Contents Page
61 Foreword ............................................................................................................................................................. 5
62 Introduction ......................................................................................................................................................... 6
63 0.1 General .......................................................................................................................................................... 6
64 0.2 The ISO standards for quality management .............................................................................................. 6
65 0.4 Plan-Do-Check-Act cycle ............................................................................................................................. 8
66 0.5 “Risk-based thinking” .................................................................................................................................. 9
67 0.6 Compatibility with other management system standards ....................................................................... 9
68 1 Scope .................................................................................................................................................... 11
69 2 Normative references .......................................................................................................................... 12
70 3 Terms and definitions ......................................................................................................................... 12
71 4 Context of the organization ................................................................................................................ 25
72 4.1 Understanding the organization and its context .............................................................................. 25
73 4.2 Understanding the needs and expectations of interested parties ................................................. 25
74 4.3 Determining the scope of the quality management system ........................................................... 25
75 4.4 Quality management system and its processes .............................................................................. 26
76 5 Leadership ........................................................................................................................................... 26
77 5.1 Leadership and commitment ............................................................................................................. 26
78 5.2 Quality policy ....................................................................................................................................... 27
79 5.3 Organizational roles, responsibilities and authorities .................................................................... 28
80 6 Planning for the quality management system .................................................................................. 28
81 6.1 Actions to address risks and opportunities ..................................................................................... 28
82 6.2 Quality objectives and planning to achieve them ............................................................................ 29
83 6.3 Planning of changes ........................................................................................................................... 29
84 7 Support ................................................................................................................................................. 30
85 7.1 Resources ............................................................................................................................................ 30
86 7.1.1 General ................................................................................................................................................. 30
87 7.1.2 People ................................................................................................................................................... 30
88 7.1.3 Infrastructure ....................................................................................................................................... 30
89 7.1.4 Environment for the operation of processes.................................................................................... 30
90 7.1.5 Monitoring and measuring resources ............................................................................................... 30
91 7.1.6 Organizational knowledge .................................................................................................................. 31
92 7.2 Competence ......................................................................................................................................... 31
93 7.3 Awareness ............................................................................................................................................ 31
94 7.4 Communication ................................................................................................................................... 32
95 7.5 Documented information .................................................................................................................... 32
96 7.5.1 General ................................................................................................................................................. 32
97 7.5.2 Creating and updating ........................................................................................................................ 32
98 8 Operation .............................................................................................................................................. 33
99 8.1 Operational planning and control ...................................................................................................... 33
100 8.2 Determination of requirements for products and services ............................................................. 33
101 8.2.1 Customer communication .................................................................................................................. 33
102 8.2.2 Determination of requirements related to products and services ................................................. 34
103 8.2.3 Review of requirements related to products and services ............................................................. 34
104 8.3 Design and development of products and services ........................................................................ 34
105 8.3.1 General ................................................................................................................................................. 34
106 8.3.2 Design and development planning .................................................................................................... 35
107 8.3.3 Design and development Inputs ........................................................................................................ 35
108 8.3.4 Design and development controls ..................................................................................................... 35
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8.3.5 Design and development outputs ...................................................................................................... 109 36
110 8.3.6 Design and development changes .................................................................................................... 36
111 8.4 Control of externally provided products and services .................................................................... 36
112 8.4.1 General ................................................................................................................................................. 36
113 8.4.2 Type and extent of control of external provision ............................................................................. 36
114 8.4.3 Information for external providers ..................................................................................................... 37
115 8.5 Production and service provision ..................................................................................................... 37
116 8.5.1 Control of production and service provision ................................................................................... 37
117 8.5.2 Identification and traceability ............................................................................................................. 38
118 8.5.3 Property belonging to customers or external providers ................................................................. 38
119 8.5.4 Preservation ......................................................................................................................................... 38
120 8.5.5 Post-delivery activities ........................................................................................................................ 38
121 8.5.6 Control of changes .............................................................................................................................. 39
122 8.6 Release of products and services ..................................................................................................... 39
123 8.7 Control of nonconforming process outputs, products and services ............................................ 39
124 9 Performance evaluation ...................................................................................................................... 40
125 9.1 Monitoring, measurement, analysis and evaluation ........................................................................ 40
126 9.1.1 General ................................................................................................................................................. 40
127 9.1.2 Customer satisfaction ......................................................................................................................... 40
128 9.1.3 Analysis and evaluation ...................................................................................................................... 40
129 9.2 Internal audit ........................................................................................................................................ 41
130 9.3 Management review ............................................................................................................................ 41
131 10 Improvement ........................................................................................................................................ 42
132 10.1 General ................................................................................................................................................. 42
133 10.2 Nonconformity and corrective action ................................................................................................ 42
134 10.3 Continual improvement ...................................................................................................................... 43
135 Annex A (informative) Clarification of new structure, terminology and concepts ................................... 44
136 Annex B (informative) Quality management principles .............................................................................. 47
137 Annex C (informative) The ISO 10000 portfolio of quality management standards ................................. 49
138 Bibliography ...................................................................................................................................................... 52
