Quality management and quality assurance STANDARDs—Part 1: Guidelines for selection and use
Some standard content:
GB/T 19000. 1—1994
This standard is equivalent to IS09000-1: 1994 Quality Management and Quality Assurance Standards Part 1: Selection and Use Guide, replacing GB/T 19000—92—ISO 9000: 1987. This standard directly uses the term "IS9000 family" because it has a special definition. However, in China, "IS9000 family" and "GB/T19000 family" are synonymous. The GB/T19000 family refers to all national standards converted from the ISO90 family international standards according to the principle of equivalence under the jurisdiction of the National Technical Committee for Quality Management and Quality Assurance Standardization (CSBTS/TC151). Appendix A of this standard is the appendix of the standard;
The appendix, appendix (.Appendix), and appendix F of this standard are all indicative appendices. This standard was proposed and approved by the National Technical Committee for Quality Management and Quality Assurance Standardization CSBTS/TC151. This standard was drafted by the Quality System Technical Committee of the National Technical Committee for Quality Management and Quality Assurance of Standardization of CSBTS/TC151/SC2.
The drafters of this standard are: China Academy of Mechanical Science, China Institute of Standardization and Information Classification and Coding, Renmin University of China, 708 Institute of China Aerospace Industry Corporation, China National Tobacco Industry Corporation. The main contributors to this standard are: Gan Hongzhang, Li Renliang, Yang Wenshi, Zhang Zhizhen, Zhou Yunsheng, Xu Yougang, An Qianhao. GB/T19000.1—1994
ISO Foreword
ISO (International Organization for Standardization) is a worldwide federation of national standardization bodies (ISO member bodies). The work of formulating international standards is usually done by ISO technical committees. If each member body is interested in a specific project of a technical committee, it has the right to participate in the work of that committee. International organizations (official or unofficial) that maintain relations with ISO may also participate in the relevant work. In the field of electrotechnical standardization, ISO maintains a close cooperative relationship with the International Electrotechnical Commission (IF). : The international standard draft adopted by the technical committee is submitted to the member groups for voting. It needs to obtain the consent of at least 100 voting member groups before it can be officially published as an international standard. International Standard ISO 9000-1 was developed by the Quality Systems Subcommittee of the ISO Technical Committee on Quality Management and Quality Assurance, H[ISO]/TC176/SC2. The first edition (first edition) of ISO 9000-1 replaced ISO 9000U:1987. ISO/IC176 adopted the ISO 9000 series revision strategy first published in 1987 in 1990, which was the first revision. This part of ISO 9000, which has a roadmap function, has made significant progress. The general title of IS000 is the quality management and quality assurance standard, and it consists of the following parts: Part 1: Guide to selection and use
Part 2: Guide to the implementation of IS009001, IS09002 and IS09003 Part 3: Guide to the application of IS009001 in software development, application and maintenance Part 4: Guide to reliability management program
Appendix A is an integral part of IS0001, and Appendices B, C, D and E are for reference: GB/T 190001-1994
Every organization - industrial, commercial or government - hopes to provide products that meet the needs or requirements of customers. The increase in individual competition has led to higher and higher expectations of customers for quality. In order to compete and maintain good economic benefits, organizations/suppliers need to use more effective systems. Such systems should lead to continuous quality improvement and continuously improve the satisfaction of customers and other beneficiaries of the organization (employees, owners, suppliers, and society).
Customer requirements are usually reflected in "specifications". If the organizational system that provides and supports products is not perfect, then the specifications themselves may not always meet customer requirements. Therefore, this concern has led to the creation of quality system standards and guidelines as a supplement to the product requirements in technical specifications. The S00 family of standards is used to provide a common quality system standard core, applicable to a wide range of industries. Industry and economic sector 7).
