This standard specifies the requirements for the quality system and is used in situations where it is necessary to verify the supplier's ability to design and provide qualified products. The main purpose of the requirements specified in this standard is to satisfy the customer by preventing non-conformities from all stages from design to service. GB/T 19001-1994 Quality system Quality assurance model for design, development, production, installation and service GB/T19001-1994 Standard download decompression password: www.bzxz.net
This standard specifies the requirements for the quality system and is used in situations where it is necessary to verify the supplier's ability to design and provide qualified products. The main purpose of the requirements specified in this standard is to satisfy the customer by preventing non-conformities from all stages from design to service.

GB/T19001—1994
This standard is equivalent to IS09001:1994 Quality System Design, Development, Production, Installation and Service Quality Assurance Model, replacing GB/T 19001: : 92: 1S09001:1987. This standard no longer translates "process" as "process" or "technique", but uniformly translates it as "process" so as to meet the needs of manufacturing, process and service industries at the same time, and also unify the use of terms. Appendix A of this standard is the appendix of the introduction.
This standard is proposed and coordinated by CSBTS/TC 151 National Quality Management and Quality Assurance Standardization Technical Committee. This standard is drafted by CSBTS/TC151/SC2 National Quality Management and Quality Assurance Standardization Technical Committee Quality System Technical Committee.
The drafting organizations of this standard are: China National Accreditation Service for Quality System Certification, Shanghai Quality System Audit Center, China New Era Quality System Certification Center, Beijing Institute of Technology, China Classification Society Quality Certification Company, and National Defense Science and Technology Commission Quality and Reliability Research Center. The main drafters of this standard are: Xiao Jianhua, Yue Yizhi, Qu Chunyuan Xiaoqian, Lang Zhizheng, Gu Zuofu, and Guo Ruixia. ISO Foreword
ISO (International Organization for Standardization) is a worldwide federation composed of national standardization bodies (ISO member bodies). The work of formulating international standards is usually done by ISO's technical committees. Each member body has the right to participate in the work of the committee if it is interested in a project established by an industry technical committee. National standardization organizations (official or unofficial) that maintain contact with ISO may also participate in the relevant work. In the field of electrotechnical standardization, ISO maintains a close cooperative relationship with the International Electrotechnical Commission (IEC). The draft international standard adopted by the technical committee is submitted to the member groups for voting. It must obtain the consent of at least 75% of the member groups participating in the voting before it can be officially released as a national standard. The international standard ISO9001 was developed by the Quality System Subcommittee of the Quality Management and Quality Assurance Technical Committee of the International Organization for Standardization ISU/TC176/SC2.
This version (second edition) has made technical revisions to the first edition and replaces the first edition (I509001:1987). Appendix A of this standard is for reference only.
This standard is one of the three standards for quality system requirements used by external quality assurance. The quality assurance models specified in the following three standards represent three different quality system requirements for suppliers to prove their capabilities and external assessment of their capabilities. a) GB/T19001-IS09001 quality assurance model for quality system design, development, production, installation and service-is used by suppliers to ensure compliance with specified requirements at each stage of design, development, production, installation and service. b) GB/T19002--ISO9002 Quality System: Quality Assurance Model for Production, Installation and Service - used by suppliers to ensure compliance with specified requirements during the production, installation and service stages. e) GB/T19003--ISO9003 Quality System Final Inspection and Test Quality Assurance Model - used by suppliers to ensure compliance with specified requirements during the final inspection and test stages. It should be emphasized that the quality system requirements specified in this standard and GB/T19002--ISO9002 and GB13/T19003--IS09003 are supplementary to (not replacing) the specified technical (product) requirements. These standards specify requirements to determine the elements that must be included in the quality system, and their purpose is not to force the uniformity of the quality system. Standards are general: they are not specifically formulated for a specific industrial industry or economic sector. The design and implementation of the quality system will be affected by the changing needs of the organization, its specific day, the products and services provided, and the processes involved and its internal practices. These three standards can generally be adopted in their existing form, and sometimes they can be tailored according to specific contractual circumstances, that is, some quality system requirements can be added or subtracted. GB/T19000.1-ISO9000-1 provides guidance on the selection and tailoring of three quality assurance models: GB/T19001-ISO9001, GB/T19002-ISO9002 and GB/T19003-ISO9003. 1 Scope
