This document discusses the key elements of Section 4 of the ISO 9001 quality management system standard, which includes understanding the organization and its context, the needs and expectations of interested parties, determining the scope of the quality management system, and designing quality management system processes. It provides details on each of these elements, such as identifying internal and external issues, requirements of interested parties, products and services covered by the scope, and factors to consider when designing processes such as inputs, outputs, sequence, interactions, criteria and methods for monitoring and improvement. Records are required to support process operation and demonstrate that processes are carried out as planned.

1. CONTEXT of the
Organization
Quality is Culture 1 10/21/15

2. Quality is Culture 2
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10/21/15

3. Quality is Culture 3
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10/21/15

4. *
4.1 Understanding the organization and it
context
4.2 Understanding the needs and
expectations of interested parties
4.3 Determining the scope of the QMS
4.4 Quality Management System and its
processes
Quality is Culture 4 10/21/15

5. *
4.1 Understanding the organization and its context
“Organization shall determine external and internal
issues that are relevant to its purpose and its strategic
direction and that affect it ability to achieve the intended
results of the QMS.”
- Monitor and review information <record requirement>
“issues” = (external) legal, technological, competitive,
market, cultural, social, economic, international,
national, regional, local.
(internal) values, culture, knowledge, performance
Quality is Culture 5 10/21/15

6. *
4.2 Understanding the needs and expectations of
interested parties
“Due to the impact or potential impact on the organizations
ability to consistently provide products and services that
meet customer and applicable statutory and regulatory
requirements, the organization shall determine:
a. Interested parties that are relevant to the QMS (see
Annex A)
b. Requirements of these interested parties
Monitor and review the information <record requirement>
Quality is Culture 6 10/21/15

7. *
4.3 Determine the scope of the QMS
“The organization shall determine the boundaries and
applicability of the QMS to establish its scope.”
Consider:
a. The external and internal issues
b. The requirements of relevant interested parties
c. The products and services of the organization
Quality is Culture 7 10/21/15

8. 10/21/15Quality is Culture 8
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“The scope shall be available and maintained as
documented information, stating the:
- Products and services covered by the QMS
- Justification for any instance where a requirement
cannot be applied.”

9. *
4.4 QMS and its process <design the right processes>
-inputs, outputs
-sequence and interaction
-criteria, methods, measurements, indicators to ensure effective operation and
control
-resources
-responsibilities and authorities
-risks and opportunities
-methods for monitoring, measuring, evaluating, and required changes to
achieve intended results
-evaluate these processes and implement any changes needed to ensure the
intended results
“ The organization shall maintain documented information to the extent
necessary to support the operation of the processes and retain documented
information to the extent necessary to have confidence that the processes are
being carried out as planned.”
Quality is Culture 9 10/21/15