This document provides an overview of ISO 9001 implementation guidelines and quality management principles. It discusses the need for a quality management system and factors to consider when establishing one, including understanding customer and stakeholder needs and expectations. The document also outlines the seven quality management principles: customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management. It provides details on each principle and emphasizes the importance of continual improvement through methods like the PDCA cycle.

1. ISO 9001 Implementation
Guidelines
Session – 1
Saravanan Babu
Plastics Pipe Testing and QMS specialist
Plasco Limited

2. The Need for QMS
• Design and Implementation of the Organization’s
QMS is influenced by the context of the
organization and the changes in that context,
with respect to:
– Its specific objectives
– The risks associated with its context and objectives
– The needs and expectations of its customers and
other relevant interested parties
– The production and services it provides
– Complexity of the processes and their interactions
– Competence of people
– Its size and organizational structure

3. The Need for QMS
• The QMS approach encourages
organizations to:
– Identify customer needs and expectations
– Define business processes
– Keep processes under control
– Resolve quality problems
• Top Management shall participate in
the development, implementation and
improvement of the QMS.

4. Factors for Establishing a QMS
• Understand Internal factors – Organization culture
• Understand External factors – socio-economic
conditions
• Determine the needs and expectations of
customers and other interested parties
• Establish Quality policy and Quality objectives
• Identify the processes responsible to achieve the
objectives
• Establish methods to measure process effectiveness
• Determine the means of preventing NC’s and eliminate their causes
• Provide adequate monitoring and review systems

5. ISO 9000 series
Three standards in the series:
ISO 9004
Guidanceto achieve
sustainedsuccess
ISO 9001
QualityManagement
Systems
ISO 9000
Fundamentals&Vocabulary
NewRevisionsreleasedtogetherin2015 Revisedin2018
TimelineforISO9001

6. The 7 Quality Management Principles
1. Customer Focus:
 Understand the needs of existing and future
customers
 Align organizational objectives with customer
needs and expectations
 Meet customer requirements
 Measure customer satisfaction
 Manage customer relationships
 Aim to exceed customer expectations

7. The 7 Quality Management Principles
The Customer Experience
 Delivering the right product or service for the
customer's needs
 Selling the product or service honestly
 Ensuring ease of use and preventing failures
 Making it easy for customers to do business
with the organization
 Creating an emotional connection and
providing added value when appropriate

8. The 7 Quality Management Principles
2. Leadership:
Leadership is defined as the act of directing and
managing a project, group of people, or an
organization.
 Establish a vision and direction for the
organization
 Set challenging goals
 Model organizational values
 Establish trust
 Equip and empower employees
 Recognize employee contributions

9. The 7 Quality Management Principles
Types of Leadership:
1. Operational Leadership
 Ensuring that organizational processes are
effectively carried out on a day-to-day basis
 Monitoring performance
 Addressing constraints
 Ensuring that employees understand what is to be
done and are provided with the authority,
knowledge, and skills to do it

10. The 7 Quality Management Principles
Types of Leadership:
2. Strategic Leadership
 Define the overall vision and mission of an
organization
 Develop strategies, systems, and structures to
achieve the vision and mission
 Create both technical and social systems that
are effectively integrated, and which address the
needs of both customers and employees

11. The 7 Quality Management Principles
3. Engagement of people:
Employee empowerment is defined as the ways in
which organizations provide their employees with a
certain degree of autonomy and control in their day-to-
day activities.
 Ensure that people’s abilities are used and valued
 Make people accountable
 Enable participation in continual improvement
 Evaluate individual performance
 Enable learning and knowledge sharing
 Enable open discussion of problems and constraints

12. The 7 Quality Management Principles
3. Engagement of people:

13. The 7 Quality Management Principles
4. Process Approach:

14. The 7 Quality Management Principles
4. Process Approach – Types of Processes:
Management processes:
 Provide direction and governance for an
enterprise
 They are generally conducted by senior leaders
to set organizational goals, develop and deploy
strategy to attain goals, establish and manage
organization designs, and manage performance
goals
 Management processes also shape and manage
the business and support processes used by the
enterprise.

15. The 7 Quality Management Principles
4. Process Approach – Types of Processes:
Business processes:
 Reflect the unique competencies of the
enterprise and are mission-critical
 They tend to lie on, or close to, the core value-
creating activities of the enterprise and are the
processes that are seen and experienced by
external customers
 Value-creating business processes begin and
end with the external customer, tend to be
large in scope, and commonly span multiple
organizational components.

16. The 7 Quality Management Principles
4. Process Approach – Types of Processes:
Support processes:
 Exist to sustain the enterprise.
 Since the support needs of business
organizations are similar, these processes tend
to be fairly standard and are frequent
candidates for outsourcing.
 The customers of support processes are internal
customers within the organization.

17. The 7 Quality Management Principles
4. Process Approach – Types of Processes:

18. The 7 Quality Management Principles
5. Improvement:
Continual Improvement is the ongoing improvement
of products, services or processes through
incremental and breakthrough improvements.
These efforts can seek "incremental" improvement
over time or "breakthrough" improvement all at
once.
 Improve organizational performance and
capabilities
 Align improvement activities
 Empower people to make improvements
 Measure improvement consistently
 Celebrate improvements

19. The 7 Quality Management Principles
The Continual Improvement Model:
Among the most widely used tools for the
continuous improvement model is a four-step
quality assurance method—the plan-do-check-act
(PDCA) cycle:
Plan: Identify an opportunity and plan for change.
Do: Implement the change on a small scale.
Check: Use data to analyze the results of the change
and determine whether it made a difference.
Act: If the change was successful, implement it on a
wider scale and continuously assess your results. If
the change did not work, begin the cycle again.

20. The 7 Quality Management Principles
6. Evidence Based Decision Making:
Use evaluation and decision-making tools when you
want to narrow a group of choices to the best one,
or when you want to evaluate how well you’ve done
something. This includes evaluating project results.
 Use appropriate methods to analyze data
 Ensure the accessibility of accurate and reliable
data
 Make decisions based on analysis
 Balance data analysis with practical experience

21. The 7 Quality Management Principles
7. Relationship Management:
 Identify and select suppliers to manage costs,
optimize resources, and create value
 Establish relationships considering both the short
and long term
 Share expertise, resources, information, and plans
with partners
 Collaborate on improvement and development
activities
 Recognize supplier successes

22. Thank you for Listening