Quality Management Systems – Requirements for Aviation, Space and Defen Organizations 1.Scope 1.1General This standard includes ISO 9001:2008 quality management system requirements and specifies additional aviation, space and defen industry requirements, definitions and notes as shown in bold, italic text. It is emphasized that the requirements specified in this standard are complementary (not alternative) to contractual and applicable statutory and regulatory requirements. Should there be a conflict between the requirements of this standard and applicable statutory or regulatory requirements, the latter shall take precedence. This International Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including process for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. NOTE 1 In this International Standard, the term “product” only applies to a) product intended for, or required by, a customer, b) any intended output resulting from the product realization process. NOTE 2 Statutory and regulatory requirements may be expresd as legal requirements. 1.2Application All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. Where exclusions are made, claims of conformity to this International Standard are not acceptable unless the exclusions are limited to requirements within clau 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements. This standard is intended for u by organizations that design, develop and/or produce aviation, space and defen products; and by单词音标查询 organizations providing post-delivery support, including the provision of maintenance, spare parts or materials for their own products. Organizations who primary business is providing maintenance, repair and overhaul rvices for aviation commercial and military products; and original equipment manufacturers with maintenance, repair and overhaul operations that operate autonomously, or that are substantially different from their manufacturing/production operations; should u the IAQG-developed 9110 standard (e Bibliography). Organizations that procure parts, materials and asmblies and rell the products to a customer in the aviation, space and defen industries, including organizations that procure products and split them into smaller quantities for resale, should u the IAQG-developed 9120 standard (e Bibliography). 2.Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2005, Quality management systems — Fundamentals and vocabulary. 3. Terms and definitions For the purpos of this document, the terms and definitions given in ISO 9000 apply. Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “rvice”. 3.1 Risk An undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative conquence. 3.2 Special requirements Tho requirements identified by the customer, or determined by the organization, which have high risks to being achieved, thus requiring their inclusion in the risk management process. Factors ud in the determination of special requirements include product or process complexity, past experience and product or process maturity. Examples of special requirements include performance requirements Impod by the customer that are at the limit of the industry’s capability, or requirements determined by the organization to be at the limit of its technical or process capabilities. 3.3 Critical items Tho items (e.g., functions, parts, software, characteristics, process) having significant effect on the product realization and u of the product; including safety, performance, form, fit, function, producibility, rvice life, etc.; that require specific actions to ensure they are adequately managed. Examples of critical items include safety critical items, fracture critical items, mission critical items, key characteristics, etc. 3.4 Key Characteristic An attribute or feature who variation has a significant effect on product fit, form, function, performance, rvice life or producibility, that requires specific actions for the purpo of controlling variation. NOTE Special requirements and critical items are new terms and, along with key characteristics, are interrelated. Special requirements are identified when determining and reviewing requirements related to the product (e 7.2.1 and 7.2.2). Special requirements can require the identification of critical items. Design output (e 7.3.3) can include identification of critical items that require specific actions to ensure they are adequately managed. Some critical items will be further classified as key characteristics becau their variation needs to be controlled. 4 Quality management system 4.1 General requirements The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. The organization’s quality management system shall also address customer and applicable statutory and regulatory quality management system requirements. The organization shall a) determine the process needed for the quality management system and their application throughout the organization (e 1.2), b) determine the quence and interaction of the process, c) determine criteria and methods needed to ensure that both the operation and control of the process are effective, d) ensure the availability of resources and information necessary to support the operation and monitoring of the process, e) monitor, measure where applicable, and analy the process, and f)implement actions necessary to achieve planned results and continual improvement of the process. The process shall be managed by the organization in accordance with the requirements of this International Standard. Where an organization choos to outsource any process that affects product conformity to requirements, the organization shall ensure control over such process. The type and extent of control to be applied to the outsourced process shall be defined within the quality management system. NOTE 1 Process needed for the quality management system referred to above include process for management activities, provision of resources, product realization, measurement, analysis and improvement. NOTE 2 An “outsourced process” is a process that the organization needs for its quality management system and which the organization choos to have performed by an external party. NOTE 3 Ensuring control over outsourced process does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as a) the potential impact of the outsourced process on the organization’s capability to provide product that conforms to requirements, b) the degree to which the control for the process is shared, c) the capability of achieving the necessary control through the application of 7.4. 4.2 Documentation requirements 4.2.1 General The quality management system documentation shall include a) documented statements of a quality policy and quality objectives, b) a quality manual, c) documented procedures and records required by this International Standard, and d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its process. The organization shall ensure that personnel have access to, and are aware of, relevant quality management system documentation and changes. NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document. NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to a) the size of organization and type of activities, b) the complexity of process and their interactions, and c) the competence of personnel. NOTE 3 The documentation can be in any form or type of medium. 4.2.2 Quality manual The organization shall establish and maintain a quality manual that includes a) the scope of the quality management system, including details of and justification for any exclusions (e 1.2), b) the documented procedures established for the quality management system, or reference to them, and c) a description of the interaction between the process of the quality management system. 