National Standard of the People's Republic of China
Quality systems-- Model for quality assurance fn design .development.production,installatlon and servlcingGB/T 19001—1994
idt IS0 9001:1994
Replaces GB/T 19001 :-92
This standard specifies the requirements for a quality system and is used in situations where it is necessary to verify the supplier's ability to design and provide quality products. The main purpose of the requirements specified in this standard is to satisfy the customer by preventing nonconformities from all stages from design to service. This standard is used in the following situations:
a) Design is required and product requirements (mainly in terms of performance) are specified or are yet to be established; h) When the supplier's design, development, production, installation and service capabilities are appropriately verified, it can be believed that the product meets the specified requirements. Note 1: References are in Appendix A (informative appendix). 2 Referenced standards
The clauses contained in the following standards constitute the clauses of this standard through reference in this standard. When this standard was published, the versions indicated were valid. All standards are subject to revision, so parties using this standard should investigate the possibility of using the latest versions of the following standards. Quality management and quality assurance terminology (idt ISO8402: 1994) GB/T 6583-19945
3 Definitions
This standard adopts the definitions of GB/T6583-ISO8402 and the following definitions. 3.1 Product product
The result of an activity or process.
2 Products can include services, hardware, process materials, software or a combination of them. 3 Products may be tangible (such as components or process materials), intangible (such as knowledge or concepts) or a combination of them: 1 In this standard, the term *product\ applies only to products that are expected to be provided, rather than undesirable "by-products" that affect the environment. This is different from the definition in CB/T6583-1S)8402. 3.2 Bid Terle Invitation to supply An offer to provide products that meet intermediary requirements. 3.3 Contract A requirement agreed upon by both parties, transmitted in any way between the supplier and the customer. 4 Quality system requirements 4.1 Management responsibilities 4.1.1 Quality policy Approved by the State Administration of Technical Supervision on December 24, 1994 and implemented on June 30, 1995 GB/T19001-1994 The supplier management with executive responsibility shall define the quality policy, including quality objectives and commitment to quality, and document it. The quality policy shall reflect the supplier's organizational objectives and customer expectations and needs. The supplier shall ensure that its personnel at all levels understand the quality policy and adhere to its implementation.
4.1.2 Organization
4.1.2.1 Responsibilities and Authorities
The qualifications, authorities and relationships of personnel involved in management, execution and verification activities related to quality shall be defined and documented, particularly those who need to exercise independent authority to:) take action to prevent nonconformities related to products, processes and quality systems;) identify and record problems related to products, processes and quality systems; c) obtain, recommend or propose solutions through defined channels; d) verify the effectiveness of solutions;
e) control the further processing, delivery or installation of nonconforming product until the defect or noncompliance with requirements is corrected. 4.1.2.2 Resources
For management, execution and verification activities (including internal quality audits), the supplier shall determine the resource requirements and provide adequate resources, including trained personnel (see 4.18). 4.1-2.3 Management Representative
Supplier management with executive responsibilities shall designate a member of their own management as the management representative, regardless of their other responsibilities, and shall have clear authority to: a) ensure that the quality system is established, implemented and maintained in accordance with the requirements of this standard; b) report the operation of the quality system to the supplier management for evaluation and as a basis for quality system improvement. Note 5: The position of the management representative may also include liaison work with external parties on matters related to the supplier quality system. 4.1.3 Management Review
The supplier's management with performance responsibility shall review the quality system at specified intervals to ensure its continued suitability and effectiveness to meet the requirements of this International Standard and the supplier's stated quality policy and objectives (see 4.1.1). Records of the reviews shall be retained (see 4.16). 4.2 Quality System
4.2.1 General
The supplier shall establish, document and maintain a quality system as a means of ensuring that product conforms to specified requirements. The supplier shall prepare a quality manual covering the requirements of this International Standard. The quality manual shall include or reference quality system procedures and outline the structure of the quality system documentation. NOTE 6 IS0 10013 provides guidance on the preparation of a quality system manual. 4.2.2 Quality System Procedures
The supplier shall:
a) establish documented procedures consistent with the requirements of this International Standard and the supplier's stated quality policy; and b) establish procedures for the effective implementation of the quality system and its documented procedures. Based on the principles of this International Standard, the quality system procedures that form part of the quality system, their scope and level of detail shall depend on the magnitude of the work, the methods used, and the skills and training required of the personnel involved in carrying out the activity. NOTE: A documented procedure may refer to a work instruction that specifies how an activity is to be performed. 4.2.3 Quality Planning The supplier shall define and document how quality requirements will be met. The quality planning shall be consistent with all other requirements of the supplier's quality system and documented as appropriate for the supplier's operations. To meet the requirements of the product, project or contract, the supplier shall give due consideration to the following activities: a) Prepare a quality test plan; b) Determine and provide the necessary controls, processes, equipment (including inspection and test equipment), process equipment, resources and skills to achieve the required quality; c) Ensure the compatibility of design, production processes, installation, service, inspection and test procedures and related documents! GB/T 19001—1994
d) update quality control, inspection and testing techniques, including development of new test equipment, as necessary; e) determine all measurement requirements, including those that are beyond the current level but can be developed within a sufficient time frame; ↑ determine appropriate verification at appropriate stages of product development; ) define acceptance criteria for all characteristics and requirements, including those that contain subjective factors; h) determine and prepare quality records (see 4.16). The quality plan referred to in 4.2.3a) may be implemented in the form of an annual application of appropriate documented procedures, which form part of the supplier's quality system.
4.3 Weekly Review
4. 3.1 General
The supplier shall establish and maintain documented procedures for contract review and coordination of contract review activities. 4.3.2 Review
Before submitting a bid or accepting a contract or order (statement of requirements), the supplier shall review the bid, contract or order to ensure that: a) all requirements are clearly defined and documented; in the case of an order received verbally without a written statement of requirements, the supplier shall ensure that the order requirements are agreed before it is accepted; b) any contract or order requirements that are inconsistent with the bid have been resolved; and e) the supplier has the ability to meet the requirements of the contract or order. 4.3.3 Contract Amendment
The supplier shall determine how contract amendments are to be made and properly communicated to the relevant functional departments within the supplier's organization. 4.3.4 Records
Records of contract review shall be maintained (see 4.16). NOTE 9: The supplier shall establish communication channels and interfaces with the customer regarding contract matters. 4.4 Design Control
4. 4.1 General
The supplier shall establish and maintain documented procedures for product design control and verification to ensure that specified requirements are met. 4.4.2 Planning of Design and Development
The supplier shall prepare a plan for each design and development activity. The plan shall describe or list the activities to be carried out and define the responsibilities for carrying out these activities. Design and development activities shall be assigned to qualified individuals and adequately resourced. The plan shall be reviewed as the design progresses.
4.4.3 Organizational and Technical Interfaces
The organizational and technical interfaces between the various departments involved in the design process shall be defined, and the necessary information shall be documented, transferred and reviewed in due course.
4.4.4 Design Inputs
The supplier shall determine the design input requirements related to the product, including applicable statutory and regulatory requirements, document them, and review their adequacy. Any unclear, ambiguous or ambiguous requirements shall be resolved with the originator. Design inputs shall take into account the results of the contract review activities: 4.4.5 Design Outputs
The design outputs shall be documented and expressed in a form that can be verified and validated against the design input requirements. The design output shall: a) meet the requirements of the design input; b) contain or reference the acceptance criteria; c) indicate the design characteristics that are important to the safety and normal operation of the product (such as the requirements for operation, storage, handling, maintenance and disposal). The design output document shall be reviewed before release. 4.4.6 Design Review GE/T 19001—1994 At the appropriate stage of design, a formal review of the design results shall be planned and documented. The reference for each design review shall include representatives of all functional departments related to the design stage of the unit being reviewed, and other experts shall be included as necessary. These review records shall be kept (see 4.16). 4.4.7 Design Verification Design verification shall be carried out at the appropriate stage of design to ensure that the output of the design stage meets the requirements of the input of the design stage. Design verification shall be recorded (see 4.16).
