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Download ISO Standards

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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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9/20/2014 10:57:33 PM UTC