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ISO 9000 COLLECTION 1



The ISO
9000 Collection 1 package was especially created for quality management needs.
This quality management package contains guidelines for performance
improvements, quality / environmental management systems auditing and the vocabulary,
fundamentals and requirements for quality management systems. This collection
contains the following ISO 9000 series documents: ISO
9000:2005, ISO 9001:2008, ISO
9004:2009 and ISO 19011:2002.



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ISO 9000:2005

Quality management systems -
Fundamentals and vocabulary



ISO 9000:2005 describes fundamentals of quality management systems, which
form the subject of the ISO 9000 family, and defines related terms.



It is applicable to the following:



a) Organizations seeking advantage through the implementation of a
quality management system;



b) Organizations seeking confidence from their suppliers that their
product requirements will be satisfied;



c) Users of the products;



d) Those concerned with a mutual understanding of the terminology used in
quality management (e.g. suppliers, customers, regulators);



e) 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);



f) Those internal or external to the organization who give advice or
training on the quality management system appropriate to that organization;



g) Developers of related standards.



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ISO 9001:2008

Quality management systems --
Requirements



ISO 9001:2008 specifies requirements for a quality management system where
an organization




Needs to
demonstrate its ability to consistently provide product that meets
customer and applicable statutory and regulatory requirements, and





Aims to enhance
customer satisfaction through the effective application of the system,
including processes for continual improvement of the system and the
assurance of conformity to customer and applicable statutory and
regulatory requirements.




All requirements of ISO 9001:2008 are generic and are intended to be
applicable to all organizations, regardless of type, size and product provided.



Where any requirement(s) of ISO 9001:2008 cannot be applied due to the
nature of an organization and its product, this can be considered for
exclusion.



Where exclusions are made, claims of conformity to ISO 9001:2008 are not
acceptable unless these exclusions are limited to requirements within Clause 7,
and such exclusions do not affect the organization's ability, or
responsibility, to provide product that meets customer and applicable statutory
and regulatory requirements.



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ISO 9004:2009

Managing for the sustained success of an
organization - A quality management approach



ISO 9004:2009 provides guidance to organizations to support the
achievement of sustained success by a quality management approach. It is
applicable to any organization, regardless of size, type and activity.



ISO 9004:2009 is not intended for certification, regulatory or
contractual use.



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ISO 19011:2002

Guidelines for quality and/or
environmental management systems auditing



ISO 19011:2002 provides guidance on the principles of auditing, managing
audit programmes, conducting quality management system audits and environmental
management system audits, as well as guidance on the competence of quality and
environmental management system auditors.



It is applicable to all organizations needing to conduct internal or
external audits of quality and/or environmental management systems or to manage
an audit programme.



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The application of ISO 19011 to other types of audits is possible in
principle provided that special consideration is paid to identifying the
competence needed by the audit team members in such cases.



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