Omnex offers online training in ISO 9001:2008
ISO 9000:2000, Quality Management Systems - Establishes a starting point for understanding
the standards and defines the fundamental terms and definitions used in the ISO
What is ISO 9000?
The ISO 9000 series of documents was created by the International Organization for
Standardization (ISO) to set international requirements for quality management systems.
Now adopted by over 80 countries, use of the series of standards has become commonplace
in the business world. The ISO 9000 standards are a set of international quality
management system standards and guidelines. The term ISO 9000 refers to a group
of quality management standards. ISO 9000 currently includes three quality standards:
ISO 9000:2000, ISO 9001:2008, and ISO 9004:2000. ISO 9001:2008 presents requirements,
while ISO 9000:2000 and ISO 9004:2000 present Quality guidelines. All of these are
process standards (not product standards).
ISO 9000 was published in 1987, then revised in 1994 and 2000. "ISO 9000:2000 is
used to describe the whole family of standards beginning with 900x.
It is important to have standard operating procedures in the global market. With
millions of ISO 9000 users worldwide, it is imperative that the introduction of
these standards be as seamless as possible. In pursuit of these goals, ISO/TC 176/SC
2, which handled the revision of the ISO 9001 and ISO 9004 standards, has developed
an introduction plan to facilitate the successful launch of the new standards.
What is the ISO 9000 Series?
The ISO 9000:2000 series consist of only one Specification Standard ISO 9001:2008
- compared to the older series ISO 9000:1994 which was comprised of three specification
standards - ISO 9001, ISO 9002, ISO 9003 and its relevant guidelines. The ISO 9001:1994
Series was designed to remain in effect until December 15, 2003 when the first surveillance
audits for ISO 9001:2008 would be completed.
The series itself is generic and is designed to be applicable to any manufacturing
or service process. The series is revised and controlled by Technical Committee
(TC) 176, made up of international members from many industries and backgrounds.
ISO 9000:2000 is applicable to:
- Organizations seeking a competitive advantage through the implementation of a quality
- Organizations seeking a greater supplier confidence that product requirements will
- Those concerned with a mutual understanding of the terminology used in quality management
(e.g. suppliers, customers, regulators);
- Those internal or external to the organization who assess the quality management
system or audit it for conformity with the requirements of ISO 9001 (e.g. auditors,
regulators, certification/registration bodies);
- Developers of related standards.
There are many different ways of applying the ISO 9000:2000 quality management principles.
The nature of the organization and the specific challenges it faces will determine
how to implement them.
Background to ISO 9000 standards
ISO 9000 has revolutionized the quality domain It controls quality, saves money,
customers expect it, and savvy suppliers use it. ISO 9000 can be applied to all
kinds of organizations. It helps both product- and service- oriented institutions
attain unprecedented improvements in quality. It can be implemented in small, medium
and large-scale organizations, and it is applicable to organizations in the industrial,
software and service sectors.
The needs of modern businesses are numerous and manifold. The ISO 9000 standards
are applicable to all areas of the international business, because they are international
in scope. Furthermore, ISO 9001:2008's new focus on customer satisfaction ensures
that supplier product precisely meets the needs of the customer. The revised standards
will be of specific help to organizations wishing to go beyond simple compliance
with Quality Management System requirements for the sake of certification.
The present day business-wide needs, whether quality-related or not, are exacting.
Keeping in line with this trend of reasoning, the ISO members thought it essential
to introduce structural changes to the standards, while maintaining the basic requirements
of the original standards.
Essential Changes to the ISO 9000 Series
In order to reflect modern management approaches and to improve organizational practices,
structural changes were necessary. ISO has taken care to maintain the essential
requirements of the past ISO 9000 standards.
The ISO 9000 family contained more than 20 standards and documents. This proliferation
of standards was a particular concern of ISO 9000 users and customers. To respond
to this concern, the ISO 9000:2000 family was narrowed down to four primary standards
supported by a considerably reduced number of supporting documents (guidance standards,
brochures, technical reports, technical specifications). To the extent possible,
the key points in the past documents were integrated into the four primary standards,
and sector needs addressed while maintaining the generic nature of the standards.
