Quality management systems—Guidelines for the application of GB/T 19001 in small businesses
Some standard content:
ICS 03. 120. 10
National Standardization Guiding Technical Documents of the People's Republic of China GB/Z19036-2009
Quality management systems-
Guidelines for the application of GB/T 19001 in small and medium-sized organizationsQuality management systems-
Guidelines for the application of GB/T 19001 in small and medium-sized organizations busimesses2009-09-30 Issued
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China National Standardization Administration
Anti-counterfeiting
2009-12-01 Implementation
0.2 Process-based quality management system model 1
Normative references
Terms and definitions
Quality management system
General requirements
Document requirements
Heqing Zhigui
Management commitment
5.2 Customer focus
5.3 Quality policy
Planning·
5.5 Responsibility, authority and communication
5.6 Management review·
6 Resource management·
Resource provision·
6.2 Human resources
6.3 Infrastructure and working environment·
?Product realization
7.1 Planning of product realization
7.2 Customer-related processes·
7.3 Design and development·
7.4 Procurement…．
Production and provision of services·
7. G Control of monitoring and measuring devices
8 Measurement, analysis and improvement
8. General principles·..
8.2 Monitoring and measurement
8.3 Control of nonconforming products-
8.4 Data analysis
References
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GB/Z 19036 -2009
G/Z19036—2009
This guidance technical document is formulated with reference to the IS0 booklet "Guidelines for the Application of ISO9001:2000 in Small Organizations" In order to improve the effectiveness of various organizations, especially small and medium-sized organizations in implementing the (G3/T19001 standard, this guidance technical document provides guidance on how to apply GB/T19001 to various organizations, especially small and medium-sized organizations. In order to facilitate the application of this guidance technical document, this guidance technical document contains GB/T190012000 Summer The solid line frame shows the relevant guidance for these requirements. This guidance technical document is for reference only. Suggestions and comments on this guidance technical document may be sent to the standardization administrative department of the State Council.
The guidance technical document was proposed and coordinated by the National Technical Committee for Standardization of Quality Management and Quality Assurance (SAC/TC151). This guidance technical document was drafted by the National Standardization Research Institute. The originating units of this guidance technical document are: China National Institute of Standardization, Huafu Certification Center Co., Ltd., China National Accreditation Service for Conformity Assessment, China Certification and Accreditation Service Association, China Electronic Quality Management Association, Beijing Zhaowei Electric (Group) Co., Ltd., China Building Materials Inspection and Certification Center, Jiangsu Dongqiang Yinfen Co., Ltd. The drafters of this guidance technical document: Li Renliang, Li Zhao, Li Zongban, Liang Xiaowen, Yang Zhiding, Zhang Xuefeng, Li Duanping, Ma Zhenlai, Chen Zihong.
G219036--2009
0.1 General
The adoption of a quality management system should be a strategic decision of the organization. "The design and implementation of an organization's quality management system is subject to various needs, specific standards, and the products provided. , the processes used, and the size and structure of the organization. The structure or documentation of the quality management system is not the purpose of this standard. The quality management system requirements specified in this standard are in addition to the product requirements. The "NOTE" is a guide to understanding and explaining the relevant requirements.
This standard can be used internally and externally (including certification bodies) to assess the ability of an organization to meet customer, legal and regulatory requirements and the organization's own requirements.
The development of this standard has taken into account the quality management principles specified in GB/T 19000 and GB/T 19004. 0.1 Overview
GB/T 19001 states that the quality management system requirements described in
are internationally recognized good practices for management of quality. For certification or registration, the quality management system can be evaluated. This is not mandatory, but customers can use this as a requirement for the organization.
One of the purposes of an organization to demonstrate its ability is to provide confidence to its customers and tell them that the organization is in good operating condition, which requires customer and relevant regulatory requirements. Showing the record of the organization's past performance can give potential customers full confidence in the organization's capabilities. The management method of the organization is not the only one. The GB/T19001 standard provides organizations with a good management method system that can be used for organizational operations. It clarifies the requirements of the system, but does not explain the methods to meet these requirements. Therefore, there is considerable freedom in meeting the requirements of the GB/T19001 standard. The actual business activities should establish their quality management system. The organization needs to give priority to improving the process and methods that meet the requirements. The organization should not rewrite all the existing quality system documents in order to meet the GB/T19001 standard. For small and medium-sized organizations, it is not only a matter of trade quantity, but also a matter of organizational business philosophy. For a small organization with only a few members, communication is often simpler and more direct: one member is responsible for a large number of functions and various types of work within the organization, while decision-making is limited to a few people, or even one person. This guidance technical document describes how the GB/T19001 standard is applied to small and medium-sized organizations. Some of the content also involves larger organizations, which is not always suitable for larger organizations. Organizations hope to get a good return on their time and efforts by improving business processes and products and services. Especially for managers of small and medium-sized organizations, the implementation of a quality management system is a matter that requires time, energy and money. Managers should pay attention to the establishment and implementation of a quality management system as much as they pay attention to other business. 0.2 Process approach
This standard encourages the use of a process approach in the establishment, implementation and improvement of the effectiveness of a quality management system, in order to meet customer needs and enhance customer satisfaction.
