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 requirements and applicable statutory and regulatory requirements; b) aim to enhance customer satisfaction through the effective application of the system, including the effective application of the system's continual improvement process, and to ensure compliance with customer requirements and applicable statutory and regulatory requirements. All requirements specified in this standard are generic and are intended to be applicable to organizations of all types, sizes and products. GB/T 19001-2008 Quality Management System Requirements GB/T19001-2008 Standard Download Unzip Password: www.bzxz.net
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 requirements and applicable statutory and regulatory requirements; b) aim to enhance customer satisfaction through the effective application of the system, including the effective application of the system's continual improvement process, and to ensure compliance with customer requirements and applicable statutory and regulatory requirements. All requirements specified in this standard are generic and are intended to be applicable to organizations of all types, sizes and products.
This standard is equivalent to ISO9001:2008 "Quality Management System Requirements" (English version).
This standard replaces GB/T19001-2000 "Quality Management System Requirements". By revising it, the expression is clearer and the compatibility with GB/T24001-2004 is enhanced.
Appendix B gives the specific changes between GB/T19001-2008 and GB/T19001-2000.
Appendix A and Appendix B of this standard are informative appendices.
This standard is proposed and managed by the National Technical Committee for Quality Management and Quality Assurance (SAC/TC151).
This standard is drafted by the China National Institute of Standardization.
The drafting organizations of this standard are: China National Institute of Standardization, Certification and Accreditation Administration of the People's Republic of China, China Certification and Accreditation Association, China National Accreditation Service for Conformity Assessment, China Quality Certification Center, Fangyuan Mark Certification Group, China Classification Society Quality Certification Company, Shanghai Quality System Audit Center, Shenzhen Huantong Certification Center, CESI Certification Center, Huaxia Certification Center Co., Ltd., Guopei Certification Training (Beijing) Center, China Building Materials Inspection and Certification Center, Shanghai Steam Turbine Co., Ltd.
The main drafters of this standard are: Tian Wu, Li Zhao, Liu Zhuohui, Li Qiang, Li Hefang, Li Ming, Zhao Zhiwei, Wang Jianning, Sun Chunyi, Qu Xintian, Wan Juyong, Wang Mei, Li Ping, Shi Xinyong, Ni Hongwei.
The previous versions of the standards replaced by this standard are:
--- GB/T10300.2-1988, GB/T19001-1992, GB/T19001-1994, GB/T19001-2000.
The clauses in the following documents become the clauses of this standard through reference in this standard. For all dated referenced documents, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, the parties who reach an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For all undated referenced documents, the latest versions are applicable to this standard.
GB/T19000-2008 Quality management systems, fundamentals and vocabulary (ISO9000:2005, IDT)
Foreword III
Introduction IV
0.1 General principles IV
0.2 Process approach IV
0.3 Relationship with GB/T19004 V
0.4 Compatibility with other management systems V
1 Scope 1
1.1 General principles 1
1.2 Application 1
2 Normative references 1
3 Terms and definitions 1 4
Quality management system 1
4.1 General requirements 1
4.2 Documentation requirements 2
5 Management responsibilities 2
5.1 Management commitment2
5.2 Customer focus3
5.3 Quality policy3
5.4 Planning3
5.5 Responsibility, authority and communication3
5.6 Management review3
6 Resource management4
6.1 Provision of resources4
6.2 Human resources4
6.3 Infrastructure4
6.4 Work environment4
7 Product realization4
7.1 Planning of product realization4
7.2 Customer-related processes5
7.3 Design and development5
7.4 Purchasing6
7.5 Production and service provision7
7.6 Control of monitoring and measuring equipment7
8 Measurement, analysis and improvement8
8.1 General8
8.2 Monitoring and measurement8
8.3 Control of nonconforming products9
8.4 Data analysis9
8.5 Improvement9
Appendix A (Informative Appendix) Comparison between GB/T19001-2008 and GB/T24001-200410
Appendix B (Informative Appendix) Changes between GB/T19001-2000 and GB/T19001-200815
References22

ICS03.120.10
National Standard of the People's Republic of China
GB/T19001—2008/IS09001:2008 replaces GB/T19001--2000
Quality management systems---Requirements(IS0 9001 :2008,IDT)
