1. What is ISO
ISO is the English abbreviation of an organization. Its full name is International Organization for Standardization, translated into Chinese is "International Organization for Standardization". Also known as the "Economic United Nations" (more than 120 current member states).
ISO is a non-governmental international scientific and technological organization, and it is the world's largest and most authoritative organization for formulating and revising international standards. It was established on February 23, 1947. The highest authority of ISO is the annual "General Assembly", and its daily office is the Central Secretariat, located in Geneva, Switzerland.
ISO declares that its purpose is to "develop international standards, promote global consistency of standards, and promote cooperation in international trade and science and technology."
ISO currently has 120 members in countries and regions.
 

2. What is ISO9000
ISO standards are formulated by the Technical Committee (TECHNICAL COMMITTEES for short TC). ISO has more than 200 technical committees and more than 2,200 sub-technical committees (referred to as SC).
ISO9000 refers to the quality management system standard. It does not refer to a standard, but a general term for a family of standards. ISO9000 is all international standards formulated by TC17 (TC176 refers to the Technical Committee of Quality Management System). ISO9000 is the best-selling and most popular product among more than 12,000 standards issued by ISO.
 

Three, what is certification
The original meaning of the word "certification" in English is an act of issuing certification documents. The definition of "certification" in ISO/IEC Guide 2: 1986 is: "The activity of a third party that can be fully trusted to verify that an authenticated product or service conforms to a specific standard or normative document."
For example, for the products or services provided by the first party (supplier or seller), the second party (demand or buyer) cannot determine whether the quality is qualified or not, but the third party will make the determination. The third party is responsible for both the first party and the second party. It is impartial, and the certificate issued must be able to gain the trust of both parties. Such an activity is called "authentication."
This means that third-party certification activities must be open, fair, and fair in order to be effective. This requires that the third party must have absolute power and prestige, must be independent of the first party and the second party, must have no economic interest relationship with the first party and the second party, or have the same interest, or Only with the obligation and responsibility to safeguard the rights and interests of both parties can we obtain the full trust of both parties.
 

Fourth, the origin of ISO9000
ISO9000 was developed by western quality assurance activities. During World War II, the demand for weapons for the expansion of the war skyrocketed, and American arms manufacturers failed to satisfy "all for war" due to the limitations of the size, technology, and personnel of the weapons manufacturing plants at that time. For this reason, the US Department of Defense is faced with the practical problem of doing everything possible to expand the production of weapons while at the same time ensuring quality. Analyze the enterprises at the time: most management is based on the foreman's experience management, directing production, and the technology is all in his head. However, the number of people managed by a foreman is very limited, and the output is of course limited, which is far from the demand for war. Therefore, the Ministry of National Defense organized technical personnel from large enterprises to compile technical standard documents, set up training courses, and conducted a large number of trainings for employees from other related original machinery factories (such as hardware, tools, and foundry factories) so that they could be able to do so in a short time. Learn to identify process drawings and process rules, master key technologies required for weapon manufacturing, and quickly "copy" "special technology" to other machinery factories, miraculously solving war problems effectively. After the war, the Ministry of National Defense summarized and enriched the valuable experience of "process documentation" and compiled more detailed standards to promote and apply them in factories across the country, and also achieved satisfactory results. At that time, the documentary style prevailed in the United States. Later, this experience of the US military industry was quickly adopted by the military industry departments of other industrialized countries, and gradually extended to civilian industries, and flourished in Western countries.
With the rapid development of the above-mentioned quality assurance activities, the certification bodies of various countries have gradually increased the content of auditing the quality assurance system of enterprises when conducting product quality certification, which has further promoted the development of quality assurance activities. In the late 1970s, BSI (British Standards Institute), a certification body in the United Kingdom, first launched the certification business of a separate quality assurance system. The quality assurance activities were developed from second-party audits to third-party certifications, which were welcomed by all parties. Promoted the rapid development of quality assurance activities.
Through three years of practice, BSI believes that the certification of this quality assurance system has a wide range of adaptability, great flexibility, and has the value of being promoted to the international community. As a result, a proposal was submitted to ISO in 1979. According to BSI's recommendation, ISO decided to establish a "Quality Assurance Committee" on the basis of the "Quality Assurance Working Group" of the ISO Certification Committee. In 1980, ISO formally approved the establishment of the "Quality Assurance Technical Committee" (ie TC176) to start this work, which led to the birth of the "ISO9000 family" standards, which improved the independent quality system certification system, and expanded the original The business scope of quality certification agencies, on the other hand, has led to the birth of a large number of new specialized quality system certification agencies.
Since the ISO9000 series standards came out in 1987, in order to strengthen quality management and meet the needs of quality competition, entrepreneurs have adopted ISO9000 series standards to establish a quality management system within the enterprise and apply for quality system certification, which soon formed a worldwide trend. . At present, more than 100 countries and regions around the world are actively implementing the ISO9000 international standard.