4.2.3 Control of documents Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4. A documented procedure shall be established to define the controls needed a) to approve documents for adequacy prior to issue, b) to review and update as necessary and re-approve documents, c) to ensure that changes and the current revision status of documents are identified, d) to ensure that relevant versions of applicable documents are available at points of u, e) to ensure that documents remain legible and readily identifiable, f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and g) to prevent the unintended u of obsolete documents, and to apply suitable identification to them if they are retained for any purpo. 4.2.4 Control of records Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records. The documented procedure shall define the method for controlling records that are created by and/or retained by suppliers. Records shall remain legible, readily identifiable and retrievable. 5 Management responsibility 5.1 Management commitment Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality objectives are established, d) conducting management reviews, and e) ensuring the availability of resources. 5.2 Customer focus Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (e 7.2.1 and 8.2.1). Top management shall ensure that product conformity and on-time delivery performance are measured and that appropriate action is taken if planned results are not, or will not be, achieved. 5.3 Quality policy Top management shall ensure that the quality policy a) is appropriate to the purpo of the organization, b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, c) provides a framework for establishing and reviewing quality objectives, d) is communicated and understood within the organization, and e) is reviewed for continuing suitability. 5.4 Planning 5.4.1 Quality objectives Top management shall ensure that quality objectives, including tho needed to meet requirements for product [e 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy. 5.4.2 Quality management system planning Top management shall ensure that a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority Top management shall ensure that the responsibilities and authorities are defined and communicated within the organization. 5.5.2 Management reprentative Top management shall appoint a member of the organization’s management who, irrespective of other responsibilities, shall have responsibility and authority that includes a) ensuring that process needed for the quality management system are established, implemented and maintained, b) reporting to top management on the performance of the quality management system and any need for improvement, c) ensuring the promotion of awareness of customer requirements throughout the organization, and d) the organizational freedom and unrestricted access to top management to resolve quality management issues. NOTE The responsibility of a management reprentative can include liaison with external parties on matters relating to the quality management system. 5.5.3 Internal communication Top management shall ensure that appropriate communication process are established within the organization and that communication takes place regarding the effectiveness of the quality management system. 5.6 Management review 5.6.1 General Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include asssing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from management reviews shall be maintained (e 4.2.4). 5.6.2 Review input The input to management review shall include information on a) results of audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective actions, e) follow-up actions from previous management reviews, f) changes that could affect the quality management system, and g) recommendations for improvement. 5.6.3 Review output The output from the management review shall include any decisions and actions related to a) improvement of the effectiveness of the quality management system and its process, b) improvement of product related to customer requirements, and c)resource needs. 6 Resource management 6.1 Provision of resources The organization shall determine and provide the resources needed a) to implement and maintain the quality management system and continually improve its effectiveness, and b) to 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 on the basis of appropriate education, training, skills and experience. NOTE Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the quality management system. 6.2.2 Competence, training and awareness The organization shall a) determine the necessary competence for personnel performing work affecting conformity to product requirements, b) where applicable, provide training or take other actions to achieve the necessary competence, c) evaluate the effectiveness of the actions taken, d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and e) maintain appropriate records of education, training, skills and experience (e 4.2.4). 6.3 Infrastructure The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable a) buildings, workspace and associated utilities, b) process equipment (both hardware and software), and c) supporting rvices (such as transport, communication 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 "work environment" relates to tho conditions under which work is performed including physical, environmental and other factors (such as noi, temperature, humidity, lighting, or weather). 7 Product realization 7.1 Planning of product realization The organization shall plan and develop the process needed for product realization. Planning of product realization shall be consistent with the requirements of the other process of the quality management system (e 4.1). In planning product realization, the organization shall determine the following, as appropriate: a)quality objectives and requirements for the product; NOTE Quality objectives and requirements for the product include consideration of aspects such as -product and personal safety, -reliability, availability and maintainability, -producibility and inspectability, -suitability of part and materials ud in the product, -lection and development of embedded software, and -recycling or final disposal of the product at the end of its life. b)the need to establish process and documents, and to provide resources specific to the product; c)required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance; d)records needed to provide evidence that the realization process and resulting product meet requirements (e 4.2.4); e)configuration management appropriate to the product; f)resources to support the u and maintenance of the product. The output of this planning shall be in a form suitable for the organization’s method of operations. NOTE 1 A document specifying the process of the quality management system (including the product realization process) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan. NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization process. 7.1.1 Project Management As appropriate to the organization and the product, the organization shall plan and manage product realization in a structured and controlled manner to meet requirements at acceptable risk, within resource and schedule constraints. 7.1.2 Risk Management The organization shall establish, implement and maintain a process for managing risk to the achievement of applicable requirements, that includes as appropriate to the organization and the product. a) assignment of responsibilities for risk management, b) definition of risk criteria (e.g., likelihood, conquences, risk acceptance), c) identification, asssment and communication of risks throughout product realization, d) identification, implementation and management of actions to mitigate risks that exceed the defined risk acceptance criteria, and g)acceptance of risks remaining after implementation of mitigating actions. 