List of Illustrations |
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Chapter 1 Frequently Asked Questions and Myths |
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1 | (10) |
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How Can I Become Certified to ISO 9000 |
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1 | (1) |
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1 | (1) |
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My Business Is Different from Anyone Else's |
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2 | (1) |
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How Can ISO Tell Me How to Run My Company? |
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2 | (1) |
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Why Do I Need More Documentation? |
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3 | (1) |
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Do I Have Everything That ISO Says to Do in the Standard? |
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4 | (1) |
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How Long Will It Take to Get Certification? |
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5 | (1) |
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What Happens if I Do Not Like the ISO 9001 Layout |
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6 | (1) |
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Will the Registrar Fail Me on the Certification Audit |
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6 | (1) |
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Can I Direct the Registrar's Questions to My Consultant Instead of My Employees or Myself |
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7 | (1) |
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How Much Does Registration Cost |
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7 | (1) |
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ISO 9000 Does Not Apply to Service Industries |
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8 | (1) |
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Do I Have to Send My Internal Auditors on a Lead Auditor Training Course? |
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8 | (1) |
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Can I Advertise My ISO 9001 Certification on My Products? |
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9 | (2) |
Chapter 2 Basic Requirements of a Quality Manual |
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11 | (18) |
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12 | (1) |
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12 | (5) |
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17 | (1) |
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17 | (2) |
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19 | (4) |
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20 | (1) |
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20 | (3) |
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Section 2: Quality Policy |
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23 | (3) |
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26 | (3) |
Chapter 3 Clause 4 Quality Management System |
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29 | (8) |
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29 | (1) |
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4.2 Documentation Requirements |
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30 | (7) |
Chapter 4 Clause 4.2.2 Quality Manual |
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37 | (4) |
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Requirements of the Standard |
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37 | (1) |
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37 | (4) |
Chapter 5 Clause 4.2.3 Control of Documents |
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41 | (10) |
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Requirements of the Standard |
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41 | (1) |
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41 | (10) |
Chapter 6 Clause 4.2.4 Control of Records |
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51 | (8) |
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Requirements of the Standard |
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51 | (1) |
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51 | (8) |
Chapter 7 Clause 5.1 Management Commitment |
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59 | (4) |
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Requirements of the Standard |
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59 | (4) |
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5.1 Management Commitment |
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59 | (4) |
Chapter 8 Clause 5.2 Customer Focus |
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63 | (4) |
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Requirements of the Standard |
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63 | (1) |
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63 | (4) |
Chapter 9 Clause 5.3 Quality Policy |
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67 | (4) |
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Requirements of the Standard |
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67 | (1) |
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67 | (4) |
Chapter 10 Clause 5.4 Planning |
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71 | (6) |
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Requirements of the Standard |
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71 | (1) |
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71 | (1) |
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5.4.2 Quality Management System Planning |
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72 | (1) |
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Requirements of the Standard |
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72 | (1) |
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73 | (4) |
Chapter 11 Clause 5.5 Responsibility, Authority, and Communication |
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77 | (14) |
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Requirements of the Standard |
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77 | (2) |
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5.5.1 Responsibility and Authority |
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77 | (2) |
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5.5.2 Management Representative |
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79 | (1) |
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Requirements of the System |
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79 | (1) |
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79 | (12) |
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5.5.3 Internal Communication |
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80 | (11) |
Chapter 12 Clause 5.6 Management Review |
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91 | (4) |
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Requirements of the Standard |
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91 | (4) |
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91 | (1) |
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92 | (1) |
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92 | (3) |
Chapter 13 Clause 6 Resource Management |
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95 | (4) |
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Requirements of the Standard |
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95 | (4) |
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6.1 Provision of Resources |
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95 | (4) |
Chapter 14 Clause 6.2 Human Resources |
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99 | (6) |
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Requirements of the Standard |
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99 | (6) |
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99 | (1) |
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6.2.2 Competence, Awareness, and Training |
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99 | (6) |
Chapter 15 6.3 Infrastructure |
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105 | (4) |
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Requirements of the Standard |
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105 | (1) |
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105 | (4) |
Chapter 16 Clause 6.4 Work Environment |
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109 | (4) |
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Requirements of the Standard |
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109 | (4) |
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109 | (1) |
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110 | (3) |
Chapter 17 Clause 7 Product Realization |
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113 | (10) |
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Requirements of the Standard |
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113 | (10) |
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7.1 Planning of Product Realization |
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114 | (9) |
Chapter 18 Clause 7.2 Customer-Related Processes |
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123 | (12) |
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Requirements of the Standard |
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123 | (12) |
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7.2.1 Determination of Requirements Related to the Product |
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123 | (2) |
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7.2.2 Review of Requirements Related to the Product |
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125 | (3) |
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7.2.3 Customer Communication |
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128 | (7) |
Chapter 19 Clause 7.3 Design and Development |
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135 | (20) |
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Requirements of the Standard |
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135 | (3) |
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7.3.1 Design and Development Planning |
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137 | (1) |
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7.3.2 Design and Development Inputs |
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138 | (1) |
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Requirements of the Standard |
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138 | (1) |
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138 | (1) |
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7.3.3 Design and Development Outputs |
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139 | (1) |
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Requirements of the Standard |
