ISO 9001:2015 Quality Management System

Briefing

Clause 4 : Context of the

Organization
 Main Clauses of ISO 9001:2015

Recap
4.0 ISO 9001:2015 10.0

Quality
Management
5.0 System 9.0

4.0 Context of the 10.0 Improvement

6.0 8.0
Organization
7.0

9.0 Performance
5.0 Leadership
Evaluation

6.0 Planning 8.0 Operation

7.0 Support
 Main Clauses of ISO 9001:2015

Recap
4.1 Understanding the Organization and its Context

4.2 Clarify Needs & Expectations Of Interested

4.0 Parties
Context of
the
Organization

4.3 Define Scope Of your Quality Management System

(QMS)

4.4 Develop a Quality Management System which suits

your context
 ISO 9001:2015 QUALITY MANAGEMENT SYSTEM
Clause 4.0: Context of the Organization

Stakeholder/ 4.1 and 4.2 Understanding the

Interested PESTLE# / organization and its context , the
STEEPLE SWOT
parties * needs and expectations of
Analysis interested parties
analysis

Where are we? Gap Analysis Scope QMS

Where do we want to get to
(determine scope and QMS)?

* Employees, Employers, Investors, customers, local community, regulators, Authorities, competitors,

Suppliers, contractors, subcontractors, etc and of those who is relevant to the QMS.
# For External Issues: Political/Economic/Social/Technological/Legal/Environmental
# For Internal Issues – e.g. strategies, Legislation compliance, culture, activities, products, services, participation…
ISO 9001:2015 QUALITY MANAGEMENT SYSTEM
Scope of QMS(4.3/4.4)
External
and internal
issues (4.1)
6 Planning

Plan Do
Clause 4.0:
Intended
Context of the 5 Leadership Outcomes
10 & 7 Support of the
Organization Improvement Worker 8 Operation QMS
Participation

Needs and Act Check

expectations 9
Performance
of workers and Evaluation
other interested
parties (4.2)
Source: based on ISO 9001:2015 Fig. 1
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