7.1.3Configuration Management The organization shall establish, implement and maintain a configuration management process that includes, as appropriate to the product a)configuration management planning, b)configuration identification, c)change control d)configuration status accounting, and e)configuration audit. NOTE See ISO 10007 for guidance 7.1.4Control of Work Transfers The organization shall establish, implement and maintain a process to plan and control the temporary or permanent transfer of work (e.g., from one organization facility to another, from the organization to a supplier, from one supplier to another) and to verify the conformity of the work to requirements. 7.2 Customer-Related process 7.2.1 Determination of Requirements Related to the Product The organization shall determine a)requirements specified by the customer, including the requirements for delivery and post-delivery activities, b)requirements not stated by the customer but necessary for specified or intended u, where known, c)statutory and regulatory requirements applicable to the product, and d) any additional requirements considered necessary by the organization. NOTE Requirement related to the product can include special requirement, NOTE Post-delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance rvices, and supplementary rvices such as recycling or final disposal. 7.2.2 Review of Requirements Related to the Product The organization shall review the requirements related to the product. This review shall be conducted prior to the organization’s commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that a)product requirements are defined, b)contract or order requirements differing from tho previously expresd are resolved, c)the organization has the ability to meet the defined requirements d) special requirement of the product are determined, and e)risks (e.g., new technology, short delivery time frame ) have been identified (e7.1.2) Records of the results of the review and actions arising from the review shall be maintained (e 4.2.4). Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance. Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements. NOTE: In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material. 7.2.3 Customer communication The organization shall determine and implement effective arrangements for communicating with customers in relation to: a)product information, b)enquiries, contracts or order handling, including amendments, and c)customer feedback, including customer complaints. 7.3 Design and Development 7.3.1 Design and Development Planning The organization shall plan and control design and development of product. During the design and development planning, the organization shall determine a)the design and development stages, b)the review, verification and validation that are appropriate to each design and development stage, and c)the responsibilities and authorities for design and development. Where appropriate, the organization shall divide the design and development effort into distinct activities and, for each activity, define the tasks, necessary resource, responsibilities, design content, input and output data and planning constraints. The different design and development tasks to be carried out shall be bad on the safety and functional objectives of the product in accordance with customer, statutory and regulatory requirements. Design and development planning shall consider the ability to produce, inspect, test and maintain the product. The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility. Planning output shall be updated, as appropriate, as the design and development progress. NOTE Design and development review, verification and validation have distinct purpos. They can be conducted and recorded parately or in any combination as suitable or the product and the organization. 7.3.2 Design and Development Inputs Inputs relating to product requirements shall be determined and records maintained (e 4.2.4). The input shall include a)functional and performance requirements, b)applicable statutory and regulatory requirements, c)where applicable, information derived from previous similar designs, and d)other requirements esntial for design and development. The inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other. 7.3.3 Design and Development Outputs The outputs of design and development shall be in a form suitable for verification against the design and development input and shall be approved prior to relea. Design and development outputs shall a)meet the input requirements for design and development, b)provide appropriate information for purchasing , production and rvice provision, c)contain or reference product acceptance criteria, d) specify the characteristics of the product that are esntial for its safe and proper u, and e) specify, as applicable, any critical items, including any key characteristics, and specific actions to be taken for the items. The organization shall define the data required to allow the product to be identified, manufactured, inspected, ud and maintained including for example: -the drawings, part lists and specifications necessary to define the configuration and the design features of the product, and -the material, process, manufacturing and asmbly data needed to ensure conformity of the product. NOTE information for production and rvice provision can include details for the prervation of product. 7.3.4 Design and Development Review At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (e 7.3.1) a)to evaluate the ability of the results of design and development to meet requirements, b) to identify any problems and propo necessary actions, and c) to authorize progression to the next stage. Participants in such reviews shall include reprentatives of functions concerned with the design and development stage(s) being reviewed. Records of the result of the reviews and any necessary actions shall be maintained (e 4.2.4) 7.3.5 Design and Development Verification Verification shall be performed in accordance with planned arrangements (e 7.3.1) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (e 4.2.4) 7.3.6 Design and Development Validation Design and development validation shall be performed in accordance with planned arrangements (e 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended u, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (e 4.2.4).日出江花 7.3.6.1Design and Development Verification and Validation Testing Where tests are necessary for verification and validation, the tests shall be planned, controlled, reviewed, and documented to ensure and prove the following: a.test plans or specifications identify the product being tested and the resources being ud, define test objectives and conditions, parameters to be recorded, and relevant acceptance criteria; b.test procedures describe the method of operation, the performance of the test, and the recording of the results; c.the correct configuration of the product is submitted for the test; d.the requirements of the test plan and the test procedures are obrved, and e.the acceptance criteria are met. 7.3.6.2Design and Development verification and Validation Documentation At the completion of design and/or development, the organization shall ensure that reports, calculations, test results, etc., demonstrate that the product definition meets the specification requirements for all identified operational conditions. 7.3.7 Control of Design and Development Changes Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions shall be maintained (e 4.2.4) Design and development changes shall be controlled in accordance with the configuration management process (e 7.1.3) Records of the results of the review of changes and any necessary actions shall be maintained (e 4.2.4). 