Some standard content:
GB/T 19001—2000
This standard adopts ISO 9001:2000 Quality Management System Requirements. This standard is one of the GB/T19000 family of standards. The "shall" in the standard indicates a requirement, and the "shoild" serves as a guide.
This standard has made technical revisions to GB/T19001—1994, GB/T19002—1994 and GB/T19003—1994. Therefore, when this standard is released, it replaces GB/T19001—3994, GB/T19002—1994 and GB/T19003-1994. Appendices A and B of this standard are informative appendices. This standard was proposed and assigned to the National Technical Committee for Standardization of Quality Management and Quality Assurance (CSBTS/TC151). This standard was drafted by the China Standardization Research Center. This standard was drafted by: China Standard Research Center, China National Accreditation Service for Conformity Assessment, CESI Certification Center, Shenzhen Quality Certification Center, China Import and Export Quality Certification Center, China Association for Standardization, Northwest Electric Power Design Institute of State Grid Corporation, Qingdao Haier Group. The main drafters of this standard are Li Renliang, Xiao Jianhua, Shi Weidong, Wan Juyong, Qu Xintian, Li Jie, Tian Wu, Chen Chuanjing, and Liu Jianzhong. GB/T19001—2000
ISO Foreword
The International Organization for Standardization (ISO) is a worldwide federation of national standardization bodies (ISO member bodies). The work of preparing international standards is usually done by ISO technical committees. Each member body has the right to participate in the work of a technical committee if it is interested in an item determined by the committee. International organizations (governmental or non-governmental) that maintain ties with ISO may also participate in the work. ISO maintains a close cooperative relationship with the International Electrotechnical Commission (IEC) in the field of electrotechnical standardization. International standards are drafted in accordance with the rules of Part 3 of the ISO/IEC Guidelines. Draft international standards adopted by the technical committee are circulated to the member bodies for voting. They can only be officially published as national standards if they are approved by at least 75% of the member bodies voting. Attention should be paid to the possibility that some of the contents of this standard may involve some patent rights issues. ISO is not responsible for identifying any such patent rights issues.
International Standard ISO 9001 was prepared by ISO/TC176/SC2 Quality Management and Quality Assurance Technical Committee, Subcommittee on Quality Systems. This third edition of ISO 9001 replaces the second edition of ISO 9001:1994, as well as ISO 9002:1994 and ISO 9003:1954, and includes technical revisions to these documents. Organizations that have already used ISO 9002:1994 and ISO 9003:1994 may continue to use this standard provided that certain requirements are reduced in accordance with the provisions of 1.2.
The name of this standard has changed, and there is no longer a "quality assurance" title. This reflects that the quality management system requirements specified in this standard, in addition to product quality assurance, also enhance customer satisfaction. Appendix A and Appendix B of this standard are only indicative appendices. GB/T190012000
0.1 General
The use of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is affected by various needs, specific goals, products provided, processes adopted, and the size and structure of the organization. It is not the purpose of this standard to unify the structure or documents of the quality management system.
Quality management system requirements specified in this standard It is a supplement to product requirements. "Note" is a guide to understand and explain the relevant requirements. This standard can be used internally and externally (including certification bodies to assess the ability of organizations to meet customer, legal and regulatory requirements and the organization itself. The formulation of this standard has taken into account the quality management principles set forth in GB/T19000 and GB/T1900411. 0.2 Process approach
This standard encourages the use of a process approach when establishing, implementing a quality management system and improving its effectiveness, in order to strengthen customer satisfaction by meeting customer requirements.
