ISO 9001 Quality Management Systems (eBook)

Dhanasekharan Natarajan retired as Assistance Professor in RV College of Engineering, Bangalore. He has authored two other books with Springer, A Practical Design of Lumped, Semi-lumped and Microwave Cavity Filters (2013) and Reliable Design of Electronic Equipment: An Engineering Guide (2015)..

Preface 7
Acknowledgements 10
Contents 11
About the Author 18
1 Introducing Quality Management System 19
Abstract 19
1.1 Introduction 19
1.2 Relating Internal and End Customers 19
1.3 Understanding Quality 20
1.3.1 Needs and Expectations of Internal and End Customers 21
1.3.1.1 Needs and Expectations of End Customer 21
1.3.1.2 Needs and Expectations of RF Filter Assembly 21
1.4 Quality Management System 22
References 22
2 Establishing ISO 9001 QMS Documentation 23
Abstract 23
2.1 Documented QMS 23
2.1.1 Needs for Documentation 23
2.1.2 Basic Considerations 24
2.2 Process Approach 25
2.2.1 Defining Process Characterization 25
2.2.2 Monitoring and Measurement 25
2.2.2.1 Control Purposes 26
2.2.2.2 Ensuring Process Effectiveness 26
2.2.2.3 Improving Process Efficiency 27
2.3 Illustrating Process Characterization 27
2.3.1 Inputs 27
2.3.2 Process Procedure with Acceptance Criteria 27
2.3.3 Quality Needs of Internal Customer 28
2.3.4 Monitoring and Measurement 28
2.3.5 Outputs 28
2.4 Process Approach for Controlling Engineering Documents 29
2.4.1 Inputs and Outputs 29
2.4.2 Quality Needs of Customers and Acceptance Criteria 29
2.4.3 Monitoring and Measurement 30
2.5 QMS Processes 30
2.5.1 Sequence and Interaction of QMS Processes 30
2.5.1.1 Illustration 31
2.5.1.2 Additional Information for Process Interactions 31
2.6 QMS Documents 31
2.6.1 Quality Manual 32
2.6.2 Expertise for Preparing QMS Documents 32
References 33
3 Management Processes 34
Abstract 34
3.1 Introduction 34
3.2 Organization and Its Context 35
3.2.1 Documentation Requirements 35
3.2.1.1 The Procedure 35
3.2.1.2 Suggested List of External and Internal Issues 36
3.2.2 Monitoring External and Internal Issues 36
3.2.2.1 Internal Issues 36
3.3 Needs and Expectations of Interested Parties 36
3.3.1 Interested Parties 37
3.3.2 Requirements of Interested Parties 37
3.3.3 Determining, Monitoring and Reviewing 38
3.4 Scope of Quality Management System 38
3.5 Quality Management System and Its Processes 39
3.5.1 Establishing QMS 40
3.5.1.1 Characterizing QMS Processes 40
3.5.1.2 Assigning Responsibilities and Authorities 40
3.5.1.3 Addressing Risks and Opportunities 40
3.5.2 Implementing, Maintaining and Improving QMS 41
3.5.3 Maintaining and Retaining Documented Information 41
3.5.3.1 Retaining Documented Information 41
3.6 Leadership 41
3.6.1 Leadership and Commitment 42
3.6.1.1 Taking Accountability 42
3.6.1.2 Establishing Quality Policy and Quality Objectives 42
3.6.1.3 Integrating QMS with Business Processes 42
3.6.1.4 Promoting Process Approach and Risk-Based Thinking 42
3.6.1.5 Ensuring the Resources for QMS 43
3.6.1.6 Communicating QMS Requirements 43
3.6.1.7 Achieving the Intended Results of QMS 43
3.6.1.8 Engaging, Directing and Supporting the Effectiveness of QMS 43
3.6.1.9 Promoting Improvement 43
3.6.1.10 Supporting Other Management Roles 44
3.6.2 Customer Focus 44