V. Significance of implementing the ISO9000 standard
The ISO9000 standard is a scientific summary of the practical experience of quality management in many developed countries in the world. It has applicability and guidance. It can promote the improvement and perfection of the organization's quality management system, and has a good effect on promoting international trade activities and improving the level of organization management.
5.1 Conducive to improving product quality and protecting the interests of consumers.
The establishment of a quality system in accordance with the requirements of the ISO9000 standard, through effective operation, promotes the continuous improvement of products and process control by enterprises, and realizes the stability and improvement of product quality. It is undoubtedly the most effective protection for consumers’ interests, and it also increases consumers’ Trust.
5.2 Provide effective methods to improve the organization's operational capabilities.
The ISO9000 standard encourages organizations to develop and implement a quality management system process method, through the identification and management of numerous interrelated activities, and systematic management and continuous monitoring of these activities, to achieve customer acceptable products.
In addition, the quality management system provides a framework for continuous improvement and increases related opportunities.
5.3 It is conducive to enhancing the actual cooperation of the organization
In international economic and technical cooperation, the ISO9000 family of standards is one of the basis for mutual recognition and overcoming non-tariff barriers. The ISO9000 certification system is mutually recognized internationally and incorporated into the conformity assessment procedure. The implementation of ISO9000 provides an international common language and norms for international economic and technological cooperation, and a weapon to enhance competitiveness.
5.4 Conducive to the organization's continuous improvement and meeting customer requirements
The needs and expectations of customers are constantly changing, which prompts companies to continuously improve products and processes. The establishment and implementation of a quality management system provides an effective way for organizations to improve their products and processes. The ISO9000 standard distinguishes the quality management system requirements from the product requirements. It is a supplement to product requirements, rather than replacing product requirements. This is conducive to the organization's continuous improvement and continuous satisfaction of customer needs and expectations.
6. What benefits will the implementation of ISO9001:2015 standard bring:
6.1 Through the establishment and implementation of a quality management system, as well as third-party certification, promote the management of the organization from the rule of people to the rule of law.
Quality policies, objectives, quality manuals, procedure documents, operating specifications, implementation records, and applicable laws and regulations are indispensable regulatory documents for the quality management system. Every member of the organization must implement them. The implementation process is a rule of law. Education, training and popularization.
6.2 Standardize the organization's systems and modern management systems related to quality management over the years, urging the organization to form an efficient management model, which is integrated and integrated with the standard requirements.
6.3 Adopt the "process method" to continuously monitor and control the interaction of multiple processes in the quality management system and their linkages and process combinations to achieve the effectiveness of the quality management system.
6.4 The most basic requirement of the quality management system is to ensure that the process activities that affect product quality are under control. The purpose of all control is to reduce and eliminate nonconformities, especially to prevent nonconformities. The "final inspection check" is transferred to the "prevention first" management philosophy to increase the first pass rate and reduce costs.
6.5 ISO9001:2015 is carried out according to four major processes (management responsibilities, resource management, product realization, monitoring and improvement), applying the P D C A method to continuously improve the quality management system, which leads to the continuous improvement of the organization and management level.
6.6 It is conducive to all employees participating in quality management, creating a strong corporate culture atmosphere, and achieving the goal of creating a first-class enterprise.
6.7 Facilitate the assignment and implementation of responsibilities and authorities, and avoid mutual prevarication.
6.8 Provide effective methods to effectively improve the operational capabilities of enterprises and enhance market competitiveness.
6.9 The ISO9001:2015 standard based on eight quality management principles helps managers systematically establish quality management theories, understand the connotation of standards, and improve management.
6.10 Obtain a market entry permit. (Access Pass)
Seven, why the industry should implement the ISO9001:2015 standard
With the development of regionalization, groupization, and globalization of the economy, market competition is becoming fierce, and customer expectations are getting higher and higher. In order to adapt to competition and maintain good economic benefits, every organization is trying to improve its own competitiveness to meet the needs of market competition. In order to successfully lead and operate an organization, it is necessary to adopt a systematic and transparent way of management, implement and maintain a management system for continuous improvement of its performance in response to all related needs, so as to make the enterprise successful.
The ISO9001:2015 standard summarizes the quality management experience of advanced enterprises in Western countries, and provides a scientific management model for all product categories, different scales and various types of organizations, and promotes the organization’s quality management, achieves its quality goals, and improves Product quality and customer satisfaction have had a positive impact. Since its inception, this standard has been adopted as a national standard by more than 150 countries and regions around the world, and is widely used in industry, economy and government management. How to achieve total quality management as soon as possible is a big and unsolved issue in front of all walks of life.
The implementation of the ISO9000 standard can be summarized as: what should be said (document compliance), what is said to be done (effectiveness), what is done must be recorded (providing verification), and seeking opportunities for improvement (continuous improvement ideas). Or it boils down to the "document → implementation → verification → improvement" process.
The purpose of various organizations for economic activities is to provide high-quality products to the society on the one hand, and to obtain the best benefits and create wealth for the society on the other hand. Therefore, the organization should implement the ISO9001:2015 standard and establish and maintain an effective quality management system.
8. Implement the basic process of ISO9001:2015 standard
Decision-making consultation—→publicity and launch—→standard training—→implementation organization—→distribution of functions—→document writing—→trial file—→audit training—→internal audit—→management review—→application for certification.