4.4 Quality management system and its processes The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard. Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system. The scope of the organization s quality management system shall be available and be maintained as documented information. The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.
When determining this scope, the organization shall consider: 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. 4.3 Determining the scope of the quality management system The organization shall determine the boundaries and applicability of the quality management system to establish its scope. The organization shall monitor and review information about these interested parties and their relevant requirements. 4.2 Understanding the needs and expectations of interested parties Due to their effect or potential effect on the organization s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine: a) the interested parties that are relevant to the quality management system b) the requirements of these interested parties that are relevant to the quality management system.
NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization. NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local. NOTE 1 Issues can include positive and negative factors or conditions for consideration.
The organization shall monitor and review information about these external and internal issues. 1 of 14 Client: Date: Client ID: Auditor Audit Report Key - SAT: Satisfactory OBS: Observation NC: Nonconformance N/A: Not Applicable at this time Clause Requirement Comply Auditor Notes / Evidence 4 Context of the organization 4.1 Understanding the organization and its context The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.
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