NOTE 10 In addition to conducting design reviews (see 4.4.6), design verification may include the following activities: 1. Design changes; 2. Comparison of new designs with proven similar designs, when possible; 3. Testing and verification; 4.4.8 Design Validation
Design validation shall be performed to ensure that the product meets the specified user needs and/or requirements. NOTE
11 Design validation is performed after successful design verification (see 4.4.7). 12 Validation is normally performed under specified operating conditions. 13 Validation is normally performed on the final product, but may also be performed at various stages before the product is completed. 14 Multiple validations may also be performed if different intended uses are used. 4.4.9 Design changes
All design changes and modifications shall be identified, documented, reviewed and approved by authorized personnel before implementation. 4.5 Document and Information Control
4.5.1 General
The supplier shall establish and maintain a documented procedure to control all documents and information related to the requirements of this standard, including external documents such as standards and customer-supplied drawings to an appropriate extent. NOTE 15: Documents and information may be in any form of media, such as hard copy or electronic media. 4.5.2 Approval and Release of Documents and Information
Documents and information shall be approved for applicability by authorized personnel prior to release. A control list or equivalent document control procedure shall be established and readily available to identify the current revision status of documents to prevent the use of expired and/or obsolete documents. This control should ensure that:
8] valid versions of relevant documents are available at all locations that are important to the effective operation of the quality system; b) invalid and/or obsolete documents are promptly removed from all locations of issuance or use, or otherwise ensured to prevent misuse; c) any obsolete documents retained for the purpose of eliminating regulations and/or accumulating knowledge should be appropriately marked. 4.5.3 Changes to documents and information
Unless otherwise specified, changes to documents and information should be approved by the original approval department/organization of the document. If other departments/organizations are designated for approval, the department/organization should obtain relevant background information on which the approval is based. When feasible, the nature of the change should be indicated on the document or relevant attachment. 4.6 Purchasing
4.6.1 General
The supplier shall establish and maintain documented procedures to ensure that purchased products (see 8.1) conform to specified requirements. 4.6.2 Evaluation of subcontractors
The supplier shall:
a) evaluate and select subcontractors based on their ability to meet the requirements of the subcontract (including the quality system and specific quality assurance requirements); b) clarify the manner and extent of the supplier's control over the subcontractors. This manner and extent depends on the type of product and the impact of the subcontracted product on the quality of the finished product. Where appropriate, it also depends on the quality market audit reports and/or quality records of the proven subcontractor's capabilities and performance.
GE/T 190011994
c) Establish and maintain quality records of qualified subcontractors (see 4.16). 4.6.3 Procurement Documents
The procurement documents shall clearly state the information of the ordered products, which may include a) category, type, grade or other identification method b) name or other clear identification and applicable version of specifications, drawings, process requirements, inspection procedures and other relevant technical information (including approval or qualification requirements for products, procedures, process equipment and personnel); c) name, number and version of applicable quality system standards. The supplier shall review and approve the appropriateness of the specified requirements before the procurement documents are issued. 4.6.4 Verification of Purchased Products
4.6.4.1 Supplier's Verification at Subcontractor's Source When the supplier proposes to verify the purchased products at the subcontractor's source, the supplier shall specify the verification arrangements and the method of product verification in the procurement documents.
4.6.4.2 Customer Verification of Subcontractor's Products When the contract stipulates, the supplier's customer or its representative shall have the right to verify at the subcontractor's and the supplier's location whether the subcontracted products meet the specified requirements. The supplier shall not use this verification as evidence that the subcontractor has exercised effective control over the quality. Verification by the customer does not relieve the supplier of its responsibility to provide acceptable product nor does it preclude subsequent rejection by the customer. 4.7 Control of Customer-Supplied Product
The supplier shall establish and maintain documented procedures for the verification, storage and maintenance of customer-supplied product (for use in supplies or related activities). Any loss, damage or unsuitability shall be recorded and reported to the customer (see 4.16). Verification by the supplier does not relieve the customer of its responsibility to provide acceptable product. 4.8 Product Identification and Traceability
Where necessary, the supplier shall establish and maintain documented procedures for the identification of products in an appropriate manner at the stages of receipt and production, delivery and installation.