In order for an organization to operate effectively, it is necessary to identify and manage numerous interrelated activities. Through the use of resources and management, the activities that transform inputs into outputs can be considered processes. Usually, a process 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 referred to as the "process approach." The advantage of the process approach is the continuous exploration of the connections between individual processes in the system of processes, as well as the combination and interaction of processes. When applying the process approach to the quality management system, it emphasizes the importance of the following aspects: a) Understanding and meeting requirements; b) The need to consider processes from a value-added perspective; c) Obtaining results on process performance and effectiveness; d) Continuously improving processes based on objective measurements. 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 defining customer requirements. Monitoring of customer satisfaction requires evaluating information about the customer's perception of whether the organization has met their requirements. Although this model covers all the requirements of this standard, it does not reflect each process in detail. Note: In addition, the method called "PDCA" can be applied to all processes. The PDCA model can be briefly described as follows: P-Planning: Establish the necessary objectives and processes to provide results based on customer requirements and organizational policies. D: Implementation: Implement process +
C-Check: Monitor and measure processes and products according to policies, objectives and product requirements, and communicate the results A-Disposal: Take measures to continuously improve process performance. GB/T 19001—2000
Continuous improvement of the quality management system
Management qualifications
Resource management
Value-added activities
Information flow
Product quality
Measurement, analysis and improvement
Process-based quality management system model 0.3 Relationship with GB,T 19004
GB/T 19001 and GB/T 19004 have been formulated as a pair of coordinated quality management system standards. They complement each other but can also be used separately. Although the two standards have different scopes, they have similar structures to facilitate their application as a coordinated pair of standards:
GB/T 19001 specifies the requirements for quality management systems and can be used for internal use by organizations or for certification or contractual purposes. In terms of meeting customer requirements, GB/T 19001 focuses on the effectiveness of the quality management system. Compared with GB/T19001, GB/T19004 provides guidance for a wider range of objectives of quality management systems. In addition to effectiveness, this standard also pays special attention to the continuous improvement of the overall performance and efficiency of the organization. For those organizations whose top management hopes to go beyond the requirements of GB/T 19001 by pursuing continuous improvement, GB/T 19004 recommends guidelines. However, the content of GB/T 19004 is not the date of certification.
0.4 Compatibility with other management systems
For the benefit of users, this standard is promoted to converge with GB/T 24001-1996 to enhance the compatibility of the two types of standards. This standard does not include requirements for other management systems, such as specific requirements for environmental management, occupational health and safety management, financial management or risk management. However, the standard enables organizations to combine or integrate their own quality management system with relevant management system requirements, and organizations may change their existing management systems in order to establish a quality management system that meets the requirements of this standard. 1 Scope
1.1 General
National Standard of the People's Republic of China
Quality management system
Quality management systems-Requirements This standard specifies the requirements for a quality management system for organizations with the following needs GB/T19001-2000
idt IS0 9001:2000
Replaces GB/T19001-1994
GB/T 19002-1994
GB,T19003-—1994
Self) Demonstrate its ability to consistently provide products that meet customer and applicable statutory and regulatory requirements b) Enhance customer satisfaction through the effective application of the system, including a process for continuous improvement of the system and ensuring compliance with customer and applicable statutory and regulatory requirements.
Note: In this standard, the term "product" applies only to products intended to be provided to customers or required by customers. 1.2 For use
All requirements specified in this standard are generic and are intended to be applicable to organizations of all types and sizes and providing different products. When any requirement of this standard is not applicable due to the characteristics of the organization and its products, it may be considered to be reduced. Conformity to this standard cannot be claimed unless the exclusion is limited to those requirements in Clause 7 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. 2 Referenced standards
The following standards contain clauses that are incorporated into this standard by reference in this standard. The versions shown are valid at the time of publication of this standard. All standards are subject to revision. Parties using this standard should investigate the possibility of using the latest versions of the following standards: GB/T19000-2000 Quality Management System Fundamentals and Vocabulary (idtJS09000:2000) 3 Terms and definitions
This standard adopts the terms and definitions in GB/T S000. 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, and the term "supplier\ is used to replace the term "subcontractor".
