ISO9001-2015 - DIS 英文

ISO 9001:2015 DIS 版

4 Context of the organization

932 4.1 Understanding the organization and its context

933 The organization shall determine external and internal issues that are relevant to its purpose and its 934 strategic direction and that affect its ability to achieve the intended result(s) of its quality management 935 system.

936 The organization shall monitor and review the information about these external and internal issues. 937 NOTE 1 Understanding the external context can be facilitated by considering issues arising from legal, 938 technological, competitive, market, cultural, social, and economic environments, whether international, national, 939 regional or local.

940 NOTE 2 Understanding the internal context can be facilitated by considering issues related to values, culture 941 knowledge and performance of the organization.

942 4.2 Understanding the needs and expectations of interested parties

943 Due to their impact or potential impact on the organisation’s ability to consistently provide products 944 and services that meet customer and applicable statutory and regulatory requirements, the

945 organization shall determine:

946 a) the interested parties that are relevant to the quality management system;

947 b) the requirements of these interested parties that are relevant to the quality management system. 948 The organization shall monitor and review the information about these interested parties and their 949 relevant requirements.

950 4.3 Determining the scope of the quality management system

951 The organization shall determine the boundaries and applicability of the quality management system 952 to establish its scope.

953

© ISO 2014 – All rights reserved 26 ISO/TC 176/SC2/WG24/N111

When determining this scope, the organization 954 shall consider:

955

956 a) the external and internal issues referred to in 4.1;

957 b) the requirements of relevant interested parties referred to in 4.2;

958 c) the products and services of the organization.

959 Where a requirement of this International Standard within the determined scope can be applied, then it

960 shall be applied by the organization.

961

962 If any requirement(s) of this International Standard cannot be applied, this shall not affect the 963 organization’s ability or responsibility to ensure conformity of products and services.

964

965 The scope shall be available and be maintained as documented information stating the:

966

967 ¾ products and services covered by the quality management system;

968 ¾ justification for any instance where a requirement of this International Standard cannot be applied. 969 4.4 Quality management system and its processes

970 The organization shall establish, implement, maintain and continually improve a quality management 971 system, including the processes needed and their interactions, in accordance with the requirements of

972 this International Standard.

973 The organization shall determine the processes needed for the quality management system and their 974 application throughout the organization and shall determine:

975 a) the inputs required and the outputs expected from these processes;

976 b) the sequence and interaction of these processes;

977 c) the criteria, methods, including measurements and related performance indicators needed to 978 ensure the effective operation, and control of these processes;

979 d) the resources needed and ensure their availability;

980 e) the assignment of the responsibilities and authorities for these processes;

981 f) the risks and opportunities in accordance with the requirements of 6.1, and plan and implement

ISO 9001:2015 DIS 版

982 the appropriate actions to address them;

983 g) the methods for monitoring, measuring, as appropriate, and evaluation of processes and, if 984 needed, the changes to processes to ensure that they achieve intended results;

985 h) opportunities for improvement of the processes and the quality management system.

986 The organization shall maintain documented information to the extent necessary to support the 987 operation of processes and retain documented information to the extent necessary to have

confidence

988 that the processes are being carried out as planned.

989 5 Leadership

990 5.1 Leadership and commitment

991 5.1.1 Leadership and commitment for the quality management system

© ISO 2014 – All rights reserved 27 ISO/TC 176/SC2/WG24/N111

Top management shall demonstrate leadership and commitment with respect 992 to the quality

993 management system by:

994 a) taking accountability of the effectiveness of the quality management system;

995 b) ensuring that the quality policy and quality objectives are established for the quality management 996 system and are compatible with the strategic direction and the context of the organization;

997 c) ensuring that the quality policy is communicated, understood and applied within the organization; 998 d) ensuring the integration of the quality management system requirements into the organization’s 999 business processes;

1000 e) promoting awareness of the process approach;

1001 f) ensuring that the resources needed for the quality management system are available;

1002 g) communicating the importance of effective quality management and of conforming to the quality 1003 management system requirements;

1004 h) ensuring that the quality management system achieves its intended results;

1005 i) engaging, directing and supporting persons to contribute to the effectiveness of the quality 1006 management system;

1007 j) promoting continual improvement;

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