Where traceability requirements are specified, the supplier shall establish and maintain documented procedures for the unique identification of each product or batch of products. Such identification shall be recorded (see 4.16). 4.9 Process Control
The supplier shall determine and plan the production, installation and service processes that directly affect quality and ensure that these processes are carried out under controlled conditions. A controlled state includes:
a) documented procedures for production, installation and service methods where quality cannot be assured without documented procedures,
b) use of appropriate production, installation and service equipment and an appropriate working environment;
conformity with relevant standards/regulations, quality plans and/or documented procedures;
d) monitoring and control of appropriate process parameters and product characteristics;
e) approval of processes and equipment where necessary;
f) specification of skill qualification criteria in the most clear and practical manner (e.g. written standards, samples or drawings);
g) appropriate maintenance of equipment to maintain process capability. When the results of a process cannot be fully verified by subsequent inspection and testing of the product, such as machining defects that are not revealed until after use, these processes should be performed by qualified operators and/or require continuous monitoring and control of process parameters to ensure that the specified requirements are met.
Any qualification requirements for the operation of the process [including the equipment and operators (see 4.18)] should be specified. NOTE 16: Processes that require prior qualification of process capability are often referred to as "special processes". Where necessary, records of qualified processes, equipment and personnel shall be maintained (see 4.16).
4.10 Inspection and testing
4.10.1 General
GB/T 19001—1994
The supplier shall establish and maintain documented procedures for conducting inspection and testing activities to verify that the product meets the specified requirements. The required inspections and tests and the records established shall be specified in detail in the quality plan or documented procedures. 4.10.2 Incoming inspection and testing
4.10.2.1 The supplier shall ensure that products are not put into service or processing without inspection or verification of compliance (except as provided in 4.10.2.3). Compliance with the specified requirements shall be verified in accordance with the quality plan and/or documented procedures. 4.10.2.2 When determining the amount and nature of incoming inspection, consideration shall be given to the extent of control exercised at the subcontractor's location and the evidence of compliance provided.
4.10.2.3 If the product is released due to urgent production needs and there is no time for verification, the product should be clearly marked and records should be made (see 4.16) so that it can be returned and replaced immediately if it is found that it does not meet the specified requirements. 4.10.3 Process inspection and testing
The supplier shall:
a) inspect and test the product according to the requirements of the quality plan and/or documented procedures, and b) shall not release the product before the required inspection and testing are completed or the necessary reports are received and verified. Exception release is allowed only when there is a reliable tracking procedure (see 4.10.2.3), but the provisions of 4.10.38) shall still be implemented. 4.10.4 Final inspection and testing
The supplier shall perform all final inspections and tests in accordance with the quality plan and/or documented procedures to provide evidence that the finished product meets the specified requirements.
The quality plan and/or documented procedures for final inspection and testing shall require that all specified inspections and tests (including incoming inspection and in-process inspection) have been completed and the results meet the specified requirements. Products may only be released after all activities specified in the quality plan and/or documented procedures have been satisfactorily completed and the relevant data and documents are complete and approved.
4.10.5 Inspection and test records
The supplier shall establish and maintain records indicating that the product has been inspected and/or tested. These records shall clearly indicate whether the product has passed the inspection and/or test in accordance with all specified acceptance criteria. When a product fails a certain inspection and/or test, the nonconforming product control procedure shall be implemented (see 4.13).
The records shall identify the authorized inspector responsible for the release of conforming product (see 1.16). 4.11 Control of inspection, measuring and test equipment 4.11.1 General
The supplier shall establish and maintain documented procedures for the control, calibration and maintenance of the inspection, measuring and test equipment (including test software) used to demonstrate conformity of the product to specified requirements. The inspection, measuring and test equipment shall be used in such a way that its measurement uncertainty is known and consistent with the required measurement capability.
