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Page 2 of 25
4 Context of the Organization
No. Question Proc. Ref. Comments
4.1 Understanding the Organization
and its context 1Has the organization determined external and
internal issues that are relevant to its purpose, strategic direction and that affect its ability to achieve the intended result(s) of its quality management system? 2Is the organization monitoring and reviewing
information about these external and internal issues?4.2 Understanding the needs and
expectations of interested parties 3Has the organization:
a) Determined the interested parties that are relevant to the quality management system? b) Determined the requirements of these interested parties that are relevant to the quality management system? 4Is the organization reviewing and monitoring
information about these interested parties and their relevant requirements?4.3 Determining the scope of the quality
management system 5Has the organization determined the boundaries
and the applicability of the quality management system in order to establish its scope? 6When establishing the scope has the organization
taken into consideration: a) The external and internal issues referred to in 4.1? b) The requirements of relevant interested parties referred to in 4.2? c) The products and services of the organization? 7Has the organization applied all of the
requirements of the ISO 9001:2015 InternationalStandard (if applicable) within the determined
scope of its quality management system? 8Is the scope of the organization"s quality
management system available and maintained as documented information? 9Does the organization"s scope state the types of
products and services covered?Page 3 of 25
10Does the scope provide any justification for any
requirement of the ISO 9001:2015International
Standard that the organization determines is not
applicable to the scope of its quality management system? 11Can the organization claim conformity to the ISO
9001:2015 International Standard by:
a) Ensuring that requirements determined as not applicable do not affect the organization's ability or responsibility to ensure the conformity of its products, services and enhancement of customer satisfaction?4.4 Quality Management System and its
Processes
4.4.1 12Has the organization established, implemented,
maintained and continually improved the quality management system including the processes needed and their interactions? 13Has the organization determined the processes
needed for the quality management system and their application throughout the organization by: a) Determining the inputs required and the outputs expected from these processes? b) Determining the sequence and interaction of these processes? c) Determining and applying the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes? d) Determining the resources needed for these processes and ensuring their availability? e) Assigning responsibility and authority for these processes? f) Addressing the risks and opportunities as determined in accordance with the requirements of 6.1? g) Evaluating these processes and implementing any changes needed to ensure that these processes achieve their intended results? h) Improving the processes and the quality management system? 4.4.2 14Has the organization to the extent necessary:
Page 4 of 25
a) Maintained documented information to support the operation of its processes? b) Retained documented information to have confidence that the processes are being carried out as planned?5 Leadership
No. Question Proc. Ref. Comments
5.1 Leadership and commitment
5.1.1 General
1Has top management demonstrated leadership
and commitment with respect to the quality management system by: a) Taking accountability for the effectiveness of the quality management system? b) Ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization? c) Ensuring the integration of the quality management system requirements into the organization's business processes? d) Promoting the use of the process approach and risk-based thinking? e) Ensuring that the resources needed for the quality system are available? f) Communicating the importance of effective quality management and of conforming to the quality management system requirements? g) Ensuring that the quality management system achieves its intended results? h) Engaging, directing and supporting persons to contribute to the effectiveness of the quality management system? i) Promoting improvement? j) Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility?5.1.2 Customer Focus
2Has top management demonstrated leadership
and commitment with respect to customer focus by: a) Ensuring that customer and applicable statutory and regulatory requirements arePage 5 of 25
determined, understood and consistently met? b) Ensuring that the risks and opportunities that can affect conformity of products and services along with the ability to enhance customer satisfaction are determined and addressed? c) Ensuring that the focus on enhancing customer satisfaction is maintained?5.2 Policy
5.2.1 Establishing the quality policy
3Has top management established, implemented
and maintained a quality policy that: a) Is appropriate to the purpose and context of the organization and supports its strategic direction? b) Can provide a framework for setting quality objectives? c) Includes a commitment to continual improvement to satisfy applicable requirements? d) Includes a commitment to continual improvement of the quality management system?5.2.2 Communicating the Quality Policy
4Is the quality policy:
a) Available and maintained as documented information? b) Communicated, understood and appliedquotesdbs_dbs4.pdfusesText_7[PDF] chef de projet cv
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