Quality management systems – Requirements 1 Scope 1.1 General This International Standard specifies requirements for a quality management system where an orga-nization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable 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 regulatory re-quirements. NOTE In this International Standard, the term “product” applies to the product intended for, or required by, a customer. 1.2 Application All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Were any requirement(s) of this international Standard cannot be applied due to the nature of an organization and its product, this can be con-sidered 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 organization’s ability, or responsibility, to provide product that meets customer and applicable regulatory requirements. 2 Normative reference The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subquent amendments to, or revisions of, any of the publications do not apply. However, parties to agreements bad on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 9000:2000, Quality management systems – Fundamentals and vocabulary. 3 Terms and definitions For the purpos of this International Standard, the terms and definitions given in ISO 9000 apply. The following items, ud in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently ud: supplier → organization → customer The term “organization” replaces the term “supplier” ud in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”. Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “rvice”. 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 Inter-national Standard. The organization shall a)identify 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 in-formation necessary to support the operation and monitoring of the process, e)monitor, measure and analyze the process, and f)implement actions necessary to achieve planned results and continual improvement of the process. The process shall be managed by the orga-nization in accordance with the requirements of this International Standard. Where an organization choos to outsource any process that affects product conformity with requirements, the organization shall ensure control over such process. Control of such outsourced process shall be identified within the quality management system. NOTE Process needed for the quality ma-nagement system referred to above should include process for management ac-tivities, provision of resources, product rea-lization and measurement. 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 required by this Inter-national Standard, d)documents needed by the organization to ensure the effective planning, operation and control of its process, and e)records required by this International Standard (e 4.2.4) NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to a)the size of the organization and type of activities, b)the complexity of process and their inter-actions, and c)the competencies 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 (e1.2.), 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 version 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 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 shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. 5 Management responsibility 5.1 Management commitment Top management shall provide evidence of its commitment to the development and imple-mentation of the quality management system and continually improving its effectiveness by a)communicating to the organization the im-portance 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 met with the aim of enhancing customer satisfaction (e 7.2.1 and 8.2.1). 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 re-quirements and continually improve the effectiveness of the quality management system, c)provides a framework for establishing and re-viewing quality objectives, d)is communicated and understood within the organization, and e)is reviewed for continuing suitability. 何足挂齿的意思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 im-plemented. 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority Top management shall ensure that the responsibilities, authorities are defined and communicated within the organization. 5.5.2 Management reprentative Top management shall appoint a member of management who, irrespective of other re-sponsibilities, shall have responsibility and authority that includes a)ensuring that process needed for the quality management system are established, im-plemented and maintained, b)reporting to top management on the per-formance of the quality management system and any need for improvement, and c)ensuring the promotion of awareness of cus-tomer requirements throughout the organization. NOTE The responsibility of a management re-prentative can include liaison with external parties on matters relating to the quality ma-nagement 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 review 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 ma-nagement system, and g)recommendations for improvement. 5.6.3 Review output The output from the management review shall include any decisions and actions relate 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 product quality shall be competent on the basis of a-ppropriate education, training, skills and ex-perience. 