The term "product" appearing in this standard may also refer to "service". 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 standard, and continually improve its effectiveness. The organization shall:
a) identify the processes required for the quality management system and their application to the organization (see 1.2); b) determine the sequence and relative role of these processes: National Quality and Technical Supervision Department 2000-12-28 Approved 2001-06-01 Implementation
GB/T19001·-2000
Center) determine the criteria and methods required to ensure the effective operation and control of these processes d) ensure that the necessary resources and confidence are available to support the operation of these processes and the monitoring of these processes; e) monitor, measure and analyze these processes1
f) implement the necessary actions to achieve the results of these processes and continuous 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 that the organization chooses, the organization shall ensure that they are controlled. The control of such outsourced processes shall be identified in the quality management system. The processes required by the quality management system mentioned above shall include those related to management activities, resource provision, product realization and performance. 4.2 Documentation requirements 4.2.1 General The quality management system documentation shall include: a) documented quality policy and quality objectives, b) quality records, c) documented procedures required by this International Standard, d) documents required by the organization to ensure the effective planning, operation and control of its processes, and c) records required by this International Standard (see 4.2.4). Note 1: Where the term "documented procedure" appears in this International Standard, it requires that the procedure be established, documented, implemented and maintained. Note 2: The length and degree of detail of the quality management system documentation for different organizations depends on: a) the size of the organization and the type of activities, h) the complexity of the processes and their interactions, and h) the competence of the personnel. Note 3: Documents may be in any form or type of media. 4.2.2 Quality Manual
The organization shall prepare and maintain a quality manual, which shall include: a) the scope of the quality management system, including details and justification for any exclusions (see 1.2); b) documented procedures for the quality management system, or reference to them; c) a description of the interactions between the quality management system processes. 4.2.3 Document Control
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled in accordance with the requirements of 1.2.4.
A documented procedure shall be established to specify the control required for: a) approval of documents before they are issued to ensure that they are adequate and appropriate; b) review and update documents as necessary and re-approval; c) ensuring that changes to documents and the current revision status are identified; d) ensuring that relevant versions of applicable documents are available at the point of use; e) ensuring that documents remain legible and easily identifiable; ensuring that documents of external origin are identified and their distribution is controlled; g) preventing the unintended use of obsolete documents and appropriately identifying them if they are retained for any reason. 4.2.4 Record Control
Records shall be established and maintained to provide evidence of conformity to requirements and the effective operation of the quality management system. Records shall be kept legible, easily identifiable and retrievable. A documented procedure shall be established to specify the control required for the identification, storage, protection, inspection, retention period and disposal of records. 5 Quality management is the key to success
5.1 Management commitment
GB/T 19001—2000
Top management should provide evidence of its commitment to establish, implement and continually improve the effectiveness of the quality management system through the following activities: a) communicate the importance of meeting customer and statutory and regulatory requirements to the organization; f) formulate a quality policy; c) ensure the establishment of quality objectives; d) conduct management reviews; e) ensure the availability of resources.
5.2 Customer focus
Top management should ensure that customer requirements are determined and met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1). 5.3 Quality Policy
Top management shall ensure that the quality policy:
a) is appropriate to the purpose of the organization;
b) includes a commitment to meet requirements and to continuing to improve the effectiveness of the quality management system;
c) provides a framework for setting and reviewing quality objectives;
d) is communicated and understood within the organization;
e) is reviewed for continuing suitability. 5.4 Planning
5.4.1 Quality objectives
Top management shall ensure that quality objectives are established at relevant functions and levels of the organization. Quality objectives include what is needed to meet product requirements [see 7.1], are measurable, and are consistent with the quality policy. 5.4.2 Quality management system planning
Top management shall ensure that:
a) the quality management system is planned to meet the quality objectives and the requirements of 4.1. b) the integrity of the quality management system is maintained when planning and implementing changes to the quality management system. 5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
The top management shall ensure that responsibilities and authorities are defined and communicated within the organization. 5.5.2 Management representative
The top management shall designate a replacement manager, regardless of his/her other responsibilities, who shall have the following responsibilities and authority:
) Ensure that the processes required for the quality management system are established, implemented and maintained; 5) Report to top management on the performance of the quality management system and any need for improvement; c) Ensure that awareness of customer requirements is promoted throughout the organization. NOTE: The joint responsibilities of the management representative may include external liaison on matters related to the quality management system. 5.5.3 Internal communication
Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place on the effectiveness of the quality management system. 5.6 Management review
5.6.1 General
The top management shall review the quality management system at planned intervals to ensure its continuing suitability, adequacy and effectiveness. The review shall include an assessment of opportunities for improvement and the need for changes to the management system, including the quality policy and quality objectives. Records of management reviews shall be maintained (see 4.2.4). 5.6.2 Review inputs
GB/T 19001
The input to the management review should include information on the following: a) audit results; b) customer feedback; c) performance of processes and product conformity; 8) status of preventive and corrective actions; f) changes that may affect the quality management system; g) suggestions for improvement.