The management approach of an organization is influenced by the organization's objectives, products and specific practices, and therefore the quality management system of each organization is different. The key to quality management is to integrate systems and processes to achieve continuous improvement of the quality base. This standard has been significantly expanded as a roadmap for the ISO 9000 family: in particular, this standard includes guiding concepts that were not included in the 1987 edition. These concepts are firstly based on the need for effective understanding and current application of the ISO 9000 family; and secondly, they are prepared to be fully integrated with the structure and content of future revisions of the ISO 9000 family. In the ISO 9000 family, the ISO 9000 family is the first revision of the ISO 9000 family. In the revisions of the IS 50 family, the structure of IS 5001, IS 5002, IS 5003 and IS 5004 has not changed significantly (however, compared with the 1987 version, IS 5003 has added this clause). Each of these international standards has been revised on a small scale. These changes are intended for future revisions to better meet the requirements of use. This standard and all other standards in the IS 50 family are not bound by a specific industry or economic sector. They provide guidance for quality management and provide general quality requirements for quality assurance. The IS 5000 family of standards summarizes what the factory quality system should include, rather than describing a specific group. How to implement these elements. Mandatory uniformity of quality systems is not enough for these standards. The needs of organizations vary. The design and implementation of quality systems must of course be based on an understanding of the organization's objectives, products and processes and the impact on their specific practices. This standard specifies the basic concepts related to quality contained in the international standards for quality management and quality assurance developed by ISO/TC 176 and provides guidance for the selection and use of these standards. 1 Specification
This standard is a national standard of the People's Republic of China
Quality management and quality assurance standards
Part 1: Guidance for selection and use
Qualily Management and quality assurance standards-Part 1; Guidelines for selection and use CB/T 19000.1—1994
IDT1SO 9000-1:1994
Replaces CB/T 19000—92
) Identifies the basic concepts related to quality and the differences, references and connections between these concepts:) Provides guidance for the selection and use of ISC) 9000 family quality management and quality assurance standards. 2 Referenced standards
The clauses contained in the following standards constitute the clauses of the standards through reference in the standards. When this standard was published, the versions shown were valid. All standards will be revised. All parties using this standard should explore the possibility of using the latest versions of the following standards: GB/T6583-1991 Quality Management and Quality Assurance Terminology Idt IS08402-1991)3 Definitions
GB/T 19000-IS09000, GB/T 19001--IS09001. GR/T19002-IS9002, GB/T19003.IS)9003 and GB/T19004--ISO9004 This revision further coordinates the term "organization" in the supply chain. Table 1 lists the supply chain terms used in these standards. The usage of all these terms follows the open definitions given in GR/I6583-ISO8402. The differences in terminology shown in Table 1 also reflect, to some extent, historical continuity with the usage in the 1987 versions of these International Standards. Notes: 1 In all these standards, rather than being described in the form of guidance or requirements, the role of the organization is considered to be that of providing the product (column 3 of the table). 2 The use of the term "supplier" in line B/T 19000.1 IS0 9000C-1 in Table 1 is in contrast to the use of the term "supplier" to emphasize the supply chain relationship between two organizational units. When appropriate, especially in the context of quality management, the term "organization" is preferred to "supplier": 31 CR/T 19001--IS0 9001, CB/T 19002--[S0 9302. GB/T 19003--{S0 The use of the term "subcontractor" in 9003 reflects the situation where the relationship within the scope of external quality assurance is based on a (explicit or implicit) cooperative relationship (I/19004.1 [50]) 9001-! The use of the term "organization" in 9001-! reflects the situation where the quality management guidelines can be applied to any organization regardless of the type of product provided.It can be an independent unit or part of a larger organization. This standard uses the definitions given in GB/16583-ISO8402 and the following definitions. Note 5: In order to facilitate the use of this standard, some relevant rules selected from GB/TG583-IS084021 are included in Appendix A (Appendix to the standard). National Technical Supervision Approved on December 24, 1994
Implementation on June 30, 1995
GB/T 19000. 1--ISU 9000 1
GH/T 19001--I50 9101
1/1 19002 1S0 9002
R/) 190031S0 9001
GR/T 19004.1 ISO 9001-1
3.1 Hardwarehardware
GB/T 19000. 11994
Table 1 Relationship of organizations in the supply chain
Sub-supplier
Subcontractor
Subcontractor
A separable tangible product with a specific shape. Note 6 Hardware generally consists of manufactured, constructed or assembled parts, components and/or assemblies. 3.2 Softwaresoftware
A kind of knowledge product composed of information expressed by a carrier medium.
7 Software can be represented in the form of concepts, ideas or programs. 8 A stand-alone program is a specific instance of software. 3.3 Process materialprocessed materialA tangible product formed by converting raw materials into a predetermined state. Note 9 The state of a flow material can be liquid, gas, granular material, block, wire or plate. 10 Process materials are delivered in the form of barrels, bags, barrels, bottles, tubes, pipes or rolls. 3.4 Industry/economie sector Suppliers or organizations A collection of suppliers whose products meet the needs of similar customers and/or whose customers have close mutual relations in the market.
