ISO 9001-2000 for small and medium sized businesses

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Title:

Personal Author:

Monnich, Herbert C., 1932-

Publication Information:

Milwaukee, WI ASQ Quality Press, 2001

ISBN:

9780873895156

Subject Term:

ISO 9000 Series Standards

Quality control -- Standards

Quality assurance -- Standards

Small business -- Management

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Library	Item Barcode	Call Number	Material Type	Item Category 1	Status
Searching... PSZ JB	30000010134755	TS156.6 M66 2001	Open Access Book	Book	Searching... Unknown
Searching... PSZ KL	30000010134754	TS156.6 M66 2001	Open Access Book	Book	Searching... Unknown
Searching... PSZ KL	30000010129467	TS156.6 M66 2001	Open Access Book	Book	Searching... Unknown

New author Herbert C. Monnich, Jr. has taken readers into a seldom discussed but needed area of the ISO 9000 Standards u applying them to small and medium sized businesses. This book would be an excellent resource for someone considering implementing ISO9000 in a company of 500 or less, but isnet sure how to make each point in the standard apply to their company. As Monnich guides readers through each clause, he includes techniques for small businesses to simplify compliance for small and medium sized organizations. Terms described in the standard are defined in this guide to help you along. In this excellent, and very practical book, Herb Monnich has used his expertise to present to the potential user of the new standard, a simplified clause-by-clause analysis of stated requirements. As a guide in your pursuit of compliance to ISO 9001:2000, Monniches book is a must. Lawrence A. Wilson, Ph.D. Lead US Delegate,Intl revision process, ISO9001:2000 & ISO9004:2000 Preview a sample chapter from this book along with the full table of contents by clicking here. You will need Adobe Acrobat to view this pdf file.