5.6.3 Review output
The output of the management review should include decisions and actions related to the following: a) improvements in the effectiveness of the quality management system and its processes; h) improvements in products related to customer requirements; c) resource requirements:
6 Resource management
6.1 Resource provision
The organization shall determine and provide the resources needed to: b) implement, maintain and continually improve the effectiveness of the quality management system; and b) enhance customer satisfaction by meeting customer requirements. 6.2 Human Resources
6. 2.1 General
Personnel performing work that affects product quality shall be competent based on appropriate education, training, skills and experience. 6.2.2 Competence, awareness and training
The organization shall:
a) determine the necessary competence of personnel performing work that affects product quality; b) provide training or take other actions to meet these needs; c) evaluate the effectiveness of the actions taken;
1) ensure that personnel recognize the relevance and importance of the activities they perform and how they contribute to the achievement of quality objectives; and c) maintain appropriate records of education, training, skills and experience (see 4.2.4). 6.3 Infrastructure
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity of product to requirements. Where applicable, infrastructure includes: a) buildings, workspaces and associated facilities; 5) transit equipment (hardware and software);
centre) supporting services (such as transport or communication). 6.4 Work environment
The organization shall determine the work environment needed to achieve conformity of product to requirements. 7 Product realization
7.1 Strategy for product realization
The organization shall plan and develop the processes needed for product realization. The strategy for product realization shall be consistent with the requirements of other processes in the quality management system (see 4.1).
When planning for product realization, the organization shall determine the appropriate content of: a) the quality standards and requirements for the product;
GB/T19001--2000
b) the requirements for process documents and resources for the product; d) the verification, validation, monitoring, inspection and testing activities required for the product, and the product acceptance criteria; d) the records needed to provide evidence that the processes and their products meet the requirements (see 4.2.4). The output of planning shall be in a form that is appropriate to the way the organization operates. NOTE 1 The document that specifies the processes of the management system (including the product realization processes) and the resources that apply to a specific product, project or contract may be considered a quality management area. NOTE 2 The organization may also apply the requirements of 7.3 to the development of the product realization processes. 7.2 Customer-related processes 7.2.1 Determination of product-related requirements The organization shall determine: a) requirements specified by the customer, including requirements for delivery and post-delivery activities; b) requirements necessary for the intended use, if not stated by the customer; c) statutory and regulatory requirements related to the product; d) any additional requirements determined by the organization.
7.2.2 Review of product-related requirements
The organization shall review product-related requirements. The review shall be conducted before the organization makes a commitment to provide the product to the customer (e.g., submitting a tender, accepting a contract or order, and accepting changes to a contract or order). It shall ensure that: a) product requirements are determined; b) contract or order requirements that are inconsistent with previous statements have been resolved; and 3) the organization is able to meet the specified requirements. Records of the review results and actions resulting from the review shall be maintained (see 4.2.4). If the requirements provided by the customer are not documented, the organization shall confirm the customer requirements before accepting them. If product requirements change, the organization should ensure that relevant documents are modified and that relevant personnel are aware of the changed requirements. Note: In some cases, such as online sales, it may not be practical to conduct a formal review of individual orders. Instead, review relevant product information, such as product catalogs, product advertising content, etc. 7.2.3 Customer Communication
The organization should clearly implement effective arrangements for communicating with customers in the following aspects: a) Product information:
6) Handling of inquiries, contracts or orders, including their modifications; c) Customer feedback, including customer complaints.
7.3 Design and Development
7.3.1 Design and Development Planning
The organization should conduct a comprehensive review of the design and development of the product. Planning and control. When planning design and development, the organization should determine: a) design and development stages;
b) review, verification and validation activities appropriate for each design and development stage; c) responsibilities and authorities for design and development.
The organization should manage the interfaces between different groups involved in design and development to ensure effective communication and clarify the division of responsibilities. As design and development progress, the output of planning should be updated as appropriate. 7.3.2 Design and development inputs
Inputs related to product requirements should be identified and records should be maintained (see 4.2.4). These inputs should include:) functional and performance requirements;
b) applicable legal and regulatory requirements;
GB/T 19001—2000
c) where applicable, confidence from previous similar designs; d) other requirements necessary for design and development. These inputs should be reviewed to ensure that they are adequate and appropriate. Requirements should be complete, clear and not self-contradictory. 7.3.3 Design and development outputs
Design and concurrent outputs should be presented in a form that can be verified against the design and development inputs: and should be approved before release.