7.4 Purchasing 7.4.1 Purchasing process The organization shall ensure that purchad product conforms to specified purcha requirements. The type and extent of control applied to the supplier and the purchad product shall be dependent upon the effect of the purchad product on subquent product realization or the final product. The organization shall be responsible for the conformity of all products purchad from suppliers, including product from sources defined by the customer. The organization shall evaluate and lect suppliers bad on their ability to supply product in accordance with the organization’s requirements. Criteria for lection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (e 4.2.4) NOTE One factor that can be ud during supplier lection and evaluation is supplier quality data from objective and reliable external sources, as evaluated by the organization (e.g., information from accredited quality management system or process certification bodies, organization approvals from government authorities). U of such data would be only one component of an organization’s supplier control process and the organization remains responsible for verifying that purchad product meets specified purcha requirements. The organization shall: a.maintain a register of its suppliers that includes approval status (e.g., approved, conditional, disapproved) and the scope of the approval (e.g., product type, process family), b.periodically review supplier performance; the result of the reviews shall be ud as a basis for establishing the level of controls to be implemented; c.define the necessary actions to take when dealing with suppliers that do not meet requirements; d.ensure where required that both the organization and all suppliers u customer-approved special process sources, e.Define the process, responsibilities and authority for the approval status decision, changes of the approval status and conditions for a controlled u of suppliers depending on the supplier’s approval status, and f. determine and manage the risk when lecting and using suppliers (e 7.1.2). 7.4.2 Purchasing information Purchasing information shall describe the product to be purchad, including where appropriate a)requirements for approval of product, procedures, process and equipment, b)requirements for qualification of personnel, c)quality management system requirements, d)the identification and revision status of specifications, drawings, process requirements, inspection/verification instructions and other relevant technical data, e)requirements for design, test, inspection, verification (including production process verification), u of statistical techniques for product acceptance, and related instructions for acceptance by the organization, and as applicable critical items including key characteristics, f)requirements for test specimens (e.g., production method, number, storage conditions) for design approval, inspection/verification, investigation or auditing, g)requirements regarding the need for the supplier to -notify the organization of nonconforming product, -obtain organization approval for nonconforming product disposition, -notify the organization of changes in product and/or process, change of suppliers, changes of manufacturing facility location and, where required, obtain organization approval, and -flow down to the supply chain the applicable requirements including customer requirements, h)records retention requirements, and i)right of access by the organization, their customer and regulatory authorities to the applicable areas of all facilities, at any level of the supply chain, involved in the order and to all applicable records, The organization shall ensure the adequacy of specified purcha requirements prior to their communication to the supplier. 7.4.3 Verification of Purchad Product The organization shall establish and implement the inspection or other activities necessary for ensuring that purchad product meets specified purcha requirements. NOTE 1 Customer verification activities performed at any level of the supply chain should not be ud by the organization or the supplier as evidence of effective control of quality and does not absolve the organization of its responsibility to provide acceptable product and comply with all requirements. NOTE 2 Verification activities can include a.obtaining objective evidence of the conformity of the product from suppliers (e.g., accompanying documentation, certificate of conformity, test reports, statistical records, process control records), b.inspection and audit at the supplier’s premis, c.review of the required documentation, d.inspection of products upon receipt, and e.delegation of verification to the supplier or supplier certification. Where purchad product is relead for production u pending completion of all required verification activities, it shall be identified and recorded to allow recall and replacement if it is subquently found that the product does not meet requirements. Where the organization delegates verification activities to the supplier, the requirements for delegation shall be defined and a register of delegations maintained. Where the organization or its customer intends to perform verification at the supplier’s premis, the organization shall state the intended verification arrangements and method of product relea 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 rvice provision under controlled conditions. Controlled conditions shall include, as applicable a)the availability of information that describes the characteristics of the product, NOTE This information can include drawings, parts lists, materials and process specifications. b)the availability of work instructions, as necessary, NOTE Work instructions can include process flow charts, production documents (e.g., manufacturing plans, travelers, routers, work orders, process cards) and inspection documents. c)the u of suitable equipment, NOTE Suitable equipment can include product specific tools (e.g., jigs, fixtures, molds) and software programs. d)the availability and u of monitoring and measuring equipment, e)the implementation of monitoring and measurement, f)the implementation of product relea, delivery and post-delivery activities, g)accountability for all product during production(e.g., parts quantities, split orders, nonconforming product), h)evidence that all production and inspection/verification operations have been completed as planned, or as otherwi documented and authorized, i)provision for the prevention, detection, and removal of foreign objects, j)monitoring and control of utilities and supplies (e.g., water, compresd air, electricity chemical products) to the extent they affect conformity to product requirements, and k)criteria for workmanship, specified in the clearest practical way (e.g., written standards, reprentative samples or illustrations). Planning shall consider, as appropriate, - establishing, implementing and maintaining appropriate process to manage critical items, including process controls where key characteristics have been identified. - designing, manufacturing and using tooling to measure variable data, -identifying in-process inspection/verification points when adequate verification of conformance cannot be performed at a later stage of realization, and -special process (e 7.5.2). 7.5.1.1 Production Process Verification The organization shall u a reprentative item from the first production run of a new part or asmbly to verify that the production process, production documentation and tooling are capable of producing parts and asmblies that meet requirements. This process shall be repeated when changes occur that invalidate the original result (e.g., engineering changes, manufacturing process changes, tooling changes). NOTE This activity is often referred to as first article inspection. 7.5.1.2 Control of Production Process Changes Personnel authorized to approve changes to production process shall be identified. The organization shall control and document changes affecting process, production equipment, tools or software programs. The results of changes to production process shall be assd to confirm that the desired effect has been achieved without adver effects to product conformity. 