2008-12-30 Issued
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
Standardization Administration of the People's Republic of China
2009-03-01 Implementation
Process approach
0.3 Relationship with GR/T 19004
0.4 Compatibility with other management systems.
1 Scope
Normative references
Terms and definitions
Quality management system
General requirements
4.2 Documentation requirements
5 Management responsibilities
Management commitment
Customer focus Point
Quality Hall
Responsibility, Authority and Communication
Management Review
Resource Management
Resource Provision
Human Resources
Infrastructure
Work Environment
Product Realization
7.1 Planning of Product Realization
Customer-Related Processes
7.3 Design and Development
7.4 Procurement
Production and Service Provision
Control of Monitoring and Measuring Equipment
8 Measurement, Analysis and Improvement·
8.1 General
Monitoring and Measurement
Control of Nonconforming Product
Data Analysis
GB/T 19001—2008/IS0 9001:20081
GB/T 19001—2008/IS0 9001:20088.5 Improvement
Appendix A (Informative Appendix) Comparison between GB/T19001—2008 and GB/T24001.~2004 Appendix B (Informative Appendix) Changes between GB/T19001—2000 and GB/T19001—2008 References
GB/T19001--2008/IS09001:2008 This standard adopts ISO9001:2008 "Quality Management System Requirements" (English version). This standard replaces GB3/T19001—2008 "Quality Management System Requirements". Through its revision, the expression is made clearer and the consistency with GB/T 24001-2004. Appendix B gives the specific changes between G3/T19001-2008 and GB/T19001-2000. Appendix A and Appendix I3 of this standard are informative appendices. This standard is proposed and managed by the National Technical Committee for Quality Management and Quality Assurance (SACIC:151). This standard is drafted by the China Standardization Promotion and Research Institute. The drafting units of this standard are: China National Institute of Standardization, National Certification and Accreditation Administration, China Certification and Accreditation Association, China National Accreditation Service for Conformity Assessment, China Quality Certification Center, Fangyuan Mark Certification Group, China Classification Society Quality Certification Company, Shanghai Quality System Audit Center, Shenzhen Huantong Certification Center, Saijia Certification Center, Huaxia Certification Center Co., Ltd., Guopei Certification Training (Beijing) Center, China Building Materials Inspection and Certification Center, Shanghai Steam Turbine Co., Ltd. The main drafters of this standard are: Riwu, Li Zhao, Liu Zhuohui, Li Qiang, Li Hefang, Li Ming, Zhao Zhiwei, Wang Jianning, Sun Chunyi, Qu Xintian, Wan Juyong, Wang Mei, Li Ping, Shi Xin, Ni Hongyi.
The previous versions of the standards replaced by this standard are: -GB/T 10300.2—1988, GR/T 19001—1992, GB/T 19001 —1994, GB/T 19001-.-2000. GB/T 19001—2008/ISO 9001:20080.1 General
Adopting a quality management system is a strategic decision for an organization. The design and implementation of an organization's quality management system is influenced by the following factors:
a) the organization's environment, changes in that environment, and the risks associated with that environment;
the organization's changing needs;
the organization's specific objectives:
the products provided by the organization;
the processes adopted by the organization;
the size and structure of the organization.
It is not the purpose of this standard to unify the structure or documents of a quality management system. The quality management system requirements specified in this standard are a supplement to the product requirements. "Symptoms" are 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 requirements, applicable product legal and regulatory requirements, and the organization's own requirements:
The development of this standard has taken into account the quality management principles set out in GB/T 19000 and GB/T19004. 0.2 Process approach
This standard encourages the use of a process approach when establishing, implementing, and improving the effectiveness of a quality management system, in order to meet customer requirements and enhance customer satisfaction.