11 The terms "industry" and "economic sector" are used together to take into account that each term has a clear meaning in a specific country or language. 12 Industries or economic sectors include administration, aviation, finance, chemicals, construction, education, food, health care, entertainment, insurance, mining, retail communications, textiles, tourism, etc.
13 Industry or economic sector refers to the global economy or the economic sector of a country. 3.5 Stakeholders Individuals or groups of people who have a common interest in the performance of the supplier organization and the operating environment of the supplier organization. 3.6 IS0 9000 family IS0 9000 family are all international standards developed by ISO/TC176 Technical Committee. Note 1: Foreword, IS 9000 family includes:
) All international standards from 1S9000 to TS9001, including the sub-standards of 1509001 and 1S9004; h) All international standards from 1S140(21 to 10020, including the sub-standards: 2S8402.
4 Basic concepts
4.1 Main quality standards and quality responsibilities
An organization should:
a) achieve, maintain and seek to continuously improve the quality of its products in accordance with quality requirements; b) improve the quality of its own work to continuously meet the explicit and implicit needs of all customers and other stakeholders; ) provide confidence to its internal management and other employees that quality requirements are being achieved and maintained and that customer improvements are being implemented:
GB/T 19000.1 1994
d) provide confidence to customers and other stakeholders that the required requirements are being or will be met in the delivered product, and e) provide confidence that the quality system requirements are being met. 4.2 Stakeholder contexts
An organization that is a supplier has several basic characteristics; its customers, its employees, its owners, its sub-suppliers and its relationships, and
supply requirements and expectations: Supplier stakeholders
Ownerships
Supply practices
Typical expectations or needs||tt ||Product quality
Job income/satisfaction
Investment benefits
Opportunity to continue operating
Responsible social service
ISO00 family standards have been providing customers with data and zero demand for years. As one of the five beneficiaries, its requirements are becoming more and more stringent worldwide. In addition, the expected profit needs are becoming more and more certain. The issues to be considered are: health and safety in the workplace: environmental protection (including the protection of energy and natural resources) and social security. Considering the family standards, it is difficult to meet the quality requirements. Management systems provide a widely used approach, and these management principles are also useful for other issues of concern to society: management systems strive to promote the effectiveness of an organization in these different areas. We should also recognize that product and process specifications are different from management system requirements, so separate specifications should be prepared for these areas.
4-3 The distinction between quality system requirements and product requirements The IS0000 family of standards distinguishes between quality system requirements and product requirements. This distinction allows the IS9000 family of standards to provide a variety of General product categories are organizations and all quality characteristics of products. The associated requirements are supplementary to the product technical requirements. The applicable product technical specifications (such as those specified in the product specifications) are distinguishable and different from the requirements of the applicable S family standards. Both S family standards, guidelines and requirements are supported in accordance with the full quality plan. These standards do not specify how to achieve this standard - but leave this choice to the organization. 4.4 General product categories It is useful to divide it into four general product categories! See Appendix 8 of Chapter 3 (Appendix to the standard). The four categories are: a) hardware; b) software; c) process materials +; and c) services. These four product categories cover all types of products provided by the organization. The ISO 9000 family of standards applies to all four general product categories. For all product categories, the quality system requirements are the same, but the details and emphasis of the management system vary.
Any group! Regardless of the industry or economic sector (see Chapter 3), the products provided on the market usually have one or more general product categories: for example, most organizations that provide hardware, software or flow materials will also provide a certain level of service. Customers (and other beneficiaries) will seek value from each of the general products provided. Taking analytical instruments as an example, hardware (instruments), software (calculation work performed around the test), process materials (such as titration solutions or catalysts), and services (such as training or maintenance) may all be important characteristics of the supply. A service organization such as a restaurant has a service component, as well as hardware, software and flow materials. 4.5 Several aspects of quality assurance
GB/T 19000.1 1994
The four main aspects that have an impact on product quality can be summarized as follows: a) Quality related to determining product needswww.bzxz.net
Quality related to determining and continuously improving products is the first aspect. b) Quality related to product design
Quality related to designing features into products is the second aspect. To be more precise, quality related to product design refers to product design features that affect expected performance within a specified level, and product design features that affect the overall performance (robustness) of products under different production and use conditions.) Quality related to the conformity of product design Quality related to the ability to consistently conform to the product design and to provide the designed features and value to customers and other stakeholders is the first aspect.
d) Quality related to product assurance
Quality related to providing product assurance as required during the product life cycle in order to provide the designed features and value to customers and other stakeholders is the fourth aspect.
