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ISO 9001: 2000 Quality Management System Design de Jay J. Schlickman

ISO 9001: 2000 Quality Management System Design: Artech House Technology Management and Professional Developm

Autor Jay J. Schlickman
en Limba Engleză Hardback – 31 dec 2002
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.
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Specificații

ISBN-13: 9781580535267
ISBN-10: 1580535267
Pagini: 377
Dimensiuni: 186 x 237 x 31 mm
Greutate: 0.9 kg
Ediția:New.
Editura: Artech House Publishers
Seria Artech House Technology Management and Professional Developm

Cuprins

Preface. QMS Foundations – The Relevance of Standards. Core Competencies. Selection of a QMS Baseline. The ISO 9001:2000 QMS – The ISO 9000 QMS Design Context. Effective QMS Processes. The ISO 9000 QMS Process Model. QMS Continual Improvement Framework – Continuous/Continual Improvement is Inherent. Continuous Improvement Cycle within Elements. Mandatory Documentation Requirements. Recommended QMS Documentation – Overview of Documentation Requirements. The Four-Tier Pyramid Concept. The ISO 9001:2000 QMS is to be Documented. Quality Manual Design – A Quality Manual is a Mandatory Document. The Quality Manual Controversy. Strategic Framework for the Manual. Cross-functional Manual Action Teams. Shall Analysis. Manual Section Length. Concomitance. Non-applicability of Specific Shalls. Appropriate Detail Level. Level of Detail in Practice. Pyramid for a Manual. Quality Manual Sequences. Manual Configurations. Multi-divisional Manuals. Sector Specific Manuals. Potential Manual Readership. Manual Objectives. Process Document Design – The Process Document. The Trouble with Tier II. ISO 9000 Quality Plans (Optional). Process Flow Charts. Procedure Design – Some Procedures are Mandatory Documents. The Special Case of Work Instructions (Optional). Forms & the Control of Records – Forms versus Records. Records are Mandatory Documents. The Records Master List. Other Mandatory Documents – Shall Analysis of Other Mandatory Documents. The Special Case of Product Characteristics. Mandatory Organizational Requirements. Mandatory Effective Implementation Requirement. Non-mandatory Sensible Requirements. Special Mandatory Requirements. Mandated Standards and Codes Requirement. The Quality Manual Scope of Effort – Estimates. Discussion. HUB Documents – Definition. HUB Template. Quality Manual Issues – Hard Copy Manual Issues. Online Manual Issues. Leadership – ISO 9000 Stewardship. The Stewards Take Our Temperature. Team Leaders. Certification Audits. The Biggest Change in ISO 9001:2000 from ISO 9001:1994! Quality Objectives. Readership and Form – Which Comes First? The Manual or the Processes or the Procedures? Par 4.2.1 of the Standard. The Adverse Effects of Paraphrasing – The Two Classes of Paraphrasing. Paraphrased Class I Characteristics. Paraphrased Class II Characteristics. Conclusions. Publication Media – Selection of a Publication Media (Hardcopy versus Electronic). Generic Numbering System. Writing Style. Issue Resolution – Proposal. Benefits. QMS Documentation & Implementation Design Rules – Design Rule Tables. Closing Invitation to the Case Studies. Case-study #1 The Growth Corporation Upgrades to ISO 9001:2000 – Choice Point. Application Notes to the Upgraded Quality Manual. Cover Page to the Upgraded ISO 9001:2000 Quality Manual. Quality Management System (QMS). Management Responsibility. Resource Management. Product Realization. Measurement, Analysis, & Improvement. Case-study #2 Mike’s Advice on ISO 9001:2000 from the Ground Floor Up—The Phone Call. The Certification Plan from the Ground Floor Up. Appendices – ISO 9000 Stewardship & Team Leader Summary. Further Examples of Quality Policy Statements. Checklist for ISO 9001:2000 Element 4.2.3 Control of Documents Quality Manual Requirements. An Example of Excellent’s Process Flow Charting Protocol, Excellent’s Audit Process. Index.