This document provides an overview of ISO 9001:2015 for quality management systems. It discusses the seven quality management principles and the ten clauses of the ISO standard. The principles are customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management. The ten clauses cover the scope, leadership, planning, support, operation, performance evaluation, and improvement aspects of an effective quality management system. The document provides explanations of the key elements within each clause.

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ISO 9001: 2015
Standard
By: Eng.Mahmoud Fathy Saad

2. Quality Management Principles
Quality
Management
Principles
1- Customer focus
2- Leadership
3- Engagement of
people
4- Process approach
5- Improvement
6- Evidence-based decision
making
7- Relationship
management
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3. ISO 9001
What is ISO organization?
Non-governmental organization concerned with
publishing standards that improve entities
performance.
ISO is derived from the Greek isos, meaning
equal.
What is ISO 9001?
A set of standards for quality management
system (QMS)
Why we need ISO 9001?
1- Consistently provide product/service
2- Enhance customer satisfaction
3- Addressing risks and opportunities
4- Continually improve performance
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4. ISO 9001
1- Scope
2- Normative references
3-Terms and definitions
4- Context of the organization
5- Leadership
6- Planning
7- Support
8- Operation
9- Performance evaluation
10- Improvement

5. 5
Context of the organization
Organization
Legal, technological, competitive,
market, cultural, social and economic
environments, whether international,
national, regional or local.
Interested parties
Needs: something that solves an
actual or imaginary problem
Expectations: the anticipated
circumstances of a purchase

6. Leadership
• Accountability for the effectiveness of the QMS
• Quality policy and quality objectives
• Risk-based thinking
• Ensuring that the QMS achieves its results
• Ensuring that the QMS is maintained
• Promoting improvement
• Enhance customer satisfaction

7. Planning
7
Actions to address risks and opportunities
- Integrate and implement the actions
- Evaluate the effectiveness of these actions.

8. Planning
8
Planning of Objectives
• Be consistent with the quality policy
• Be measurable
• Customer satisfaction
• QMS (Monitored, Communicated, and Updated)

9. Planning
9
Planning of changes
• Purpose
• Integrity
• Availability of resources
• Responsibilities and authorities

10. Support
10
Resources
• People
• Infrastructure (buildings,
equipment, information)
• Environment (Social, psychological,
physical)
• Knowledge
Awareness
• Quality policy
• Quality objectives

11. Support
11
Documented information
• Creating (description, format,
media)
• Control (available, suitable for use,
protected, distribution, access,
storage, control of changes,
retention and disposition)
Communication
What, when, who, with whom, how

12. Operation
12
Requirements for products and services
• Customer communication (Information, contracts,
changes, feedback, customer property)
• Determining the requirements for products and services
• Review
• Control changes

13. Operation
13
Design and development of products and services
• Plan (duration, process stages, verification and validation, resources, responsibilities
and authorities, controls)
• Inputs (requirements, similar design, regulatory requirements, consequences of failure)
• Control (results to be achieved, meet requirements, verification activities)
• Outputs (meet requirements, adequate for the subsequent processes, characteristics of
the products and services, post-delivery activities)
• Changes (development changes, results of reviews, authorization of the changes, actions
to prevent adverse impacts)

14. Operation
14
Release of products and services
• Document (evidence of conformity with the acceptance
criteria, person(s) authorizing the release, nonconformities)
• Control of nonconformities (correction, informing the
customer, acceptance under concession)

15. Operation
15
Control of externally provided processes,
products and services
• Ensure that externally provided processes controlled
• Impact of the externally provided processes
• Effectiveness of the controls

16. Performance evaluation
16
Monitoring, measurement, analysis and evaluation
• What, When, How, when analyzed and evaluated
• Customer satisfaction

17. Performance evaluation
17
Internal Audit
• Requirements of QMS
• Define the audit criteria and scope
• Plan, establish, implement and maintain audit program
• Take appropriate correction and corrective actions
• Retain documented information as evidences

18. Performance evaluation
18
Management review
• Inputs (customer feedback, quality objectives status,
process performance, audit results, performance of
external providers, effectiveness of actions for risks and
opportunities, opportunities for improvement)
• Outputs (need for changes to the QMS - resource needs)

19. Improvement
19
Continual improvement
Results of analysis and evaluation, and the
outputs from management review
Corrective action
• Correction
• Analyze for corrective action
• Implement
• Review effectiveness
• Update risks and opportunities
• Change QMS if needed
• Document

20. Conclusion
20

21. Thanks
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