In order for an organization to operate effectively, it should identify and manage a number of interrelated activities. The activities that transform inputs into outputs through the use of resources and management are considered processes. Usually, the output of one process directly forms the input of the next process. The systematic application of processes within an organization, together with the identification and interaction of these processes and their management, can be called a "process approach".
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GB/Z 19036—2009
The advantage of the process approach is the continuous control of the links between individual processes in the system of processes and the combination and interaction of processes.
When the process force method is applied in the quality management system, the importance of the following aspects is emphasized! a) Understanding and meeting requirements;
b) The process needs to be considered from the perspective of value-added;) Obtaining results of process performance and effectiveness; d) Continuously improving the process based on objective measurement. The process-based quality management system model reflected in Figure 1 shows the process connections proposed in Chapters 4 to 8. This display reflects that the customer plays an important role in specifying input requirements. Customer satisfaction requires the evaluation of information about the customer's feelings about whether the organization has met their requirements. This model covers all requirements of this standard, but it does not reflect each process in detail.
Note: In addition, the method called \PDCA\ can be applied to all processes. PD: A model can be briefly described as follows: Plan: Establish the necessary process to provide the results according to the customer's requirements and the organization's policies; Implement: Implement the process; Check: Monitor and test the process and product according to the policy, objectives and product requirements, and report the results; Action: Take measures to improve the process. Continuous improvement of the quality management system, management responsibilities, resource management, increase and avoid activities, information flow, measurement, analysis and improvement. Figure 1 Process-based quality management system model 0.2 Process-based quality management system model Customer
The process-based quality management system model is a conceptual model (Figure 1 of GB/I1900), which is the key point of GB/I1900 standard and plays an important role in understanding the standard. Because the figure highlights the key processes that are inseparable from the standard, these processes may have already been carried out in the organization, but they have not been presented in this unique way before. The perspective adopted by this model is that all quality-related processes start and end with the customer. Therefore, this model is customer-driven. In the figure, the customer appears on the left and right sides, in most cases it is the same customer, but it can also be different customers. This model uses customer opinions and requirements as the input of the quality management system (the circle in the figure), and the input is converted into the planning of production and service and the requirements of products and services.
The main process of products and services is in the lower part of the figure, marked as "product realization". This box covers the organization's product realization and provision of htt
GB/Z 19036—2009
The various activities of service are put into the form of products or services as the output of the organization. This model emphasizes the importance of obtaining customer satisfaction information (the dotted arrow on the right points to the measurement, analysis and improvement part), and other measurements and evaluations become the main feedback of the organization's performance. These measurement systems are marked as "measurement, analysis and improvement" boxes. The "management responsibilities" section explains the importance of the role of managers in the quality management system. Managers need to understand the operation of the system through these information and data, and provide or adjust the necessary resources to maintain and improve the system. The model also points out the necessity of maintaining customer relationships in order to understand customer needs and meet them. Managers need to formulate policies and set goals. Objectives, based on which the correct planning must be carried out. Planning includes process identification and ensuring appropriate documentation, which is required to define the way the processes operate.
Ensure that there are sufficient resources to ensure the quality of products and services. Resources include working environment, equipment, raw materials and personnel. It is also necessary to ensure that personnel are trained so that they are capable of undertaking the assigned tasks. These are marked as "Resource Management" and are the boxes on the left, and data and analysis are the boxes on the right, marked as "Measurement, Analysis and Improvement". Suggestions for improving the quality management system can be made, as shown in the items in the boxes pointed by the arrows.