In order for an organization to operate effectively, it is necessary to identify and manage a number of interrelated activities. An activity or group of activities that transforms inputs into outputs through the use of resources and management can be considered a process. Usually, the output of a process directly forms the input of the next two processes. In order to produce the desired results, the application of a system composed of processes within an organization, together with the identification and interaction of these processes, and the management of these processes, can be called a "process approach". The advantage of the process approach is the continuous control of the connection between individual processes in the process system and the combination and interaction of processes.
When applying the process approach to a quality management system, the importance of the following aspects is emphasized: a) understanding and meeting requirements;
b) the need to consider processes from the perspective of value added; c) obtaining results of process performance and effectiveness; and) 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. The figure reflects that the customer plays an important role in specifying input requirements. Monitoring of customer satisfaction requires the organization to evaluate information about customers' perceptions 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--Plan: Establish necessary standards and processes to provide results according to customer requirements and organizational policies; D--Implementation: Implement the process C--Check: Monitor and measure processes and products according to policies, standards and product requirements, and report the results; A--Disposition: Take measures to continuously improve process performance. Customer GB/T19001-2008/ISO9001:2008 Continuous improvement of quality management system Management responsibilities Resource management Value-added activities Information measurement Measurement, analysis and improvement Process-based quality management system model 0, 3 and GB/T 19004 Relationship
GI3/T19001 and GB/T19004 are both quality management system standards. The two standards complement each other but can also be used separately. GB/T19001 specifies the requirements for quality management systems and can be used for internal use by organizations as well as for certification or contractual purposes. GB/T19001 focuses on the effectiveness of the quality management system in meeting customer requirements. When this standard was released, GB/T 1900 was in the process of revision. The revised GB/T 19004 will provide management guidelines for organizations to achieve continued success in a complex, more demanding and ever-changing environment. Compared with GB/T19001, GB/T19004 focuses on a wider range of quality management; meeting the needs and expectations of all relevant parties through systematic and continuous improvement of the organization's performance: However, G3/T19004 is not intended for certification, legal and regulatory purposes, and contracts. 0.4 Compatibility with other management systems
For the convenience of users,During the revision process, this standard has taken appropriate consideration of the contents of GB/T 24001-2004 to enhance the compatibility of the two standards. Appendix A shows the correspondence between GB/T 19001-2008 and GH/T 21001-2004. This standard does not include specific requirements for other management systems, such as specific requirements for environmental management, occupational health and safety management, financial management or risk management. However, this standard enables organizations to coordinate or integrate their own quality management system with relevant management system requirements. In order to establish a quality management system that meets the requirements of this standard, an organization may change its existing management system. 1 Scope
1.1 General
Quality Management System
This standard specifies the quality management system requirements for organizations with the following needs: GB/T 19001-2008/1S0 9001.2008a) To demonstrate its ability to consistently provide products that meet customer requirements and applicable legal and regulatory requirements! b) Aims to enhance customer satisfaction through the effective application of the system, including the effective application of the system's continual improvement process, and to ensure conformity to customer requirements and applicable statutory and regulatory requirements. Note 1: In this standard, the term "product" applies only to a) the product intended to be provided to the customer or required by the customer; b) any intended output produced by the product realization process. Note 2: Legal and regulatory requirements may be referred to as statutory requirements. 1.2 Application
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 inapplicable due to the nature of the organization and its products, it may be considered for deletion. If deletions are made, they should be limited to the requirements of Clause 7 of the standard, and such deletions should not affect the organization's ability to provide products that meet customer requirements and applicable statutory and regulatory requirements. or responsibility, otherwise it cannot claim to conform to this standard. 2 Normative references
The clauses in the following documents become the clauses of this standard through the application of this standard. Any dated referenced documents, with all amendments (excluding errata) or revised versions accompanying them, are not applicable to this standard. However, parties to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For any undated referenced documents, the latest version applies to this standard GB/T19000-2008 Quality Management System Fundamentals and Vocabulary (ISO9000:20051DT) 3 Terms and Definitions
