(The)ISO 9000 answer book

목차 (Table of Contents)

• CONTENTS
• PREFACE = xi
• HOW TO USE THIS BOOK = xiii
• PART ONE ISO 9000 OVERVIEW = 1
• 1. What is ISO 9000? = 1
• 2. What is the goal and scope of an ISO 9000 quality system? = 3
• 3. Why do organizations implement ISO 9000 systems? = 4
• 4. What are the advantages or benefits of implementing an ISO 9000 quality system? = 6
• 5. What is the ISO? = 9
• 6. What is ISO 9000 registration or certification all about? = 11
• 7. What is a quality systems registrar? = 13
• 8. What is the cost of registering to ISO 9000? = 15
• 9. How long does it take to register to ISO 9000? = 19
• 10. What are the benefits of ISO 9000 registration? = 21
• 11. How can we keep our ISO 9000 system from fading away? = 23
• 12. We're leaders in our market. Our customers love us. Our quality is unquestioned. What does ISO 9000 offer us that we don't have already? = 25
• PART TWO TECHNICAL REQUIREMENTS AND GUIDELINES = 27
• RULES OF THE ROAD = 28
• 13. What is the overall requirement for the quality management system? = 28
• 14. Do all the requirements of the Standard apply to us? = 31
• 15. How does ISO 9001 relate to ISO 9004? = 33
• 16. How does ISO 9001 relate to other management systems such as environmental or safety management? = 34
• 17. What is the overall nature and structure of the quality management system? = 35
• DOCUMENTING AND COMMUNICATING THE QUALITY MANAGEMENT SYSTEM = 38
• 18. What sorts of quality documentation must we have? = 38
• 19. What sorts of communication activities are we required to implement? = 43
• 20. What kind of quality manual must we have? = 45
• 21. How must we control the documents in our quality system? = 48
• 22. What records are we required to keep? = 51
• MANAGEMENT'S RESPONSIBILITIES FOR QUALITY = 55
• 23. What are the overall requirements for top management? = 55
• 24. What are top management's obligations with respect to the customer? = 58
• 25. Do the quality system requirements make any reference to legal rules／regulations? = 61
• 26. What sort of "quality policy" is management expected to set? = 63
• 27. What sorts of quality objectives are we required to set? = 66
• 28. How are we required to plan our quality system? = 68
• 29. How are we to define responsibility and authority? = 71
• 30. Who is ultimately responsible for running the QMS? = 73
• 31. What is "management review" all about? = 76
• HUMAN AND OTHER RESOURCES = 80
• 32. What does the Standard say about resources to operate the quality system? = 80
• 33. What kind of education and skills does the Standard require our employees to have? = 82
• 34. What are the components of the training system required by the Standard? = 84
• 35. Is information management mentioned anywhere in the Standard? = 87
• 36. How is infrastructure addressed by the Standard? = 89
• 37. Aside from human resources and infrastructure, what other types of resources are mentioned by the Standard? = 91
• 38. Does the Standard impose requirements about work environment? = 93
• PROCESS DESIGN AND IMPROVEMENT = 96
• 39. What does the Standard say about process design? = 96
• 40. What does the Standard say about process validation? = 100
• 41. Are processes subject to measurement too? = 103
• 42. What about process improvement? = 105
• DESIGNING PRODUCTS AND SERVICES = 106
• 43. How must we operate our design and development process? = 106
• 44. What are the requirements for design input? = 109
• 45. What form is required for design output? = 112
• 46. Are we supposed to review the designs? = 114
• 47. How are we to confirm the quality of designs? = 116
• 48. What else must we do to confirm design quality? = 118
• 49. How must we handle design changes? = 120
• MEETING CUSTOMER NEEDS = 122
• 50. How does the Standard address process management? = 122
• 51. Does the Standard make any mention of communicating with customers? = 124
• 52. What must we do to identify our customers' requirements? = 126
• 53. What steps should we take to review customer requirements? = 128
• 54. What must we do to control our purchasing processes? = 130
• 55. Must we use any special purchasing documents? = 133
• 56. What must we do to verify the quality of purchased products and／or services? = 136
• 57. What are the requirements for production of product and/or service? = 138
• 58. Are we required to inspect and test product and／or service? = 140
• 59. What are the requirements for identification and traceability? = 143
• 60. How are we to handle customer property? = 145
• 61. What controls are we required to have for handling, packaging, storage, preservation, delivery? = 148
• 62. How should we control measuring and testing equipment? = 150
• MEASURING AND IMPROVING = 154
• 63. Why a whole section devoted to measurement, analysis, and improvement? = 154
• 64. What are the general requirements for measurement, analysis, and improvement? = 156
• 65. How are we supposed to track customer satisfaction? = 158
• 66. We must measure customer satisfaction. Must we also measure the satisfaction of any other groups? = 160
• 67. Are other measurement／monitoring methods mentioned by the Standard? = 162
• 68. Are we required to audit ourselves? = 163
• 69. How must we handle nonconforming product or service? = 167
• 70. What must we do with data that we collect? = 171
• 71. What overall approach does the Standard take on the issue of improvement? = 173
• 72. What does "corrective action" mean? = 176
• 73. What is preventive action all about? = 179
• PART THREE IMPLEMENTING - A FIRST-TIMER'S GUIDE = 183
• 74. How should we plan and schedule our implementation program? = 184
• 75. Internally, who should we involve in the implementation process from the start? = 189
• 76. In what sequence should we develop and implement our quality management system? = 192
• 77. When organizations start working on ISO 9000, what elements of the Standard are most often found to be lacking? = 197
• 78. If our organization has more than one location, what is the best way to set up our quality system? = 199
• 79. What types of training should we provide to employees during the implementation process? = 201
• 80. What are the rules for creating effective quality system documents? = 205
• 81. Instead of creating procedures and other documents from scratch, can we adapt documents we already have? = 209
• 82. What about writing documents from scratch? Are there any special steps? = 212
• 83. What about "canned" ISO 9000 documents on disk? Does it make sense to start with those? = 215
• 84. When our documents are done, then what? = 216
• 85. What's the best way to set up our internal audit program? = 219
• 86. How can we maximize the effectiveness of our internal audit program? = 222
• 87. What are some of the common perils and pitfalls to successful implementation? = 227
• 88. How can we tell if our ISO 9000 system is really working? = 228
• 89. Once safely registered, how can we best capitalize on our ISO 9000 system? = 230
• 90. Should we hire a consultant to help us implement our ISO 9000 system? = 232
• 91. What is the one key thing we can do to make our system work better for us? = 234
• PART FOUR REGISTRATION - AND AFTER = 237
• 92. What are the general requirements for registration to ISO 9000? = 238
• 93. How should we choose our ISO 9000 registrar? = 239
• 94. What steps does the typical registration process include? = 242
• 95. What is the typical ISO 9000 registration audit like? = 246
• 96. What happens if the assessors find noncompliances in our system? = 250
• 97. What must we do to keep ISO 9000 registration? = 252
• PART FIVE ISO 9001:2000 - MAKING THE TRANSITION = 255
• 98. What is the overall nature of the changes to the Standard? = 256
• 99. What are the new requirements in the Standard? = 258
• 100. What existing requirements have been tightened／strengthened? = 259
• 101. Are there any 1994 requirements that were not changed or made more demanding? = 261
• APPENDIX CROSS-REFERENCE TABLES = 262
• INDEX = 268