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139 | (1) |
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139 | (2) |
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7.3.4 Design and Development Review |
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141 | (1) |
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Requirements of the Standard |
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141 | (1) |
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141 | (2) |
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7.3.5 Design and Development Verification |
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143 | (1) |
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Requirements of the Standard |
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143 | (1) |
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143 | (1) |
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7.3.6 Design and Development Validation |
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144 | (1) |
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Requirements of the Standard |
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144 | (1) |
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144 | (1) |
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7.3.7 Control of Design and Development Changes |
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144 | (1) |
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Requirements of the Standard |
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144 | (1) |
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145 | (10) |
Chapter 20 Clause 7.4 Purchasing |
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155 | (12) |
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Requirements of the Standard |
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155 | (4) |
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155 | (4) |
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7.4.2 Purchasing Information |
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159 | (1) |
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Requirements of the Standard |
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159 | (1) |
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159 | (8) |
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7.4.2 Purchasing Information |
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159 | (1) |
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7.4.3 Verification o f Purchased Product |
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160 | (7) |
Chapter 21 Clause 7.5 Production and Service Provision |
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167 | (8) |
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Requirements of the Standard |
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167 | (8) |
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7.5.1 Control of Production and Service Provision |
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167 | (8) |
Chapter 22 Clause 7.5.2 Validation of Processes |
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175 | (4) |
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Requirements of the Standard |
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175 | (1) |
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175 | (4) |
Chapter 23 Clause 7.5.3 Identification and Traceability |
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179 | (8) |
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Requirements of the Standard |
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179 | (1) |
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179 | (8) |
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180 | (1) |
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180 | (1) |
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181 | (1) |
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181 | (6) |
Chapter 24 Clause 7.5.4 Customer Property |
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187 | (4) |
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Requirements of the Standard |
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187 | (4) |
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Products Supplied for Incorporation into a Project |
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187 | (1) |
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Products Supplied for Repair |
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188 | (3) |
Chapter 25 Clause 7.5.5 Preservation of Product |
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191 | (6) |
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Requirements of the Standard |
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191 | (6) |
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191 | (1) |
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192 | (1) |
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192 | (1) |
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192 | (1) |
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193 | (1) |
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193 | (4) |
Chapter 26 Clause 7.6 Control of Monitoring and Measuring Devices |
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197 | (8) |
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Requirements of the Standard |
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197 | (1) |
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198 | (7) |
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198 | (7) |
Chapter 27 Clause 8.1 General |
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205 | (4) |
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Requirements of the Standard |
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205 | (1) |
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205 | (4) |
Chapter 28 Clause 8.2 Monitoring and Measurement |
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209 | (6) |
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Requirements of the Standard |
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209 | (1) |
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209 | (1) |
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8.2.1 Customer Satisfaction |
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210 | (1) |
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Requirements of the Standard |
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210 | (1) |
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210 | (5) |
Chapter 29 Clause 8.2.2 Internal Audit |
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215 | (10) |
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Requirements of the Standard |
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215 | (1) |
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216 | (9) |
Chapter 30 Clause 8.2.3 Monitoring and Measurement of Processes |
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225 | (4) |
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Requirements of the Standard |
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225 | (1) |
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225 | (4) |
Chapter 31 Clause 8.2.4 Monitoring and Measurement of Product |
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229 | (8) |
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Requirements of the Standard |
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229 | (1) |
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229 | (8) |
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Receiving Inspection and Testing |
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230 | (1) |
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231 | (1) |
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231 | (1) |
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Inspection and Test Records |
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232 | (5) |
Chapter 32 Clause 8.3 Control of Nonconforming Product |
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237 | (14) |
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Requirements of the Standard |
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237 | (1) |
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237 | (1) |
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Review and Disposition of Nonconforming Product |
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238 | (7) |
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Sample Nonconformance/Corrective Action Report |
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245 | (1) |
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245 | (2) |
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247 | (1) |
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Review of Nonconformance Report/Disposition |
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247 | (1) |
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247 | (4) |
Chapter 33 Clause 8.4 Analysis of Data |
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251 | (6) |
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Requirements of the Standard |
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251 | (1) |
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252 | (5) |
Chapter 34 Clause 8.5 Improvement |
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257 | (10) |
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Requirements of the Standard |
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257 | (1) |
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8.5.1 Continual Improvement |
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257 | (1) |
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258 | (1) |
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Requirements of the Standard |
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258 | (1) |
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258 | (1) |
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259 | (1) |
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Requirements of the Standard |
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259 | (1) |
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260 | (7) |
Chapter 35 Preparing for the Registration Audit |
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267 | (6) |
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268 | (1) |
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268 | (1) |
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269 | (1) |
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269 | (1) |
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Common Discrepancies Found |
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270 | (1) |
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Most Frequently Asked Questions By the Registrar |
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271 | (2) |
Appendix A Flow-Charting Processes |
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273 | (6) |
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273 | (1) |
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274 | (5) |
Index |
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