This standard uses GB/T 19000. The term "product" that appears 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:
Determine the processes of the quality management system and their application throughout the organization (see 1.2): a
Determine the sequence and interaction of these processes; c)
Determine the principles and methods needed to ensure the operation and control of these processes are effective; l) Ensure that the necessary resources and information are available to support the operation of these processes and to monitor, observe, measure (where applicable) and analyze these processes: Implement the necessary actions to achieve the planned results and continual improvement of these processes. The organization shall manage these processes in accordance with the requirements of this standard. If the organization chooses to outsource any process that affects product conformity to requirements, it shall ensure control of these processes. For such outsourced processes GB/T 19001—2008/ISO 9001:2008 The type and extent of control shall be defined in the quality management system. 1: The processes required for the quality management system mentioned above include those related to the provision of resources for management activities, product realization and improvement, as well as measurement, analysis and collection. 2: "Outsourcing" is the process selected and implemented by an external party for the purpose of "quality management system performance". 3: The organization shall ensure the control of the outsourced processes and relieve it of the responsibility for meeting all customer requirements and statutory and regulatory requirements. The type and extent of control over outsourced processes may vary, such as: 》 The potential impact of the outsourced process on the organization's ability to provide products that meet requirements; h) The degree of sharing of control over the outsourced process; C) The ability to achieve control by applying 7.4. 4.2 Document requirements
4.2.1 General
The quality management system documents shall include:
a) Documented quality policy and quality objectives;
b) Quality manual:
Documents required by this standard
The documents determined by the organization to be necessary for effective planning, operation and control; Where a "procedure" is specified, it is required to establish, document, implement and maintain the procedure. A document may include the requirements of one or more procedures. NOTE: This standard appears in the form of a document.
The requirements of a documented library may be included in multiple documents. NOTE: Different organizations have different quality management systems. The amount and level of detail of the system documentation may vary, depending on a) the types of activities of the organization; b) the complexity of the processes and quality functions; and c) the capabilities of the personnel. 3. Documentation may take multiple or multiple forms. 4.2.2 Quality Manual The organization shall prepare a quality manual which shall include: (i) the scope of the quality management system, including details of any requirements and their justification (see 1.2); (ii) documented procedures for the quality management system or their use; and (iii) a description of the interactions between the quality management system and the processes. S
4.2.3 Document Control
Documents required by the quality management system shall be controlled, recorded, and documented in a manner that specifies the following:
Documents are a special type of document and shall be controlled in accordance with the requirements of 2.4 to ensure that the following controls are required:
Documents are approved before they are issued;
Documents are updated and re-approved when necessary;
Changes to documents and their current status are identified;
Relevant versions of applicable documents are available at points of use;
Documents are kept clear and easily identifiable;
External documents determined by the organization to be required for the planning and operation of the quality management system are identified and their distribution is controlled;
Prevent the unintended use of obsolete documents and, if obsolete documents are retained for some reason, apply appropriate identification to them. g
4.2.4 Record Control
Records established to provide evidence of conformity to requirements and the effective operation of the quality management system shall be controlled. The organization shall establish documented procedures to define the controls needed for the identification, storage, protection, retrieval, retention and disposal of records. Records shall remain legible and easy to identify and retrieve. 5 Management Responsibility
Management Commitment
The top manager shall provide evidence of its commitment to establishing, implementing and continually improving its effectiveness through the following activities: b)
Develop quality objectives:
Ensure the establishment of quality objectives;
d) Conduct management reviews;
Ensure the availability of resources:
5.2 Customer focus
GB/T 19001—2008/1S0 9001:2008 The top manager shall 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:
is appropriate to the purpose of the organization;
indicates commitment to meeting requirements and continual improvement of the effectiveness of the quality management system;
provides a framework for setting and reviewing quality objectives;
is communicated and managed within the organization and
is continually reviewed for suitability.
5.4 Planning
5.4.) Quality objectives
Top management shall ensure that quality objectives are established at relevant functions and levels of the organization. Quality objectives include those needed to meet product requirements [see 7.1a.].