The four primary standards are:
- ISO 9000: Quality management systems - Fundamentals and vocabulary
- ISO 9001: Quality management systems - Requirements
- ISO 9004: Quality management systems - Guidance for performance improvement
- ISO 19011: Guidelines on quality and/or environmental management systems auditing
(To be published)
The revised ISO 9001 and ISO 9004 standards were developed as a "consistent pair"
of standards. The revised ISO 9001 clearly addresses the quality management system
requirements for an organization, to demonstrate its capability to meet customer
requirements and enhance customer satisfaction. The revised ISO 9004 is intended
to go beyond ISO 9001 and examine satisfaction for interested parties.
Both ISO 9001 and ISO 9004 use a common vocabulary as defined in ISO 9000, which
also describes the underlying fundamentals. A logical, systematic approach has been
adopted in formulating the definitions used in ISO 9000, with the intention of generating
a more consistent terminology that is "user-friendly".
The 1994 editions of ISO 9001, ISO 9002 and ISO 9003 standards are consolidated
into the single ISO 9001:2008 standard. Because of the generic nature of the standard,
some excluded requirements are allowed in clause 7. A guidance document on "Application"
is available on the ISO TC 176/SC2 web site.
ISO 9001:1994 had 20 clauses, but ISO 9001:2008 had done away with this structure.
ISO 9001:2008 is divided into five sections. To the maximum extent possible, the
key points in the original 20 documents will be integrated into the four primary
standards, and sector needs will be addressed while maintaining the generic nature
of the standards. These changes have made ISO 9001 more seamless with other ISO
ISO 9001:2008 is focused on the customer. Both from the standpoint of customer expectations
and customer satisfaction, the standard insists that you recognize the voice of
the customer. ISO 9001 evaluates the effectiveness and suitability of your quality
management system, and identifies and implements improvements. It is perhaps the
concept of 'continuous improvement' that is most relevant to ISO 9000:2000. Customers
of ISO 9000-certified companies have benefited by receiving products and/or services
that have conformed to their requirements, and delivered consistent performance.
Among the benefits claimed by ISO 9000:2000 are: 'people within the organization'
will profit from better working conditions, increased job satisfaction, improved
morale, and stability of employment. 'Owners and investors' will benefit from an
increased return on investment, larger market share, increased profits and improved
operational results, and 'society' will gain from the fulfillment of legal and regulatory
requirements, and reduced environmental impacts.
Before, a registering company called itself a "supplier", because it supplied product
to customers. But this confused many companies, so ISO changed "supplier" to "organization."
Now "supplier" replaces "subcontractor" and refers to the registering company's
suppliers. ISO has also introduced the phrase product realization. This realization,
including the determination and specification of customer requirements and organizational
self-assessment, is a driver for improvement of processes and methods.
The standard has completely abandoned the "chimney approach" to auditing and uses
a process-oriented approach. ISO 9001:2008 examines about 21 processes in its scope.
In fact, the Quality Management System as a whole is a process. The process approach
is the elemental core or groundwork of ISO's perspective of Quality Management System.
According to this approach, a QMS can be thought of as a single large process that
avails many inputs to generate many outputs.
The "Consistent Pair" of Quality Management Standards
The revised ISO 9001 and 9004 are being designed to constitute a "consistent pair"
of standards. Their structure and sequence will be identical in order to facilitate
an easy and useful transition between them. The primary aim of the "consistent pair"
is to relate modern quality management to most of the processes and activities of
an organization, including the promotion of continual improvement and achievement
of customer satisfaction. Furthermore, it is intended that the ISO 9000 standards
have global applicability. Major changes in the revised ISO 9000 standards are:
increased focus on top management commitment and customer satisfaction, the emphasis
on processes within the organization, and the introduction of continual improvement
In this way, all organizations, whether private or public, large or small, producing
manufactured goods, services, or software, are being offered tools with which to
achieve internal and external benefits. In the ISO 9000 family there will be a single
Quality Management Requirements standard, that is clear, concise and universal.