About the author |
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xiii | |
Foreword |
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xv | |
Preface |
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xvii | |
1 What is quality? |
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1 | (8) |
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1.1 But who is responsible for managing quality in an organisation? |
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5 | (1) |
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1.2 And so what is the difference between a product and a service? |
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5 | (1) |
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1.3 What about Quality Control and Quality Assurance? |
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6 | (3) |
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7 | (1) |
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7 | (2) |
2 What is a Quality Management System? |
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9 | (68) |
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2.1 What are the requirements of a Quality Management System? |
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17 | (3) |
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2.2 What are the costs and benefits of having a Quality Management System? |
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20 | (3) |
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2.3 What is a Quality Manual? |
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23 | (3) |
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2.3.1 What goes into a Quality Manual? |
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24 | (2) |
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2.3.2 What does each part of the Quality Manual do? |
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26 | (1) |
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2.4 What is a Quality Policy? |
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26 | (7) |
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27 | (1) |
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2.4.2 Corporate policy statement |
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28 | (1) |
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2.4.3 Process-specific policies |
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28 | (2) |
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2.4.4 How to set quality objectives |
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30 | (2) |
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2.4.5 How to go about setting measurable objectives |
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32 | (1) |
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33 | (1) |
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2.5 What is a Quality Process? |
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33 | (13) |
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2.5.1 The process approach |
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35 | (1) |
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2.5.2 Core Business Process |
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36 | (2) |
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2.5.3 What types of Core Processes would a business require? |
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38 | (2) |
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2.5.4 Supporting processes |
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40 | (4) |
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2.5.5 Inter-relationship of process documentation |
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44 | (1) |
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2.5.6 The hierarchy of processes |
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45 | (1) |
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2.6 What is a Quality Plan? |
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46 | (7) |
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2.6.1 What should be covered by a Quality Plan? |
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49 | (1) |
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2.6.2 Management responsibility |
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49 | (1) |
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50 | (1) |
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50 | (1) |
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50 | (1) |
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50 | (1) |
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2.6.7 Customer-supplied products and services |
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50 | (1) |
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2.6.8 Product and service identification and traceability |
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51 | (1) |
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51 | (1) |
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2.6.10 Inspection and testing |
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51 | (1) |
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2.6.11 Inspection, measuring and test equipment |
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51 | (1) |
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2.6.12 Nonconforming products and services |
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52 | (1) |
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2.6.13 Other considerations |
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52 | (1) |
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2.7 What is a Quality Procedure? |
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53 | (5) |
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2.7.1 What is the best way to write a Quality Procedure? |
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53 | (1) |
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2.7.2 What should go into a Quality Procedure? |
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54 | (4) |
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2.8 What is a Work Instruction? |
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58 | (3) |
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2.8.1 What should go into a Work Instruction? |
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60 | (1) |
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2.8.2 How many Work Instructions can I have? |
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61 | (1) |
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2.9 Who controls quality in an organisation? |
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61 | (3) |
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2.9.1 Who has overall responsibility? |
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61 | (1) |
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2.9.2 Management responsibilities |
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62 | (1) |
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2.9.3 The Quality Management Team |
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62 | (2) |
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64 | (1) |
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2.10 How quality helps during the life cycle of products and services |
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64 | (6) |
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66 | (1) |
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2.10.2 Manufacturing stage |
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67 | (1) |
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67 | (1) |
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68 | (1) |
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68 | (2) |
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2.11 What are the purchaser's responsibilities? |
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70 | (1) |
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2.12 What are the supplier's responsibilities? |
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71 | (2) |
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2.13 Quality Management and computer technology |
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73 | (4) |
3 The history of quality standards |
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77 | (20) |
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3.1 1979 - BS 5750:1979 Parts 1, 2 and 3 |
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81 | (4) |
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85 | (1) |
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3.3 1987 - ISO 9000:1987 Parts 1, 2 and 3 |
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85 | (1) |
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3.4 1994 - BS EN ISO 9000:1994 |
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86 | (1) |
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87 | (5) |
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92 | (1) |
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93 | (1) |
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94 | (3) |
4 Who produces quality standards? |
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97 | (12) |
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99 | (2) |
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4.2 Who and what is the IEC? |
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101 | (1) |
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4.3 Who and what is the ITU? |
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102 | (1) |
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4.4 How important is the work of all these committees? |
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103 | (1) |
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104 | (1) |
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104 | (5) |
5 A brief summary of ISO 9001:2015 |
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109 | (30) |
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110 | (1) |
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5.2 Why has ISO 9001 been revised? |