7.5.1.3 Control of Production Equipment, Tools and Software Programs Production equipment, tools and software programs ud to automate and control/monitor product realization process, shall be validated prior to relea for production and shall be maintained. Storage requirements, including periodic prervation/ condition checks, shall be defined for production equipment or tooling in storage. 7.5.1.4Post-Delivery Support Post-delivery support shall provide as applicable for the a.collection and analysis of in-rvice data, b.actions to be taken including investigation and reporting when problems are detected after delivery. c.control and updating of technical documentation, d.approval, control, and u of repair schemes, and e.controls required for off-site work (e.g., organization’s work undertaken at the customer’s facilities). 7.5.2 Validation of Process for Production and Service Provision The organization shall validate any process for production and rvice provision where the resulting output cannot be verified by subquent monitoring or measurement and, as a conquence, deficiencies become apparent only after the product is in u or the rvice has been delivered. NOTE The process are often referred to as special process. Validation shall demonstrate the ability of the process to achieve planned results. The organization shall establish arrangements for the process including, as applicable a)defined criteria for review and approval of the process, b)approval of equipment and qualification of personnel, c)u of specific methods and procedures, d)requirements for records (e 4.2.4), and e)revalidation. 7.5.3 Identification and Traceability Where appropriate, the organization shall identify the product by suitable means throughout product realization. The organization shall maintain the identification of the configuration of the product in order to identify any differences between the actual configuration and the agreed configuration. The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization. When acceptance authority media are ud (e.g., stamps, electronic signatures, passwords), the organization shall establish appropriate controls for the media. Where traceability is a requirement, the organization shall control and record the unique identification of the product and maintain records (e 4.2.4). NOTE Traceability requirements can include -identification to be maintained throughout the product life; - the ability to trace all the products manufactured from the same batch of raw material, or from the same manufacturing batch to the destination (e.g., delivery, scrap) -for an asmbly, the ability to trace its components to the asmbly and then to the next higher asmbly, and -for a product, a quential record of its production ( manufacture, asmbly, inspection/verification) to be retrieved. NOTE In some industry ctors, configuration management is a means by which identification and traceability are maintained. (e 7.1.3) 7.5.4 Customer property The organization shall exerci care with customer property while it is under the organization’s control or being ud by the organization. The organization shall identify, verify, protect and safeguard customer property provided for u or incorporation into the product. If any customer property is lost, damaged or otherwi found to be unsuitable for u, the organization shall report this to the customer and maintain records (e 4.2.4). NOTE Customer property can include intellectual property and personal data, 7.5.5 Prervation of product The organization shall prerve the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, prervation shall include identification, handling, packaging, storage and protection. Prervation shall also apply to the constituent parts of a product. Prervation of product shall also include, where applicable in accordance with product specifications and applicable statutory and regulatory, provisions for: a.cleaning; b.prevention, detection and removal of foreign objects; c.special handling for nsitive products; d.marking and labeling including safety warnings; e.shelf life control and stock rotation, and f.special handling for hazardous materials. 7.6 Control of Monitoring and M日本帝京大学easuring Equipment The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements. The organization shall maintain a register of the monitoring and measuring equipment and define the process employed for their calibration/verification including details of equipment type, unique identification, location, frequency of checks, check method and acceptance criteria. NOTE Monitoring and measuring equipment include, but is not limited to: test hardware, test software, automated test equipment (ATE) and plotters ud to produce inspection data. It also includes personally owned and customer supplied equipment ud to provide evidence of product conformity. The organization shall establish process to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. The organization shall ensure that environmental conditions are suitable for the calibrations, inspections, measurements and testing being carried out. Where necessary to ensure valid results, measuring equipment shall a)be calibrated or verified at specified intervals, or prior to u, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis ud for calibration or verification shall be recorded (e 4.2.4); b)be adjusted or re-adjusted as necessary; c)have identification in order to determine its calibration status; d)be safeguarded from adjustments that would invalidate the measurement result; e)be protected from damage and deterioration during handling, maintenance and storage; The organization shall establish, implement and maintain a process for the recall of monitoring and measuring equipment requiring calibration or verification. In addition, the organization shall asss and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (e 4.2.4). When ud in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial u and reconfirmed as necessary. NOTE Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for u. 8 Measurement, analysis and improvement 8.1 General The organization shall plan and implement the monitoring, measurement, analysis and improvement process needed a)to demonstrate conformity to product requirement, b)to ensure conformity of the quality management system, and c)to continually improve the effectiveness of the quality management system. This shall include determination of applicable methods, including statistical techniques, and the extent of their u. NOTE：According to the nature of the product and depending on the specified requirements, statistical techniques can be ud to support: -design verification (e.g., reliability, maintainability, safety); -process control: - lection and inspection of key characteristics; - process capability measurements; - statistical process control; - design of experiment; -inspection, and -failure mode ,effect and criticality analysis. 8.2 Monitoring and measurement 8.2.1 Customer satisfaction As one of the measurement of the performance of the quality management system, the organization shall monitor information relating to customer perceptions as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined. Information to be monitored and ud for the evaluation of customer satisfaction shall include, but is not limited to, product conformity, on-time delivery performance, customer complaints and corrective action requests. Organization shall develop and implement plans for customer satisfaction improvement that address deficiencies identified by the evaluations, and asss the effectiveness of the results. NOTE Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, ur opinion surveys, lost business analysis, compliments, warranty claims and dealer reports. 