Customers are demanding it, industry regulations are requiring it, and competitive pressures are making it a must for doing business in the high-tech marketplace.
It is ISO 9000 certification and nearly half a million companies worldwide have implemented quality management systems to gain this sought after certification.
This guide shows the ins and outs of designing a quality management system that is fully compliant with ISO 9001:2000.
It unravels the complexities of the ISO standards so that quality professionals can make the upgrade quickly and effectively.
Based on the author's experience of working in ISO certification, the volume can also be used as a tool for quality professionals who must design from scratch quality management systems.
The book’s objective is to establish an engineering design approach to create a compliant ISO 9001:2000 QMS. Its design rules are constructed to effectively minimize documentation in a way that still increases implementation usage and fosters a dynamic demonstration of continual improvement.
An effectively designed QMS should do the following:
Unify the organization’s economic needs with its quality requirements;
Optimize the flow of information to a wide range of users;
Maintain full compliance with the ISO 9001:2000 International Standard (Standard);
Provide a dynamic presentation of the organization’s drive towards a
meaningful ISO 9000 QMS;
Propose a resolution as to just what a quality manual should contain
and thereby provide a basis for a less diverse set of practitioner
The book’s approach is based primarily upon an interpretation of the
requirements stated in the Standard and its associated guidelines.
The directives are encased within the context of 39 years of experience in the management of high-tech research, engineering, marketing and sales, quality, manufacturing, and service organizations.
Although the design rules are generic, the text covers 1994–2000 upgrades in detail (the cut-and-paste and fill-in techniques) because over 400,000 1994-certified sites require upgrades prior to December 15, 2003.
As a result, the upgrade requirement was used as the basis for the first case study.
The second case study is designed for someone who needs to create a QMS from the ground floor using the book’s design rules.
The second case study is much shorter, as the first case study ends up with a complete quality manual that, in tone and structure, is similar to a first created quality manual.
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