Académique Documents
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objectives.
by top management)
Ref: NOTE 2
Ref: NOTE 3
Understanding the internal context can be facilitated by considering issues related
to values, culture, knowledge and performance of the organization (capabilities &
constraints).
its QMS.
Eg.,
Customers, communities, suppliers, regulators, non‐governmental
organizations, investors and employees.
Note : to ―perceive itself to be affected‖ means the perception has been made
known to the organization.
Determine
(on-going review & monitoring)
Relationship Examples of relevant interested parties Examples of relevant needs and expectations
(6.1.1)
Regulatory requirements
10.3)
Consider;
Determining the
a) External / Internal Issues (4.1)
QMS Scope (4.3)
b) Needs & Expectations of IPs (4.2)
(boundaries & applicability)
c) its products and services;
made available to
relevant
Documented
information
interested parties
and reputation (to ensure that the scope is not defined in a way
parties)
Integrate / Embed
Knowledge
gained from
4.1 & 4.2
and resources
What matters?
Establish Organizational Context (External & Internal
Issues, needs & expectations of interested parties /
stakeholders)
4.1 4.2
Statutory &
Conformity of Customer
Regulatory
Products & Services Satisfaction
requirements
Bottom approach
(Operational / Process Risk)
— avoiding risk,