If test software or comparison standards (e.g. test hardware) are used as a means of verification, they shall be calibrated prior to use to demonstrate their suitability for use in verifying the acceptability of the product during production, installation and service and shall be rechecked at specified intervals. The supplier shall specify the content and intervals of rechecking and maintain records as evidence of control (see 4.16). Where technical data on inspection, measuring and test equipment are available on request, the supplier shall provide such data when requested by the customer or its representative to demonstrate that the inspection, measuring and test equipment is functioning properly. NOTE 17 In this standard, the term \measuring equipment\ includes measuring devices. 4. 11.2 Control Procedures The supplier shall: a) determine the measurement task and the required accuracy, and select appropriate inspection, measurement and test equipment with the required accuracy and precision. b) confirm that all inspection, measurement and test equipment that affect product quality shall be calibrated and adjusted according to the prescribed period or before use against certified equipment with a known valid relationship to relevant internationally or nationally recognized standards. When the above references do not exist, the basis for calibration shall be documented:
c) specify the process for calibrating inspection, measuring and test equipment, including equipment model, unique identification, location, calibration cycle, calibration method, acceptance criteria, and the measures to be taken when problems are found; d) inspection, measuring and test equipment shall be marked with appropriate marks or approved identification records indicating its calibration status; e) calibration records of inspection, measuring and test equipment shall be maintained (see 4.16); f) the validity of the verification and test results shall be assessed and documented when inspection, measuring or test equipment deviates from the calibration state; +) ensure appropriate environmental conditions for calibration, inspection, measurement and testing; h) ensure that the accuracy and suitability of inspection, measuring and test equipment are maintained during handling, protection and storage; i) prevent inspection, measuring and test equipment (including test hardware and software) from losing its calibration due to improper adjustment. Note 18: The metrological confirmation system for measuring equipment provided in GB/T 19022-IS () 10012 can be used as a guide. 4.12 Inspection and test status
The inspection and test status of the product shall be marked in an appropriate manner to indicate whether the product has passed the inspection and test. During the entire process of product production, installation and service, the inspection and test status identification shall be protected in accordance with the requirements of the quality plan and/or documented procedures to ensure that only products that have passed the specified inspection and test (or authorized concession release (see 4.13.2)) can be issued, used or installed.
4.13 Control of nonconforming products
4.13.1 General
The supplier shall establish and maintain a documented procedure for the control of nonconforming product to prevent the unintended use or installation of nonconforming product. The identification, recording, evaluation, isolation (where practicable) and disposal of nonconforming product shall be controlled and the relevant competent authorities shall be notified. 4.13.2 Review and Disposal of Nonconforming Product
The responsibility for reviewing nonconforming product and the authority for handling it shall be specified. Nonconforming products shall be reviewed in accordance with the documented procedure and may be: a) reworked to meet the specified requirements; b) accepted as a concession with or without rework; d) downgraded for other use; l) rejected or scrapped.
When required by the contract, the supplier shall not use or repair products that do not meet the specified requirements (see 4.13.2b) The customer or his representative shall be requested to make a concession application. If agreed, the nonconformity and rework shall be recorded to indicate the actual status of the nonconforming product (see 4.16). Repaired and/or reworked products shall be re-inspected in accordance with the quality plan and/or documented procedures. 4.14 Corrective and Preventive Actions
4. 14.1 General
The supplier shall establish and maintain a documented procedure for implementing corrective and preventive actions. Any corrective or preventive action taken to eliminate the cause of actual or potential nonconformity shall be commensurate with the significance of the problem and the risk assumed. bzxZ.net
The supplier shall implement and record any changes to the documented procedures resulting from corrective and preventive actions. 4.14.2 Corrective action The corrective action procedure should include: a) effectively handling customer comments and reports of product nonconformities; h) investigating the causes of nonconformities related to the product, process and quality system, and recording the results of the investigation (see 4.16); c) determining the corrective actions needed to eliminate the causes of nonconformities; d) implementing controls to ensure the implementation and effectiveness of corrective actions. 4.14.3 Preventive action The preventive action procedure should include: a) using appropriate sources of information such as processes and operations affecting product quality, concessions, audit results, quality records, service reports and customer comments to identify, analyze and eliminate potential causes of nonconformities; b) determining the necessary steps to deal with any issues requiring preventive action; c) taking preventive actions and implementing controls to ensure effectiveness; d) ensuring that relevant information on actions taken is submitted to management for review (see 4.1.3). 4.15 Handling, Storage, Packaging, Protection and Delivery 4.15.1 General
The supplier shall establish and maintain documented procedures for the handling, storage, packaging, protection and delivery of products. 4.15.2 Handling
The supplier shall provide transportation methods to prevent product damage or deterioration. 4.15.3 Storage
The supplier shall use designated storage areas or warehouses to prevent product damage or deterioration before use or delivery. The management method for the issuance of authorized receivers shall be specified.