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111 | (1) |
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5.3 How are these standards revised? |
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112 | (2) |
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5.4 What effect did this revision have on ISO 9001? |
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114 | (2) |
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114 | (2) |
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116 | (6) |
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5.5.1 What is the new structure of Annex SL? |
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119 | (2) |
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5.5.2 What is the current status of Annex SL revisions? |
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121 | (1) |
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5.6 But what exactly is meant by the 'ISO 9000 family of standards'? |
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122 | (4) |
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5.6.1 ISO 9000:2015 Quality Management Systems: Fundamentals and vocabulary |
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123 | (1) |
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5.6.2 ISO 9004:2009 Managing for the sustained success of an organisation. A quality management approach |
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124 | (1) |
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5.6.3 ISO 9001:2008 Quality Management Systems: Requirements |
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125 | (1) |
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5.7 The seven principles of management |
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126 | (4) |
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129 | (1) |
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5.8 What is the new structure of ISO 9001? |
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130 | (3) |
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5.9 What are the major clause changes seen in ISO 9001:2015? |
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133 | (6) |
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5.9.1 Are there any other significant changes? |
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133 | (3) |
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5.9.2 What about the revised duties of Top Management? |
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136 | (3) |
6 What other standards are based on ISO 9001:2015? |
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139 | (10) |
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143 | (1) |
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6.2 Auditing management systems |
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143 | (1) |
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143 | (1) |
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143 | (1) |
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143 | (1) |
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144 | (1) |
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144 | (1) |
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6.8 Electoral organisations |
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144 | (1) |
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6.9 Energy management systems |
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144 | (1) |
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6.10 Explosive atmospheres |
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144 | (1) |
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144 | (1) |
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6.12 Good manufacturing practice |
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145 | (1) |
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145 | (1) |
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145 | (1) |
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6.15 Information technology |
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145 | (1) |
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6.16 Information security |
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145 | (1) |
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145 | (1) |
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6.18 Measurement manufacturing systems |
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146 | (1) |
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146 | (1) |
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6.20 Multi-layer piping systems |
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146 | (1) |
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6.21 Packaging: transport packages for dangerous products |
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146 | (1) |
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6.22 Petroleum, petrochemical and natural gas industries |
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146 | (1) |
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6.23 Quality Management System consultants |
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146 | (1) |
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6.24 Quality Management Systems projects |
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147 | (1) |
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147 | (1) |
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6.26 Ships and marine technology |
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147 | (1) |
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6.27 Software engineering |
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147 | (1) |
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147 | (1) |
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6.29 Supply chain management |
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147 | (1) |
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148 | (1) |
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6.31 Telecommunications industry |
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148 | (1) |
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6.32 Testing and calibration laboratories |
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148 | (1) |
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148 | (1) |
7 What to do once your QMS is established |
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149 | (20) |
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150 | (4) |
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154 | (6) |
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7.2.1 What are the benefits of achieving certification to ISO 9001:2015? |
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154 | (1) |
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7.2.2 What are the differences in being a certified, accredited and/or registered ISO 9001:2015 organisation? |
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155 | (1) |
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7.2.3 But can't I just work 'in compliance' with ISO 9001? |
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156 | (1) |
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7.2.4 OK, so how do I become an ISO 9001-registered organisation then? |
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156 | (2) |
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7.2.5 What would the budgetary costs be for doing all this? |
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158 | (1) |
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7.2.6 How long will it take to become certified? |
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158 | (1) |
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7.2.7 What is the certification process? |
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159 | (1) |
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7.3 What to do once my QMS is established |
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160 | (5) |
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160 | (2) |
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162 | (1) |
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7.3.3 Process improvement tools |
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163 | (1) |
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7.3.4 How do I apply Six Sigma to improve my processes? |
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164 | (1) |
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7.3.5 Why have six Sigmas when one would do? |
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165 | (1) |
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7.4 How do I upgrade my existing ISO 9001:2008 registration to meet ISO 9001:2015's requirements? |
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165 | (1) |
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7.4.1 Does my organisation have to scrap its existing processes and procedures and start again? |
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166 | (1) |
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7.4.2 Does my organisation need to re-certify now that ISO 9001:2015 is published? |
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166 | (1) |
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7.4.3 How can I prepare for the new standard? |
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166 | (1) |
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7.5 How can all this be achieved? |
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166 | (3) |
Annex A - ISO 9001:2015 - a summary of requirements |
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169 | (72) |
Abbreviations and acronyms |
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241 | (4) |
Reference standards for Quality Management Systems |
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245 | (2) |
Glossary of terms used in Quality Management standards |
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247 | (6) |
Books by the same author |
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253 | |