1 INTRODUCTION 1
Who and/or what is ISO? 1
What is a standard? 1
Who is responsible? 2
What is the ISO 9000 family of standards? 2
What is ISO 9000? 4
Why implement ISO 9000? 5
What are the benefits of ISO 9000? 5
Internal 6
External 6
What are the steps to registration? 7
2 QUALITY MANAGEMENT PRINCIPLES 8
What is a quality management principle? 8
What were the major changes to the standard? 8
What are the eight quality management principles? 8
Customer Focus 9
Leadership 10
Involvement of People 10
Process Approach 10
Systems Approach to Management 12
Continual Improvement 12
Six Classic Steps 13
Continuous Improvement Methodologies 13
Benchmarking 14
Cause & Effect Diagrams 15
Nominal Group Technique 15
Quality Function Deployment 15
Pareto Charts 15
Statistical Process Control 16
Histograms 16
Check Sheets 16
Input/Output Analysis 16
Scatter Diagram 16
Concurrent Engineering 16
Design of Experiments 16
Cost of Quality 17
Control Charts 17
Process Flow Analysis 17
PDCA or Shewhart Cycle 17
Factual Approach to Decision Making 18
Mutually Beneficial Supplier Relationships 19
3 DOCUMENTATION 20
What documentation is necessary 20
What procedures are required 21
What records are required 22
What is the typical documentation structure 22
How do I develop ISO documentation 23
What should be included in a quality manual 23
What format should be used for procedures 24
How do I document a process/procedure 25
What information does a controlled document
typically include 26
4 KEY TERMS AND DEFINITIONS 27
Audit 27
Conformity 27
Continual Improvement 27
Corrective Action 27
Customer Satisfaction 27
Document 27
Preventive Action 27
Process 27
Product 27
Quality 27
Quality Management System 28
Quality Objective 28
Quality Plan 28
Quality Policy 28
Record 28
Top Management 28
Validation 28
Verification 28
5 ISO 9001:2000 REQUIREMENTS 29
What is the scope of the ISO 9001 standard? 29
ISO 9001 requirements paraphrased 29
4 Quality Management System 29
4.1 General requirements 29
4.2 Documentation requirements 30
4.2.1 General 30
4.2.2 Quality manual 30
4.2.3 Control of documents 30
4.2.4 Control of records 31
5 Management Responsibility 31
5.1 Management commitment 31
5.2 Customer focus 31
5.3 Quality policy 31
5.4 Planning 32
5.4.1 Quality objectives 32
5.4.2 Quality management system planning 32
5.5 Responsibility, authority and communication 32
5.5.1 Responsibility and authority 32
5.5.2 Management representative 32
5.5.3 Internal communication 32
5.6 Management review 32
5.6.1 General 32
5.6.2 Review input 33
5.6.3 Review output 33
6 Resource Management 33
6.1 Provision of Resources 33
6.2 Human Resources 33
6.2.1 General 33
6.2.2 Competence, Awareness & Training 34
6.3 Infrastructure 34
6.4 Work Environment 34
7 Product Realization 34
7.1 Planning of Product Realization 34
7.2 Customer Related Processes 35
7.2.1 Determination of Product Requirements 35
7.2.2 Review of Product Requirements 35
7.2.3 Customer Communication 35
7.3 Design and Development 35
7.3.1 Design & Development Planning 35
7.3.2 Design & Development Inputs 36
7.3.3 Design & Development Outputs 36
7.3.4 Design & Development Review 36
7.3.5 Design & Development Verification 37
7.3.6 Design & Development Validation 37
7.3.7 Control of Design & Dev. Changes 37
7.4 Purchasing 37
7.4.1 Purchasing Process 37
7.4.2 Purchasing Information 38
7.4.3 Verification of Purchased Product 38
7.5 Production & Service Provision (P&S) 38
7.5.1 Control of P & S Provision 38
7.5.2 Validation of Process for P & S Provision 38
7.5.3 Identification and Traceability 39
7.5.4 Customer Property 39
7.5.5 Preservation of Product 39
7.6 Control of Monitoring & Measuring Devices 40
8 Measurement, Analysis & Improvement 40
8.1 General 40
8.2 Monitoring & Measurement 40
8.2.1 Customer Satisfaction 40
8.2.2 Internal Audit 41
8.2.3 Monitoring & Measurement of Processes 41
8.2.4 Monitoring & Measurement of Product 41
8.3 Control of Non-conforming Product 42
8.4 Analysis of Data 42
8.5 Improvement 42
8.5.1. Continuous Improvement 42
8.5.2 Corrective Action 43
8.5.3 Preventive Action 43
5 Key Areas 43
6 ISO COMPARISON MATRIX 44
1994 : 2000 44
2000 : 1994 45
7 ISO 9000:2000 FINDINGS 46
Top 5 Areas of Non-Conformance 46
Perceived Benefits 46
Bottom Line Improvements 4
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Understanding ISO 9000:2000