6.2.2 Competence, awareness and training The organization shall a)determine the necessary competency for personnel performing work affecting product quality, b)provide training or take other actions to satisfy the needs, 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)building, workspace and associated utilities; b)process equipment (both hardware and soft-ware), and c)supporting rvices (such as transport or com-munication). 6.4 Work environment The organization shall determine and manage the the work environment needed to achieve con-formity to product requirements. 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 pro-duct; b)the need to establish process, documents, and provide resources specific to the product; c)required verification, validation, monitoring, 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). 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 requirement given in 7.3 to the development of product realization process. 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 related to product, and d) any additional requirements determined by the organization. 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, and c)the organization has the ability to meet the defined requirements. 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 re-quirements 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 in 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, 移动硬盘打不开b)enquiries, contracts or order handling, including amendments, and c)customer feedback, including customer com-plaints. 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. 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. 7.3.2 Design and development inputs Inputs relating to product requirements shall be determined and records maintained (e 4.2.4). The shall include a)functional and performance requirements, b)applicable statutory and regulatory re-quirements, c)where applicable, information derived from pre-vious similar designs, and 减肥锻炼计划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 provided in a form that enables 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 for rvice provision, c)contain or reference product acceptance criteria, and d)specify the characteristics of the product that are esntial for its safe and proper u. 7.3.4 Design and development review At suitable stages, systematic reviews of design and development shall be performed in ac-cordance with planned arrangements (e 7.3.1) a)to evaluate the ability of the results of design and development to meet requirements, and b)to identify any problems and propo necessary actions. 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). 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) 7.4 Purchasing 7.4.1 Purchasing process The organization shall ensure that purchad product conforms to specified purcha re-quirements. 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 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) 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, and c)quality management system requirements. The organization shall ensure the adequacy of specified requirements prior to their communication to the supplier.作文梦想 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. 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 rvice provision 7.5.1 Control of production and rvice 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, b)the availability of work instructions, as ne-cessary, c)the u of suitable equipment, d)the availability and u of monitoring and me-asuring devices, e)the implementation of monitoring and me-asurement, and f)the implementation of relea, delivery and post-delivery activities. 7.5.2 Validation of process for production and rvice provision The organization shall validate any process for production and rvice provision where the resulting output cannot be verified by subquent monitoring or measurement. This includes any process where deficiencies become apparent only after the product is in u or the rvice has been delivered. 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 per-sonnel, c)u of specified methods and procedures, d)requirements for records (e 4.2.4), and e)revalidation. 7.5.3 Identification and tractability Where appropriate, the organization shall identify the product by suitable means throughout product realization. The organization shall identify the product status with respect to monitoring and measurement requirements. Where traceability is a requirement, the orga-nization shall control and record the unique identification of the product (e 4.2.4). NOTE In some industry ctors, configuration management is a means by which identification and traceability are maintained. 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, this shall be reported to the customer and records maintained (e 4.2.4). NOTE Customer property can include intellectual property. 7.5.5 Prervation of product The organization shall prerve the conformity of product during internal processing and delivery to the intended destination. This prervation shall include identification, handling, packaging, storage and protection. Prervation shall also apply to the constitute parts of a product. 7.6 Control of monitoring and measuring devices The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (e 7.2.1). 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. 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 me-asurement standards; where no such standards exist, the basis ud for calibration or verification shall be recorded; b)be adjusted or re-adjusted as necessary; c)福建漳浦be identified to enable the calibration status to be determined; d)be safeguarded from adjustments that would invalidate the measurement result; e)be protected from damage and deterioration during handling, maintenance and storage. 