ISO 9000:2005

ISO 9000:2005

The ISO 9000 family of standards listed below has been developed to assist organizations, of all types and sizes, to implement and operate effective quality management systems.

  • ISO 9000 describes fundamentals of quality management systems and specifies the terminology for quality management systems,
  • ISO 9001 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide products that fulfill customer and applicable regulatory requirements and aims to enhance customer satisfaction.
  • ISO 9004 provides guidelines that consider both the effectiveness and efficiency of the quality management system. The aim of this standard is improvement of the performance of the organization and satisfaction of customers and other interested parties.
  • ISO 19011 provides guidance on auditing quality  management systems.

ISO 9000:2005 describes fundamentals of quality management systems, which form the subject of the ISO 9000 family, and defines related terms. ISO 90050:2005 have been prepared by technical committee ISO/TC 176, Quality Management and quality Assurance, Subcommittee SC1, Concepts and terminology.   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.
The standard consist of the following:

1 Scope 
2 Fundamentals of quality management systems 
2.1 Rationale for quality management systems 
2.2 Requirements for quality management systems and requirements for products 
2.3 Quality management systems approach 
2.4 The process approach  
2.5 Quality policy and quality objectives
2.6 Role of top management within the quality management system 
2.7 Documentation 
2.8 Evaluating quality management systems 
2.9 Continual Improvement  
2.10 Role of statistical techniques 
2.11 Quality management systems and other management system focuses 
2.12 Relationship between quality management systems and excellence models 
3 Terms and definitions 
3.1 Terms relating to quality 
3.2 Terms relating to management 
3.3 Terms relating to organization 
3.4 Terms relating to process and product 
3.5 Terms relating to characteristics 
3.6 Terms relating to conformity 
3.7 Terms relating to documentation
3.8 Terms relating to examination
3.9 Terms relating to audit 
3.10 Terms relating to quality management of measurement processes 

The scope 

The scope of ISO 9000:2005 describes the fundamentals of Quality Management System and some of the related  terms, and this standard is applicable to:
a) Organization who wish to implement Quality Management system.
b) Organization who wish that their supplier meet their product requirement.
c) Users of product.
d) those who wants to understand the the terminology used in quality management (e.g.  suppliers, customers, regulators).
e) Those who wish to assess the quality management system in an organization or audit it for conformity with the requirements of ISO 9001 such as internal auditors, external auditors, regulators, certification/registration bodies)
f) Trainers and consultants who gives advice or provided training to the organization relating to Quality Management system.
g) Developers of related standards.

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