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Context of the organization - Coggle Diagram
Context of the organization
4.1 Understanding the organization and its context
The organization shall:
determine external & internal issues
relevant to its purpose & its strategic direction
affect its ability to achieve the intended result(s) of its QMS
monitor & review information about these external & internal issues.
positive & negative factors or conditions for consideration
External context
by considering issues arising from legal, technological, competitive, market, cultural, social & economic environments, whether international, national, regional or local.
Internal context
by considering issues related to values, culture, knowledge & performance of the organization.
4.2 Understanding the needs and expectations of interested parties
Recognize relevant stakeholders, their requirements and interested relevant to QMS
Continuously monitor and review their expectations.
4.3 Determining the scope of the quality management system
a) the external & internal issues referred to in 4.1
b) the requirements of relevant interested parties referred to in 4.2
c) the products & services of the organization.
4.4 Quality management system and its processes
4.4.1 Process Management: Establish, implement, maintain, and improve QMS processes
b) determine the sequence & interaction of these processes
c) determine & apply the criteria & methods (including monitoring, measurements & related performance indicators) needed to ensure the effective operation & control of these processes
d) determine the resources needed for these processes & ensure their availability;
e) assign the responsibilities & authorities for these processes
f) address the risks & opportunities as determined in accordance with the requirements of 6.1
g) evaluate these processes & implement any changes needed to ensure that these processes achieve their intended results
h) improve the processes & the QMS
a) determine the inputs required & the outputs expected from these processes
4.4.2 Documentation
a) Maintain documented information to support the operation of its processes
b) Retain records to ensure planned process execution