Design and development outputs should:
a) meet the requirements of design and development inputs; b) provide appropriate information for procurement, production and service providers; c) contain or reference product acceptance criteria;
| specify product characteristics necessary for the safety and proper use of the product. 7.3.4 Design and development reviews
At appropriate stages, according to planned arrangements (see 7.3. 1) Conduct a systematic review of design and development to: a) evaluate the ability of the results of design and development to meet requirements; and b) identify any problems and propose necessary actions. The review shall include representatives of functions relevant to the design and development phase being reviewed. Records of the results of the review and any necessary actions shall be maintained (see 4.2.4).
7.3.5 Design and development verification
Design and development shall be verified in accordance with planned arrangements (see 7.3.1) to ensure that the outputs of design and development meet the requirements of the inputs. Records of the results of verification and any necessary actions shall be maintained (see 4.2.4). 7.3.6 Design and development validation
Design and development shall be validated in accordance with planned arrangements (see 7.3.1) to ensure that the product meets the specified application requirements or the requirements of the intended use, as known, and, wherever practicable, prior to product delivery or implementation. Records of the results of validation and any necessary actions shall be maintained (see 4.2.4).
7.3.7 Control of design and development changes
Design and development changes shall be identified and records maintained. Design and development changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include an evaluation of the impact of the change on the product component and delivered product. Records of the results of the review of the changes and any necessary actions shall be maintained (see 4.2.4). 7.4 Purchasing
7.4.7 Purchasing process
The organization ensures that purchased product conforms to specified purchasing requirements. The type and extent of control over suppliers and purchased product shall depend on the impact of the purchased product on subsequent product realization or the final product. The organization shall evaluate and select suppliers based on their ability to provide product to the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of the evaluation and any necessary actions resulting from the evaluation shall be maintained (see 4.2.4). 7.4.2 Purchasing information
Purchasing information describes the products to be purchased and includes, as appropriate, a) approval requirements for products, procedures, processes and equipment; b) requirements for personnel qualifications; c) requirements for quality management programs.
Before communicating with suppliers, the organization shall ensure that the specified purchasing requirements are sufficient and appropriate. 7.4.3 Verification of purchased products
The organization shall determine and implement inspection or other necessary activities to ensure that the purchased products meet the specified purchasing requirements. GB/T 19001-2000
When the organization or its customer intends to implement verification at the supplier's site, the organization shall specify the arrangements for verification and the method of product release in the purchasing information.
7.5 Production and service provision
7.5. 1 Control of production and service provision
The organization shall plan and carry out production and service provision under controlled conditions. Where applicable, controlled conditions shall include: a) obtaining information describing the characteristics of the product;
6) obtaining work instructions when necessary; bZxz.net
c) using appropriate equipment;
d) obtaining and using monitoring and measuring devices;
e) implementing monitoring and measuring devices;
f) implementing release, delivery and post-delivery actions. 7.5.2 Validation of production and service provision processes The organization shall validate any production and service provision processes when their outputs cannot be verified by continuous monitoring or measurement. This includes processes where problems become apparent only after the product is in use or the service has been delivered. Validation shall demonstrate the ability of these processes to achieve planned results. The organization shall make arrangements for these processes, including, where applicable: a) defined criteria for review and approval of processes; b) qualification of equipment and personnel; c) use of specific methods and procedures; d) requirements for records (see 4.2.4); and revalidation. 7.5.3 Identification and traceability Where appropriate, the organization shall use appropriate methods to identify products throughout product realization. The organization shall identify the status of the product with respect to monitoring and measurement requirements. Where traceability is required, the organization shall control and record the unique identification of the product (see 42.4). Method: In some industries, technical status records are a method of maintaining identification and traceability. 7.5.4 Customer property
The organization shall care for customer property while it is under the organization’s control or in its use. The organization shall identify, verify, protect and maintain customer property that is used by the organization or that forms part of the product. If customer property is lost, damaged or found to be unsuitable for use, it shall be reported to the customer and records maintained (see 4.2.4).
