iSO and ISO 9000 series standard introduction
1. International Organization for Standardization (ISO)
ISO is the English abbreviation of the International Organization for Standardization. ISO was founded on February 23, 1947. The headquarters of ISO is Geneva , located in , Switzerland . Responsible for standardization activities in many important areas, except for electricians and electronics, military industry, oil and ship manufacturing. The development of international standards is usually done by the ISO's technical committee. ISO and International Electrotechnical Commission (IEC) maintain a close cooperative relationship in the standardization of electrical technology.
ISO is a world-wide consortium composed of 117 national standardization groups (ISO member groups). China is a full member of the ISO. The State Administration of China (SAC) represents China.
Technical Committee 176 and ISO9000 series
main work on drafting standards was completed by different technical committees. The technical committee responsible for quality management and quality assurance TC176 was established in 1979 and aims to develop a general quality management system standard - ISO 9000.
2. History of ISO 9000
As early as the fifties, the United States did not publish the US military standard MIL-Q-9858 based on the quality management and quality assurance experience of military products. Various quality system standards based on the same concept are constantly developing. The UK released BS5750 in 1979 based on its early quality system standards, the Ministry of Defense's DEF-STAN05 experience.
In 1987, the ISO 9000 series standard based on BS5750 was officially released.
quality system standard development and evolution can be briefly listed as follows:
MIL-Q-9858 | 1959 | (U.S. Military Standard) |
AQAP | 1969 | ( NATO joint quality assurance publication) |
ANSI N45.2 | 1971 | (National Standards Association) |
CSA Z 299 | 1975 | (Canadian Standards Association) |
BS5750 | 1979 | (British Standards Association ) |
ISO 9000 | 1987 | (International Organization for Standardization) |
GB/T19000 | 1992 | (China National Standard) |
In 1988, the GB/T10300 series was also released, which is equivalent to the national standard of ISO9000 series. In 1992, GB/T10300 was revised to a national standard equivalent to ISO9000. That is, GB/T19000-ISO9000 series standard.
3. ISO 9000 Standard Series
The latest ISO 9000 series standards consist of three core standards, which are:
(1) ISO 9000-2005 Basic and Vocabulary of Quality Management System
(2) ISO 9001-2008 Quality Management System -- Requirements
(3) ISO 9004-2009 Organizations continue to manage successfully -- A method of quality management of
Basic concept of quality management
1, quality quality
A set of inherent characteristics meets the requirements of to the extent that .
Note 1: The term "quality" can be modified using adjectives such as poor, good or excellent.
Note 2: "Inherent" refers to the permanent characteristic that exists in something or something, especially.
2, requirements or expectations that are express, usually implicit or must be fulfilled.
Note 1: "Often implicit" refers to the convention or general habit of organization , that is, it is self-evident to consider the needs or expectations of its customers and other related parties .
Note 2: Specific requirements can be expressed using modifiers, such as product requirements, quality management requirements, and customer requirements.
Note 3: The requirements are express requirements, as explained in the file .
Note 4: The requirements can be proposed by different relevant parties.
3, customer satisfaction customer satisfaction
Customers feel the degree to which their requirements have been satisfied.
Note 1: Customer complaining is the most common way of expression with low satisfaction, but no complaining does not necessarily mean that the customer is satisfied.
Note 2: Even if the customer's requirements are appropriate and satisfied, it is not necessary to ensure that the customer is very satisfied.
4. Management system management system
system to establish policies and goals and achieve these goals.
Note: A group of Implant management system can include several different management systems, such as quality management system , financial management system or environmental management system .
5. Quality Management System quality management system
Guidance and control Organization About Quality Management system .
6. Quality policy quality policy
The highest manager is officially released by the organization's total quality intent and quality direction.
Note 1: Usually the quality policy is consistent with the overall policy of the organization and provides a framework for formulating the quality target .
Note 2: The quality management principle proposed in this standard can be used as the basis for formulating quality policies.
7. Quality objective quality objective
The purpose pursued by quality .
Note 1: Quality targets are usually based on the quality policy .
Note 2: The quality goals are usually specified for the relevant functions and levels of organization .
quality system file and structure
1. Documentation system filed
ISO9000 series standard requires suppliers to establish and maintain a filed quality system to ensure that the product meets the specified requirements. In fact, if the principles required by the standard are applied to the quality system and documented, customers and certification agencies will believe that the supplier has formulated an effective quality system.
2. Quality system file structure
In the eyes of some people, the quality system is nothing more than a accumulation of a large number of files, which can only lead to documentary . However, the intention of the ISO9000 series standards is not the case. Although many elements require the establishment of documents, the traditional and simplified procedures of documents will be determined according to the actual situation of the enterprise. The general requirements for fileization of
ISO 9000 series standards are shown in the figure below:
