ISO 9000:2005, Quality Management Systems Fundamentals and Vocabulary

MN5554
ISO 9000
ISO 9000 Series of Standards
• ISO 9000:2005, Quality management systems ‐ Fundamentals
and vocabulary
− Covers the basics of what quality management systems are and also
contains the core language of the ISO 9000 series of standards. A
guidance document, not used for certification purposes.
• ISO 9001:2008 Quality management systems ‐ Requirements
− Intended for use in any organization which designs, develops,
manufactures, installs and/or services any product or provides any form
of service.
• ISO 9004:2009 Managing for the sustained success of an
organization ‐ A quality management approach
− Gives guidance for organizations whose top management wish to move
beyond ISO 9001, to address the needs and expectations of all
interested parties and their satisfaction, by systematic and continual
improvement of the organization's performance.
Copyright © Dr QP Yang 1
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Evolution of ISO 9000 Series
ISO 9004
Encourage
business
ISO 9004 sustainability
encourage
improvement
ISO 9000 series
Published
moving from a
quality/inspecti
ISO 9000
ISO Starts on based
Series
work on standard to
Published
BS 5750 ISO 9001 management
Published ISO 9000 system based
amended standard
ISO 9000 Revision 2000
(Carnignana, 2008)
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Eight QM Principles (1)
1. Focus on Your Customers
Organizations depend on their customers and therefore should
understand current and future customer needs, should meet customer
requirements and strive to exceed customer expectations.
2. Provide Leadership
Leaders establish unity of purpose and direction of the organization. They
should create and maintain the internal environment in which people can
become fully involved in achieving the organization's objectives.
3. Involvement of People
People at all levels are the essence of an organization and their full
involvement enables their abilities to be used for the organization's
benefit.
4. Use a Process Approach
A desired result is achieved more efficiently when activities and related
resources are managed as a process.
Eight QM Principles (2)
5. System Approach to Management
Identifying, understanding and managing interrelated processes as a
system contributes to the organization's effectiveness and efficiency in
achieving its objectives.
6. Continual Improvement
Continual improvement of the organization's overall performance should
be a permanent objective of the organization.
7. Factual Approach to Decision Making
Effective decisions are based on the analysis of data and information.
8. Mutually Beneficial Supplier Relationships
An organization and its suppliers are interdependent and a mutually
beneficial relationship enhances the ability of both to create value.
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Structure of the Standard
4 Quality 5 Management 6 Resource 7 Product 8 Measurement
Management Responsibility Management Realization Analysis &
System improvement
Management
General Commitment Provision of Planning General
requirements resources
Customer focus Customer Monitoring &

Documentation Human related measurement
Requirements resources processes
Quality policy
Control of NCP
Infrastructures Design &
development
Planning Analysis of data
Work
environment Purchasing
Responsibility, Improvements
authority & Production &
communication service
provision
Management
Reviews Control of
monitor. & mea.
equipment
General Requirements
• Identification of processes required (their sequences and
interactions)
• Criteria and methods to ensure effective process operation & control
• Availability of resources & information for operation & monitoring of
the processes
• Monitor, measure if applicable, and analyze the processes
• Necessary actions to achieve planned results
• Continual improvements
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Document Requirements
• Quality Policy
• Quality Objectives
• Quality Manual
• Documented procedures and records required by the Standard
• Documents necessary for the organization to ensure the
effective planning, operation and control of its processes
• Control of documents and records
Basic Quality Manual Elements
1) Introduction
2) Policy and Objectives
3) Definitions
4) Quality System
5) Organization
6) Authority and Responsibilities
7) Compliance
8) Internal Review and Audit
9) Documentation and Change
10) Purchasing
11) Inspection and Testing
12) Training
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Model of a Process‐based Quality
Management System
Extended Model
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Latest Versions of ISO 9000 and ISO 9001 standards
(Published in 2015)
• ISO 9000:2015, Quality management systems ‐ Fundamentals
and vocabulary
• ISO 9001:2015 Quality management systems ‐ Requirements
QM Principles
Eight QM Principles New Seven QM Principles
1. Focus on Your Customers 1. Customer focus
2. Provide Leadership 2. Leadership
3. Involvement of People 3. Engagement of people
4. Use a Process Approach 4. Process approach
5. System Approach to Management 5. Improvement
6. Continual Improvement 6. Evidence‐based decision making
7. Factual Approach to Decision Making 7. Relationship management
8. Mutually Beneficial Supplier Relationships
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Schematic representation of the elements of a single process
New Structure, Terminology and Concepts
• Structure and terminology
• Products and services
• Understanding the needs and expectations of interested
parties
• Risk‐based thinking
• Applicability
• Documented information
• Organizational knowledge
• Control of externally provided processes, products and
services
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New Structure of the Standard (1)
4 Context of the
5 Leadership 6 Planning 7 Support
Organization
Understanding the
Actions to
organization and its Leadership and Resources
address risks and
context commitment
opportunities
Understanding the
Policy Competence
needs and
Quality objectives
expectations of
and planning to
interested parties
Organizational achieve them Awareness
roles,
Determining the responsibilities
scope of the quality and authorities Planning of Communication
management changes
system
Documented
Quality information
management
system and its
processes
New Structure of the Standard (2)
8 Operation 9 Performance 10 Improvement

evaluation
Operational planning
Monitoring,
and control
measurement, General
analysis and
Requirements for evaluation
products and services Nonconformity and
corrective action
Internal audit
Design and
development of products Continual
and services improvement
Management review
Control of externally
provided processes,
products and services
Production and service

provision
Release of products and

services
Control of
nonconforming outputs
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Representation of the structure of new ISO 9001:2015
in the PDCA cycle
NOTE: Numbers in brackets refer to the clauses in ISO 9001:2015.
Major Differences in Terminology between ISO
9001:2008 and ISO 9001:2015
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Adoption of ISO 9000 by Countries Around the World
(Heras-Saizarbitoria, 2011)
Top 10 Countries for ISO 9001 Certification
(ISO Survey, 2008)
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Top Industries for ISO 9000 Certification
(ISO Survey, 2000)
Main Motives for ISO 9000 Certification
(Corbett, et al., 2002)
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Benefits of Implementing ISO 9000
ISO 9000 Impact
(Badiru, et al., 1995)
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Increased Efficiency through ISO 9000 Certification
(Capistrano, 2008)
Main Initiators for ISO 9000 Certification

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MN5554

Customer focus Customer Monitoring &

3. Involvement of People 3. Engagement of people

8 Operation 9 Performance 10 Improvement

Production and service

Release of products and

(ISO Survey, 2008)

(ISO Survey, 2000)

(Corbett, et al., 2002)

(Corbett, et al., 2002)

(Badiru, et al., 1995)

(Corbett, et al., 2002)

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