3. Introduction – General
• The adoption of a quality management system is a strategic
decision for an organization that can help to improve its
overall performance and provide a sound basis for
sustainable development initiatives.
• International Standard can be used by internal and external
parties
• International Standard to imply the need for:
a) uniformity in the structure of different quality
management systems
b) alignment of documentation to the clause structure of
this International Standard
c) the use of the specific terminology of this International
Standard within the organization
4. General Changes in ISO 9001:2015
• High level structure and core text from “Annex SL”
• Increased requirements for top management
commitment and involvement (leadership).
• Emphasis on risk-based thinking
• Increased emphasis on achieving value for the
organization and its customers (“output matters”)
• Need to understand the context of the
organization and the needs and expectations of
interested parties
• Increased flexibility on the use of documentation
5. General Changes in ISO 9001:2015
• Explicit requirement for process approach
• Preventive action disappears as explicit
requirement – included in risk-based approach
• More readily applicable by “service” type
organizations
• Enhance requirements for competence of
personnel
• Revised Quality Management Principles
6. Risk-based thinking
• To conform to the requirements ISO
9001:2015, an organization needs to plan and
implement actions to address risks and
opportunities.
• Addressing both risks and opportunities
establishes a basis for increasing the
effectiveness of the quality management
system, achieving improved results and
preventing negative effects.
7. ISO 9001:2008 Vs ISO 9001:2015
ISO 9001:2008 ISO 9001:2015
0-Introduction 0-Introduction
1-Scope 1-Scope
2-Normative reference 2-Normative reference
3-Terms and Definitions 3-Terms and Definitions
4-Quality management system 4-Context of the organization
5-Management responsibility
5-Leadership
6-planning
6-Resource management 7-Support
7-Product realization 8-Operation
8-Measurement, analysis and
improvement
9-Performance evaluation
10-Improvement
8. Context of the organization
Define the context of the organization in terms
of:
• Issues within its external and internal
environments
• Needs and expectations of interested parties
• Scope of Quality Management system
• Quality Management system and its processes
9. Leadership
Is about ways that top management needs to
demonstrate leadership and commitment with respect to
the QMS, Here are some things that are important to
show that top management has a commitment to the
Quality Management System:
• QMS effectiveness is measured, and management is
involved in assessing this.
• The Quality Policy and objectives are in place per
management direction, communicated in the
organization, and tracked for progress.
• The QMS is part of the business processes, not a side
project.
10. Leadership
• Continual improvement is promoted and supported by
management
• There is a way to ensure customer, statutory, and
regulatory requirements are understood and met, and
people understand why this is important.
• There is a management focus on customer satisfaction.
• Organizational roles, responsibilities, and authorities
are assigned, understood by the person who is
assigned, and known to those employees who need to
assess a person in a certain role.
11. Planning
Actions to address risks &
opportunities
Quality objectives & planning
Planning of changes
Planning
12. Planning
1 Taking action to address the identified risk and opportunities within the
organization's external and internal environment , including associated
needs and expectations of interested parties
2 Establishing quality objective and associated actions plans at relevant
functions , level and processes
3 Control all changes that can have impact on the QMS
14. Support
1 Determine and providing necessary resources such as
people,infrastructrue,work environment
2 Taking action to ensure that the workforce is competent
on the basis of appropriate education , training or
experience
3 Ensuring that everyone is aware of the quality policy and
objectives
4 Determine what information needs to be communicated
with internal and external parties
5 Implementing effective control of documented
information used within the QMS
15. Operation
1 Determining the requirements for the products and
services
2 Establishing criteria for the processes and acceptance of
products and services
3 Determining the resources needed to achieve conformity
to the product and service requirements
4 Implementing control of the processes in accordance with
the criteria
5 Determining and keeping documented information in
order to have confidence that the process have been
carried out as planned and demonstrate the conformity of
products and services to their requirements
16. Performance evaluation
1 Monitoring and measuring key process indicators
2 Monitoring and measuring customers satisfaction
levels
3 Analyzing and evaluating all gathered data
4 Implementing internal audit
5 Reviewing the QMS performance and making
decision with regards to opportunities
improvements , changes to the QMS and resource
needs
17. Improvement
1 Controlling nonconformities including their
consequences and applying corrective action
to them
2 Identifying opportunities for improvement
and taking actions to improve the products,
services and the QMS processes in terms of
suitability , adequacy and effectiveness