Inspect the condition of stored products at appropriate intervals to detect deterioration in a timely manner. 4.15.4 Packaging
The supplier shall exercise necessary control over the packing, packaging and labeling processes (including materials used) to ensure compliance with specified requirements. 4.15.5 Protection
When products are under the control of the supplier, the supplier shall adopt appropriate protective and isolation measures. 4.15.6 Delivery
After complete inspection and testing, the supplier shall take measures to protect the quality of the product. When required by the contract, this protection shall continue to the destination of delivery.
4.16 Control of quality records
The supplier shall establish and maintain documented procedures for the identification, collection, cataloguing, review, filing, storage, custody and disposal of quality records. Quality records shall be preserved to demonstrate that the requirements of the storage regulations are met and the quality system is operating effectively. The quality records of the contractor shall also be made an integral part of these documents.
All quality records shall be legible, the storage facilities shall be easy to access and inspect, and the storage facilities shall provide a suitable environment to prevent damage, deterioration and loss. The retention period of quality records shall be specified and recorded. When required by the contract, quality records shall be available to the customer or its representative for evaluation within an agreed period.
Note 13: Records may be in any form of media, such as hard copy or electronic media. 4.17 Internal Quality Audit
The supplier shall establish and maintain a documented procedure for planning and conducting internal quality audits to verify that quality activities and related results are in accordance with the planned arrangements and to determine the effectiveness of the quality system. Internal quality audits shall be planned based on the actual situation and importance of the audited activities and shall be conducted by personnel who are not directly responsible for the audited activities.
The results of the quality audit (see 1, 16) shall be recorded and brought to the attention of the responsible personnel of the audited area. For problems found during the audit, the management personnel responsible for the area shall take corrective measures in a timely manner. In follow-up audit activities, the actual situation and effectiveness of the corrective actions taken shall be verified and recorded (see 4.16). NOTE
20 The results of the internal quality audit are part of the input to the management review activities (see 4.1.3). 21 GB, T19021—IS10011 provides guidance on quality system audits. 4.18 Training
GB/T19001—1994
The supplier shall establish and maintain a documented procedure to identify training needs and provide training to all personnel performing work that affects quality. Personnel performing special work shall be qualified according to the required education, training and/or experience. Appropriate training records shall be maintained (see 4.16).
4.19 Services
Where service requirements are specified, the supplier shall establish and maintain a documented procedure for the implementation, verification and reporting of the services so that the services meet the specified requirements.
4.20 Statistical Techniques
4.20.1 Determine the Needs
The supplier shall identify the needs for the statistical techniques required to determine, control and verify process capability and product characteristics. 4.20.2 Procedures
The supplier shall establish and maintain a documented procedure to implement the statistical techniques identified in 4.20.1 and control their application.3 Storage
The supplier shall use designated storage areas or warehouses to prevent the product from being damaged or deteriorating before use or delivery. The management method for the issuance of authorized receipts shall be specified.
The condition of stored products shall be checked at appropriate intervals to detect deterioration in a timely manner. 4.15.4 Packaging
The supplier shall exercise necessary control over the packing, packaging and marking processes (including the materials used) to ensure compliance with the specified requirements. 4.15.5 Protection
When the product is under the control of the supplier, the supplier shall adopt appropriate protection and isolation measures. 4.15.6 Delivery
After the final inspection and testing, the supplier shall take measures to protect the quality of the product. If required, this protection shall continue to the destination of delivery.
4.16 Control of quality records
The supplier shall establish and maintain documented procedures for the identification, collection, cataloging, review, archiving, storage, custody and disposal of quality records. Quality records should be kept to prove that the requirements of the regulations are met and the quality system is operating effectively. The quality records of the contractor should also be made part of these materials. All quality records should be clear, the storage should be easy to access and inspect, and the storage facilities should provide a suitable environment to prevent damage, deterioration and loss. The retention period of quality records should be specified and recorded. When required by the contract, quality records can be provided to the customer or his representative for evaluation within the agreed period. Note 13: Records can be in any form of media, such as hard copy or electronic media. 4.17 Internal Quality Audit The supplier shall establish and maintain a documented procedure for planning and conducting internal quality audits to verify whether quality activities and related results are in accordance with the planned arrangements and to determine the effectiveness of the quality system. Internal quality audits should be arranged according to the actual situation and importance of the audited activities and should be conducted by personnel who have no direct responsibility for the audited activities.