3.6.3 Establishing and Communicating Quality Policy 45
3.6.3.1 Communicating Quality Policy 45
3.6.4 Organizational Roles, Responsibilities and Authorities 46
3.7 Planning 46
3.7.1 Understanding Risks and Opportunities 47
3.7.2 Practical Considerations 48
3.7.3 Determining Risks and Opportunities 48
3.7.3.1 Addressing Risks and Opportunities 49
3.7.4 Planning Actions to Address Risks and Opportunities 49
3.7.4.1 Managing Risks 50
3.7.4.2 Maintaining Records 50
3.8 Example-1: Risks and Opportunities in Design and Development 50
3.8.1 Risks and Their Causes 51
3.8.2 Identifying the Actions to Address Opportunities 51
3.8.3 Integrating the Actions with QMS Process 52
3.9 Example-2: Risks and Opportunities in Customer Enquiries 52
3.9.1 Risks and Their Causes 53
3.9.2 Identifying the Actions to Address Opportunities 53
3.9.3 Integrating the Actions with QMS Process 53
3.10 Example-3: Risks and Opportunities in Production Processes 54
3.10.1 Opportune Actions and Integrating Them with QMS Process 54
3.11 Quality Objectives 55
3.11.1 Requirements 55
3.11.2 Planning to Achieve Quality Objectives 56
3.11.3 Planning Changes 57
References 57
4 Support Processes 59
Abstract 59
4.1 Introduction 59
4.2 Resources 59
4.2.1 People, Infrastructure and Environment 60
4.2.1.1 Infrastructure 60
4.2.1.2 Environment 60
4.3 Monitoring and Measuring Resources 61
4.3.1 Determining and Providing Resources for Measurement 61
4.3.1.1 Providing Resources for Measurement 61
4.3.1.2 Practical Considerations 62
4.3.1.3 Linking Measurement Parameters with Resources 62
4.3.2 Fitness of Measuring Resources 63
4.3.2.1 Calibration, Inspection and Checking 63
4.3.2.2 Maintenance 63
4.3.2.3 Quality Procedures and Records 64
4.3.3 Measurement Traceability 64
4.3.3.1 Definition of Traceability 64
4.3.3.2 Measuring Resources Requiring Traceability 65
4.3.3.3 Ensuring Measurement Traceability 65
4.3.4 Calibration Against Measurement Standards 65
4.3.4.1 Calibration Intervals 66
4.3.4.2 Constraints 67
4.3.5 Verification Against Measurement Standards 67
4.3.5.1 Services of External Providers 67
4.3.5.2 Examples for Verification Using Working Standards 67
4.3.5.3 Accuracy and Resolution of Working Standards 68
4.3.6 Non-existent of Measurement Standards 68
4.3.7 Calibration with Lower Accuracy Ratio Standards 69
4.3.8 Calibration Status and Safeguarding 69
4.4 Organizational Knowledge 70
4.5 Competence 71
4.5.1 Acquiring Competence and Evaluating Effectiveness 71
4.6 Awareness 71
4.7 Communication 72
4.8 Documentation Requirements 72
4.8.1 Creating and Updating 73
4.8.2 Control of Documented Information 74
4.8.2.1 Procedure 74
4.8.2.2 Quality Records 75
References 75
5 Operational Processes 77
Abstract 77
5.1 Operation 77
5.2 Operational Planning and Control 78
5.2.1 Planning 78
5.2.1.1 Establishing Product Specific Processes 78
5.2.1.2 Organizing for Implementation 79
5.2.2 Implementation, Control and Outputs 79
5.2.2.1 Outputs 79
5.2.2.2 Quality Records 80
5.2.3 Addressing Planned and Unintended Changes 80
5.2.3.1 Planned Changes 80
5.2.3.2 Unintended Changes 80
5.3 Requirements for Products and Services 81
5.3.1 Customer Communication 82
5.3.1.1 Customer Complaints, Relating to Products 82
