1. What is the ISO 9000 family standard?
“ISO 9000 Family†is a concept proposed by the International Organization for Standardization (ISO) in 1994. It refers to “all international standards established by the International Organization for Standardization Quality Management and Quality Assurance Technical Committee (ISO/TC 176). standard". This family of standards helps organizations implement and effectively operate quality management systems and is a common requirement or guide for quality management systems. It is not restricted by specific industry or economic sectors and can be applied to organizations of all types and sizes to promote mutual understanding in domestic and international trade.
2. What are the core parts of the 2000 version of the ISO 9000 standard?
(1) ISO 9000:2000 "Quality Management System Foundation and Terminology", which describes the basic knowledge of the quality management system and defines the terminology of the quality management system.
(2) ISO 9001:2000 "Quality Management System Requirements", which stipulates the requirements of the quality management system to verify the organization's ability to provide products that meet customer requirements and applicable regulatory requirements, with the aim of enhancing customer satisfaction.
(3) ISO 9004:2000 “Guidelines for Quality Management System Performance Improvementâ€, which provides guidance on both the effectiveness and efficiency of the quality management system, with the aim of promoting organizational performance improvement and customer and other stakeholders' satisfaction.
(4) ISO 19011:2000 “Guidelines for the Audit of Quality and/or Environmental Management Systemsâ€, providing guidance on audit quality and environmental management systems.
3. How did the ISO 9000 family standard develop?
The International Organization for Standardization established the Quality Management and Quality Assurance Technical Committee (TC 176) in 1979 to develop quality management and quality assurance standards. In 1986, ISO 8402 "Quality Terminology" was issued. In 1987, ISO 9000 "Guidelines for Selection and Use of Quality Management and Quality Assurance Standards" and ISO 9001 "Quality Assurance Mode for Quality System Design, Development, Production, Installation and Service" were released. ISO 9002 "Quality Assurance Model for Quality System Production and Installation", ISO 9003 "Guidelines for Quality Management and Quality System Elements" and other five standards. The above six standards are commonly referred to as the ISO 9000 series of standards. Immediately after the release of this standard, it caused a strong response around the world.
The 1994 ISO 9000 series of standards was revised and the concept of "ISO 9000 family" was proposed. In order to meet the needs of different industries and different products, the 1994 version of the ISO 9000 family standard has reached 27 standards and documents. It is divided into terminology standards, use or implementation guidelines for two types of standards, quality assurance standards, quality management standards and support. Five categories of technical standards.
4. What is the application prospect of the ISO 9000 family of standards?
The ISO 9000 family standard has been adopted as a national standard by more than 150 countries and regions around the world, and is widely used in industrial, economic and government management fields. More than 50 countries and regions have established quality system certification systems and obtained quality systems. More than 340,000 companies have been certified.
5. Why should the ISO 9000 family standard be revised frequently?
In order to improve the operational capabilities of the organization, provide effective methods; enhance international trade, promote global prosperity and development; enable any institution and individual to have confidence in obtaining any desired products from all over the world and their products can be sold all over the world.
6. What is the file structure of the 2000 version of the ISO 9000 family standard?
2000 version of the ISO 9000 family of document structure core standards other standard technical report booklet ISO 9000
ISO 9001
ISO 9004
ISO 19011 ISO 10012
(Quality assurance requirements for measuring equipment) ISO/TR 10006
ISO/TR 10007
ISO/TR 10013
ISO/TR 10014
ISO/TR 10015
ISO/TR 10017. Quality Management Principles
.Selection and use guide
. Small business applications
7. What is the purpose of the ISO 9000:2000 standard?
ISO 9000:2000 "Quality Management Systems Fundamentals and Terminology" describes the basics of the quality management system in the ISO 9000 family of standards and identifies relevant terms.
The standard clarifies the eight principles that help organizations achieve sustainable quality management, is the framework for organizational improvement, and is the basis for ISO 9000 quality management system standards. It describes the 12 standards that should be followed in establishing and operating a quality management system. The quality management system foundation reflects the specific application of the eight quality management principles.
The standard gives a total of 80 terms related to quality, divided into 10 parts, clarifying the meaning of all quality terms in the field of quality management. Expressed in a more general language, the relationship between concepts is expressed in the form of a concept map to help users understand the interactions and relationships between concepts, terms and definitions more vividly, and grasp the connotation between them. .
8. What is the purpose of the ISO 9001:2000 standard?
The ISO 9001:2000 Quality Management System Requirements standard provides a quality management system that can be applied when an organization needs to demonstrate its ability to consistently provide customer requirements and adapt to the requirements of laws and regulations. Organizations can be applied through the effective application of the system, including the process of continuous improvement of the system and the ability to ensure compliance with customers and products that meet the requirements of laws and regulations. The effective application of the organization's manageable system, including the process of continuous improvement of the system and ensuring compliance with customers and applicable laws and regulations, and enhancing customer satisfaction.
This standard replaces ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 as the only standards for auditing and third-party certification. It can be used internally and externally (second party or third party) to evaluate an organization's ability to meet the organization's own requirements and customer and legal requirements. When the characteristics of the organization and its products are not applicable, consideration can be given to deletion. Derogation is limited to the requirements of Chapter 7 “Product realization†of the standard that do not affect the ability or responsibility of the organization to provide products that meet customer and legal requirements, otherwise it cannot be claimed to meet this standard.