For some products, important quality characteristics include reproducibility. Dependability (i.e. reliability, maintainability, and reproducibility) may be affected by all four aspects of product quality. The goal of the ISO9000 family of guidelines and requirement standards is to meet the needs of all four aspects of product quality. Some aspects of quality may be Particularly important, for example in contractual situations, but, in general, all aspects have an impact on product quality. In terms of a), b), c), and d), the 15(a) 9000 family clearly provides general quality management guidelines and requirements for external quality assurance. When considering the entire product supply, the customer will carefully consider other factors, including: - The supplier's market position and strategy. If the supplier has a stable and reputable market position and/or strategy and is achieving satisfactory market share, then the customer is likely to place a higher value on the supplier's supplies. - The supplier's financial situation and strategy. If the supplier has a stable and reputable financial situation and/or strategy and is improving its financial situation, then the customer is likely to place a higher value on the supplier's supplies. The customer may place a higher value on the finished product if the supplier has a stable and reputable talent pool and/or strategy, and is developing better skills, doing more work and making promises in terms of talent pool.
This additional factor is important when managing the supplier organization as a complete enterprise (not a business). NOTE 15: Product value includes both quality and price. Therefore, price is not the only aspect of quality. 4.6 The concept of process
The IS(R) 9000 family of standards is based on the recognition that all work is done through processes (see Figure 1). Processes are people. Outputs are the result of processes. Outputs are tangible and intangible products: Processes are (or should be) a value-added transformation. Each process involves people and/or other resources in a variety of ways. · An output may be, for example: an invoice, computer software, liquid fuel, a medical device, a banking service or any general purpose final or intermediate product. At the input end, there are opportunities for measurement at different points in the process and at the output end, as shown in Figure 2. There are several types of inputs and outputs: Type
Related to the product
(solid lines in Figure 2)
Related to information
(dashed lines in Figure 2)
Raw materials
Intermediate products
Final products
Product requirements
Information on product characteristics and status
Delivery of assurance functions
Feedback on product performance and needs
Measurement data obtained from samples
GB/T 19000.1:1994
Figure 2 shows the supply chain relationship between suppliers, suppliers and customers. As shown in Figure 2, in this supply chain tree, various inputs and outputs need to flow in different directions. It should be emphasized that the "product" here includes all four general product categories. The quality management of an organization is achieved through the management of various processes within the organization. Therefore, it is necessary to manage processes in two aspects: the structure and operation of the process itself through which products or information flow, and the quality of the products or information flowing within this structure. Input
A possible measurement point
The process of distribution and allocation
4.7 The process network of an organization
Increase and conversion
Including people and other resources
Figure 1 All work is completed through a process. Sugar people related to products
Product characteristics and status
Storage process
Computer hardware
Liquid materials
Medical equipment
Banking services
Intermediate products
Output related to products
The process of spraying
Product characteristics and status Figure 2 Process supply chain system with product flow and information flow Every organization exists to achieve value-added, which is accomplished through a process network. The structure of the network is usually not a simple sequential structure, but is generally quite complex. Within an organization, there are many functions to be performed, including production, product design, technical management, marketing, training, human resource management, strategic planning, delivery, settlement and maintenance. Most organizations are complex, so it is more important to emphasize the key processes, simplify and prioritize the processes for quality management. An organization needs to identify, organize and manage its process network and interfaces. The organization creates, improves and provides stable supply quality through the process network, which is the basis of a basic concept of the ISO000 family. All processes and their interfaces should be analyzed and continuously improved. When people have to manage several processes and their interrelationships, especially large processes involving several functions, some problems often arise. In order to clarify the interfaces, responsibilities and authorities, each process should be responsible for a specific person. It is particularly important to implement the quality of the manager's own process (such as strategic planning).
