, as it defines the fundamental terms used in the ISO 9000 "family", or set of standards relating to quality management. ISO 9001 specifies requirements for a quality management system whereby you can demonstrate ability to provide products that fulfil customer requirements as well as applicable regulatory requirements; it also aims to enhance customer satisfaction. ISO 9004 provides you with guidance on continual improvement of your quality management system so that the needs and expectations of all interested parties are met. These interested parties include customers and end-users; directors and staff in the organization; owners/ investors; suppliers and partners; and society at large.

 

History

ISO 9001 and ISO 9004 are a "consistent pair" of standards that relate modern quality management to the processes and activities of an organization, and emphasize the promotion of continual improvement and achievement of customer satisfaction. ISO 9001, which focuses on the effectiveness of the quality management system in assembly customer requirements, is used for certification or for contractual agreements between suppliers and buyers. On the other hand, ISO 9004 cannot be used for certification as it does not prescribe requirements but provides guidance for the continual improvement of an organization's performance.

ISO 9001 focuses on "effectiveness", i.e. doing the right things, whereas ISO 9004 emphasizes both "effectiveness" and "efficiency", i.e. doing the right thing in the right way (Bamford, 2003).

There is sometimes a misconception that ISO 9000 is mandatory for export to the European Union. This is not correct. When exporting products covered by the New Approach and the Global Approach to the European Union, manufacturers have a choice between various alternatives to satisfy the regulator. Where the module chosen by the manufacturer requires a quality system, compliance with ISO 9001 gives a presumption of conformity, provided that the quality system takes into account, as necessary, the specific requirements of the products for which they are implemented. Compliance with the module does not demand a certified quality system, although the latter provides a useful means of establishing compliance.

Manufacturers should implement an ISO 9001 system if that is a prerequisite imposed upon them by their buyers in their purchasing contract.

Discussion

In a number of fields, such as that of medical devices, compliance to quality systems, often ISO 9001, can be important in some countries. In the United States, for instance, lack of attention to quality systems can result in hefty fines and some very large indirect ...