ISO 9001 IS QUALITY MANAGEMENT SYSTEM STANDARD. It has 10 clauses.Structure and core text is same in all standards QMS, EMS, IT Security etc.

1. ISO 9001:2015
Standard
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2. Table of Contents
q Structure
q System Thinking
q Context of Organization
› Context Issues for external risk
› Some causes of internal risk
q Leadership
q Planning for QMS
› Controlling areas of risk
› Cascade of objectives
› Planning to achieve objectives
q Support
› Resources
› Competency
› Documentation
› New wording-Information Flow
› Documentation Requirements
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ISO 9001:2015
Page 2
qOperation
qPerformance Evaluation
– Feed Results to management
Review
qImprovement
– The improvement cycle

3. Structure
› Structure and core text is same in all standards QMS, EMS, IT
Security etc.
› Organisational context for driving strategy added: Internal
& External (Purchasing/ outsourcing)
› Less focus on procedures to mitigate risk, Preventive action
is replaced by Risk based thinking.
› More emphasis on flow of information than documentation
› Management Review core focus is on “Monitoring”. MR title
removed.
› Increased “Leadership "requirements
› Documented Information
› External provision replaces “Purchasing & Outsourcing”
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4. Structure
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Linkage between PDCA is vital.

5. System thinking
› System: A set of interrelated and interacting elements.
› Management System is network of people, process &
technology
› Problem in one department can lead to problem in
another.
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Technology
People
Process

6. 4 Context of organisation
4.1 The organization and its context
› Strategic issues
4.2 Needs/Expectations interested parties
› Not just customers
4.3 Scope of the QMS
› Define Boundaries – Exclusions (Can not exclude
clause if it would impact conformance to customer.)
4.4 QMS and its processes - PDCA
› As 9001:2008 §4.1
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7. 4.1 Context Issues For External Risk
What are strategic risks to organisation (4.1 -6.1)
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Awareness session ISO 9001:2015
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Context Issues
(Examples)
Impact
(1-5)
Probability
(1-5)
Detectability
(1-5)
Impact x
Probability ÷
Detectability
Technology
Exchange
rate
Competition
Legislation
Vendors
Market
Etc.

8. Process Map
Process owner
Developer
Manager
Technician
General Manager
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Process maps are used to identify risks in process steps

9. SIPOC Diagram
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Supplier Input Process Output Customer diagram helps in
identification of risks.

10. Some causes of internal risk
› Low Competency| Train Resources
› Frequent Change of Persons| Maintain shift logs
› Task Performed Infrequently| Identify process done
once a year
› Complex Process| Identify
› Old Equipment (i.e. Failure) or new equipment (People
unfamiliar)
› Unclear Customer Requirements| During process chain
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11. 5 Leadership
5.1 Leadership and commitment
› Accountability, awareness, engagement | Linkage of QMS to
business
5.2 Quality policy
› similar to 9001:2008. + ‘applied’ | Evidences of cascaded
objectives from policy
5.3 Roles, responsibilities and authorities
› QMS Reporting (Management Rep title removed)
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12. 6 Planning for the QMS
6.1 Address risks and opportunities
› QMS ability to achieve intent, mitigate risk.
6.2 Objectives + planning to achieve them | SMART
› Measurable, link to policy, updated
› Resources to meet objectives, evaluate results
6.3 Planning of changes
• Purpose of change
› Resource and responsibility
Note: Clause 4 and 6 are linked.
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13. 6.1 Controlling areas of risk
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Risk Mitigation
x
Controlled
Competency
Risk
Technology
Risk

14. 6.2 Cascade of Objectives
Policy 5.2
Brief Statement
Strategic long term objective
Planning 6.2
Specific Objective
Awareness 7.3
Individual Objectives
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Hoshin Kanri

15. Planning to achieve
objectives (6.2.2)
Objective What is to be
done
Resource
needed
Who is
responsible
When it will
be done
How results
will be
evaluated
SMART
objective
Activity Support Process
Owner
Timeline/
schedule
Measurement
/ monitoring
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16. 7 Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documents | Less
Note: All above helps in risk mitigation
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17. 7.1 RESOURCES
7.1.1 General
› Resource constraints, external resources
7.1.2 People
› Provide necessary persons
7.1.3 Infrastructure | Data Back, IT audit
› Information and communication technology
7.1.4 Environment for operating processes
› As 9001:2008 §6.4
7.1.5 Monitoring and measuring resources
› Calibration (Major risk area)
7.1.6 Organizational knowledge
› Knowledge acquisition and management
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18. 7.1.6 Organisational
knowledge
› determine knowledge for process operation
› maintain knowledge, make it available & retrievable
› address changing needs and trends,
› how to acquire additional knowledge.
consider;
› internal sources
› learning from failure and success,
› experts within the organization
› external sources
› standards, academia, conferences,
› customers or providers
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19. 7.2 Competence
Competence: The ability to apply knowledge to achieve intended
results
› determine the necessary competence of person(s)
› take actions to acquire competence,
› evaluate the effectiveness of actions taken:
› actions can include,
› training, mentoring, hiring competent persons.
› retain documented evidence of competence.
Note: Evidence f competence is required and not records of training.
Eg: Annual PMS, testing results done by a person etc.
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20. 7.5 Documents
7.5.1 General
The extent of documents for a QMS can differ due to:
› organization size, process complexity, competence.
7.5.2 Creating and updating
Ensure identification, review and approval.
7.5.3 Control of documents
› ensure availability, confidentiality
› address distribution, access, storage and
preservation,
› legibility; control of changes and disposition.
Documents of external origin shall be controlled.
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21. New wording- Focus on
Information
Document
Maintain
documented
information
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Record
Retain
documented
information

22. 8 Operation Clauses (ISO
9001:2008-7)
8.1 Operational planning and control | Apply risk
mitigation
8.2 Requirements for products + services
8.3 Design and development
8.4 Externally provided products and services
8.5 Production and service provision
8.6 Release of products and services | Inspection & testing
8.7 Control of nonconformity| NCP removed
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23. 9 Performance Evaluation
Clauses
9.1 Monitoring, measurement, analysis, evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.3 Management review
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KPI
Results/
Monitor
process
control
Quarterly
Monitoring

24. 10 Improvement
10.1 General
› Similar to 9001:2008 §8.5.1
10.2 Nonconformity and corrective action
› Similar to 9001:2008 §8.5.2
› Addition of complaints
10.3 Continual improvement
› Link to analysis, evaluation, management review
› Address underperformance
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25. Thank you!