8.2.2 Internal audit The organization shall conduct internal audits at planned intervals to determine whether the quality management system a)conforms to the planned arrangements (e 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and NOTE Planned arrangements include customer contractual requirements. 李姓女孩名字b)is effectively implemented and maintained. An audit programme shall be planned, taking into consideration the status and importance of the process and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work. A documented procedure shall be established to define the responsibilities and requirements for planning and conducing audits, establishing records and reporting results. Records of the audits and their result shall be maintained (e 4.2.4) The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their caus. Follow-up activities shall include the verification of the actions taken and the reporting of verification results (e 8.5.2). NOTE See ISO 19011 for guidance. 8.2.3 Monitoring and measurement of process The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system process. The methods shall demonstrate the ability of the process to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate. NOTE When determining suitable methods for monitoring or measurement appropriate to each of its process in relation to their impact on the conformity to product requirement and on the effectiveness of the quality management system. In the event of process non-conformity, the organization shall a.take appropriate action to correct the nonconforming process, b.evaluate whether the process nonconformity has resulted in product nonconformity c.determine if the process nonconformity is limited to a specific ca or whether it could have affected other process or products, and d.identify and control any nonconforming product (e 8.3) 8.2.4 Monitoring and measurement of product The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (e 7.1). Evidence of conformity with the acceptance criteria shall be maintained. Measurement requirements for product acceptance shall be documented and shall include a)criteria for acceptance and/or rejection, b)where in the quence measurement and testing operations are to be performed, c)required record of the measurement results(at a minimum, indication of acceptance or rejection),and d)any specific measurement instruments required and any specific instructions associated with their u. When critical items, including key characteristics, have been identified the organization shall ensure they are controlled and monitored in accordance with the established process. When the organization us sampling inspection as a means of product acceptance, the sampling plan shall be justified on the basis of recognized statistical principles and appropriate for u. （i.e. matching the sampling Plan to the criticality of the product and to the process Capability). When product is relead for production u pending completion of all required measurement and monitoring activities, it shall be identified and recorded to allow recall and replacement if it is subquently found that the product does not meet requirements. Records shall indicate the person(s) authorizing relea of product for delivery to the customer (e 4.2.4) Where required to demonstrate product qualification the organization shall ensure that records provide evidence that the product meets the defined requirements. The relea of product and delivery of rvice to the customer shall not proceed until the planned arrangements (e 7.1) have been satisfactorily completed, unless otherwi approved by a relevant authority, and, where applicable, by the customer. The organization shall ensure that all documents required to accompany the product are prent at delivery. 8.3 Control of Nonconforming Product The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended u or delivery. A documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with nonconforming product. NOTE The term “non-conforming product” includes nonconforming product returned from a customer. The organization’s documented procedure shall define the responsibility and authority for the review and disposition of nonconforming product, and the process for approving personnel making the decisions. Where applicable, the organization shall deal with nonconforming product by one or more of the following ways: a)by taking action to eliminate the detected nonconformity; b)by authorizing its u, relea or acceptance under concession by a relevant authority and, where applicable, by the customer; c)by taking action to preclude its original intended u or application. d)by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconformity product is detected after delivery or u has started; -The organization’s nonconforming product control process shall provide for timely reporting of delivered nonconforming product; NOTE Parties requiring notification of nonconforming product may include suppliers, internal organizations, customers, distributors, and regulatory authorities. e) by taking action necessary to contain the effect of the nonconformity on other process or products. Dispositions of u-as-is or repair shall only be ud after approval by an authorized reprentative of the organization responsible for design. NOTE Authorized reprentative includes personnel/having delegated authority from the design organization. The organization shall not u dispositions of u-as-is or repair, unless specifically authorized by the customer, if the nonconformity results in a departure from the contract requirements. Product dispositioned for scrap shall be conspicuously and permanently marked, or positively controlled, until physically rendered unusable. When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements. Records of the nature of the nonconformities and any subquent actions taken, including concessions obtained, shall be maintained (e 4.2.4). 8.4 Analysis of Data The organization shall determine, collect and analy appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data shall provide information relating to a)customer satisfaction (e 8.2.1), b)conformity to product requirements (e 8.2.4), c)characteristics and trends of process and products including opportunities for preventive action(e 8.2.3 and 8.2.4), and d)suppliers.(e 7.4) 8.5 Improvement 8.5.1 Continual improvement The organization shall continually improve the effectiveness of the quality management system through the u of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. The organization shall monitor the implementation of improvement activities and evaluate the effectiveness of the result. NOTE Continual improvement opportunities can result from lessons learned, problem resolutions and the benchmarking of best practices. 8.5.2 Corrective action The organization shall take action to eliminate the cau of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered. A documented procedure shall be established to define requirements for a)reviewing nonconformities (including customer complaints); b)determining the caus of nonconformities, c)evaluating the need for action to ensure that nonconformities do not recur, d)determining and implementing the action needed, e)records of the results of action taken (e 4.2.4), f)reviewing the effectiveness of the corrective action taken, g)flowing down corrective action requirements to a supplier, when it is determined that the supplier is responsible for the nonconformity, h)specific actions where timely and/or effective corrective actions are not achieved, and i)determining if additional nonconforming product exists bad on the caus of the nonconformities and taking further action when required. 