Continuous improvement of the quality management system
Objective... One major feature is to make greater use of feedback as a powerful management tool. It is a tool for shift operations. When the process needs attention, feedback is used as a means of monitoring to check and remind operators or managers to take measures to restore it to a positive state. Without such a mechanism, waste will increase and morale will be lost, both of which will affect the normal production of the organization. Potential opportunities for improvement should be identified. If it is proven that it does exist, then necessary measures should be taken to put it into practice. The process model in the figure is closely linked to continuous improvement, reflecting two mechanisms that can be used for improvement as part of the quality management system (referring to the arrows in the inner circle), including nonconforming product control, corrective actions and preventive measures. Review process active audit, self-assessment, management Management review, as well as monitoring and measurement, these processes can improve the quality management system and are critical to the entire quality management system.
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1 Scope
1.1 General
Quality Management System
Guide to the application of GB/19001 in small and medium-sized organizations This standard specifies the requirements for a quality management system for organizations that have the following needs: a) need to demonstrate their ability to consistently provide products that meet customer and applicable legal and regulatory requirements; B/Z19036—2009
b) enhance customer satisfaction through the effective application of the system, including a process for continual improvement of the system and ensuring compliance with customer and applicable legal and regulatory requirements.
Note: In this standard, the term "product" only applies to products intended for or required by customers. 1.2 Application
All requirements specified in this standard are generic and applicable to organizations of all types, sizes and providing different products. When certain requirements of this standard are not applicable due to the characteristics of the organization and its products, they may be considered for deletion. Unless the deletion is limited to those requirements in clause ? of this standard that do not affect the organization's ability or responsibility to provide products that meet customer and applicable statutory and regulatory requirements, no claim of conformity to this standard can be made. 1 Scope
This guidance technical document provides guidance for the application of GB/TJ9001 in small and medium-sized organizations and is also of guiding significance to large organizations. This guidance technical document does not set any requirements, nor does it add or change the requirements of GB/T19001. Clause 1.2 "Application" of the standard provides necessary flexibility. Only when the requirements in 1.2 are met can a claim of conformity to GB/T19001 be made. The standard stipulates that clause ? of the standard can be deleted. When the requirements in Chapter 7 are not applicable to the organization (neither the activities of the relevant clauses in Chapter 7 nor the activities responsible for the corresponding activities of these clauses are applicable to the products and services provided), the deletion of such requirements under this condition will not affect the quality of the products and services. The corresponding requirements in Chapter 7 of the standard cannot be deleted because of unwillingness to accept these requirements. The fact that these requirements have not been implemented in the past does not mean that these requirements are not applicable to the organization. If you do not understand a certain requirement, ask the following questions to understand what are the ideas and principles behind the requirement? What kind of problems can be prevented by meeting this requirement? Will meeting this requirement gain customer trust? If you are not responsible for this requirement, who is responsible? For example: If the organization does not design If the equipment is not used for measurement, then there is no need to calibrate as required (7.6). If there is no risk of damage to the equipment, then there is no need to perform 7.5.1. There may be situations where some items in Chapter 7 may contain content that can be deleted. For example, in clause 7.5.3 of the standard, traceability requirements can be considered as an exception, but the relevant identification requirements cannot be considered as an exception. Any requirements in Chapter 7 that affect the quality of products and services cannot be omitted. Exceptions to any requirement should be captured in the quality manual (see 1.2.2). 1
GB/7:19036— 2009
2 Cited standards
The clauses contained in the following standards become the clauses of this standard through reference in this standard. When this standard is published, all versions are valid. All standards will be revised. Parties using this standard should explore the possibility of using the latest versions of the following standards.
G3/T19000-2000 Fundamentals and Vocabulary of Quality Management Systems (idtISO9000:2000) 2 Normative referenced documents
The clauses in the following documents become the clauses of this guiding technical document through reference in this guiding technical document. For all cited documents with a date, all their amendments (excluding errata) or revised versions are not applicable to this guiding technical document. However, it is encouraged that the parties who reach an agreement based on this guidance technical document should use the latest versions of these documents. For any undated referenced documents, the latest versions shall apply to this guidance technical document. GB/T19000 Quality Management System: Basic Terms and Terms (GB/T19C00-2008, ISO9000.2005.IDT) G13/T19001 Quality Management System Requirements (G1/T19001--2008, ISO9001:20C8, 1I)T) GB/T19004 Quality Management System Performance Improvement Guide (GB/T190042000, il.IS09004:2000) 3 Terms and Definitions
This standard adopts GB/T 19000, the following terms used in this standard to describe the supply chain have been modified to reflect current usage: supplier → organization → customer
The term "organization" in this standard is used to replace the term "supplier" used in GB/T 19001-1994. The term "supplier" is used to replace the term "subcontractor".
