Résumé
An effective ISO 9001:2000 quality management system,
driven by a fully compliant quality manual, is key in
meeting ISO 9000 quality standards and a must for obtaining
ISO certification. Written by an RAB certified quality
management systems lead auditor, with forty years of
industrial experience - who has a 10-year track record in
either the consultation or auditing support of over
one-hundred ISO certified organizations - this book
provides you with the design principles and techniques for
implementing an effective quality management system.
The book describes the design rules required to document,
implement, and demonstrate quality management system
effectiveness in compliance with the latest version of the
ISO 9000 International Standard. This systematic and
engineering approach simplifies the many complexities in
maintaining compliance with ISO standards. This hands-on
guide is packed with tips and insights the author has
garnered from personally designing quality management
systems that integrate organizational strategy with quality
management. Moreover, the book helps you create meaningful
documentation and a user-friendly, informative quality
manual that together form the core of an effective and
responsive quality management system.
- 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.
L'auteur - Jay J. Schlickman
Jay J. Schlickman is an RAB certified quality management systems lead auditor; an RAB qualified ISO 9001:2000 auditor; a certified Canadian medical devices conformity assessment system auditor; and quality management systems consultant based in Lexington MA. He received his B.S. and M.S. in physics from Northeastern University. He is a Life Member of the Institute of Electrical & Electronics Engineers (IEEE), a member of the American Physical Society (APS), and a member of the American Society for Quality (ASQ).
Caractéristiques techniques
| PAPIER | |
| Éditeur(s) | Artech House |
| Auteur(s) | Jay J. Schlickman |
| Parution | 19/02/2003 |
| Nb. de pages | 400 |
| Format | 18 x 23,5 |
| Couverture | Relié |
| Poids | 901g |
| Intérieur | Noir et Blanc |
| EAN13 | 9781580535267 |
| ISBN13 | 978-1-58053-526-7 |
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