5.3.2 Determining the Requirements for Products 83
5.3.2.1 Statutory Requirements of Products 83
5.3.2.2 Regulatory Requirements of Products 83
5.3.2.3 Product Requirements Identified by Organization 83
5.3.3 Review of Product Requirements 84
5.3.3.1 Ability of Organization 84
5.3.3.2 Requirements Specified by Customer 84
5.3.3.3 Legal and Other Requirements, Identified by Organization 85
5.3.3.4 Resolving the Differences 85
5.3.3.5 Retaining Documented Information 85
5.3.4 Changes to Requirements for Products 85
5.4 Design and Development of Products 86
5.4.1 Design and Development Planning 86
5.4.1.1 Nature, Duration and Complexity 86
5.4.1.2 Determining Process Stages with Reviews, Verification and Validation 87
5.4.1.3 Responsibilities, Authorities, Resource Needs and Interfaces 88
5.4.1.4 Customer Involvement and Controls 88
5.4.1.5 Subsequent Provision of Products 88
5.4.1.6 Documented Information for Demonstration 89
5.4.2 Design and Development Inputs 89
5.4.2.1 Functional, Performance, Statutory and Regulatory Requirements 89
5.4.2.2 Information Derived from Previous Similar Designs 89
5.4.2.3 Additional Considerations and Documentary Evidences 90
5.4.3 Design and Development Controls 90
5.4.3.1 Design Review 90
5.4.3.2 Design Verification 91
5.4.3.3 Design Validation 91
5.4.4 Design and Development Outputs 92
5.4.5 Design and Development Changes 93
5.5 Control of Externally Provided Processes and Products 93
5.5.1 Applicability of Controls 93
5.5.1.1 Pre-requisites for Controls 94
5.5.2 Evaluation of External Providers 94
5.5.2.1 Evaluation Methods 95
5.5.2.2 Actions Arising from Evaluations 96
5.5.3 Selection and Monitoring 96
5.5.4 Re-evaluation of External Providers 96
5.5.5 Type and Extent of Control 97
5.5.5.1 Controls on Externally Provided Processes 97
5.5.5.2 Controls on External Providers 97
5.5.5.3 Controls on the Outputs of External Providers 98
5.5.5.4 Extent of Control 98
5.5.5.5 Verification or Other Activities on Externally Provided Items 98
5.6 Information for External Providers 99
5.6.1 Practical Considerations 100
5.6.1.1 Additional Purchasing Information 100
5.6.2 Requirements of Processes, Products and Services 100
5.6.3 Approval of Products and Services 100
5.6.4 Approval of Methods, Processes and Equipment 101
5.6.4.1 Approval of Methods 101
5.6.4.2 Approval of Processes and Equipment 101
5.6.5 Approval of the Release of Products and Services 101
5.6.6 Competence and Qualification of Personnel 102
5.6.7 Interactions, Controls and Monitoring 102
5.6.8 Verification and Validation 102
5.7 Control of Production and Service Provision 103
5.7.1 Availability of Documented Information 103
5.7.2 Monitoring and Measuring Resources and Activities 103
5.7.2.1 Monitoring and Measuring Activities 104
5.7.3 Infrastructure, Environment and Competence of Personnel 104
5.7.3.1 Competence and Qualification of Personnel 104
5.7.4 Validation and Revalidation of Processes 104
5.7.4.1 Understanding Validation of Processes 105
5.7.4.2 Identifying Processes for Validation 105
5.7.4.3 Procedure for Validation 106
5.7.4.4 International Standards for Validating Processes 106
5.7.4.5 Revalidation of Processes 107
5.7.5 Preventing Human Errors 107
5.7.6 Release, Delivery and Post-delivery Activities 107
