WHAT IS QUALITY?

 Product / Service Quality Must Result in Customer Satisfaction

Quality = Customer Satisfaction

= Fitness for Use +
Conformance to Specifications +
Reliable Performance +
Value for Money

ISO 9001:2015 Defines Quality as degree to which a set of

inherent characteristics of an object fulfils requirements.
Evolution of Quality Management
Traditionally, materials were checked for quality and segregated
into good and bad items. This would happen at incoming, in-
process, and finished good stages of manufacture. Only good
items left the factories (and reached customers). It was called
Quality Control (QC).
Then came Quality Assurance (QA), mostly using statistical
plans for picking only a sample for quality checking and product
acceptance, assuring certain acceptable quality level (AQL).
This was followed by Total Quality Control (TQC) and Total
Quality Management (TQM) wherein supplier controls were also
put in place. TQM paved the way for ISO 9001 Quality
Management System standard and QMS certification schemes.
WHAT IS ISO ?
 International Organization for Standardization
 Non Government Organization
 International Standards Setting Body
 Founded on 23rd February 1947
 Headquarters in Geneva, Switzerland
 175 Countries as members
 Published more than 17,500 International Standards
 ISO Does not Issue Certificates
ISO 9000
 Family of standards for Quality Management System
 Developed and Maintained by ISO
 Administered by Accreditation and Certification Bodies
ISO 9000 SERIES OF STANDARDS
ISO 9001:2015 – Quality Management System Requirements
Sets out the Requirements of a Quality Management System

ISO 9001:2015 – Fundamentals and Vocabulary

Covers the Basic Concepts and Language

ISO 9004:2009 - Guidelines for Performance Improvement

Focuses on How to Make a Quality Management System More
Efficient and Effective.

ISO 19011:2011 - Guidelines for Auditing Management System

Sets Out Guidance on Internal and External Audits of Quality
Management Systems.
ISO 9001:2015 Quality Management System
 First Published in 1987
 Revised in 1994, 2000, 2008 and 2015
 Implemented by more than one million organizations in 175
countries
 Generic Standard – Applicable to all kind of organizations
Quality Management Principles
Quality management principles are a set of fundamental
beliefs, norms, rules and values that are accepted as true
and can be used as a basis for Quality Management.

The Quality Management Principles can be used as a

foundation to guide an organization’s performance
improvement.

ISO 9001:2015 Standards are based on Seven Quality

Management Principles
Seven Quality Management Principles
 Principle 1: Customer Focus

 Principle 2: Leadership

 Principle 3: Engagement of People

 Principle 4: Process Approach

 Principle 5: Improvement

 Principle 6: Evidence Based Decision Making

 Principle 7: Relationship Management

Principle 1: Customer Focus
The primary focus of quality management is to meet
customer requirements and to strive to exceed
customer expectations.
Key benefits:
 Increased Customer Value
 Increased Customer Satisfaction
 Improved customer loyalty
 Enhanced Repeat Business
 Enhanced Reputation
 Expanded Customer Base
 Increased Revenue and Market Share
Principle 2: Leadership
Leaders at all levels establish unity of purpose and
direction and create conditions in which people are
engaged in achieving the organization’s quality
objectives.

Key benefits:
 People will understand and be motivated towards the organization's
goals and objectives.
 Activities are evaluated, aligned and implemented in a unified way.
 Miscommunication between levels of an organization will be
minimized.
Principle 3: Engagement of People
Competent, empowered and engaged people at all
levels throughout the organization are essential to
enhance its capability to create and deliver value.

