The 90-Day ISO 9000 Manual

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.

Peter Mauch, James Stewart, Frank Straka

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 Forum -- ISO Adoption -- International Standards Application -- Regulation of Products for Sale in the European -- Community -- ISO/IEC Guide 25 -- European C om m unity 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 System s 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 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 Row 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.