4.8 Relationship between quality system and process network
GB/T 19000.1—1994
"Quality-based system is composed of several elements", which is a common saying. Quality system is implemented through processes. Processes exist in functions and can cross functions. In order to make the quality system effective, the organization should determine and develop these processes and their corresponding responsibilities, authorities, procedures and resources in a coordinated and consistent manner. A system is not just the sum of processes. In order to make it effective, the quality system needs its constituent processes to be coordinated and compatible with each other and determine their interfaces. 4.9 Quality system evaluation
4.9.1 General
When evaluating the quality system, the following three basic questions must be raised for each process being evaluated:) Is the process determined? Is the process procedure properly documented? h) Is the process fully developed and implemented as required by the document? c) Is the process effective in providing the expected results? The comprehensive answer to the three questions of method, development and results will determine the evaluation results. The evaluation of the quality system can vary in scope and can include a variety of activities. 4.9.2 and 4.9.3 will discuss several methods of evaluation. 4.9.2 Management Review
Evaluating the status and suitability of the quality system, including the quality policy, based on the expected benefits is one of the important activities that the executive management of the supplier organization needs to carry out system development. Management evaluation should consider many additional factors beyond the requirements of GB/T19001-ISO9001, GB/T19002-ISO9002 or GB/719003-IS(9003). The results of internal and external audits are important sources of information. It is important that the results of management review should lead to improvements in the effectiveness and efficiency of the quality system. 4.9.3 Quality System Audits
Audits are an important element in evaluating the effectiveness of a quality system. Audits can be conducted by the organization itself (first party), its customers (second party) or on behalf of the customers or by an independent body (third party). First party or third party audits can provide a higher degree of objectivity from the customer's perspective.
First party internal quality audits can be conducted by members of the organization or by other personnel on behalf of the organization. Such audits provide information for effective management review and corrective, preventive or improvement measures. Second party quality audits can be conducted by the organization's customers or by other personnel on behalf of the customers where required by a contract or multiple contracts. Such audits provide confidence in the supplier. First party internal audits can be conducted by a competent certification body for certification or certification purposes, thus providing confidence to many potential customers. GB/T 19001-IS09001, GB/T 19002-IS09002 and GB/T 19003-IS09003 1 specify the basic requirements of the quality system. GB/T19021-IS010011 provides an audit guide. Note 16: First-party audits are often referred to as internal audits, while second-party and third-party quality audits are often referred to as external quality audits. 5. Role of documents
5.1 The value of documents
In the content of the [S09000 family, the preparation and use of documents are dynamic and high value-added activities. Appropriate documents are essential for the following key tasks:
- Achieve the required (product quality):
- Evaluate the quality system:
- Quality improvement:
- Improvement maintenance.
5.2 Documentation and evaluation of the quality system
For CNNC, procedure documents are objective evidence of the following aspects: - The process has been determined; - The procedure has been approved; - The procedure is under change control.
GB/T 19000.1-1994
Only in this case can internal or external audits provide a meaningful evaluation of the suitability of both deployment and implementation. 5.3 Documentation is a support for quality policy
Documentation is important for quality improvement. When procedures are documented, deployed and implemented, it is possible to determine how to do current work and measure current performance. At the same time, it also enhances the reliable measurement of the effectiveness of the improvement. In addition, documented standard work procedures are also essential to maintain the results of quality improvement measures. 5. 4 Documentation and training
Maintaining the coordination of the procedures being developed and implemented depends on the organic combination of documents and the skills and training of the personnel. In any case, the degree of detail of the documents should be adapted to the degree of skills and training so that the documents are maintained at a reasonable level and can be maintained for an appropriate period of time. This necessary balance should be considered when conducting quality system audits. 6 Quality system situations
The IS09000 family is applicable to four situations:
a) Guidelines for quality management:
b) Contract situation, between the third party and the second party:) Second party recognition or registration:
d) Third party certification or registration.
The supplier organization shall establish and maintain a quality system. The quality system shall be designed to cover all situations a), h), c) and d) faced by the organization.
For situation b), this quality system will enhance its own competitiveness in order to achieve product quality requirements in a cost-effective manner. For situation b), the customer may be concerned about certain elements of the supplier's quality system that affect the supplier's ability to consistently produce products as required and to account for the corresponding risks. Therefore, the plan requires certain quality system elements and processes in the contract, if appropriate, to become part of the supplier's quality system by specifying a specific quality assurance model. For situation i), the supplier's quality system is assessed by the customer. The customer may make a formal determination of conformity to the standard. For situation ii), the supplier's quality system is evaluated by a certification body and the supplier agrees to maintain its quality system for all customers unless otherwise specified in the contract. This quality system certification or registration can often reduce the number and/or scope of quality system assessments by customers.
