2.1 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.
The organization shall monitor and review information about these external and internal issues.
NOTES
- Issues can include positive and negative factors or conditions for consideration.
- 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.
- Understanding the internal context can be facilitated by considering issues related to values, culture,
knowledge and performance of the organization.
2.2 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:
The organization shall monitor and review information about these interested parties and their
relevant requirements.
Checklist
2.3 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 apply all the requirements of this International Standard if they are applicable
within the determined 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 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.
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.
When determining this scope, the organization shall consider:
Checklist
2.4 Quality management system and its processes
2.4.1
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.
The organization shall determine the processes needed for the quality management system and their
application throughout the organization, and shall:
Checklist
2.4.2
To the extent necessary, the organization shall:
a) maintain documented information to support the operation of its processes;
b) retain documented information to have confidence that the processes are being carried out as
planned.
