"Increased global competition has led to increasingly more stringent customer expectations with regard to quality. To be competitive and to maintain good economic performance, organizations/suppliers need to employ increasingly effective and efficient systems."
Guidelines for Selection and Use.
What Is ISO?
The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies. ISO has developed a series of standards relating to Quality Systems known as the ISO 9000 family standards. The selection and use of these standards is itself a formal standard: ISO 9000-1, entitled Quality Management and Quality Assurance Standards...Guidelines for Selection and Use.
What Are the ISO Standards?
The standards themselves, which are the children of the ISO 9000 family, define the Quality Systems or models applicable to design, development, production, installation and servicing, final inspection and test. Since not all endeavors encompass all of these aspects of business or the quality model, three standards were developed covering differing combinations of these disciplines, and a set of guidelines was issued to assist in choosing the correct standard for application.
These standards are:
ISO 9001: Quality Systems - Models for Quality Assurance in Design, Development, Production, Installation and Servicing. ISO 9001 is the superset of the contractual models for quality systems. It contains 20 sections, each of which specifies requirements for a component of the ...
ISO 9002: Quality Systems - Models for Quality Assurance in Production, Installation and Servicing. ISO 9002 is the contractual model for quality systems which include production but do not include design. ISO 9002 is almost word-for-word equivalent to ISO 9001, except that it does not include requirements for design control. It contains 19 sections or requirements.
ISO 9003: Quality Systems - Models for Quality Assurance in Final Inspection and Test. This is the contractual model for quality systems which do not include design or production. ISO 9003 contains about half of the requirements from ISO 9001, and modifies some of the requirements to suit the inspection and final test application.
ISO 9004: Quality Management and Quality Systems - Guidelines.
What is the Difference?
As indicated by the difference in title, the standards apply to the extent of activity in which an organization engages. Those organizations involved with the last stages of product completion... Final Inspection and Test... would appropriately choose to abide by ISO 9003. Those organizations which include a stage of manufacture, prior to final assembly and test, would choose ISO 9002. Finally, those organizations which undertake design and development activities, manufacture those designs, and complete final inspection and testing, would choose ISO 9001. In effect, ISO 9001 is the superset standard, with ISO 9002 and ISO 9003 being progressively smaller subsets of that standard.
What is Covered by the ISO 9000 Standards?
The ISO 9000 standards establish a standard framework for a Quality System. A Quality System is a series of checks and balances which, when introduced and followed, will ensure quality of output, or product. The framework, as embodied by ISO 9000, identifies twenty requirements, each of which affect quality. ISO 9000 requires, for every standard, the development of a quality manual and documented procedures which define the organization and operation of the quality system. It is the responsibility of a company to create and maintain these documents, so that they are relevent and appropriate to the specific business operation.
What is a Quality Manual?
The quality manual is the highest level of documentation of an ISO 9000 quality system. It specifies or makes reference to documented procedures, which are more detailed aspects of the quality system. The quality manual is the roadmap to a quality system. It can be used as a training vehicle for
employees, as a reference for employees, and as a standard by which an auditor assesses the compliance and correct functioning of the quality system.
What are Documented Procedures?
Documented procedures are the heart of an ISO 9000 quality system. They define the correct and proper operation of a company in all aspects of quality, and the company is audited to verify that it follows its procedures. Documented procedures are a pervasive requirement of ISO 9000.
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