Suppliers are often in various situations at the same time. A supplier may purchase certain materials or components under a standard product catalogue without mentioning quality system requirements in the contract, or purchase other products with matching quality system requirements. A supplier may sell certain products under non-contractual circumstances, with or without quality system certification required by the customer, or under contract for other products. Suppliers may choose to use the IS09000 family in one of two ways, which may be referred to as "manager driven" and "stakeholder driven". In either case, the supplier should first study the schematics of this standard, the IS09000 family, in order to understand the basic concepts and the types of standards to which the IS09000 family applies.
Stakeholder driven is a popular practice in many countries and industries or sectors of the economy. The widespread use of quality system certification/registration is a factor in this approach.
For the benefit-driven approach, the supplier should first implement a quality system based on the direct requirements of customers or other stakeholders. The selected quality system should meet the requirements of an appropriate standard in GB/T19001-ISO9001, GB13/19002, GB15/19002, or GB/T19003-ISO9003. In this approach, supplier managers must play a clear leadership role, but their work should be driven by external benefit considerations. Usually, suppliers will find that product quality, cost and internal operating results have been significantly improved. At the same time or later, the supplier will also carry out quality management work to achieve further improvement and build a more comprehensive quality-based system with the selected quality assurance model as the core structure. In the manager-driven approach, the supplier's own managers should actively carry out this work to measure emerging market needs and trends. In this approach, the first thing to do is to use GB/T19004.1--IS090041 (and other applicable sub-standards of GB/T1D004--IS09001) to provide guidance for the quality management methods required to establish a quality system, so as to improve the supplier's quality. In this way, in any GB/T 19000.1 1994
Before customer requirements, as a preparatory measure, certification should be obtained as much as possible so that the supplier can use (G3/T19001-1S0)9001G13/T19002-IS9002 or G3/119003--IS09003 as a quality assurance model to verify the suitability of the quality system.
The quality system implemented in the management-driven approach is usually more comprehensive and effective than the model used to verify the suitability of the quality system.
7 Selection and use of quality standards
7.1 General|| tt||In order to develop quality management, organizations should use the IS0900 family of standards to establish, implement and improve their quality management systems in two ways: manager-driven and beneficiary-driven. The IS09000 family includes two types of guidance standards. GB/T19000-Some sub-standards of ISO9000 provide application guidance for quality assurance. GB/T10004-IS09004 sub-standards provide application guidance for quality management. These sub-standards of GB/T10004-IS09004 are not used to illustrate the requirements of quality assurance standards, but they can provide useful references. Similarly, the 10 series of international standards can also be used as a reference. Throughout the ISO 9000 family, the focus is on meeting customer needs, determining customer responsibilities, and paying attention to the evaluation of potential risks and benefits (as much as possible). All these aspects should be considered when establishing and maintaining an effective quality system and continuously improving the quality system. Special attention should be paid to GB/T 19004.1-IS05001, which: - Standard describes the quality management of any product (see 7.9). It is applicable to all general product categories and various industrial industries or economic sectors. When using GB/T 19004.1-ISO 9004-1. - Suppliers should follow The specific situation determines the applicable starting point of each quality system element and the applicable extent of its application technology: The corresponding sub-standards of the IS09000 family will provide advanced guidance. In order to enable organizations to select appropriate standards from the IS0900 core family: Sections 7.2 to 7.16 provide guidance to provide useful information for the implementation of quality control efficiency:
7.2 Selection and use
GB/T19000.1—IS090 quality management and quality assurance standards Part 1: Selection and use guidance Any organization that is planning to establish and implement a quality system should refer to GB/11900U.1-1S0)9000-1, the global competition has led to higher and higher quality expectations from customers. In order to be competitive and maintain good economic benefits, organizations and suppliers need to adopt more effective and efficient systems. To this end, GB/190001-S9000-1 clarifies the basic concepts of quality control and provides a guide for the selection and use of the ISO)000 family.
7.3 Implementation Guide
GH/T19000.2—IS09000-2 Quality Management and Quality Assurance Standard Part 1: GB/T19001
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