8.5.3 Preventive action The organization shall determine action to eliminate the caus of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems. A documented procedure shall be established to define requirements for a)determining potential nonconformities and their caus, b)evaluating the need for action to prevent occurrence of nonconformities, c)determining and implementing action needed, d)records of results of action taken (e 4.2.4), and e)reviewing the effectiveness of the preventive action taken. NOTE Examples of preventive action opportunities include risk management, error proofing, failure mode and effect analysis (FMEA), and information on product problems reported by external sources. | 质量管理体系－ 航空,航天和国防组织的要求 1范围 1.1 总则 本标准包括ISO9001：2008质量管理体系要求,规定了附加的航空,航天和国防的行业要求,定义和注释.附加要求以加粗斜体表示。 要强调的是本标准所规定的质量管理体系要求是对合同和适用法律法规要求的补充（不是取代）。如果本标准的要求和适用法律法规之间有冲突,以后者优先. 本国际标准为有下列需求的组织规定了质量管理体系要求: a)需要证实其有能力稳定地提供满足顾客和适用的法律法规要求的产品; b)通过对体系的有效应用,包括体系持续改进的过程以及保证符合顾客与适用的法律法规要求,旨在增强顾客满意。 注1： 在本国际标准中，术语“产品”仅适用于 a) 预期提供给顾客或顾客所要求的产品。 b) 产品实现过程所产生的任何预期输出。 注2： 法律法规要求可称作法定要求。 1.2 应用 本国际标准规定的所有要求是通用的，旨在适用于各种类型、不同规模和提供不同产品的组织。 本国际标准的任何要求因组织及其产品的特点而不适用时，可以考虑对其进行删减。 除非删减仅限于本国际标准的第7章中那些不影响组织提供满足顾客及适用法律法规要求的产品的能力或责任的要求，否则不可以声称符合本国际标准。 这个标准意图用于设计，开发，和/或生产航空，航天和国防产品，以及提供售后支持的组织，包括给自己的产品提供维修，备件，或材料的组织使用。 主要业务是给民用和军用航空产品提供维护，修理和大修服务的组织;和独立地进行维护，修理和大修活动，或者明显不同于他们自己的制造/生产活动的原始设备厂家，应当采用IAQG开发的9110标准(见参考目录)。 采购部件，材料和组件，并销售这些部件给航空，航天和国防工业的组织，包括采购产品并分组成小额的数量进行买卖的组织，应当采用IAQG开发的9120标准（见参考目录）， 2 引用标准 下列文件中的条款通过本标准的引用而成为本标准的条款。凡是注日期的引用文件,只有这个版本适用。凡是不注日期的引用文件，其最新版本适用于本标准。 ISO 9000:2005，质量管理体系–基础与词汇 3．术语与定义 本国际标准采用ISO9000中的术语与定义。 本国际标准所出现的术语“产品”，也可指“服务”。 3.1风险： 一种不需要的情况或环境,可能是事故的初期和会有潜在负面结果. 3.2特殊要求 由顾客识别或组织自己确定的要求,这些要求的实现由高风险,因而要求它们包含在风险管理过程中.确定特殊要求的因素包括产品或过程的复杂性,过去的经验和产品或过程的成熟性.特殊要求的例子包括顾客强加的业绩要求,而这是行业接受的最高能力或是组织确定的技术或过程能力的最高能. 3.3关键项目 对产品的实现和使用有重要影响的项目(如功能，零件,软件,特性,过程),包括安全，性能，形成，安装，功能,可生产性，服务寿命等，这些特定要求要被足够地管理。举例如关键项目包括安全临界项目，破损关键项目，任务关键项目,关键特性,等。 3.4 关键特性 是一种特性或性能，其变化将对产品装配 ,形式，功能，性能 ,服务寿命或制造性产生重大影响，因而要求采取特殊措施对其变化进行控制。 注：特殊要求和关键项目以及关键特性是相互关联的新术语，特殊要求是在确定和评审与产品有关的要求时识别的（见7.2.1和7.2.2）。特殊要求可能要求识别关键项目。设计输出（见7.2.3)可能包括识别要求采取特殊措施保证其得到充分管理的关键项目。一些关键项目由于需要对其变化进行控制会被进行一步划分为关键特性。 4 质量管理体系 4.1总要求 组织应按本国际标准的要求建立质量管理体系，形成文件，加以实施和保持，并持续改进其有效性。 组织的质量管理体系必须考虑顾客和适用法律法规的质量管理体系要求. 组织应： a)确定质量管理体系所需的过程及其在组织中的应用(见1.2)； b)确定这些过程的顺序和相互作用； c)确定为确保这些过程的有效运行和控制所需的准则和方法； d)确保可以获得必要的资源和信息，以支持这些过程的运行和对这些过程的监视； e)监视、适用时测量和分析这些过程； f)实施必要的措施，以实现对这些过程策划的结果和对这些过程的持续进。 组织应按本国际标准的要求管理这些过程。 针对组织所选择任何影响产品符合要求的外包过程，组织应确保对其实施控制。 对这些外包过程的控制类型和程度应在质量管理体系中加以识别。 注1：上述质量管理体系所需的过程应当包括管理活动、资源提供、产品实现,测量,分析和改进的过程。 注2：外包过程是经组织识别为质量管理体系所需的，但选择由组织的外部方实施的过程。 注3：确保对外包过程的控制并不免除组织满足顾客和法律法规要求的责任。对外包过程控制的类型和程度可受下列因素影响： a) 外包过程对组织提供满足要求的产品的能力的潜在影响； b) 对外包过程控制的分担程度； c) 通过应用7.4条款实现所需控制的能力。 4.2文件要求 4.2.1 总则 质量管理体系文件应包括： a)形成文件的质量方针与质量目标； b)质量手册； c)本国际标准要求的形成文件的程序和记录； d)组织确定的为确保其过程的有效策划、运行和控制所需的文件,包括记录； 组织应确保人员可以接触到并知道相关质量管理体系文件和更改。 注1：本国际标准中出现“形成文件的程序”之处，即要求该程序必须被建立、形成文件、并加以实施及维持。。一个文件可包括一个或多个程序的要求。一个形成文件的程序的要求可以被包含在多个文件中。 注2：不同组织的质量管理体系文件的多少和详略程度取决于： a)组织的规模及活动的类型， b)过程及其相互作用的复杂程度， c)人员能力。 注3：文件可采用任何形式或类型的媒体。 4.2.2 质量手册 组织应建立并保持质量手册，其包括： a)质量管理体系的范围，包括任何删减的细节与合理性 (见1.2); b)为质量管理体系编制的形成文件的程序，或对其引用;以及 c)质量管理体系过程之间的相互作用的表述。 4.2.3 文件控制 质量管理体系所要求的文件应加以控制。记录是一种特殊形式的文件，应依据4.2.4的要求加以控制。 应建立形成文件的程序，以规定以下方面必需的控制： a)文件发布前得到批准，以确保文件是充分和适宜的； b)必要时对文件进行评审和更新，并再次批准； c)确保文件的更改和现行修订状态得到识别； d)确保在使用处可获得适用文件的有关版本； e)确保文件保持清晰、易于识别； f) 确保组织所确定的策划和运行质量管理体系所需的外来文件得到识别，并控制其分发； g) 防止作废文件的非预期使用，若因任何原因而要保留作废文件时，对这些文件进行适当的标识。 4.2.4 记录控制 为符合要求和质量管理体系有效运行提供证据而建立的记录，应予以控制。 组织应编制形成文件的程序，以规定记录的标识、贮存、保护、检索、保存和处置所需的控制。 形成文件的程序应规定由供方生成的记录和/或保存的控制方法。 记录应保持清晰，易于识别和检索。 5 管理职责 5.1 管理承诺 最高管理者应通过以下活动，对其建立、实施质量管理体系并持续改进其有效性的承诺提供证据： a)向组织传达满足顾客和法律法规要求的重要性； b)制定质量方针； c)确保质量目标的制定； d)进行管理评审； e)确保资源的获得。 5.2以顾客为关注焦点 最高管理者应以增强顾客满意为目的，确保顾客的要求得到确定并予以满足。 (见7.2.1和8.2.1)。 最高管理者必须确保产品符合性和及时交付业绩被测量，如果策划的结果不能取得时，应当采取适当的措施 5.3 质量方针 最高管理者应确保质量方针 a)与组织的宗旨相适应， b)包括对满足要求和持续改进质量管理体系有效性的承诺； c)提供制定和评审质量目标的框架， d)在组织内部得到沟通和理解，以及 e)在持续适宜性方面得到评审。 5.4 策划 5.4.1 质量目标 最高管理者应确保在组织内部的相关职能和层次上建立质量目标，质量目标包括满足产品要求(见7.1.a)所需的内容。质量目标应是可测量的，并与质量方针保持一致。 5.4.2 质量管理体系策划 最高管理者应确保： a)对质量管理体系进行策划，以满足质量目标以及4.1的要求，和 b)在对质量管理体系的变更进行策划和实施时，保持质量管理体系的完整性。 5.5职责、权限与沟通 5.5.1 职责与权限 香尸谜案最高管理者应确保组织内的职责、权限得到规定和沟通。 5.5.2管理者代表 最高管理者应指定一名组织的管理者，无论该成员在其他方面的职责如何，应具有以下方面的职责和权限： a)确保质量管理体系所需的过程的得到建立、实施和保持； b)向最高管理者报告质量管理体系的业绩和任何改进的需求； c)确保在整个组织内提高满足顾客要求的意识。 d)不受组织干预和直径面对最高管理层地解决有关质量问题。 注：管理者代表的职责可包括与质量管理体系有关事宜的外部联络。 5.5.3 内部沟通 最高管理者应确保在组织内建立适当的沟通过程，并确保对质量管理体系的有效性进行沟通。 5.6 管理评审 5.6.1 总则 最高管理者应按策划的时间间隔评审质量管理体系，以确保其持续的适宜性、充分性和有效性。管理评审应包括评价质量管理体系改进的机会和变更的需要，包括质量方针和质量目标。 应保持管理评审的记录(见4.2. 4)。 5.6.2 管理评审的输入 管理评审的输入应包括以下方面的信息： a)审核结果； b)顾客反馈； c)过程的业绩和产品的符合性； d)预防和纠正措施状况； e)以往管理评审的跟踪措施； f)可能影响质量管理体系的变更； g)改进的建议。 5.6.3 管理评审输出 管理评审的输出应包括与以下方面有关的任何决定和措施： a)质量管理体系及其过程有效性的改进； b)与顾客要求有关的产品的改进； c)资源需求。 6.资源管理 6.1 资源提供 组织应确定并提供以下方面所需的资源: a)实施、保持质量管理体系并持续改进其有效性； b)通过满足顾客要求，增强顾客满意。 6.2 人力资源 6.2.1 总则 基于适当的教育、培训、技能和经验，从事影响产品与要求符合性工作的人员应是能够胜任的。 注 ：在质量管理体系中承担任何任务的人员都可能直接或间接地影响产品与要求的符合性。 6.2.2 能力、意识和培训 组织应： a)确定从事影响产品与要求的符合性工作的人员所必要的能力； b)适用时，提供培训或采取其他措施以获得所需的能力； c)评价所采取措施的有效性； d)确保员工认识到所从事活动的相互性和重要性，以及如何为实现质量目标作出贡献； e)保持教育、培训、技能和经验的适当记录(见4.2.4)。 6.3 基础设施 组织应确定、提供并维护为达到产品符合要求所需的基础设施。适用时，基础设施包括： a)建筑物、工作场所和相干的设施； b)过程设备(硬件和软件)； c)支持性服务( 例如运输,通讯或信息系统)。 6.4 工作环境 组织应确定并管理为达到产品符合要求所需的工作环境。 注：术语“工作环境”是指工作时所处的条件，包括物理的、环境的和其他因素（如噪音、温度、湿度、照明或天气）。 7 产品实现 7.1 产品实现的策划 组织应策划和开发产品实现所需的过程。产品实现的策划应与质量管理体系其他过程的要求相一致（见4.1）。 在对产品实现进行策划时，组织应确定以下方面的适当内容： a)产品的质量目标和要求； 注: 产品的质量目标和要求包括考虑下述方面,如： -产品和人员安全； -可靠性、可用性和可维护性； -可生产性和可检验性； -使用在产品中的零件和材料的适宜性； -嵌入式软件的选择和开发； -产品在寿命结束时的回收和最终处理。 b)针对产品确定过程、文件和资源的需求； c)产品所要求的验证、确认、监视、测量、检验和试验活动，以及产品接收准则； d)为实现过程及其产品满足要求提供证据所需的记录(见 4.2.4)。 e)适合于产品的技术状态管理； f)支持产品使用及维护的资源。 策划的输出形式应适合于组织的运作方式。 注1：对应用于特定产品、项目或合同的质量管理体系的过程(包括产品实现过程)和资源作出规定的文件可称之为质量计划。 注2：组织也可将7.3的要求应用于产品实现过程的开发。 7.1.1 项目管理 当适合于组织和产品时，组织应以一种结构化的和受控的方式去策划和管理产品实现，并在限定资源和时间周期内,用一种可接受的风险来满足要求。 7.1.2 风险管理 组织应建立、实施和保持风险管理过程，以实现适用的要求，适当时包括对组织和产品的要求： a)风险管理的职责分配； b)风险准则的确定（如：可能性、后果,风险接受程度）； c)在产品实现全过程中风险的识别、评估和交流； d)对于超过确定的风险接受准则时，减轻风险措施的识别、实施和管理； e)减轻风险措施实施后,风险保持在可接受水平上。 7.1.3 技术状态管理 组织应建立、实施和保持适用于产品的技术状态管理过程，包括： a) 技术状态管理策划 b) 技术状态标识； c) 更改控制； d) 技术状态纪实； e) 技术状态审核。 注：见ISO 10007作为指南。 7.1.4工作转移的控制 组织应建立、实施和保持一个策划和控制临时性或永久性转移工作的过程,（如：从组织的一处设施转移到组织的另一处， 从组织转移到供应商，从一个供应商转移到另一个供应商）,并验证工作对要求的符合性。 7.2 与顾客有关的过程 7.2.1与产品有关的要求的确定 组织应确定： a)顾客规定的要求，包括对交付及交付后活动的要求； b)顾客虽然没有明示，但规定的用途或已知的预期用途所必需的要求； c)适用于产品的法律法规要求； d)组织认为必要的任何附加要求。 注：与产品有关的要求包括特殊要求。 注：交付后活动包括，例如：担保规定下的活动、合同义务如维修服务,以及附加的服务如回收或最终处置。 7.2.2 与产品有关的要求的评审 织应评审与产品有关的要求。评审应在组织向顾客作出提供产品的承诺之前进行(如：提交标书、接受合同或订单及接受合同或订单的更改)，并应确保： a)产品要求得到规定； b)与以前表述不一致的合同或订单的要求已予解决; c)组织有能力满足规定的要求，以及 d)产品的特殊要求已得到确定， e)风险已被识别（如：新技术，短的交付期） (见7.1.2) 评审结果及评审所引起的措施的的记录应予保持(见4.2.4)。 若顾客提供的要求没有形成文件，组织在接受顾客要求前应对顾客要求进行确认。 若产品要求发生变更，组织应确保相关文件等到修改，并确保相关人员知道已变更的要求。 注：在某些情况下，例如网上销售，对每一个订单进行正式的评审可能是不实际的。而代之对有关的产品信息，如产品目录、产品广告内容等进行评审。 7.2.3 顾客沟通 组织应对以下有关方面确定并实施与顾客沟通的有效的安排： a)产品信息； b)问询、合同或订单的处理，包括对其修改； c)顾客反馈，包括顾客抱怨。 7.3 设计和开发 7.3.1 设计和开发策划 组织应对产品的设计和开发进行策划和控制。 在进行设计和开发策划时，组织应确定： a)设计和开发阶段； b)适合于每个设计和开发阶段的评审、验证和确认活动； c)设计和开发的职责和权限。 在适用的场合，组织应将设计和开发工作分解为明显的活动，对每项活动，确定任务、必需的资源、职责、设计内容、输入和输出数据以及策划限制条件。 应基于符合顾客和法律法规要求的产品安全和功能目标之上，完成不同的设计和开发任务。 设计和开发策划应考虑生产、检验、试验和维护产品的能力。 组织应对参与设计和开发的不同小组之间的接口进行管理，以确保有效的沟通，并明确职责分工。 随设计和开发的进展，在适当时，策划的输出应予更新。 注：设计和开发评审、验证和确认具有不同的目的。根据产品和组织的具体情况，可以单独或任意组合的形式进行并记录。 7.3.2 设计和开发输入 应确定与产品要求有关的输入，并保持记录(见4.2.4)。这些输入应包括： a)功能和性能要求； b)适用的法律、法规要求； c)适用时，以前类似设计提供的信息； d)设计和开发所必需的其他要求。 应对这些输入进行评审，以确保输入是充分的。要求应完整、清楚，并且不能自相矛盾。 7.3.3 设计和开发输出 设计和开发输出的方式应适合于针对设计和开发的输入进行验证, 并应在放行前得到批准。 设计和开发输出应： a)满足设计和开发输入的要求； b)给出采购、生产和服务提供的适当信息； c)包含或引用产品接收准则； d)规定对产品的安全和正常使用所必需的产品特性,和 e)适用时，规定任何关键项目，包括任何关键特性，以及对这些项目要采取的特殊措施 组织应确定对产品进行标识、制造、检验、使用和维护所要求的数据，包括例如： -定义产品技术状态和设计特性所必需的图纸，零件清单和规范； -保证产品符合性所需的材料、过程、制造和装配数据。 注：生产和服务提供的信息可能包括产品防护的细节。 7.3.4设计和开发评审 在适宜的阶段，应依据所策划的安排(见7.3.1)对设计和开发进行有系统的评审，以便： a)评价设计和开发的结果满足要求的能力； b)识别任何问题并提出必要的措施，和 c) 授权进入下一阶段。 评审的参加者应包括与所评审的设计和开发阶段有关的职能的代表。评审结果及任何必要措施的记录应予保持。(见4.2.4) 7.3.5 设计和开发验证 为确保设计和开发输出满足输入的要求，应依据所策划(见7.3.1)的安排对设计和开发进行验证。验证结果及任何必要措施的记录应予保持(见4.2.4)。 7.3.6 设计和开发确认 为确保产品能够满足规定的使用要求或已知的预期用途的要求，应依据所策划(见7.3.1)的安排对设计和开发进行确认。