Selection and use of the ISO 9000 family of standards.

1. By : Amine FATIH

2.  ISO is the International Organization for
Standardization.
 Membership of 158* national standards
institutes.
 ISO develops voluntary technical standards.
 Support the efficient, safer and cleaner
products and services.
 ISO’s portfolio is more than 17 800
standards.

3.  ISO/TC 176 is responsible for the ISO 9000
family of standards.
 National delegations of 81 countries
participate in its work.
 21 countries as an observer.

4.  Provides the fundamentals and the vocabulary.
 The stage for understanding the basic elements of
quality management.
 Introduces users to the eight Quality Management
Principles.
 Use the process approach to achieve continual
improvement,(Figure A).

5. Figure A
The ISO 9000 process approach

6.  To establish a quality management system.
 Can be certified by an external body.

7. Five sections in the standard need to be
considered :
 Overall requirements for the quality
management system and documentation.
 Management responsibility, focus, policy,
planning and objectives.
 Resource management and allocation.
 Product realization and process management.
 Measurement, monitoring, analysis and
improvement.

8.  Extend the benefits obtained from ISO 9001
to all parties that are interested in or affected
by the operations.
 Interested parties include the employees,
owners, suppliers, partners and society in
general.
 Gives guidance on a wider range of objectives
of a quality management system.
 Managing for the long-term success of an
organization.

9.  Recommended for systematic and continual
improvement and performance.
 Not intended for certification or contractual
purposes.

10.  Compatible.
 can be used separately or in combination.

11.  Auditing of quality management systems.
 Auditing of environmental management systems.
 Provides guidance on the audit programmes.
 Conduct of internal or external audits.
 Information on auditor competence.
 Provides an overview of the audit programme.
 Ensure that an implemented QMS* meets the
requirements specified in ISO 9001.
*QMS (Quality Management System)

12. For a successful implementation of the
QMS, these seven steps are
recommended.

13.  Define why you want to implement ISO 9001.
 Define the mission, vision, and values in the
organization.
 Define the organization’s stakeholders :
customers, suppliers, stockholders,
employees, society, etc.
 Define the quality policy.
 Define and align organizational objectives
and related product/ service quality
objectives.

14.  Identify key processes and the interactions
needed to meet quality objectives.

15.  Implement and manage the QMS and its
processes (using process management
techniques)

16.  Identify ISO 9001 requirements.
 Map these requirements with the implemented
QMS, where applicable.
 Make a gap analysis : identify the fulfilled
requirements.
 Include in the QMS processes the activities,
procedures and controls needed.

17.  Implement the system, train company staff
and verify effective operation of the
processes.

18.  Focus on customer satisfaction.
 Monitor and measure the operation of the
QMS.
 Strive for continual improvement.
 Consider implementing business excellence
models in the company operations.

19.  Seek third party certification/registration of
the QMS or alternatively, issue a self-
declaration of conformity.

20. The accompanying diagram depicts the
relationships of the standards in the ISO 9000
family and where they may be applied when
implementing the quality management system,
(Figure B).

21. Figure B
Quality Management Principles.

22. A metal parts fabricating company recognized the need
to demonstrate their capability to produce consistent
quality product. They first used ISO 9000 to develop a
plan to create an acceptable QMS. Next, they prepared
the quality manual and quality system procedures as
required by ISO 9001, excluding the requirements
covering product design and development because
their products are made to designs prepared by their
customers. They implemented the QMS described in
their manual and procedures and ensured the system
functioned as planned. Later, in order to bid on the
supply of parts to a major automotive company, they
upgraded their quality system to meet the automotive
sector specific requirements of ISO/TS 16949.

23. A welfare agency decided to improve the quality of
the services it provided to clients. It adopted ISO
9004 as the basis for implementing its system and
planning for improvements. The agency
recognized that ISO 9000 provided very useful
additional guidance in terminology and
understanding and applying QMS concepts to their
system. They mapped the resulting system
processes to requirements in ISO 9001. They
planned to seek certification to ISO 9001 to gain
recognition and credibility from clients and
supporters.

24.  Improvements of the organization and the
internal communication.
 Effective internal auditing and management
review of system performance.

25. http://www.iso.org/iso/home/store/publication_item.htm?pid=PUB100208