The term "product" that appears in this standard may also refer to "service" 3 Terms and definitions
This guidance technical document adopts the terms and definitions in GB/T 19000 and the following explanations (but not definitions) 3.1 wwW.bzxz.Net
Product prorlaet
The result of the process
『GB/T 19000-2008, 3.4.2]
The term is generic and is used to describe:
Tangible products:
·Services,
·Design outputs;
Computer software:
Any form of commodity service that an organization can provide. The definition of "product\" includes "service". This technical guidance document uses the terms "product" and "service" to emphasize the content involved, especially the content about small and medium-sized organizations with service as the orientation. 2
合品合作伙伴网ht
Top management
Refers to the individual or group of people who supervise and control the organization at the highest level [GB/T 19000-—2008,3.2.7]
The term refers to the following persons:
Chief Executive Officer;
General Manager:
Chairman;
Chairman:
Managing Director:
----Executive Director;
-Single Owner;
Partner,
Managermanagement
GB/Z 19036---2009
This term is used in the following parentheses (according to the appropriate meaning of the context) to represent the people who exercise power, assume responsibility, make decisions and perform similar management functions in an organization. In this guidance technical document, this term refers to the following people: single owner;
\-…-partner;
executive director;
director;
general manager;
manager;
-——senior manager.
continuai impruvemcn
continuous improvement
a cyclic activity to enhance the ability to meet requirements LGB/T 19000---2008,3.2.13
This term is used to indicate how to find opportunities to improve any part of the established quality management system. The necessary resources are required to implement any expected changes. 3.5
Reviewreview
Activities carried out to determine the suitability, adequacy and effectiveness of the subject matter to meet the specified objectives. IGB/T 19000-2CG8,3. 8.7
The occasions where this term is applicable include management review, design and release review, product and customer requirements review and nonconformity review. In each occasion, it indicates the overall review of various activities related to the situation. 3.6
Audit
A systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are met
[GB/T 190002008,3.9,1]
This can be considered as a systematic check to find out whether the planned activities related to quality and the related results are consistent with the expected or planned ones.
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GB/Z 19036—2009
Nonconformity
Failure to meet requirements
\GB/T19000—2008,3.6.2
This term is used to describe any situation where the specified requirements are not met. This may be failure to meet customer requirements, problems with products or services: inadequate quality management system, or any other situation where something is not required or expected. 3.8
Objective evidence
Data supporting the existence or authenticity of something [GB/T 190002008,3.8.1
This term can be used for information that is proven to be true, which is based on facts and is obtained from experiments, observations, measurements or other methods. 3.9
Infrastructure
The system of facilities, equipment and services necessary for the operation of an organization [(G8/T 19000 2008,3.3.3]
This term covers the plant, equipment, facilities, etc. required for operations, such as buildings, transportation, information systems, communication systems and production equipment.
Work environmentwork environmentmcnt
The set of conditions in which work is performed
IGB/T 190002008.3.3.4
This term refers to environmental conditions in the workplace that can affect product quality (see example in 6.4), but does not imply that an environmental management system or an occupational health and safety management system should be implemented. 4 Quality management system
4.1 General requirements
The organization shall establish, document, implement and maintain a quality management system in accordance with the requirements of this International Standard and continually improve its effectiveness.
The organization shall:
Identify the processes needed for the quality management system and their application to the organization (see 1.2); a)
Determine the sequence and interaction of these processes; determine the criteria and methods needed to ensure the effective operation and control of these processes; d)
Ensure that the necessary resources and information are available to support the operation and monitoring of these processes; e)
Monitor, measure and analyse these processes and
Implement the necessary measures to achieve the planned results of these processes and continual improvement of these processes. The organization shall manage these processes in accordance with the requirements of this standard. For any outsourced processes that affect product conformity selected by the organization, the organization shall ensure that they are controlled: the control of such outsourced processes shall be identified in the quality management system. Note: The above-mentioned processes required for the quality management system shall include management activities, resource allocation, and processes related to product realization and measurement. htt
4 Quality Management System
4.1 General Requirements
Establish a Quality Management System
GB/719036—2009
This clause covers the requirements for an organization to establish a quality management system and carry out related activities. These activities are described in more detail in other parts of the CB/T19001 standard. In order to meet these requirements, the organization shall ensure that its quality management system has included the contents described from α) to 1. The detailed level of the process description depends on the complexity and stability of the process activities. Simple process activities may require simple explanations.
