（1） The birth and development of quality management and quality assurance standards in European and American countries

The quality assurance standards were born from the military standards used in American military products. After World War II, the US Department of Defense learned from the experience and lessons of the quality of military products during the war and decided to implement quality assurance in the ordering of arms and military supplies. That is, the supplier not only guarantees the physical quality of the products according to the technical requirements proposed by the demand side, but also controls the quality according to the quality assurance clauses proposed at the time of ordering and already included in the contract, and submits proof of quality control when submitting the goods. After several years of implementation, the US Department of Defense proposed two military quality assurance standards in 1959 based on the quality assurance clauses applied in previous orders. After trial implementation, they were upgraded to formal quality assurance standards in 1963. Good results have been achieved after implementation.

The successful experience of applying quality assurance standards for military products in the United States was first adopted in boilers and pressure vessels. The American Society of Mechanical Engineers (ASME) issued and implemented the ASME-III-NA4000 "Boiler and Pressure Vessel Quality Assurance" standard in 1971. The implementation of quality assurance standards for boilers and pressure vessels has significantly reduced the accident rate and achieved remarkable results,

In the 1970s, the US nuclear industry introduced and implemented quality assurance standards. In 1971, the American National Standards Institute (ANSI) drew on military quality assurance standards to develop and publish the national standard ANSI N45.2 "Regulations for Safety and Quality Assurance of Nuclear Power Plants", which later evolved into ANSI/ASME NQA-1-1983. The International Atomic Energy Agency learned from the experience of the United States and issued the IAEA50-C-QA "Nuclear Power Plant Safety and Quality Assurance Regulations" in 1978, which was recognized by advanced industrial countries around the world. It includes 13 articles, commonly known as the "Thirteen Articles". Regulations play an important role in ensuring the safety of the nuclear industry.

Due to the convincing results achieved by the adoption and implementation of quality assurance standards in US military products, boilers and pressure vessels, as well as nuclear power plants, quality assurance standards have been referenced in civilian product ordering since 1978. The UK has established a set of three levels of quality assurance standards. Namely BS5750: Part1、Part2、Part3。 Canada has developed a set of four levels of quality assurance standards CSAZ299.1-299.4. In addition, countries such as France, Norway, the Netherlands, Switzerland, and Australia have also established quality assurance standards.

Quality management standards were born to adapt to the implementation of quality assurance standards. Many European and American countries have formulated quality management standards and implementation rules based on years of quality management practice, in order to adapt to the new requirements of quality assurance standards for both supply and demand sides. The implementation of quality management standards and regulations ensures the implementation of quality assurance standards.

（2） The birth and development of ISO quality management and quality assurance standards

Introduction to ISO/TC176 Technical Committee

ISO stands for International Organization for Standardization, representing the International Organization for Standardization. It was founded in 1947 as a non-governmental organization and currently has over 100 member countries. ISO/TC176 Technical Committee is one of the technical committees under ISO, with the full name of "Technical Committee on Quality Management and Quality Assurance", and its secretariat is Canada.

ISO/TC176 Technical Committee was established by ISO in 1979 on the basis of the second working group of the original ISO Certification Committee (ISO/CERTCO/WG2) to adapt to the need for quality assurance practices in the ordering of civilian goods in international trade. The committee has over 50 countries including the United Kingdom, the United States, France, Canada, West Germany, South Africa, Switzerland, Norway, Japan, and China, participating in its work and activities as "P" member states (formal member states); There are 16 "O" member countries (observation member countries) and they are constantly developing and increasing. At present, there are three sub technical committees and 12 working groups.

The SC1 Technical Committee is responsible for formulating terminology standards, with France as the Secretariat; The SC2 Technical Committee is responsible for formulating the "Quality System Standards" and has two working groups responsible for quality management and quality assurance standards, with the United States and the United Kingdom serving as the secretaries of the two working groups. The SC3 Technical Committee is responsible for formulating quality and technical standards.

The birth and development of ISO quality management and quality assurance standards

(1) Evolution of Quality Terminology Standard - ISO8402

ISO/TC176's SC1 Technical Committee, starting from October 1981, officially released the ISO 8402-1986 "Quality - Terminology" standard on June 15, 1986, based on the summary and reference of relevant national standards and practical experience around the world, through extensive consultation. This standard includes 22 terms. With the development of quality management in various countries around the world, new problems have emerged in practice, and higher requirements have been put forward for quality terminology. To this end, the SC1 Technical Committee approved the ISO 8402-1994 "Quality Management and Quality Assurance - Terminology" standard after review by the committee in 1994. This standard includes four parts of terminology, including 13 basic terms, 19 quality related terms, 16 quality system related terms, and 19 tool and technology related terms, totaling 67 terms.

(2) The birth and development of ISO9000 quality management and quality assurance standards

The SC2 Technical Committee of ISO/TC176, after hard work, released the ISO9000 series of quality management and quality assurance standards in 1987. This series of standards is the main standard in quality management and quality assurance standards, including three categories of five standards: "standard selection, quality assurance, and quality management". The birth of these five standards is a new era in quality management and quality assurance work worldwide, which has played a good role in promoting quality management and quality assurance for industrial enterprises and supply and demand sides around the world, and promoting international trade exchanges.

In recent years, with the needs of international trade development and problems arising in the implementation of standards, a comprehensive revision of the series of standards was carried out in 1994, and it was officially released and implemented on July 1 of that year. Subsequently, the development of standards progressed rapidly, with ISO9000 standards evolving into ISO9000-1, ISO9000-2, ISO9000-3, and ISO9000-4; ISO9004 has developed into standards such as ISO9004-1, ISO9004-2, ISO9004-3, and ISO9004-4.

On December 15, 2000, ISO/TC176 officially released a new version of the ISO9000 family of standards, collectively known as the 2000 version of the 9000 family of standards. The revision of this standard fully considers the usage experience of the 1987 and 1994 versions of the standards, as well as other existing management system standards. Therefore, the 2000 version of the 9000 family standards will make the quality management system more suitable for the needs of the organization and can better meet the needs of the organization to carry out its business activities.

(3) The development of technical standards for quality management and quality assurance (ISO10000 series standards): Technical Committee SC3 of ISO/TC176, after several years of hard work, has formulated and released more than ten standards since 1990, ranging from ISO10005 quality plan to ISO10016 inspection and test records standards.

ISO quality management and quality assurance standards, after more than a decade of development, currently have more than 20 standards in the three series of ISO8000, ISO9000, and ISO10000, known as the "quality management and quality assurance family standards". More than 70 countries in the world have directly adopted or equivalently converted to national standards without omission; More than 50 countries have established quality system certification/registration institutions, forming a global trend of standardization and certification.