只要可行，确认应在产品交付或实施之前完成。确认结果及任何必要措施的记录应予保持。(见4.2.4)。 7.3.6.1 设计和开发文件的验证和确认试验 当验证和确认必须进行试验时，应对这些试验进行策划、控制、评审并形成文件，以确保和证实： a.试验计划或规范确定了要进行试验的产品和使用的资源；规定了试验目的和条件、要记录的参数以及相关接收准则； b.试验程序描述了操作方法、试验的性能和记录的结果； c.提交试验的产品的样品技术状态正确； d. 遵守了试验计划和试验程序的要求； e. 满足了接收准则。 7.3.6.2 设计和开发验证和确认试验的文件 在设计和/或开发完成时，组织必须确保报告、 计算、试验结果等能够证实在所规定的运行条件下，产品的定义符合规范的要求。 7.3.7 设计和开发更改的控制 应识别设计和开发的更改，并保持记录。适当时，应对设计和开发的更改进行评审、验证和确认，并在实施前得到批准。设计和开发更改的评审应包括评价更改对产品组成部分和已交付产品的影响。 设计和开发的更改应按技术状态管理过程（见7.1.3）进行控制。 更改的评审结果及任何必要措施的记录应予保持。(见4.2.4)。 7.4 采购 7.4.1 采购过程 组织应确保采购的产品符合规定的采购要求。对供方及采购的产品控制的类型和程度应取决于采购的产品对随后的产品实现或最终产品的影响。 组织必须对所有从供应商采购的产品的符合性负责，包括从顾客指定的来源采购的产品。 组织应根据供方按组织的要求提供产品的能力评价和选择供方。应制定选择、评价和重新评价的准则。评价结果及评价所引起的任何必要措施的记录应予保持(见4.2.4)。 注：在选择和评价供应商过程中，可使用来自客观和可靠的外部来源的供应商质量数据作为组织自己的评估,（例如：来自授信的质量管理体系或过程认证机构,来自政府机构对组织的批准）。使用这种数据只能是组织对供应商控制过程的一个组成部分，组织仍然负责验证采购的产品满足规定采购要求的责任。 组织应： a)保持一份批准的供方名录，包括批准状态（如：批准，有条件批准，不批准）和批准范围（如：产品类型、过程类别）； b)周期性地评估供方的业绩；应使用这些评审结果作为确定实施控制程度的依据； c)当供应商不能满足要求时，规定采取必要的措施； d)当要求时，确保组织和所有供应商都使用顾客批准的特殊过程资源； e)对于批准状态决定、批准状态更改以及根据供应商批准状态对供应商进行控制使用的条件确定过程、职责和权力。 f)选择和使用供应商时，确定和管理风险(见7.1.2)。 7.4.2 采购信息 采购信息应表述拟采购的产品，适当时包括： a)产品、程序、过程和设备的批准要求； b)人员资格的要求； c)质量管理体系的要求； d) 规范、图样、过程要求、检验/验证说明书和其他有关的技术资料的标识和修订状态； e）组织的设计、试验、检验、验证的要求（包括生产过程的验证），用于产品接收的统计技术的使用，和有关组织接收的指导书，以及适用的关键项目包括关键特性； f）用于设计批准、检验/验证、调查或审核的 试验样件的要求（例如，生产方法，数量。储存条件）。 g)需要考虑对供应商的下述要求： -向组织通报不合格产品， -不合格品处理得到组织批准； -将产品和/或过程的更改，供应商更改，生产设施地点更改应报告组织，并且在要求时获得组织的批准； -向供应链传达适用要求，包括顾客要求； h) 记录保存要求； i) 组织及其顾客,和法规性机构可接触涉及订单的任何层次的供应链所有设施的适用区域,和所有适用记录的权利。 在与供方沟通前，组织应确保所规定的采购要求是充分与适宜的。 7.4.3 采购产品的验证 组织应确定并实施检验或其他必要的活动，以确保采购的产品满足规定的采购要求。 注1 组织或供方不应该把顾客对任何层次的供应链所做的验证活动用作质量有效控制的证据，也不能免除组织提供可接受产品和符合所有要求的责任。 注2验证活动可以包括 a)从供应商处获得产品符合性的客观证据（如随产品文件，合格证明，试验报告，统计记录，过程控制记录）； b)在供应商处的检验和审核； c)对要求的文件的评审； d)按收货单检验产品， e)对供方委托验证代表，或要求供方认证。 在等待所有要求的验证活动完成前，如果采购的产品被发放用于生产，应对其进行标识和记录，做到如果验证结果发现产品不符合要求，能够对其进行召回和更换。 在组织派人员去供应商处进行验证时，应规定委派的要求并保持委派人员的记录。 当组织或其顾客拟在供方的现场实施验证时，组织应在采购信息中对拟验证的安排和产品放行的方法作出规定。 7.5 生产和服务提供 7.5.1 生产和服务提供的控制 组织应策划并在受控条件下进行生产和服务提供。适用时，受控条件应包括： a)获得表述产品特性的信息； 注：信息可包括图纸、零件清单、材料和工艺规范。 b)必要时，获得作业指导书； 注：作业指导书可包括过程流程图、生产文件（如：制造计划、路线图、流程卡、生产指令和过程卡）和检验文件。 c)使用适宜的设备； 注：适宜的设备可包括产品专用工装（型架、夹具、模具）和软件程序。 d)获得和使用监视和测量设备； e)实施监视和测量；领导力的重要性 f)产品放行、交付和交付后活动的实施； g）在生产过程中对所有的产品负有责任（例 如：零件数量、分作业指令、不合格品等）； h）所有生产和检验/验证操作已经按计划或其他文件完成的证据并被认可； i）预防、检测和去除外来物的措施； j）对会影响产品要求符合性的用品和供给物（如水、压缩空气、电及化学产品）进行监视和控制， k）以最清楚实用的方式（例如，文字标准、样件或图示）规定工艺准则。 适用时，策划应考虑： -建立、实施和保持适当的过程来管理关键项目，包括对识别出关键特性的过程控制； -设计、制造和使用工具以测量变量数据； -当适宜的符合性验证不能在产品实现的后面阶段进行时，识别过程中的检验/验证点。 -特殊过程(见7.5.2）。 7.5.1.1 生产过程的验证 组织应使用从首批生产的新零件或组件中确定的有代表性的项目来验证生产过程、生产文件和工装能够生产满足要求的零件和部件。当发生使原来验证结果无效的更改时，应进行重新验证过程(如工程更改,制造过程更改,工装更改)。 注：此项活动通常被称为首件检验。 7.5.1.2 生产过程更改的控制 必须确定授权批准生产过程更改的人员。 组织应当对影响过程、生产设备、工装或软件程序的更改进行控制和文件化。 对生产过程更改的结果应进行评定，以便证实已达到了预期的效果并对产品符合性没有不利的影响。 7.5.1.3 生产设备、工装和软件程序的控制 生产设备、工装和用于使生产实现过程自动化和控制/监视的软件程序在使用前应进行确认，并应进行维护。 对储存的生产设备或工装必须确定储存要求，包括定期进行防护和状况检查。 7.5.1.4 交付后支持 适用时，交付后应为下述活动提供支持： a)使用中数据的收集和分析； b)当交付后发现问题时，要采取的措施，包括调查和报告； c)技术文件的控制和更新； d)修理大纲的批准、控制和使用； e)对基地外工作要求的控制（例如，组织在顾客设施上进行的工作）。 7.5.2 生产和服务提供过程的确认 当生产和服务提供的过程输出不能由后续的监视或测量加以验证，致使问题在产品投入使用后或服务已交付后才显现时，组织应对任何这样的过程实施确认。 注：这些过程通常被认为是特殊过程。 确认应证实这些过程实现所策划的结果的能力。 组织应对这些过程作出安排，适用时包括： a)为过程的评审和批准规定准则； b)设备的认可和人员资格的鉴定； c)使用特定的方法和程序； d)记录的要求 (见4.2.4)； e)再确认。 7.5.3 标识和追溯性 适当时，组织应在产品实现的全过程中使用适宜的方法识别产品。 组织应保持产品技术状态的识别，以便识别产品实际的技术状态和约定的技术状态之间的任何区别。 组织应在产品实现的全过程中，针对监视和测量要求识别产品的状态。 当使用可接受授权媒体时（例如，印章、电子签名、口令），组织应对媒体的控制作出适当规定。 在有可追溯性要求的场合，组织应控制并记录产品的唯一性标识, 并保持记录(见4.2.4)。 注：可追溯性要求可包括： -整个产品寿命期内保持标识； -能追溯由同一批原材料或同一制造批生产的所有产品，以及所有同一批产品的最终去向（如交付、报废）； -对于组件，能追溯其组合的单元件以及后面更高级的组件的标识； -对给定的产品，能追溯其生产（加工、装配、检验/验证）的连续的记录。 注：在某些行业，技术状态管理是保持标识和可追溯性的一种方法（见7.1.3）。 7.5.4 顾客财产 组织应爱护在组织控制下或组织使用的顾客财产。组织应识别、验证、保护和维护供其使用或构成产品一部分的顾客财产。若顾客财产发生丢失、损坏或发现不适用的情况时，组织应报告顾客，并保持记录（见4.2.4）。 注：顾客财产可包括知识产权和个人信息。 7.5.5 产品防护 组织应在内部处理和交付到预定的地点期间对产品提供防护，以保持与要求的符合性。适用时，这种防护应包括标识、搬运、包装、贮存和保护。 防护也应适用于产品的组成部分。 适用时，按产品规范和适用的法律法规，产品的防护还应包括下列规定： a.清洁； b.预防、检测并去除外来物； c.对敏感的产品的特殊处理； d. 包括安全警示的标记和标签，； e. 贮存期控制和存货周转；和 f.对危险材料的特殊处理。 7.6 监视和测量装置的控制 组织必须确定需实施的监控和测量及所需的监视和测量设备，为产品符合规定的要求(见7.2.1)提供证据。 组织必须保持这些监视和测量设备的清单；并规定其校准/检定所采用的过程，包括设备型号、唯一性标识、所在位置、校准周期、检验方法和接收准则。 注：监视和测量设备包括但不限于：试验硬件、试验软件、自动试验设备（ATE）和用于获取试验数据的绘图仪。也包括用于提供产品符合证据的个人拥有的和顾客提供的设备。 组织必须建立过程，以确保监视与测量活动可行，并与监视和测量的要求相一致的方式实施。 组织必须确保校准、检验、测量和试验有适宜的环境条件。 为确保结果有效，必要时，测量设备应: a)对照能溯源到国际或国家的测量标准，按照规定的时间间隔，或在使用之前，进行校准或者检定；当不存在这种标准时，必须记录校准或检定的依据（见4.2.4）。 b)进行调整或必要时再调整； c)具有标识，以确定其校准状态； d)防止可能使测量结果失效的调整； e)在搬运、维护与储存期间防止损坏或失效。 组织应对监视和测量设备要求校准和检定时的召回，建立、实施并保持一个过程。 此外，当发现设备不符合要求时，组织应对以前测量结果的有效性进行评价和记录。组织必须对该设备和任何受到影响的产品采取适当的措施。 校准和验证结果的记录必须加以保持(见4.2.4)。 当计算机软件用于规定要求的监视和测量时，应确认其满足预期用途的能力，确认必须在首次使用之前进行，必要时再重新确认。 注：确认计算机软件满足预期用途能力的典型方法包括验证和保持其适用性的配置管理（技术状态管理）。 8 测量、分析和改进 8.1 总则 组织应策划并实施以下方面所需的监视、测量、分析和改进过程： a)证实产品要求的符合性； b)确保质量管理体系的符合性； c)持续改进质量管理体系的有效性。 这应包括对统计技术在内的适用的方法及其应用程度的确定。 注：根据产品的性质并依据规定的要求，统计技术可以用于支持： －设计验证（例如：可靠性、维修性、安全性）； －过程控制： －关键特性的选择和检验； －过程能力测量； －统计过程控制； －实验设计； －检验,和 －失效模式、影响和严重度分析。 8.2监视和测量 8.2.1 顾客满意 作为对质量管理体系业绩的一种测量，组织应对顾客有关组织是否已满足其要求的感受的信息进行监视，并确定获取和利用这种信息的方法。 监视和用于评价顾客满意的信息应包括，但不限于：产品符合性，准时交付表现，顾客抱怨和纠正措施要求。组织应开发和实施顾客满意度改进计划来解决识别出的不足，并评价结果的有效性。 注：监视顾客感受可以包括从诸如顾客满意调查、来自顾客的关于交付产品质量方面数据、用户意见调查、业务损失分析、顾客赞扬、担保索赔、经销商报告之类的来源获得输入。 8.2.2 内部审核 组织应按策划的时间间隔进行内部审核，以确定质量管理体系是否： a)符合策划(见7.1)的安排，本国际标准的要求以及组织所确定的质量管理体系的要求； 注：策划的安排包括顾客合同要求。 b)得到有效实施与保持。 考虑拟审核的过程和区域的状况和重要性以及以往审核的结果，组织应对审核方案进行策划。应规定审核的准则、范围、频次和方法。审核员的选择和审核的实施应确保审核过程的客观性和公正性。审核员不应审核自己的工作。 应编制形成文件的程序，以规定审核的策划、实施以及形成记录和报告结果的职责和要求。 应保持审核及其结果的记录（见惊字组词4.2.4） 负责受审区域的管理者应确保及时采取必要的纠正和纠正措施，以消除所发现的不合格及其原因。跟踪活动应包括对所采取措施的验证和验证结果的报告（见8.5.2）。 注：作为指南，参见GB/T 19011. 8.2.3 过程的监视和测量 组织应采用适宜的方法对质量管理体系过程进行监视，并在适用时进行测量。这些方法应证实过程实现所策划的结果的能力。当未能达到所策划的结果时，应采取适当的纠正和纠正措施，以确保产品的符合性。 注： 当确定适宜的方法时，建议组织就这些过程对产品要求的符合性和质量管理体系有效性的影响，考虑监视和测量的类型与程度。 如果过程不合格，组织必须： a.采取适当的措施纠正不合格的过程； b.评估过程的不合格是否已导致产品的不合格 c.确定过程不合格是否限于特殊情况，或是否已经影响了其它过程或产品； d. 识别和控制任何的不合格品(见8.3)。 8.2.4 产品的监视与测量 组织应对产品的特性进进行监视和测量，以验证产品要求已得到满足。这种监视和测量应依据所策划的安排(见7.1)，在产品实现过程的适当阶段进行。符合接收准则的记录应予保持。 对产品接收的测量要求应形成文件并应包括： a)接收和/或拒收准则； b)按顺序进行测量和试验操作的场所； c)要求的测量结果的记录（至少表明接收还是拒收）； d)要求的任何专用测量仪器及其有关的专用使用说明书。 当关键项目，包括关键特性已被识别时，组织应保证按照建立的过程，对其进行控制和监视。 管仲和鲍叔牙的故事 当组织使用抽样检验作为产品接收的方法时，抽样计划在公认统计原理基础上应是合理的，并是适于使用（如：抽样计划与产品的重要度和过程能力相匹配）。 在等待所有要求的监视和测量活动完成前，如果产品被发放用于生产，应对其进行标识和记录，做到如果后来发现产品不符合要求，能够对其进行召回和更换。 记录必须指明有权将产品放行给顾客的人员(见4.2.4)。 在需要证明产品检验合格的场合，组织应保证记录提供产品满足确定要求的证据。 除非得到有关授权人员的批准，适用时得到顾客批准，否则在策划所作安排(见7.1)已经满意地完成之前，不得向顾客放行产品和交付服务。 组织应保证所有要求随同产品的文件在交付时一同提供。 8.3. 不合格品控制 组织应确保不符合产品要求的产品得到识别和控制，以防止其非预 期的使用或交付。应编制形成文件的程序，以对处理不合格品确定控制过程和有关责任和权限。 注：术语“不合格品”包括从顾客退回的不合格品。 组织的形成文件的程序应规定不合格品的评审和处置的职责和权限，以及批准作出这些决定的人员的过程。 在适用的场合，组织必须通过下列一种或多种途径，处置不合格品： a)采取措施，消除已发现的不符合； b)经有关授权人员批准，适用的时经顾客批准，让步使用、放行或接收不合格品。 c)采取措施，防止其原预期的使用或应用。 d)当不合格品在交付后或开始使用后才被发现，采取适合于不合格的影响或潜在影响的措施。 -组织的不合格产品控制过程应及时提供对已交付的不合格产品的报告。 注: 要求通知不合格产品的当事方可能包括：供应商、内部组织、顾客、分销商和管理当局。 e) 采取必要的措施，控制不合格品对其它过程和产品的影响； 只有经过授权的、组织负责设计的代表批准后，才可以做出原样使用或返修的处置。 注: 授权的代表包括来自设计组织委托授权的代表。 如果不合格导致偏离合同要求，除非经过顾客特殊批准，否则组织不能做出原样使用或修理的处置。 处置为报废的产品，必须做出明显的和永久性的标记，或进行有效的控制，直至在物理上不可能被使用。 在不合格品得到纠正之后，应对其再次进行验证，以证实符合要求。 应保持不合格的性质及其后所采取的任何措施的记录，包括所批准的让步的记录(见4.2.4)。 8.4 数据分析 组织应确定、收集和分析适当的数据，以证实质量管理体系的适宜性和有效性，并评价在何处可以持续改进质量管理体系的有效性。这应包括来自监视和测量的结果以及其他有关来源的数据。 数据分析应提供以下有关方面的信息: a)顾客满意(见8.2.1); b)与产品要求的符合性(见8.2.4); c)过程和产品的特性及趋势，包括采取预防措施的机会,(见8.2.3和8.2.4); d)供方(见7.4)。 8.5 改进 8.5.1 持续改进 组织应利用质量方针、质量目标、审核结果、数据分析、纠正和预防措施以及管理评审,持续改进质量管理体系的有效性。 组织应当监视改进活动的实施并评价结果的有效性。 注：持续改进机会可能来自吸取的教训、问题的解决和最佳实践的标杆。 8.5.2 纠正措施 组织应采取措施，以消除不合格的原因，防止不合格的再发生。纠正措施应与所遇到不合格的影响程度相适应。 应编制形成文件的程序,以规定以下方面的要求： a)评审不合格(包括顾客抱怨); b)确定不合格的原因; c)评价确保不合格不再发生的措施的需求; d)确定和实施所需的措施; e)记录所采取措施的结果(见4.2.4); f)评审所采取的纠正措施的有效性。 g)当确定的不符合的责任者是供应商时，向供应商传递纠正措施要求； h)当不能及时和/或有效地实现纠正措施时采取的特别措施。 i)基于不合格的原因，确定是否存在另外的不合格品，当要求时采取进行一步措施。 8.5.3 预防措施 组织应确定措施,以消除潜在不合格的原因，防止不合格的发生。预防措施应与潜在问题的影响程度相适应。 应编制形成文件的程序,以规定以下方面的要求： a)确定潜在不合格及其原因; b)评价防止不合格发生的措施的需求; c)确定和实施所需的措施; d)记录所采取措施的结果(见4.2.4); e)评审所采取的预防措施的有效性。 注：预防措施机会的例子包括风险管理、防错技术、失效模式和影响分析(FMEA)以及来自外部报告的关于产品问题的信息。 | |
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