Designed and written by professionals with extensive ISO 9000 Certification experience, the techniques and forms in this Manual have been used successfully to achieve certification at over 50 companies. The 90-Day ISO 9000 Manual provides the basic system you need in place to satisfy an ISO 9000 Audit.
First, ISO 9000 is explained and the registration process described in detail. Next, you are taken through exactly what you need to do to prepare for an audit. You are given the working instructions and forms you need to meet certification requirements. The forms are unique and have been designed specifically for ISO 9000 standards.
Since ISO 9000 is not designed to be a TQM program the authors have also included a special section that provides the information, instructions and forms needed for quality audits such as Q94 or Z1. If you want to take your program further than just ISO 9000 certification, the material is available to you.
The 90-Day ISO 9000 Manual includes the latest published draft of Q91 DIS, which is the formal public review copy. Companies that have recently been audited have noticed that certain improvements in documentation have been expected by registrars. These improvements require rewording the old standards. The new standards have been incorporated in this manual and several schemes have been modified.
The authors of The 90-Day ISO 9000 Manual have extensive experience working on ISO 9000 standards review, consulting with companies developing programs, registrar experience and international ISO 9000 activities. This manual will reflect a practical approach to registration for the next five years.
1. What Is ISO 9000 and Why Is It Needed?
Development of Standards
How Was ISO 9000 Developed?
International Aspects of ISO 9000
The ISO 9000 Forum
ISO 9000 Adoption
International Standards Application
Regulation of Products for Sale in the European Community
ISO 9000/IEC Guide 25
European Community Product Safety and Liability Directives
Quality System Registration
European Accreditation of Certification
European Organization for Testing and Certification
The European Organization for Quality
The European Committee for Quality Systems and Certification
European Network for Quality Systems Assessment and Certification
Agreements between the European Community and Other European Countries
The ISO 9000 Standard and Non-European Countries
ISO 9000 Standards for the United States
Benefits vs. Cost of ISO 9000
Selecting the Registrar
Costs of Registration
The Role of Consultants in ISO 9000 Registration
2. Quality Concepts Contributing to the ISO 9000 Standard
History of Quality Control Systems
Quality in a Craft Society
Quality in the Mill
Beginnings of Quality Control
The Quality Improvement Era
Aspects of ISO 9000 Implementation
Quality Cost
Quality as a System
Product Design
Quality Culture
Total Quality Control: The Ishikawa Approach
What Is Quality Control?
The Quality Thought Revolution
Knowing True Quality
Expressing the Quality
The Quality Circle
Why Did Zero Defects Fail?
Financial, Performance, and Quality Audits: A Comparison of Similar Approaches
ISO 9000 and Management by Objectives
3. Applying the Quality Sciences to ISO 9000
How Does Quality Apply?
Quality in Business
Quality Organization
Business Modeling
Inputs
Transformation
Output
Quality Organization as the Feedback Measure
Defining the Service
Service Analysis: A Telemarketing Example
Dilemma of Inexact Definitions
Risk Evaluation Criteria
Characteristic Parameters
Application
Defining the Process
Organizational Chart
Procedural Flow Diagrams
Procedural Analysis
Procedural Flow Diagrams and ISO 9000
Problem Solving
Inspection and Testing, Calibration, and Quality Records
Inspection and Testing
Calibration
Quality Records
Management Responsibility, Auditing, Corrective and Preventive Action
4. Quality Beyond ISO 9000
Common Issues
Problems in Implementing Quality Theory
Terminology
Comments on Quality Standards
Standard for Total Quality Management
0 Introduction
1 Scope, Purpose, and Application
2 Normative References
3 Definitions
4 Management Leadership
5 Quality Information System and Results
6 Utilization of People
7 Customer Needs Identification
8 Service, Process, and Product Development
9 Operations
10 Quality Improvement
Index
Biography
Peter Mauch, James Stewart, Frank Straka
