Professional Documents
Culture Documents
* Mid-January 2009.
Selection and use The standard can be used for
certification/registration and contractual
of the ISO 9000 family purposes by organizations seeking
of standards recognition of their quality management
system. ISO 9001 has been organized in
a user-friendly format with terms that are
easily recognized by all business sectors.
Continual improvement of
the quality management system
Management
Customers responsibility Customers
(and other (and other
interested interested
parties) parties)
Resource Measurement
analysis and Satisfaction
management improvement
Together, the five sections of ISO 9001 ISO 9004 gives guidance on a
define what you should do to consistently wider range of objectives of a quality
provide product that meets customer management system than does ISO 9001,
and applicable statutory and regulatory particularly in managing for the long-term
requirements. In addition, you will seek to success of an organization. ISO 9004 is
enhance customer satisfaction by continual recommended as a guide for organizations
improvement of your quality management whose top management wishes to extend
system. the benefits of ISO 9001 in pursuit of
systematic and continual improvement of
Further guidance can also be found
the organizations overall performance.
in the ISO 9001:2008 Introduction and
However, it is not intended for certification
Support Package prepared by ISO/TC 176
or contractual purposes.
subcommittee SC 2 which provides further
guidance on: ISO 19011 covers the area of auditing
of quality management systems and
9 9 Terminology
environmental management systems.
9 9 ISO 9001:2008 Clause 1.2 (Application) It provides guidance on the audit
9 9 Documentation requirements programmes, the conduct of internal
or external audits, and information on
9 9 The process approach
auditor competence. ISO 19011 provides
9 9 Outsourced processes an overview of how an audit programme
9 9 Implementation should operate and how management
system audits should take place.
9 9 Frequently asked questions (FAQs).
Effective audits ensure that an
ISO/TC 176 maintains a database of
implemented QMS meets the requirements
approved interpretations of the ISO 9001
specified in ISO 9001.
standard.
The nature of your organization and
ISO 9004 is used to extend the benefits
your specific needs will determine how
obtained from ISO 9001 to all parties
you apply these standards to achieve your
that are interested in or affected by your
goals and objectives. Useful hints and tips
operations. Interested parties include your
for conducting audits have been developed
employees, owners, suppliers, partners
by the ISO 9001 Auditing Practices Group.
and society in general.
Information on third party auditing has also
ISO 9001 and ISO 9004 are been developed by the joint ISO-IAF
compatible and can be used separately (International Accreditation Forum)
or in combination to meet or exceed Accreditation Auditing Practices Group.
expectations of customers and interested
1 Fully engage
top management to
2
Identify key processes and the
interactions needed to meet
quality objectives
3
Implement and manage
the QMS and its processes
(using process management
techniques)
5
Implement the system, train
company staff and verify
effective operation of your
processes
7
If necessary, seek third party
certification/registration of the
QMS or alternatively, issue a
self-declaration of conformity
Continual improvement of
the quality management system
ISO 1 0 0 1 3
ISO 1 0 0 1 4
Plan Management
Act
responsibility
Customers Customers
(and other (and other
interested interested
parties) parties)
I SO 1 9 0 1 1
Resource Measurement
management analysis and Satisfaction
improvement
ISO 1 0 0 0 4
ISO 1 0 0 1 2 I SO 1 0 0 0 1
I SO 1 0 0 0 2
I S O 10 01 5
I S O 10 01 9 Do Check ISO 1 0 0 1 7
I SO 1 0 0 0 3
Example 1 Example 3
A metal parts fabricating company An electrical appliance manufacturer
recognized the need to demonstrate their had a well-established company culture
capability to produce consistent quality of continual improvement and effective
product. They first used ISO 9000 to production control. The management
develop a plan to create an acceptable decided to improve the companys
QMS. Next, they prepared the quality development processes and to implement
manual and quality system procedures ISO 9001 to obtain certification for
as required by ISO 9001, excluding the commercial purposes. The company
requirements covering product design used ISO 9004 to guide its improvement
and development because their products processes and ISO 10006 to develop a
are made to designs prepared by their project management plan. Regulatory
customers. They implemented the QMS agencies demanded products be designed
described in their manual and procedures and packaged recognizing the end of life
and ensured the system functioned as disposition of products and packaging.
planned. Later, in order to bid on the supply The company was able to use the design
of parts to a major automotive company, and document control requirements in
they upgraded their quality system to ISO 9001 to satisfy regulators of
meet the automotive sector specific compliance to new requirements.
requirements of ISO/TS 16949.
Example 2
Based on input from the user Sales enquiries should also be directed
community, ISO/TC 176 will continue to the ISO members or to the ISO Central
to evaluate and adopt new concepts Secretariat sales department
in the field of quality management for sales@iso.org.
incorporation into ISO standards.
ISO publishes the bimonthly magazine
This can include sector specific initiatives
ISO Management Systems
and supporting documents within the
www.iso.org/ims which provides
ISO 9000 family. Most ISO technical
updates on its families of standards
committees recognize the structure of
management system and news on their
ISO 9001 when new management systems
implementation around the world.
standards are developed for other or
The magazine is available in English, French
specific purposes.
and Spanish editions.
ISOs commitment to sustaining the
ISO Focus magazine www.iso.
ISO 9000 momentum through reviews,
org/isofocus gives an overview of ISO
improvement and streamlining of the
and its standards and also includes articles
standards guarantees that your investment
on its management systems standards. It is
in ISO 9000 today will continue to provide
published 11 times a year in English only.
effective management solutions well into
the future.
ISBN 978-92-67-10494-2
ISO, 2009-02/5000. All rights reserved