Chapter 13. Quality Management Systems
B. G. Dale
Introduction
This chapter opens by examining the concept of quality assurance and the responsibilities of people within an organization for carrying out the activity. A quality system is defined and the background of quality system standards traced, the key features of the ISO 9000 series (1994) are examined, implementation guidelines and issues outlined, the quality system assessment and registration reviewed and the benefits and limitations highlighted. A model is also presented which outlines what is required for a small company to successfully achieve ISO 9000 series registration. Much has already been written about quality systems and standards (Dale and Oakland 1994; Davies 1997; Hall 1992; Jackson and Ashton 1993; Lamprecht 1992, 1993; Rothery 1993), and there are the standards themselves. This chapter is therefore restricted to an overview of the key features and issues.
What is Quality Assurance?
Quality assurance is defined in BS EN ISO 9000 (2000) as:
Part of quality management, focused on providing confidence that quality requirements will be fulfilled.
Quality assurance is often regarded as discreet policing by the quality assurance department. This is not so. The ideal role of the department is to oversee the whole process of quality assurance within an organization, provide guidance, advice on the assignment of roles and responsibilities to be undertaken by each function and person, and address weaknesses in the system. ...
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