Quality objectives shall be measurable and consistent with the quality policy. 5.4.2 Quality Management System Planning
Top management shall plan the quality system to meet quality objectives and the requirements of 4b) maintain the integrity of the quality management system when planning and implementing changes to the quality management system. 5.5 Responsibilities, authorities and communication
5.5.1 Responsibilities and authorities
The top management should define and communicate the responsibilities and authorities within the organization.2 Management representative
Top management shall designate a member of the organization's management who, regardless of his or her other qualifications, shall have the responsibility and authority to: a) ensure that the processes required for quality management (
) are established, implemented and maintained, and to report to top management on the performance of the quality management system and any need for improvement; and b) ensure awareness of customer requirements is raised throughout the organization. The responsibilities of the management representative may include liaising with external parties on matters relating 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
Top management shall evaluate the quality management system at planned intervals to ensure its continuing suitability, adequacy and effectiveness. The review shall include an evaluation of opportunities for improvement and the need for changes to the quality management system, including the need for changes to quality policies and quality standards. Records of management reviews shall be maintained (see 4.2.4). 5.6.2 Review inputs The input to management review shall include the following information: a) Audit results:
Customer feedback;
Performance of processes and conformity of products;
Status of preventive and corrective actions;
Follow-up actions from previous management reviews;
Changes that may affect the quality management system; g)
Recommendations for improvement.
5.6.3 Review output
The output of the management review shall include any decisions and actions related to: a) improving the effectiveness of the quality management system and its processes; 6)
the resource requirements for the production of products related to customer requirements.
6 Resource management
6.1 Provision of resources
The organization shall determine and provide the resources needed to: a) implement, maintain and continually improve the effectiveness of the quality management system; 6) enhance customer satisfaction by meeting customer requirements. 6.2 Human resources
6.2.1 General
Personnel performing work affecting conformity to product requirements shall be competent based on appropriate education-training, skills and experience. NOTE Personnel with any task in the quality management system may directly or indirectly affect product conformity. 6.2.2 Competence, training and awareness
The organization shall:
determine the competence of personnel performing work that affects conformity to product requirements and: a)
b) provide training or take other actions to acquire the necessary competence, as applicable; evaluate the effectiveness of the actions taken;
ensure that the organization's personnel understand the relevance and importance of the activities they perform and how they contribute to the achievement of quality objectives, and maintain appropriate records of education, training, skills and experience (see 1.2.4). e
6.3 Infrastructure
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Where applicable, infrastructure includes, a) buildings, workplaces and associated facilities; b) process equipment (hardware and hardware);
c) supporting services (such as transport, communications or information systems). 6.4 Work environment
The organization shall determine and manage the work environment needed to achieve conformity to product requirements. NOTE The term "working environment" refers to the conditions in which work is performed, including physical, environmental and other factors, such as noise, temperature, humidity, lighting or weather. 7 Product realization
7.1 Planning of product realization
The organization shall plan and develop the processes needed for product realization. The planning of product realization shall be consistent with the requirements of other processes of the quality management system (see 4.1).
When planning product realization, the organization shall determine the appropriate content of the following: a) quality objectives and requirements for the product;
b) the need for processes, documents and resources for the product; 4
GB/T 19001—2008/IS0 9001:2008c) the verification, validation, monitoring, measurement, inspection and test activities required for the product, and the criteria for product acceptance; d) the records needed to provide evidence that the realization processes and their products meet the requirements (see 4.2.4). The output of planning shall be in a form appropriate to the way the organization operates. 1: The document that specifies the processes (including product realization processes) and resources to be applied to a specific product, project or contract is called a quality plan.
