Main Clauses of Iso 9001

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Main Clauses of ISO 9001:2015

4.0 ISO 9001:2015 10.0


Quality
Management
5.0
System 9.0

4.0 Context of the 10.0 Improvement


Organization 6.0 8.0
7.0

5.0 Leadership 9.0 Performance Evaluation

6.0 Planning 8.0 Operation


7.0 Support
Main Clauses of ISO 9001:2015

4.1 Understand Your Organization’s 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
Main Clauses of ISO 9001:2015

Provide Leadership By Focusing On Quality, Customers


5.1
focus and Commitment

5.0
5.2 Provide Leadership By Establishing A Quality Policy
Leadership

5.3
Provide Leadership By Defining QMS Roles And
Responsibilities
Main Clauses of ISO 9001:2015

Define Actions To
6.1
Manage Risk and
Address
Opportunities

6.0
Planning

6.3 6.2

Plan and Control Set Quality


Changes to Your Objectives and
Quality Develop Plans to
Management Achieve them
System
Main Clauses
of 7.0
ISO 9001:2015 Support

7.1 7.2 7.3 7.4 7.5

Provide Needed Encourage and Ask Personnel Manage QMS Control


Resources For Expect to Communications QMS
QMS Competence help with QMS Information
Main Clauses of ISO 9001:2015
8.1 8.2

8.1.Develop 8.2.Determine 8.3.Carry Out


Processes Requirements Design
8.3

8.0
8.4.Monitor 8.5.Manage 8.6.Control
Operation Suppliers Production Products
8.4

8.7.Document
Your Actions
8.7 8.6
Main Clauses of ISO 9001:2015
Design
Validation
Validation Do we have the right Validation
Are we building the Design? Did we build the
right thing? right thing?
Transformation Transformation
Design Build, Code, Buy or
reuse
Stakeholder
needs and Requirements Design System
Expectations

Transformation Verification Verification Verification

Drive

Drive
Drive
Requirement Are the Did we design it Did we build
Development requirements written correctly? it correctly?
correctly?
Organizational Organizational
Organizational
Requirements code, Build
Design Guidelines
Writing Guidelines Guidelines
Main Clauses of ISO 9001:2015

Monitor, Measure, and Analyze Quality


Management System(QMS)

9.1

9.0 Set Up Internal Audit Program and use


9.2
Performance it to examine your QMS
Evaluation
9.3

Review your Organization’s QMS at


planned Intervals
Main Clauses of ISO 9001:2015
The Audit Process - Overview
AUDIT
CONCLUSION
AUDIT FINDINGS
(ISO 19011:2018
(ISO 19011:2018 - -3.11)
OBJECTIVE
3.10)
EVIDENCE
ISO
AUDIT 19011:2018 3.8
Draw a
CRITERIA
AUDIT SCOPE ISO CONCLUSION
Evaluate the
ISO 19011:2018 3.7 based on the
19011:2018 3.5 evidence to obtain
Collect the findings
FINDINGS
EVIDENCE (Good
Establish the
& Bad)
Determine the CRITERIA
SCOPE of the audit against which the
(i.e. the boundary) audit is to be
conducted
10.1
Identify and Select QMS
Improvement
Opportunities

Main Clauses
of 10.2
10.0
ISO 9001:2015 Control Nonconformities
& Take Suitable Improvement
Corrective Actions

10.3
Enhance QMS
Suitability, adequacy,
And Effectiveness
Main Clauses of ISO 9001:2015
10.0 Improvement
Customer
Satisfaction
Continuous
Improvement

Plan Do

Plan Do
Act Check

Check New
Act Standard
Previous
Standard

Time
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