The results of the quality audit should be recorded (see 1, 16) and brought to the attention of the responsible personnel of the audited area. For problems found during the audit, the management personnel responsible for the area should take corrective measures in a timely manner. During the follow-up audit activities, the implementation and effectiveness of the corrective actions taken should be verified and recorded (see 4.16). NOTE
20 The results of the internal quality audit are part of the input to the management review activities (see 4.1.3). 21 GB, T19021—IS10011 gives guidance on quality system audits. 4.18 Training
GB/T19001—1994
The supplier shall establish and maintain a documented procedure to identify training needs and train all personnel performing work that affects quality. Personnel performing special work should be qualified according to the required education, training and/or experience. Appropriate training records should be maintained (see 4.16).
4.19 Services
Where service requirements are specified, the supplier shall establish and maintain documented procedures for the performance, verification and reporting of services to ensure that the services meet the specified requirements.
4.20 Statistical Techniques
4.20.1 Determine Requirements
The supplier shall identify the requirements for statistical techniques needed to determine, control and verify process capability and product characteristics. 4.20.2 Procedures
The supplier shall establish and maintain documented procedures to implement the statistical techniques identified in 4.20.1 and control their application.3 Storage
The supplier shall use designated storage areas or warehouses to prevent the product from being damaged or deteriorating before use or delivery. The management method for the issuance of authorized receipts shall be specified.
The condition of stored products shall be checked at appropriate intervals to detect deterioration in a timely manner. 4.15.4 Packaging
The supplier shall exercise necessary control over the packing, packaging and marking processes (including the materials used) to ensure compliance with the specified requirements. 4.15.5 Protection
When the product is under the control of the supplier, the supplier shall adopt appropriate protection and isolation measures. 4.15.6 Delivery
After the final inspection and testing, the supplier shall take measures to protect the quality of the product. If required, this protection shall continue to the destination of delivery.
4.16 Control of quality records
The supplier shall establish and maintain documented procedures for the identification, collection, cataloging, review, archiving, storage, custody and disposal of quality records. Quality records should be kept to prove that the requirements of the regulations are met and the quality system is operating effectively. The quality records of the contractor should also be made part of these materials. All quality records should be clear, the storage should be easy to access and inspect, and the storage facilities should provide a suitable environment to prevent damage, deterioration and loss. The retention period of quality records should be specified and recorded. When required by the contract, quality records can be provided to the customer or his representative for evaluation within the agreed period. Note 13: Records can be in any form of media, such as hard copy or electronic media. 4.17 Internal Quality Audit The supplier shall establish and maintain a documented procedure for planning and conducting internal quality audits to verify whether quality activities and related results are in accordance with the planned arrangements and to determine the effectiveness of the quality system. Internal quality audits should be arranged according to the actual situation and importance of the audited activities and should be conducted by personnel who have no direct responsibility for the audited activities.
The results of the quality audit should be recorded (see 1, 16) and brought to the attention of the responsible personnel of the audited area. For problems found during the audit, the management personnel responsible for the area should take corrective measures in a timely manner. During the follow-up audit activities, the implementation and effectiveness of the corrective actions taken should be verified and recorded (see 4.16). NOTE
20 The results of the internal quality audit are part of the input to the management review activities (see 4.1.3). 21 GB, T19021—IS10011 gives guidance on quality system audits. 4.18 Training
GB/T19001—1994
The supplier shall establish and maintain a documented procedure to identify training needs and train all personnel performing work that affects quality. Personnel performing special work should be qualified according to the required education, training and/or experience. Appropriate training records should be maintained (see 4.16).
4.19 Services
Where service requirements are specified, the supplier shall establish and maintain documented procedures for the performance, verification and reporting of services to ensure that the services meet the specified requirements.
4.20 Statistical Techniques
4.20.1 Determine Requirements
The supplier shall identify the requirements for statistical techniques needed to determine, control and verify process capability and product characteristics. 4.20.2 Procedures
The supplier shall establish and maintain documented procedures to implement the statistical techniques identified in 4.20.1 and control their application.
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