Method: Customer property may include intellectual property. 7.5.5 Preservation of product
The organization shall provide for the preservation of conformity of the product during internal processing and delivery to the designated location. This preservation shall include identification, handling, packaging, storage and protection. Protection shall also apply to component parts of the product. 7.6 Control of monitoring and measuring devices
The organization shall determine the monitoring and measurement to be performed and the monitoring and measuring devices needed to provide evidence that the product conforms to the determined requirements (see 7.2.1).
The organization shall establish processes to ensure that monitoring and measurement activities are feasible and carried out in a manner consistent with the monitoring and measurement requirements. To ensure the validity of the results, when necessary, the measuring equipment should: a) be calibrated or verified at specified intervals or before use, against a measurement standard that can be traced back to an international or national standard. When the above standards do not exist, the basis for calibration or verification should be recorded: b) be adjusted or readjusted when necessary:
) be identified to determine its calibration status; i) be prevented from adjustments that may invalidate the measurement results; GB/T 19001—2000
e) be protected from damage or failure during transportation, maintenance and storage; In addition, when it is found that the equipment does not meet the requirements, the organization should evaluate and record the validity of previous measurement results. The organization should take appropriate measures for the equipment and any affected products. Records of calibration and verification results should be maintained (see 4.2.4). When computer software is used for monitoring and measurement of specified requirements, its ability to meet the intended purpose should be confirmed. Confirmation should be performed before initial use and, if necessary, reconfirmed:
Note: For guidance, see GB/T 19022.1 and GB/T 19022.2. 8 Measurement, analysis and improvement
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed to: a) confirm the conformity of the product; b) ensure the conformity of the quality management system; c) continually improve the effectiveness of the quality management system, which should include the determination of applicable methods, including statistical techniques, and their degree of success. 8.2 Monitoring and measurement
8.2.1 Customer satisfaction
As a measure of the performance of the quality management system, the organization shall monitor information about customer perceptions of whether the organization has met their requirements and determine methods for obtaining and using this information. 8.2.2 Internal Audits
The organization shall conduct internal audits at planned intervals to determine whether the quality management system: a) conforms to the planned arrangements (see 7.1), the requirements of this standard and the quality management system requirements determined by the organization, and b) is effectively implemented and maintained.
The audit programme shall be planned, taking into account the status and importance of the processes and areas to be audited and the results of previous audits. The principles, scope, frequency and methods of the audits shall be specified. The selection of auditors and the conduct of the audits shall ensure the objectivity and impartiality of the audit process. Auditors shall not audit their own work.
The responsibilities and requirements for planning and conducting audits and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.
The management responsible for the area audited shall ensure that timely actions are taken to eliminate detected nonconformities and their causes. Tracking activities shall include verification of actions taken and reporting of verification results (see 8.5.2). Note: As a guide, see GB/T 19021.1, CB/T 10021.2 and GI3/T 19021.3.8.2.3 Monitoring and measurement of processes
The organization shall adopt appropriate methods to monitor the quality management system processes and, where applicable, measure them. These methods shall verify the ability of the process to achieve the planned results, and when the planned results are not achieved, take appropriate corrections and corrective actions to ensure product conformity.
8.2.4 Monitoring and quality control of product
The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. Such monitoring and measurement shall be carried out at appropriate stages of the product realization process, in accordance with the planned arrangements (see 7.). Evidence of conformity to the acceptance criteria shall be maintained and recorded as the person responsible for releasing the product (see 4.2.1). Products and services shall not be released until the planned arrangements (see 7.1) have been satisfactorily completed, unless approved by relevant authorized personnel and, where applicable, the customer.
8.3 Control of nonconforming product
The organization shall ensure that products that do not conform to product requirements are identified and controlled to prevent their unintended use or delivery. Control of nonconforming product1 Rent GB/T19022, 2.8 Measurement, analysis and improvement
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes required for the following aspects: a) Confirming the conformity of products:
b) Ensuring the conformity of the quality management system
c) Continuously improving the effectiveness of the quality management system, which should include the determination of applicable methods including statistical techniques and their degree of effectiveness. 8.2 Monitoring and measurement
8.2.1 Customer satisfaction
As a measure of the performance of the quality management system, the organization shall monitor information about the customer's perception of whether the organization has met their requirements and determine methods for obtaining and using such information. 8.2.2 Internal Audits
The organization shall conduct internal audits at planned intervals to determine whether the quality management system: a) conforms to the planned arrangements (see 7.1), the requirements of this standard and the quality management system requirements determined by the organization, and b) is effectively implemented and maintained.
