Quality Management System

Quality triangle

Q-policy

Q-managementsystem

HRM ICT Financial Technical Admini-

services services stration

Primary proces
Documentation system

Q-Policy
statement

Q-manual

Procedures ( SOPs)

Instructions and forms

The Quality Management System under ISO 9000
family

The ISO 9000 family of quality

management systems standards is
designed to help organizations ensure
that they meet the needs of customers
and other stakeholders while meeting
statutory and regulatory requirements
related to a product or service
The ISO 9000 family contains these standards
• ISO 9001:2015: Quality management systems -
Requirements
• ISO 9000:2015: Quality management systems - Fundamentals
and vocabulary (definitions)
• ISO 9004:2009: Quality management systems – Managing for
the sustained success of an organization (continuous
improvement)
• ISO 19011:2011: Guidelines for auditing management
systems
 History of revisions
• Originally published in 1987 by the International
Organization for Standardization (ISO), a specialized
international agency for standardization composed of the
national standards bodies of more than 160 countries
• Underwent major revision in 2000; revised again in 2008
• Current versions of ISO 9000 and ISO 9001 were published in
September 2015
 ISO 9001
• First published in 1987, and has since been updated about
every 7 years.
• The standard details how to establish a Quality Management
System (QMS) to ensure organizations produce quality
products and services.
• It is very customer focused, and places an emphasis on
continuous improvement and top management processes
that extended throughout the organization.
Third-party certification bodies provide independent
confirmation that organizations meet the requirements
of ISO 9001.
Importance of Monitoring & Measurement
New “Terms” in the first 6 Clauses of ISO 9001:2015
1. Scope of standard
2. Normative references
3. Terms and definitions
4. “Context of the organization”
4.1 Understanding the organization and its “context”
4.2 Understanding the needs and expectations of “interested parties”
4.3 Determining the scope of the quality management system - b) the
requirements of relevant “interested parties”
4.4 Quality management system and its processes - f) address the “risks “
5. “Leadership”
6. “Planning”
6.4 Actions to address “risks and opportunities”.
Understanding the definitions and fundamental
concepts in ISO 9001:2015
The Following are examples of some of the
New, Revised or Removed Terms of ISO 9001

• Interested party New • Competence Revised

• Risk New • Output Revised

• Information
• Risk-based New Revised

thinking • Information system

Revised
• Verification
• Provider New Revised
• Validation
• Documented New
• Corrective action Revised
information
• Preventive action Revised
• Effectiveness Revised
Removed
Understanding “Context”

Context of an organization
• Understanding the context of the organization is a
process. This process determines factors which influence
the organization’s purpose, objectives and sustainability.
Context of the organization
• Combination of internal & external issues that can have
an effect on an organization’s approach to developing and
achieving its objectives.
Understanding “Interested Parties”
When determining the scope of the organization, we shall
consider the expectations of relevant interested parties
All of the following can be "interested parties"
• person having an interest in the success of an organization
• person that can affect an activity
• organization that perceives itself to be affected by a decision
• stakeholder
• person having an interest in the performance of an
organization
• providers regulators
• competitors
• opposing pressure group
• And more!!!
 Understanding “Risk”
The term “Risk” has been added to ISO 9001:2015 and is
noted in many places throughout the standard.

“Risk” - effect of uncertainty positive or negative.

consequence, or likelihood reference to potential
events the consequences of an event

This may apply, for example, to; a product, service,

process, provider, customer, consumer, environment,
employee, & the competition.
Be aware of the relevance and importance of quality
improvement processes in your organization and their
relationship to the achievement of the quality
objectives
 International Quality Standards
• ISO 9000 series
• Common quality standards for products sold in Europe (even if
made in U.S.)
• ISO 14000 series
• Standards for recycling, labeling, environmental management etc.
• ISO 18000 series
• Standards for Occupational Health & Safety
• ISO 22000 series
• Standards for food safety
• ISO 26000 series
• Standards for Corporate Social Responsibility
• Industrial Standard Z8101-1981 (Japan)
• Specification for TQM
• ASQC Q90 series; MILSTD (U.S.)
Evolution of ISO 9000 series
 Deming Circle

PLAN

ACT DO

CHECK
Key Performance Indicators
Quality Compliance Markings

China Compulsory Certificate

Eco-labels
 Implementing TQM in a
Triple Bottom Line Approach
ISO and 3rd Party Certification
 3rd Party Certification
• An independent organization has reviewed the manufacturing or
service process of a product/service and has independently
determined that the final product/service complies with specific
standards for safety, quality or performance.
• This review typically includes comprehensive formulation/material
reviews, testing and facility inspections.
• Most certified products bear the certifier’s mark on their packaging to
help consumers and other buyers make educated purchasing
decisions.
 Why do companies seek 3rd party certification?
• Demonstrate compliance with national or international standards and
regulations
• Demonstrate independent validation and verification of their
commitment to safety and quality
• Increase credibility and acceptance with retailers, consumers and
regulators
• Benefit from enhanced product quality and safety
Globalization has something to do with 3rd

party certification
. . . in every industry and sector throughout the
world, success, and in some cases survival, will
depend upon the ability of organizations to
compete globally.
Globalization has something to do with 3rd
party certification
Organizations of all types, including business,
government, education, health care, military, and
research and development, have been rethinking
their operations and management approaches.
Seeking 3rd party certification means an
organization is ready to adopt a continuous
improvement framework of management

The quality improvement approach is not a

program or an organization intervention with a
specific beginning, middle, and end.
Continuous improvement framework is a system of
management:
1) strategic in nature,
2) open to the environment,
3) cyclical in operation (producing output and receiving
feedback),
4) striving for equilibrium (a state of balance or adjustment
between opposing or divergent influences or
elements), and
5) seeking optimization (a process of arranging or combining
the efforts of all components so as to achieve a
required response).
 A System Approach
“an integrated assembly of interacting
elements [or components] designed to carry
out cooperatively a predetermined function.”
 A System Approach
In an organizational context this implies a
multiplicity of people, processes, technologies,
and materials that together perform a significant
function and contribute to a specific aim—a
service or product development.
A system of management for organizational
improvement
Strategies of organizational change and their relationship to the system of management principles