| About the Series |
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iii | (2) |
| Foreword |
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v | (2) |
| Preface |
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vii | (8) |
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xv | |
| INTRODUCTION |
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1 | (4) |
| Quality |
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1 | (4) |
| Quality management |
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2 | (1) |
| Function and importance of the quality manual |
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3 | (2) |
| PART ONE - GENERAL PRINCIPLES |
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5 | (40) |
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1 THE CONCEPTS OF QUALITY MANAGEMENT AND QUALITY ASSURANCE |
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5 | (8) |
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5 | (1) |
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1.2 Quality control and quality inspection |
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6 | (1) |
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6 | (4) |
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10 | (3) |
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2 THE QUALITY MANUAL WITHIN THE SERIES OF QUALITY SYSTEMS DOCUMENTS |
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13 | (12) |
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2.1 The quality documents pyramid |
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13 | (3) |
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2.2 Quality manuals and quality plans |
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16 | (5) |
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21 | (1) |
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2.4 The different operational documents |
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22 | (3) |
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3 PRINCIPLES FOR WRITING A QUALITY MANUAL |
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25 | (20) |
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3.1 Decision and function of top management |
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26 | (1) |
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27 | (3) |
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30 | (15) |
| PART TWO - CONTENTS OF A QUALITY MANUAL |
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45 | (162) |
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4 INTRODUCTORY PAGES AND ANNEXED DOCUMENTS |
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45 | (8) |
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45 | (1) |
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4.2 President's statement of commitment to quality |
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46 | (1) |
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4.3 Scope and field of application |
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47 | (1) |
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4.4 Definations and abbreviations |
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48 | (1) |
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48 | (1) |
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4.6 Presentation of the organization |
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48 | (2) |
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4.7 Control of the quality manual |
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50 | (1) |
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4.8 Annexed supporting documents |
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51 | (2) |
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5 TOP MANAGEMENT'S RESPONSIBILITIES |
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53 | (10) |
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5.1 Quality policy and objectives |
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53 | (1) |
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5.2 Organizational structure |
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54 | (6) |
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60 | (1) |
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60 | (3) |
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63 | (16) |
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64 | (3) |
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6.2 Structure of the quality function |
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67 | (5) |
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72 | (2) |
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6.4 Control of resources and personnel |
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74 | (1) |
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74 | (1) |
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75 | (4) |
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79 | (20) |
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79 | (1) |
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7.2 Nature and selection of documents to be controlled |
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80 | (1) |
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7.3 Creation and revision of the quality documents |
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81 | (3) |
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7.4 Implementation and circulation of quality documents |
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84 | (4) |
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7.5 Presentation and identification of documents |
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88 | (1) |
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7.6 Preparation and control of procedures |
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88 | (1) |
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7.7 Technical documents control |
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89 | (6) |
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95 | (4) |
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99 | (12) |
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99 | (1) |
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8.2 Strategic quality plans |
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100 | (1) |
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8.3 Product or process quality plans |
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101 | (1) |
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8.4 Preparation of a product or process quality plan |
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102 | (9) |
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111 | (16) |
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111 | (2) |
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9.2 Preparation of design and development |
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113 | (1) |
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9.3 Design input (definition stage) |
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114 | (1) |
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115 | (5) |
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120 | (1) |
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120 | (1) |
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120 | (1) |
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9.7 Product qualification |
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121 | (2) |
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123 | (4) |
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127 | (10) |
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127 | (1) |
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10.2 Identification of needs and selection of requirements |
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128 | (3) |
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10.3 Assessment and choice of suppliers |
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131 | (3) |
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10.4 Drawing up of orders |
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134 | (1) |
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10.5 Followup, surveillance and receiving inspection |
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134 | (3) |
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11 PRODUCTION (OR PROCESS) QUALITY |
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137 | (18) |
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137 | (2) |
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11.2 Preparation for production |
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139 | (8) |
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11.3 Inspection and tests |
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147 | (5) |
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11.4 Inspection, measuring and test equipment |
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152 | (1) |
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153 | (2) |
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12 CONTROL OF NONCONFORMITIES |
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155 | (14) |
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155 | (2) |
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12.2 Nonconformities for a product |
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157 | (10) |
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12.3 Process or procedure nonconformities |
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167 | (1) |
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12.4 Corrective and preventive actions |
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167 | (2) |
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169 | (14) |
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169 | (3) |
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172 | (1) |
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173 | (7) |
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13.4 Quality indicators and quality performance charts |
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180 | (1) |
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13.5 The forms of evaluation recognition |
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180 | (3) |
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183 | (10) |
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183 | (1) |
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14.2 Definitions related to quality and to non-quality costs |
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184 | (6) |
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14.3 Determining quality costs |
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190 | (1) |
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14.4 Improvement of economic factor |
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191 | (2) |
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193 | (6) |
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193 | (1) |
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194 | (1) |
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15.3 Awareness and training for quality |
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194 | (4) |
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15.4 Qualification of personnel |
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198 | (1) |
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199 | (8) |
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199 | (1) |
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16.2 General principles for quality improvement |
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200 | (1) |
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16.3 Quality process improvement |
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201 | (1) |
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16.4 Methods, tools and techniques |
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202 | (1) |
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203 | (4) |
| CONCLUSION |
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207 | (4) |
| NORMATIVE DOCUMENTS |
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211 | (10) |
| INDEX |
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221 | |