Complex processes require full explanation so that the organization's personnel can understand these activities, tasks and relationships and perform their duties effectively.
An important requirement is that when an organization outsources a process that affects the release of products and services, it needs to determine how to control the process. Even if a process is outsourced, the organization is still responsible for ensuring that the outsourced process complies with the contract signed between the customer and the organization. For example, if the organization is the main supplier of a project and the design is undertaken by...suppliers, the organization will need to determine how to ensure that the design produced by one supplier meets the technical specifications provided by the organization (or its customers). Examples of other outsourced processes include heat treatment, cleaning, galvanizing, painting, information technology and general maintenance. 4.2 Document requirements
4. 2. 1 General
The quality management system documents should include:
a) quality objectives and quality standards for components; b) quality manual;
c) documented procedures required by this standard; d) documents required by the organization to ensure the effective planning, operation and control of its processes; e) records required by this standard (4.2.1). Note 1: Where this standard mentions "documented procedures", it requires that the procedures be established, documented, implemented and maintained. Note 2: The amount and level of detail of the quality management system documents of an organization depends on: 1) the size of the organization and the type of activities; 2) the complexity of the processes and their analytical functions; 3) the capabilities of the personnel. Note 3: Documents may be in any form or type of media. 4.2 Document requirements 4.2.1 General 4.2.1 Documentation of the quality management system This clause describes what documents are required by the standard. "Documents" covers the different types of documents listed from a) to c). In item 1, the standard requires the organization to have specific documented procedures. ... A documented procedure is a procedure that exists in a reproducible form, such as the procedure controlled by 41.2.3. It should ensure that the requirements described in the following 6 activities are included in the documented procedure. 4.2.3
Document Control
Record Control
Department Audit
Nonconforming Product Control
Corrective Action
Preventive Action
Note: These are the only clauses that specifically require a documented procedure. The other procedures are completely determined by the organization. S
All Products
GB/Z19036—2009
Documents include the mandatory documented procedures and other documents required by the standard, such as specifications, records, etc. Item d) requires the organization to have the means of "effective planning, operation and control of the process", which can be documented or not. This depends on the organization. It is important that the workers of the organization have the information they need to complete the work, including: work methods, work procedures or work instructions: operating methods, operating instructions or operating procedures; production instructions; preferred supplier lists; technical specifications; drawings. The document should specify who does what, where to do it, when to do it, why to do it and how to do it. Documentation should not be a wish list of things that would happen in the operation, but should clearly and accurately reflect what actually happens. For example, there is no need to have a detailed document for "how to open a door"; simply putting "push" or "pull" on the door is sufficient. The organization should determine the level of detail of the document, which will depend largely on the skills required for the methods used, the training provided, and the level of management required. Excessive detail should be avoided as it will not necessarily give the organization better control over activities. If training ensures that everyone has the information they need to do their job correctly, the need for detailed documentation can be reduced. Existing documentation should be sufficient and should be easily accessible in the quality manual. Documentation types are in any reproducible form, ranging from separate formal Documents can be in the form of drawings or images, from standard documents to technical standards combined with drawings and equipment instruction manuals. Graphic formats, images or simple picture combinations can be particularly useful because visual aids usually convey more accurate information than long and tedious texts. The preparation of quality management elements and documents requires the maximum participation of the organization's personnel so that they can reflect actual work practices in detail. This work cannot be carried out in isolation. The earlier the relevant personnel are involved and the more employees are involved, the stronger their understanding, participation and sense of ownership will be. It is particularly important to note that it is not necessary to rewrite all existing quality system documents in order to meet the GB/T19001 standard. 4.2. 2 Quality manual
The organization shall prepare and maintain a quality manual which shall include:
a) the use of the quality management system, including details and justification of any omissions (see 1.2); b) documented procedures for the quality management system or references to them; and a description of the interactions between the processes of the quality management system. c
4.2.2 What the quality manual specifies
The organization may use the quality manual to provide a map or roadmap for its quality management system. In addition to the steps from a) to c) ) requirements are included, and the following can be added:
Organization's business activities:
Main features of the quality management system:
Quality policy and related quality objectives;
Description of responsibilities and authorities;
Organization introduction, such as organizational chart;
-How the document is used and where to find related procedures:
Organization's special terms and definitions
If the content is not included in the quality manual, then the quality manual should indicate where to find it. 6
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