9. What is the purpose of the ISO 9004:2000 standard?
The ISO 9004:2000 Quality Management System Performance Improvement Guidelines are based on eight quality management principles that help organizations identify and meet the needs and expectations of customers and other stakeholders in an effective and university-based manner to achieve, maintain and improve the organization. Overall performance and ability to make the organization successful.
This standard provides guidelines and recommendations that exceed ISO 9001 requirements and are not used for certification or contract purposes, nor are they an implementation guide for ISO 9001. The standard emphasizes that the design and implementation of an organization's quality management system is influenced by the various needs, specific objectives, products offered, the processes employed, and the size and structure of the organization. It is not intended to harmonize the structure or documentation of the quality management system.
This standard replaces ISO 9004-1:1994, ISO 9004-2:1994, ISO 9004-3:1994, ISO 9004-4:1994.
10. What is the purpose of the ISO 19011:2000 standard?
ISO 19011:2000 “Guidelines for the Audit of Quality and/or Environmental Management Systems†follows the principle that “different management systems can have joint management and audit requirementsâ€, which are the basic principles for quality and/or environmental management system audits and the management of audit programs. Guidance on the implementation of quality, and/or environmental management systems, and qualification requirements for quality and/or environmental management system auditors. It is suitable for organizations that run quality management and/or environmental management systems to guide the management of their internal and external audits.
11. What are the main changes in the 2000 version of the ISO 9000 family standard and the 1994 version?
The main changes include:
(1) Simplified the cultural level of the standard family itself, greatly reduced the number of standards, and there are no longer three quality assurance model standards (the quality management system requires only ISO 9001, no longer exists ISO 9002 and ISO 9003), cancel A number of guide standards (such as service, process material guide), the standard is more versatile, more convenient, flexible, and more applicable.
(2) The structure of the quality management system requirements and the guidelines are much different than the 1994 version. Its arrangement further embodies the idea of ​​process methods for quality management and uses this as a standard clause. It is more suitable for the use and operation of organizations of all walks of life, various product types and different scales, making the standard more versatile and more conducive to continuous improvement of the organization.
(3) Refining the idea of ​​total quality management generally accepted and recognized by all countries in the world into the eight basic principles of quality management, and integrating it into the 2000 version of the ISO 9000 family standard, reflecting the development of the ISO 9000 family standard from “compliance with requirementsâ€. "Pursuing results."
(4) Standards tend to pay attention to test sales, weakening some documented requirements, leaving more organizations with active space, guiding organizations to pay attention to effectiveness and efficiency to further develop and use limited resources.
(5) The 2000 version of the ISO 9000 family standard, noting further coordination with other management system standards, so that the quality management system is integrated into other management systems. Although the 2000 version of ISO 9001 is only a quality management system requirement, it does not include other management system requirements for the organization, but like other management systems, it also follows the basic principles of the management system, such as policy objectives management, commitment of top management, and management system. Evaluation, resource management, evaluation of action systems, resource management, motion control, measurement analysis and monitoring, continuous improvement, etc. This will help the organization to establish a unified management system, which will help the organization to promote the simultaneous improvement of other management systems (such as environmental, financial, occupational health and safety, risk and cost management systems) while establishing and implementing a quality management system. It is also possible to obtain multiple certificates by one certification.
12. What is the consistency of the 2000 version of ISO 9001 and ISO 9004?
Consistency is manifested in the following aspects:
(1) There is a common process-based quality management system model. To facilitate the use of the two standards, a similar structure was employed. For the convenience of the user, the ISO 9004:2000 standard places the basic content of ISO 9001:2000 in the box for each of the respective terms. This process-based schema structure is also compatible with other management standard structures such as ISO 14000.
(2) Follow the same eight principles of quality management. The eight principles management principle is the basic and most general general law expressed in a highly generalized language based on summarizing the practical experience of quality management. It is the norm that the organization's managers must follow to achieve quality objectives for quality management. The ISO 9001:2000 standard has taken into account the eight basic principles of quality management as set out in ISO 9004:2000. Each of the terms of this pair of standards reflects the eight principles of quality management.
(3) Apply the same quality management system foundation and terminology. The basis of quality management is the specific application of eight quality management principles. For example, it emphasizes the purpose and significance of establishing quality policy, quality objectives, the value of documents and the evaluation of quality management system, and points out the quality management system and other management systems. And the relationship between the organization's excellent models. This pair of standards applies the same basis for quality management and uses the same terminology.
(4) Evaluate the quality management system through quality management system audit and management review, thereby improving the suitability, adequacy and effectiveness of the quality management system, and promoting the organization to improve the process as a means to achieve continuous improvement and achieve “continuous The basic purpose of customer satisfaction.
(5) The organizational relationship of the supply chain is unified as the supplier->organization->customer. This avoids the conceptual confusion caused by the inconsistent relationship between the ISO 9001:1994 and ISO 9004:1994 supply chains, and is also conducive to Systematic management of the supply chain.
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