The audit programme shall be planned, taking into account the status and importance of the processes and areas to be audited and the results of previous audits. The principles, scope, frequency and methods of the audits shall be specified. The selection of auditors and the conduct of the audits shall ensure the objectivity and impartiality of the audit process. Auditors shall not audit their own work.
The responsibilities and requirements for planning and conducting audits and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.
The management responsible for the area audited shall ensure that timely actions are taken to eliminate detected nonconformities and their causes. Tracking activities shall include verification of actions taken and reporting of verification results (see 8.5.2). Note: As a guide, see GB/T 19021.1, CB/T 10021.2 and GI3/T 19021.3.8.2.3 Monitoring and measurement of processes
The organization shall adopt appropriate methods to monitor the quality management system processes and, where applicable, measure them. These methods shall verify the ability of the process to achieve the planned results, and when the planned results are not achieved, take appropriate corrections and corrective actions to ensure product conformity.
8.2.4 Monitoring and quality control of product
The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. Such monitoring and measurement shall be carried out at appropriate stages of the product realization process, in accordance with the planned arrangements (see 7.). Evidence of conformity to the acceptance criteria shall be maintained and recorded as the person responsible for releasing the product (see 4.2.1). Products and services shall not be released until the planned arrangements (see 7.1) have been satisfactorily completed, unless approved by relevant authorized personnel and, where applicable, the customer.
8.3 Control of nonconforming product
The organization shall ensure that products that do not conform to product requirements are identified and controlled to prevent their unintended use or delivery. Control of nonconforming product1 Rent GB/T19022, 2.8 Measurement, analysis and improvement
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes required for the following aspects: a) Confirming the conformity of products:
b) Ensuring the conformity of the quality management system
c) Continuously improving the effectiveness of the quality management system, which should include the determination of applicable methods including statistical techniques and their degree of effectiveness. 8.2 Monitoring and measurement
8.2.1 Customer satisfaction
As a measure of the performance of the quality management system, the organization shall monitor information about the customer's perception of whether the organization has met their requirements and determine methods for obtaining and using such information. 8.2.2 Internal Audits
The organization shall conduct internal audits at planned intervals to determine whether the quality management system: a) conforms to the planned arrangements (see 7.1), the requirements of this standard and the quality management system requirements determined by the organization, and b) is effectively implemented and maintained.
The audit programme shall be planned, taking into account the status and importance of the processes and areas to be audited and the results of previous audits. The principles, scope, frequency and methods of the audits shall be specified. The selection of auditors and the conduct of the audits shall ensure the objectivity and impartiality of the audit process. Auditors shall not audit their own work.
The responsibilities and requirements for planning and conducting audits and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.
The management responsible for the area audited shall ensure that timely actions are taken to eliminate detected nonconformities and their causes. Tracking activities shall include verification of actions taken and reporting of verification results (see 8.5.2). Note: As a guide, see GB/T 19021.1, CB/T 10021.2 and GI3/T 19021.3.8.2.3 Monitoring and measurement of processes
The organization shall adopt appropriate methods to monitor the quality management system processes and, where applicable, measure them. These methods shall verify the ability of the process to achieve the planned results, and when the planned results are not achieved, take appropriate corrections and corrective actions to ensure product conformity.
8.2.4 Monitoring and quality control of product
The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. Such monitoring and measurement shall be carried out at appropriate stages of the product realization process, in accordance with the planned arrangements (see 7.). Evidence of conformity to the acceptance criteria shall be maintained and recorded as the person responsible for releasing the product (see 4.2.1). Products and services shall not be released until the planned arrangements (see 7.1) have been satisfactorily completed, unless approved by relevant authorized personnel and, where applicable, the customer.
8.3 Control of nonconforming product
The organization shall ensure that products that do not conform to product requirements are identified and controlled to prevent their unintended use or delivery. Control of nonconforming product
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