5.8 Identification and Traceability 108
5.8.1 Product Identification 108
5.8.2 Product Status Identification 108
5.8.3 Traceability Requirements 108
5.9 Property of Customers and External Providers 109
5.9.1 Discrepancies in Property 109
5.10 Preservation of Product 109
5.11 Post-delivery Activities 110
5.11.1 Extent of Post-delivery Activities 110
5.12 Control of Changes 111
5.13 Release of Products and Services 112
5.14 Control of Nonconforming Outputs 112
5.14.1 Actions on Nonconforming Products 112
5.14.1.1 Correction and Segregation 113
5.14.1.2 Containment, Return or Suspension 113
5.14.1.3 Informing Customer 113
5.14.1.4 Acceptance Under Concession 114
5.14.2 Documentary Evidences 114
References 114
6 Performance Evaluation and Improvement 116
Abstract 116
6.1 Introduction 116
6.2 Monitoring, Measurement, Analysis and Evaluation 117
6.2.1 General Requirements 117
6.2.2 Needs to Be Monitored and Measured 118
6.2.2.1 Outcomes of the Needs for Monitoring 119
6.2.2.2 Measuring the Outcomes 119
6.2.3 Key Performance Indicator 119
6.2.3.1 Types of KPIs 120
6.2.4 Key Performance Indicators for QMS Processes 120
6.2.4.1 Effectiveness in Implementing Planned Activities 120
6.2.4.2 Actions Taken to Address Risks and Opportunities 121
6.2.4.3 Performance and Effectiveness of QMS 121
6.2.4.4 Performance of External Providers 121
6.2.4.5 Conformity of Products and Services 122
6.2.4.6 Customer Satisfaction 122
6.2.5 Methods for Monitoring and Measuring KPIs 122
6.2.5.1 Methods 122
6.2.6 Methods for Analyzing Data on KPIs and Evaluation 123
6.2.6.1 Evaluation Method 123
6.2.7 Periodicity of Monitoring and Measuring KPIs 124
6.2.8 Periodicity for Analyzing Data on KPIs and Evaluation 124
6.3 Customer Satisfaction 124
6.3.1 Needs and Expectations of Customers 125
6.3.1.1 Expectations of Customers 125
6.3.2 Proactive Methods 126
6.3.3 Monitoring and Measuring Customers’ Perception 126
6.3.4 Methods for Analysis and Evaluation 127
6.3.5 Practical Considerations 127
6.4 Analysis and Evaluation 128
6.5 Internal Audit 128
6.5.1 QMS Conformance to ISO 9001 Requirements 129
6.5.1.1 Planning Internal Audit 129
6.5.1.2 Performing Internal Audit and Maintaining Quality Records 130
6.5.2 QMS Conformance to Organization’s Own Requirements 130
6.5.2.1 Planning Internal Audit 130
6.5.2.2 Performing Internal Audit and Maintaining Quality Records 131
6.5.3 Audit for Effective Implementation and Maintenance of QMS 131
6.5.3.1 Understanding Effectiveness in Auditing 131
6.5.3.2 Key Requirement of Internal Audit 132
6.5.4 Audit Program 132
6.5.5 Planning Audit Program 133
6.5.6 Responsibilities, Frequency and Methods 133
6.5.6.1 Frequency of Audit 134
6.5.6.2 Audit Methods 134
6.5.7 Planning Requirements and Reporting 135
6.5.7.1 Selecting Internal Auditors 135
6.5.7.2 Audit Objective, Criteria and Scope 135
6.5.7.3 Administrative Requirements 136
6.5.7.4 Reporting Audit Findings 136
6.5.8 Impartiality and Objectivity in Conducting Audits 136
6.5.8.1 Objectivity in Internal Audits 136
6.5.9 Corrections and Corrective Actions 137
6.5.10 Quality Records 137
6.6 Management Review 138
6.6.1 Management Review Inputs 138
6.6.1.1 Actions from Previous Reviews 138
