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.
Table Of Contents
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. Checkli
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).