Preface	p. xi
Chapter 1 ISO 9001 and Small and Medium Sized Businesses	p. 1
The Advantage of Being Small	p. 1
The Process Approach--What Is It?	p. 2
Small or Medium Businesses	p. 3
ANSI/ISO/ASQ Q9000-2000 Validation Studies and Small and Medium Businesses	p. 4
ISO 9000 Survey '99	p. 5
ANSI/ISO/ASQ Q9000-2000 Family of Standards	p. 7
The "Consistent Pair" of Quality Management Standards	p. 8
ANSI/ISO/ASQ Q9001-2000 Clause 1 Scope	p. 9
1.1 General	p. 9
1.2 Application	p. 9
Unacceptable Exclusions	p. 10
Acceptable Exclusions	p. 11
Quality Management Principles	p. 12
ANSI/ISO/ASQ Q9001-2000 Clause 2 Normative Reference	p. 13
ANSI/ISO/ASQ Q9001-2000 Clause 3 Terms and Definitions	p. 15
Your Quality System	p. 16
New and Refined Changes to ANSI/ISO/ASQ Q9001-2000	p. 17
Chapter 2 ANSI/ISO/ASQ Q9001-2000 Clause 4 Quality Management System	p. 23
4.1 General Requirements	p. 23
Techniques for Small and Medium Businesses	p. 24
4.2 Documentation Requirements	p. 27
4.2.1 General	p. 27
Techniques for Small and Medium Businesses	p. 27
4.2.2 Quality Manual	p. 30
Required and Suggested Documents	p. 32
Optional Documented Procedures	p. 32
Techniques for Small and Medium Businesses	p. 32
4.2.3 Control of Documents	p. 32
Required Documented Procedures	p. 35
Techniques for Small and Medium Businesses	p. 35
4.2.4 Control of Records	p. 35
Required Documented Procedures	p. 39
Techniques for Small and Medium Businesses	p. 39
Chapter 3 ANSI/ISO/ASQ Q9001-2000 Clause 5 Management Responsibility	p. 41
5.1 Management Commitment	p. 41
Techniques for Small and Medium Businesses	p. 42
5.2 Customer Focus	p. 42
Techniques for Small and Medium Businesses	p. 43
5.3 Quality Policy	p. 45
Required and Suggested Documents	p. 45
Techniques for Small and Medium Businesses	p. 46
5.4 Planning	p. 47
5.4.1 Quality Objectives and 5.4.2 Quality Management System Planning	p. 47
Required and Suggested Documents	p. 47
Optional Documented Procedures	p. 48
Techniques for Small and Medium Businesses	p. 48
5.5 Responsibility, Authority, and Communication	p. 50
5.5.1 Responsibility and Authority	p. 50
Required and Suggested Documents	p. 50
Techniques for Small and Medium Businesses	p. 50
5.5.2 Management Representative	p. 51
Techniques for Small and Medium Businesses	p. 51
5.5.3 Internal Communication	p. 52
Techniques for Small and Medium Businesses	p. 52
5.6 Management Review	p. 52
5.6.1 General	p. 52
Required and Suggested Documents	p. 53
Required Records	p. 53
Techniques for Small and Medium Businesses	p. 53
5.6.2 Review Input	p. 53
Techniques for Small and Medium Businesses	p. 54
5.6.3 Review Output	p. 55
Techniques for Small and Medium Businesses	p. 55
Chapter 4 ANSI/ISO/ASQ Q9001-2000 Clause 6 Resource Management	p. 57
6.1 Provision of Resources	p. 57
6.2 Human Resources	p. 58
6.2.1 General	p. 58
6.2.2 Competence, Awareness, and Training	p. 58
Required and Suggested Documents	p. 59
Required Records	p. 60
Techniques for Small and Medium Businesses	p. 60
6.3 Infrastructure	p. 60
Techniques for Small and Medium Businesses	p. 61
6.4 Work Environment	p. 61
Techniques for Small and Medium Businesses	p. 62
Chapter 5 ANSI/ISO/ASQ Q9001-2000 Clause 7 Product Realization	p. 63
7.1 Planning of Product Realization	p. 63
Optional Documented Procedures	p. 64
Required Records	p. 64
Techniques for Small and Medium Businesses	p. 64
7.2 Customer-Related Processes	p. 66
7.2.1 Determination of Requirements Related to the Product	p. 66
Optional Documented Procedures	p. 67
Recommended Records	p. 67
Techniques for Small and Medium Businesses	p. 67
7.2.2 Review of Requirements Related to the Product	p. 68
Optional Documented Procedures	p. 69
Required Records	p. 69
Techniques for Small and Medium Businesses	p. 69
7.2.3 Customer Communication	p. 69
Optional Documented Procedures	p. 70
Recommended Records	p. 70
Techniques for Small and Medium Businesses	p. 70
7.3 Design and Development	p. 71
7.3.1 Design and Development Planning	p. 71
Optional Documented Procedures	p. 72
Recommended Records	p. 72
Techniques for Small and Medium Businesses	p. 72
7.3.2 Design and Development Inputs	p. 73
Optional Documented Procedures	p. 74
Required Records	p. 74
Techniques for Small and Medium Businesses	p. 74
7.3.3 Design and Development Outputs	p. 74
Required and Suggested Documents	p. 75
Optional Documented Procedures	p. 75
Techniques for Small and Medium Businesses	p. 75
7.3.4 Design and Development Review	p. 76
Optional Documented Procedures	p. 77
Required Records	p. 78
Techniques for Small and Medium Businesses	p. 78
7.3.5 Design and Development Verification	p. 78
Optional Documented Procedures	p. 79
Required Records	p. 79
Techniques for Small and Medium Businesses	p. 79
7.3.6 Design and Development Validation	p. 79
Optional Documented Procedures	p. 80
Required Records	p. 80
Techniques for Small and Medium Businesses	p. 80
7.3.7 Control of Design and Development Changes	p. 81
Required and Suggested Documents	p. 81
Optional Documented Procedures	p. 82
Required Records	p. 82
Techniques for Small and Medium Businesses	p. 82
7.4 Purchasing	p. 83
7.4.1 Purchasing Process	p. 83
Optional Documented Procedures	p. 83
Required Records	p. 83
Techniques for Small and Medium Businesses	p. 84
7.4.2 Purchasing Information	p. 84
Optional Documented Procedures	p. 85
Recommended Records	p. 85
Techniques for Small and Medium Businesses	p. 85
7.4.3 Verification of Purchased Product	p. 85
Optional Documented Procedures	p. 86
Recommended Records	p. 86
Techniques for Small and Medium Businesses	p. 87
7.5 Production and Service Provision	p. 87
7.5.1 Control of Production and Service Provision	p. 87
Required and Suggested Documents	p. 89
Optional Documented Procedures	p. 89
Techniques for Small and Medium Businesses	p. 89
7.5.2 Validation of Processes for Production and Service Provision	p. 90
Optional Documented Procedures	p. 90
Required Records	p. 91
Techniques for Small and Medium Businesses	p. 91
7.5.3 Identification and Traceability	p. 91
Optional Documented Procedures	p. 92
Required Records	p. 92
Techniques for Small and Medium Businesses	p. 92
7.5.4 Customer Property	p. 92
Optional Documented Procedures	p. 93
Required Records	p. 93
Techniques for Small and Medium Businesses	p. 93
7.5.5 Preservation of Product	p. 93
Optional Documented Procedures	p. 94
Techniques for Small and Medium Businesses	p. 94
7.6 Control of Monitoring and Measuring Devices	p. 94
Optional Documented Procedures	p. 96
Required Records	p. 96
Techniques for Small and Medium Businesses	p. 97
Chapter 6 ANSI/ISO/ASQ Q9001-2000 Clause 8 Measurement, Analysis, and Improvement	p. 99
8.1 General	p. 99
Techniques for Small and Medium Businesses	p. 100
8.2 Monitoring and Measurement	p. 103
8.2.1 Customer Satisfaction	p. 103
Optional Documented Procedures	p. 103
Techniques for Small and Medium Businesses	p. 103
8.2.2 Internal Audit	p. 104
Required Documented Procedure	p. 105
Required Records	p. 105
Recommended Records	p. 106
Techniques for Small and Medium Businesses	p. 106
8.2.3 Monitoring and Measurement of Processes	p. 107
Optional Documented Procedures	p. 108
Recommended Records	p. 108
Techniques for Small and Medium Businesses	p. 108
8.2.4 Monitoring and Measurement of Product	p. 109
Optional Documented Procedures	p. 110
Required Records	p. 110
Techniques for Small and Medium Businesses	p. 110
8.3 Control of Nonconforming Product	p. 111
Required Documented Procedures	p. 112
Required Records	p. 112
Techniques for Small and Medium Businesses	p. 113
8.4 Analysis of Data	p. 113
Optional Documented Procedures	p. 114
Techniques for Small and Medium Businesses	p. 115
8.5 Improvement	p. 115
8.5.1 Continual Improvement	p. 115
Techniques for Small and Medium Businesses	p. 115
8.5.2 Corrective Action	p. 116
Required Documented Procedures	p. 117
Required Records	p. 117
Techniques for Small and Medium Businesses	p. 117
8.5.3 Preventive Action	p. 118
Required Documented Procedures	p. 119
Required Records	p. 119
Techniques for Small and Medium Businesses	p. 119
Chapter 7 A Sample Quality Manual	p. 127
Index	p. 149

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