6.6.1.2 Changes in External and Internal Issues 138
6.6.1.3 Results of Performance Evaluation 138
6.6.1.4 Other Inputs 139
6.6.2 Management Review Outputs 139
6.7 Improvement 140
6.7.1 Improvement Actions 140
6.7.1.1 Breakthrough Improvements 140
6.7.1.2 Innovations 140
6.8 Nonconformity and Corrective Action 141
6.8.1 Corrections 141
6.8.2 Corrective Actions 142
6.8.2.1 Implementing Corrective Actions 142
6.8.3 Quality Records 142
6.9 Continual Improvement 143
References 143
7 Implementing QMS with ERP Software 144
Abstract 144
7.1 Understanding Integrated Approach 144
7.1.1 Benefits of Integrated Approach 145
7.1.2 Feasibility of Integration with ERP Software 145
7.2 Software System Engineering 146
7.2.1 Requirements and Acceptance Testing of Software 146
7.3 Integrating QMS Requirements with ERP Software 147
7.3.1 Requirements Analysis 147
7.3.2 System Functional Analysis 147
7.3.2.1 Benefits of Abbreviated Activity Diagram 147
7.3.3 Illustrations with QMS Processes 148
7.4 Software for the Control of Measuring Resources 148
7.4.1 Requirements Analysis for Operational Needs 148
7.4.1.1 Abbreviated Activity Diagram 149
7.4.2 Requirements Analysis for Monitoring Needs 149
7.4.2.1 Abbreviated Activity Diagram 150
7.4.3 Requirements Analysis for Output Needs 150
7.4.3.1 Abbreviated Activity Diagram 151
7.4.4 Acceptance Test Plan 151
References 152
8 Operational Processes with ERP Software 153
Abstract 153
8.1 Integrating Operational Processes 153
8.1.1 Illustrations for Operational Processes 153
8.1.1.1 Assumptions 154
8.2 Requirements for Products and Services 154
8.2.1 Process Flow Diagram 154
8.2.2 Requirements Analysis 155
8.2.2.1 Abbreviated Activity Diagram 156
8.2.2.2 Acceptance Test Plan 157
8.3 Operational Planning and Control 157
8.3.1 Process Flow Diagram 158
8.3.1.1 Requirements Analysis 158
8.3.1.2 Abbreviated Activity Diagram 159
8.3.1.3 Interaction with QA 159
8.3.2 Acceptance Test Plan 160
8.4 Production and Service Provision 160
8.4.1 Process Flow Diagram 160
8.4.2 Requirements Analysis 161
8.4.2.1 Abbreviated Activity Diagram 161
8.4.3 Acceptance Test Plan 162
8.5 Design and Development of Products 162
Reference 162
9 QMS Planning with Indian Classic, Thirukkural 163
Abstract 163
9.1 Indian Classic, Thirukkural 163
9.1.1 Contents of Thirukkural 163
9.1.2 Translations of Thirukkural 164
9.1.3 Thirukkural for ISO 9001 QMS Planning 164
9.1.3.1 Translation and Commentary 164
9.2 QMS Planning Requirements 165
9.3 Planning Actions to Address Risks and Opportunities 165
9.3.1 Thirukkural for Planning the Actions 166
9.3.1.1 Strength of the Deed (Kural #471) 166
9.3.1.2 Strength of His Own and Allies (Kural #471) 167
9.3.1.3 Strength of Enemy (Kural #471) 167
9.3.1.4 Ignorant of Power (Kural #473) 167
9.3.1.5 Exertion and Obstacles (Kural #676) 168
9.4 Design and Development Planning 168
9.4.1 Thirukkural for Design and Development Planning 168
9.4.1.1 Considering Ultimate Gain (Kural #461) 169
9.4.1.2 Attributes for Design and Development Planning (Kural #631) 169
9.5 Production Planning 170
9.5.1 Thirukkural for Preparing Work Instructions 170
9.5.1.1 Inappropriate Methods (Kural #468) 171
9.5.1.2 The Five Considerations (Kural #675) 171
References 172
Index 173