Key benefits:
 Improved understanding of the organization’s quality objectives by
people in the organization and increased motivation to achieve them
 Enhanced involvement of people in improvement activities
 Enhanced personal development, initiatives and creativity
 Enhanced people satisfaction
 Enhanced trust and collaboration throughout the organization
 Increased attention to shared values and culture throughout the
organization
Principle 4: Process Approach
Consistent and predictable results are achieved more
effectively and efficiently when activities are
understood and managed as interrelated processes
that function as a coherent system.
Key benefits:
 Enhanced ability to focus effort on key processes and opportunities
for improvement
 Consistent and predictable outcomes through a system of aligned
processes
 Optimized performance through effective process management,
efficient use of resources, and reduced cross-functional barriers
 Enabling the organization to provide confidence to interested
parties as to its consistency, effectiveness and efficiency
Principle 5: Improvement
Successful organizations have an ongoing focus on
improvement.
Key benefits:
 Improved process performance, organizational capabilities and
customer satisfaction
 Enhanced focus on root-cause investigation and determination,
followed by prevention and corrective actions
 Enhanced ability to anticipate and react to internal and external
risks and opportunities
 Enhanced consideration of both incremental and breakthrough
improvement
 Improved use of learning for improvement
 Enhanced drive for innovation
Principle 6: Evidence Based Decision Making
Decisions based on the analysis and evaluation of data
and information are more likely to produce desired
results.
Key benefits:
 Improved decision-making processes
 Improved assessment of process performance and ability to achieve
objectives
 Improved operational effectiveness and efficiency
 Increased ability to review, challenge and change opinions and
decisions
 Increased ability to demonstrate the effectiveness of past decisions
Principle 7: Relationship Management
For sustained success, an organization manages its
relationships with interested parties, such as
suppliers.
Key benefits:
 Enhanced performance of the organization and its interested
parties through responding to the opportunities and constraints related
to each interested party
 Common understanding of goals and values among interested
parties
 Increased capability to create value for interested parties by sharing
resources and competence and managing quality-related risks
 A well-managed supply chain that provides a stable flow of goods
and services
ISO 9001:2015 Requirements
4. Context of the Organization
 Understanding the organization and its context
The organization shall determine external and internal issues that are relevant to its purpose and
its strategic direction and that affect its ability to achieve the intended result(s) of its quality
management system. The organization shall monitor and review information about these
external and internal issues.
 Understanding the needs and expectations of interested parties
Due to their effect or potential effect on the organization’s ability to consistently provide
products and services that meet customer and applicable statutory and regulatory
requirements. The organization shall monitor and review information about these interested
parties and their relevant requirements.
 Determining the scope of the quality management system
The organization shall determine the boundaries and applicability of the quality management
system to establish its scope.
 Quality management system and its processes
The organization shall establish, implement, maintain and continually improve a quality
management system, including the processes needed and their interactions, in accordance with
the requirements of this International Standard.
ISO 9001:2015 Requirements
5. Leadership
 Leadership and Commitment
Top management shall demonstrate leadership and commitment with respect to the quality
management system
 Quality Policy
Top management shall establish, implement and maintain a quality policy
 Organizational roles, responsibilities and authorities
Top management shall ensure that the responsibilities and authorities for relevant roles are
assigned, communicated and understood within the organization.
ISO 9001:2015 Requirements
6. Planning
 Actions to address risks and opportunities
When planning for the quality management system, the organization shall consider the issues
and requirements and determine the risks and opportunities.
 Quality objectives and planning to achieve them
The organization shall establish quality objectives at relevant functions, levels and processes
needed for the quality management system.
 Planning of changes
When the organization determines the need for changes to the quality management system, the
changes shall be carried out in a planned manner.
ISO 9001:2015 Requirements
7. Support
 Resources
The organization shall determine and provide the resources needed for the establishment, implementation,
maintenance and continual improvement of the quality management system.
 Competence
The organization shall determine the necessary competence of person(s) doing work under its control that
affects the performance and effectiveness of the quality management system; ensure that these persons are
competent on the basis of appropriate education, training, or experience; where applicable, take actions to
acquire the necessary competence, and evaluate the effectiveness of the actions taken; retain appropriate
documented information as evidence of competence.
 Awareness
The organization shall ensure that persons doing work under the organization’s control are aware of the
quality policy; relevant quality objectives; their contribution to the effectiveness of the quality management
system, including the benefits of improved performance; the implications of not conforming with the quality
management system requirements.
 Communication
The organization shall determine the internal and external communications relevant to the quality
management system
 Documented Information
The organization’s quality management system shall include documented information determined by the
organization as being necessary for the effectiveness of the quality management system.
ISO 9001:2015 Requirements
8. Operation
 Operational Planning and Control
 Requirements for Products and Services
 Design and Development of Products and Services
 Control of externally provided processes, products and services
 Production and Service Provision
 Release of Products and Services
 Control of Nonconforming Outputs
ISO 9001:2015 Requirements
9. Performance Evaluation
 Monitoring, measurement, analysis and evaluation
 Internal Audit
 Management Review
ISO 9001:2015 Requirements
10. Improvement
 General
 Nonconformity and Corrective Action
 Continual Improvement
Benefits of ISO 9001:2015
Internal Benefits
 Better management of core business processes
 Increased awareness of quality among staff
 Improved productivity and quality
 Improved internal communications
 Reduced costs of quality
Benefits of ISO 9001:2015
External Benefits
 Improved customer satisfaction
 Higher perceived quality by market place
 Quicker time to market new products
 Enhanced competitive edge
 Increased market share