Note 2: The organization may also apply the requirements of 7.3 to the development of product realization processes. 7.2 Customer-related processes
7.2.1 Determination of product-related requirements
The organization shall determine:
Requirements related to the product, including requirements for delivery and post-delivery activities: a)
Requirements necessary for the specified use or intended use, although not stated by the customer; c) Legal and regulatory requirements applicable to the product;
Any additional requirements considered necessary by the organization. NOTE Delivery activities include measures such as those required by warranty terms, contractual obligations (e.g. maintenance services), additional services (e.g. recycling or final disposal), etc. 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 the customer to supply the product (e.g. submission of a tender, acceptance of a contract or order and acceptance of changes to a contract or order) and shall ensure that: a) the product requirements have been specified; b) contract or order requirements that are inconsistent with previous statements have been resolved; and c) the organization is capable of meeting the specified requirements. Records of the results of the review and actions arising from the review shall be maintained (see 4.2.1). If the customer does not provide documented requirements, the organization shall confirm the customer requirements before accepting them. If product requirements change, the organization shall ensure that relevant documents are revised and that relevant personnel are aware of the changed requirements. NOTE: In some circumstances, such as online sales, it may not be practical to conduct a formal review of each order: as an alternative, relevant product information, such as product catalogues, product advertising content, etc. may be reviewed. 7.2.3 Customer Communication
The organization shall determine and implement effective arrangements for communicating with customers regarding: e) product information; b) handling of enquiries, contracts or orders, including amendments to them; c) customer feedback, including customer complaints:
7.3 Design and development
7.3.1 Design and development planning
The organization shall plan and control the design and development of the product. When planning design and development, the organization shall determine: r) the stages of design and development; b) the review, verification and validation activities appropriate for each stage of design and development; c) the responsibilities and authorities for design and development. bzxz.net
The organization shall manage the interfaces between the different groups involved in design and development to ensure effective communication and clear division of responsibilities. The output of the plan shall be updated as appropriate as design and development progress. NOTE Design and concurrent review, verification and validation have different purposes and may be performed and recorded separately or in a combination of tasks, depending on the specific circumstances of the product and the organization.
7.3.2 Design and development inputs
Inputs related to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include: a) functional requirements and performance requirements;
GB/T 190012008/I50 9001:2008b) applicable statutory and regulatory requirements;
c) information from previous similar designs, where applicable; d other requirements necessary for design and development
These inputs shall be reviewed for adequacy and suitability. Requirements shall be complete, clear and not contradictory. 7.3.3 Design and development outputs
Design and development outputs shall be in a form suitable for verification against design and development inputs and shall be approved before release. Design and development outputs shall: a) meet the requirements for design and development inputs; b) provide appropriate information to purchasing, production and services; include or reference product acceptance criteria; and specify product characteristics necessary for safe and proper use of the product. Note: The information provided by production and services may include details of the protection of the product according to planned installations. 7.3.4 Design and development reviews shall include details of the protection of the product according to planned installations. 1) Systematic evaluation of design and development shall be carried out at an appropriate stage to: a) evaluate the ability of the design and development results to meet requirements; b) identify any problems and correct errors as necessary. Participants in the review shall include records. (See 4.3.4.)5 Design and development verification
To ensure that the design is acceptable, representatives of functions relevant to the design and development stage being assessed shall be engaged. The results of the assessment and any necessary follow-up actions shall be verified in accordance with the planned arrangements (see 7.3.1). 7.3.6 Design and development validation To ensure that the product meets the specified requirements for use or the requirements of the known intended users, designs and developments shall be validated in accordance with the planned arrangements (see 3.1). Records shall be maintained (see 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 evaluated, verified and validated as appropriate, and the review of design and development changes shall include an evaluation of the impact of the changes on product components and delivered products. Approval shall be obtained before implementation, and the results of the evaluation of the changes shall be reviewed and approved. Records of the results and any necessary criteria shall be maintained (see 4.2.4). 7.4 Purchasing 7.4.1 Purchasing process 2.4 3. The organization shall ensure that the purchased products meet the specified purchasing requirements. The type and extent of control over suppliers and purchased products shall depend on the effect of the purchased products on subsequent product realization or the final product. The organization shall evaluate and select suppliers based on their ability to provide products in accordance with the organization's requirements. Procedures for selection, evaluation and re-evaluation shall be established. Records of the results of the evaluation and any necessary actions resulting from rejections shall be maintained (see 4.2.4). 7.4.2 Purchasing information Purchasing information shall describe the product to be purchased and include, as appropriate: a) product, process and equipment requirements; 5) personnel qualification requirements; c) quality management system requirements. The organization shall ensure that the specified purchasing requirements are adequate and appropriate before communicating with suppliers. 7.4.3 Verification of purchased product
The organization shall determine and implement inspection or other necessary activities to ensure that purchased products meet the specified purchase requirements.
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