ISO 9000 : preparing for registration / James L. Lapmrecht.

Format:

Book

Author/Creator:

Lamprecht, James L., 1947-

Series:

Quality and reliability ; 32.

Quality and reliability ; 32

Language:

English

Subjects (All):

Quality assurance--Management.

Quality assurance.

Quality control--Standards.

Quality control.

Physical Description:

xvii, 241 pages ; 24 cm.

Place of Publication:

Milwaukee : ASQC Quality Press New York : Marcel Dekker, 1992.

Summary:

A guide for quality managers in companies wanting to register and document that they are adhering to the International Standard Organization 9000 standards, or to implement a quality program based on the standards. Industrial customers are increasingly requiring such documentation from their supplie

Contents:

What Is the ISO 9000 Series? 1

Architecture of the ISO 9000 Series of Standards 3

Field and Scope of Application 4

What Model to Choose (9001, 9002 or 9003)? 8

Who Should Implement an ISO 9000 Quality System? 8

ISO 9000

Trade Barrier or Opportunity to Improve? 10

Clarifying Some Misunderstandings About the ISO Standards 12

ISO and OSHA 15

ISO and Other Standards (American Petroleum Institute Q1 and the Federal Aviation Regulations) 15

Which ISO Philosophy Do You Subscribe To? 18

2 Overview of the ISO 9001/Q91 Requirements 21

The ISO 9001 Model for Quality Assurance in Design/Development, Production, Installation, and Servicing 24

4.1 Management Responsibility 24

4.2 Quality System 26

4.3 Contract Review 26

4.4 Design Control 27

4.5 Document Control 28

4.6 Purchasing 29

4.7 Purchaser Supplied Product 29

4.8 Product Identification and Traceability 30

4.9 Process Control 30

4.10 Inspection and Testing 31

4.11 Inspection, Measuring, and Test Equipment 33

4.12 Inspection and Test Status 33

4.13 Control of Nonconforming Product 33

4.14 Corrective Action 34

4.15 Handling, Storage, Packaging, and Delivery 35

4.16 Quality Records 35

4.17 Internal Quality Audits 35

4.18 Training 36

4.19 Servicing 36

4.20 Statistical Techniques 36

3 How to Interpret and Address ISO 9001 39

How to Read the Standard 40

Additional Comments Regarding Interpretation 42

Word Processors, Electronic Mail and Document Control 46

A Word of Caution Regarding the Use of Word Processing 46

4 The ISO Quality Assurance System: How to Proceed? 48

Prerequisites to the Quality Assurance System 48

Quality Policy 48

Quality Management 48

Quality System 48

The ISO Quality Assurance Model and Total Quality Management 49

Scope and Field Application: Issues to Consider 52

How to Proceed? 53

Organizational Issues and Certification 54

Case Studies Relating to? What to Register?? 55

5 Suggestions on How to Organize a Quality Assurance System: The Pyramid of Quality Model 61

Preliminary Comments 61

Tier One: The Quality Manual 64

Format of the Quality Manual 64

6 Tier Two Documentation 71

7 Tier Three Documentation 84

Some Hints on Documentation 84

How Not to Do It 85

Some Examples of Effective, Easy to Write Third Tier Documentation 87

Example 1 Checklist for Unloading Tank Cars 88

Example 2 Unloading procedure for trucks 88

Example 3 Combining Training with Procedure Writing 89

How to Document Complex Procedures 89

8 Documenting Your Procedures 97

How to Document Procedures 97

How to Flow Chart 98

Flow Charting Exercise 1 103

Flow Charting Exercise 2 105

9 How to Proceed? 106

How Much Time? 112

Implementation Schedule 113

The Cost of Certification 117

Table 9.3 Estimated ISO 9000 Certification Costs (1991) 118

Table 9.4 Estimated ISO 9000 Implementation Costs (1991) 118

10 Often Asked Questions 120

11 On Registrars and EN 45011/2 133

Not all Registrars are Created Equal 133

Which Registrar to Choose? 134

U.S., British and Other Registrars 137

EN 45011/2 Criteria for Certification Bodies 138

Clause 1 Object and field of application 138

Clause 4 Administrative structure 139

Clause 5 Terms of reference of governing body 139

Clause 6 Organizational structure 140

Clause 7 Certification personnel 140

Clause 8 Documentation and change control 141

Clause 9 Records 141

Clause 10 Certification and surveillance procedures 142

Clause 11 Certification and surveillance facilities required 142

Clause 12 Quality Manual 142

Clause 13 Confidentiality 143

Clause 14 Publications 144

Clause 15 Appeals 144

Clause 16 Audit and periodic review 144

Clause 17 Misuse of certificate 144

Clause 19 Withdrawal and cancellation of certificates 145

12 The Third Party Audit 146

On Audits 146

Types of Audits 147

Second Party Versus Third Party Audits 148

Third Party Auditors 149

Qualification Criteria for Quality Systems Auditors 149

The Third Party Audit Process 151

Pre-audit Visit 152

Documentation Review or Adequacy Review 152

Preparation Audit Trail Matrix (Compliance Audit) 152

Establish Program 152

The Audit 154

Closing Meeting (One Hour) 155

Surveillance 155

13 How to Facilitate an Internal Audit 157

The Need for Internal Audit 157

A Word of Caution 157

Elements of Successful Interviews 158

Preparing for the Interview 159

Conducting the Interviews 160

Relation Auditor-Auditee 160

Formulating Questions 161

Types of Questions 162

Other Types of Questions 163

Repeating 163

Some Advice on How to Ask Questions 164

Auditor's Behavior 164

Where Should I Start? 166

How Much Time Should I Spend? 166

The Report 167

How to Be Ready for an Audit? What to Say and How to Say it? 168

14 The ISO 9000 Series in 1992 and Beyond 170

Recommended Updates for the ISO 9000 Series 1992 170

Clauses Which May be Amended 172

Clauses Which May be Expanded 173

ISO and the Year 2000 173

How to Get There? 176

ISO's Recognition 178

ISO and the EEC Directives 180

A Brief Look at Directives Concerning Medical Devices 182

Some Pitfalls, Criticisms and Suggestions Regarding the Standards 183

ISO and the Service Industries 185

Consulting and ISO 9000: A Few Words of Caution 186

Types of Consulting and Services 187

What Services Should You Contract For? 189

Appendix A Guidelines on What to Include in a Quality Manual 196

Appendix B Quality System Registrars 216

Appendix C How to Use the ISO Questionnaire 221.

Notes:

Includes bibliographical references and index.

ISBN:

0824787412

OCLC:

25281548