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 See ISO 10012-1 and ISO 10012-2 for guidance. 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 of the product, 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. 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. 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 b)is effectively implemented and maintained. An audit program 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. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (e 4.2.4) shall be defined in a documented procedure. The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected non-conformities 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 10011-1, ISO 10011-2 and ISO 10011-3 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, to ensure conformity of the product. 8.2.4 Monitoring and measurement of product 农忙假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. Records shall indicate the person(s) authorizing relea of product (e 4.2.4) Product relea and rvice delivery 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. 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. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure. 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. Records of the nature of the non-conformities and any subquent actions taken, including concessions obtained, shall be maintained (e 4.2.4). When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements. When nonconforming product is detected after delivery or u has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity. 8.4 Analysis of data The organization shall determine, collect and analyze 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)conformance to product requirements (e 7.2.1), c)characteristics and trends of process and products including opportunities for preventive action, and d)suppliers. 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 ma-nagement review. 8.5.2 Corrective action The organization shall take action to eliminate the cau of non-conformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the non-conformities encountered. A documented procedure shall be established to define requirements for a)reviewing non-conformities (including customer complaints); b)determining the caus of non-conformities, c)evaluating the need for action to ensure that non-conformities do not recur, d)determining and implementing the action need-ed, e)records of the results of action taken (e 4.2.4), and f)reviewing corrective action taken. 8.5.3 Preventive action The organization shall determine action to eliminate the caus of potential non-conformities 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 non-conformities and their caus, b)evaluating the need for action to prevent occurrence of non-conformities, c)determining and implementing action needed, d)records of results of action taken (e 4.2.4), and e)reviewing preventive action taken. | 品質管理系統 -- 要求 1範圍 1.1 通則 當組織有下列要求時，本國際標準界定其品質管理系統的需求： a)需要展現其能力足以穩定地提供符合客戶及適用法規要求之產品，和 纸上谈兵造句b)透過系統的有效運用，包括持續改善系統之過程與保證符合客戶及適當法規要求，以增進客戶滿意。 備註 在本國際標準中，”產品”一詞適用於預期提供予顧客或其所需要之產品。 1.2 應用 此國際標準的所有要求乃通用性要求且期望能適用於所有組織，無論其行業、規模及所提供的產品。 本國際標準的任何要求若因組織或產品之特性而無法適用時可考慮予以排除。 當本國際標準的任何要求被排除時，則組織不得宣稱其符合本國際標準，除非所排除的要求侷限於本國際標準的第七節且不影響組織提供符合客戶及適當法規要求產品的能力或責任。 2 引用標準 本國際標準引用下列標準的內容以構成本國際標準的條款。所引用的標準如具日期版次，則其後之修訂或改版均不適用於本國際標準。然而依據本國際標準達成共識之各團體仍應探求使用下列引用標準最新版次的可能。引用的標準如未指定日期版次，則應使用最新的引用標準。ISO及IEC會員皆維持有最新有效國際標準的登錄清單。 ISO 9000:2000 品質管理系統 – 綱要與辭彙 3 名詞與定義 ISO 9000（2000）中之名詞與定義均適用於本國際標準。 本國際標準（ISO 9001）用來描述供應鏈之名詞改變如下，以反映目前的用語習慣： 供應商 → 組織 → 顧客 本版次以“組織”取代先前ISO 9001：1994版次使用的”供應商”，以表示採用本國際標準的單位。而”供應商”則用來取代之前版次的”分包商”。 本國際標準全文之中，”產品”一詞可表示為”服務”的意思。 4 品質管理系統 4.1一般要求 組織應遵照本國際標準的要求建立、文件化、執行、維持品質管理系統並持續改善其有效性。 組織應： a)鑑別品質管理系統所需的過程及其在組織中之運用(見1.2)， b)決定這些過程的順序及相互關係， c)決定確保這些過程有效運作及管制的必要的準則及方法， d)確保提供支援這些過程的運作及監督必要的資源與資訊， e)監控、量測及分析這些過程，和 f)採取必要行動以達成這些過程的預期結果及持續改善。 組織應遵照本國際標準的要求管理這些過程。 當組織選擇將會影響產品符合要求的部分過程委外時，組織應確保其管制亦及於此等委外之過程，且在品質管理系統中界定其管制方式。 備註：上述品質管理系統所須之過程包括管理活動、資源提供、產品實現與量測等過程。 4.2文件化要求 4.2.1 通則 品質管理系統文件化應包括： a)品質政策與品質目標， b)品質手冊， c)本國際標準要求的文件化程序， d)組織為確保其過程有效規劃、運作及管制所需要的文件，及 e)本國際標準要求之紀錄 (見4.2.4) 備註1 本國際標準中出現”文件化程序”之處，係要求該程序須被建立、文件化、實施及維持。 備註 2 各組織其品質管理系統文件化的程度或有差別，端賴下列而定 a)組織的規模及活動的型態， b)過程的複雜性及相互關係， c)員工的能力。 備註3 文件可能為任何形式或種類的媒體。 4.2.2 品質手冊 組織應建立與維護品質手冊，其內容包含 a)品質管理系統的範圍，包括對排除部份的細節與理由 (見1.2)， b)品質管理系統所建立的文件化程序，或參考該等程序，及 c)描述品質管理系統各過程的順序及其彼此間之相互關係。 4.2.3 文件管制 品質管理系統運作所要求之文件應加以管制，紀錄為一特殊型態之文件應依據條文4.2.4之要求加以管制。 應建立文件化之程序用以管制 a)文件發行前，核准其正確性， b)審查、必要的更新與再次核准文件， c)確保文件的改變及目前版次狀態被標明， d)確保使用文件各場所，持有相對應版次的適當文件， e)確保維持文件易於閱讀及容易識別， f)確保外來原始文件被識別及管制其分發，和 g)防止作廢文件被誤用，如因任何目的而留存時，應被適當的識別。 4.2.4 記錄管制 品質管理系統所須之記錄應被建立與維持，以證明符合品質管理系統的要求及有效運作。品質紀錄應易於閱讀、識別及取用。應建立文件化程序以定義記錄的識別、儲存、取用、保護、保存期限與處置方式。 5 管理責任 5.1 管理承諾 高階管理者應透過下列方式，以證明對其品質管理系統的發展、實施與持續改善系統有效性之承諾： a)於組織內部傳達 - 符合客戶及法令、法規要求的重要性， b)建立品質政策， c)確保品質目標被建立， d)執行管理審查，和 e)確保提供必要的資源。 5.2 顧客為重 高階管理者應確保顧客之需求已被決定且滿足，以達到增進客戶滿意為目的(見7.2.1及8.2.1)。 5.3 品質政策 高階管理者應確保其品質政策 a)適合於組織的目的， b)包括符合品質管理系統需求及持續改善系統有效性之承諾， c)提供一個建立及審查品質目標之體制， d)於組織中被傳達及瞭解， e)審查其持續的適切性。 5.4 規劃 5.4.1 品質目標 高階管理者應確保組織內各相關機能及各層級之品質目標被建立，品質目標包含符合產品要求之各項需求(見7.1.a)。品質目標應可被量測，且必須與品質政策相一致。 5.4.2 品質管理系統規劃 高階管理者應確保： a)規劃品質管理系統以符合條文4.1及品質目標之要求，和 b)當品質管理系統計劃將有或已有變化時，仍得以維持品質管理系統之完整性。 5.5 責任、授權與溝通 5.5.1 責任與授權 高階管理者應確保組織內之責任、授權已被定義及溝通。 5.5.2管理代表 高階管理者應指派管理階層中之一員，不受其他責任影響下，明定其責任與授權包含 a)確保品質管理系統中所需之過程被建立、實施與維持； b)向高階管理者報告品質管理系統執行之成效及任何必要之改善； c)確保組織全員對客戶需求認知的提昇。 備註 管理代表的責任可以包括與外部機構對品質管理系統有關事務的聯繫。 5.5.3 內部溝通 高階管理者應確保組織內之溝通過程已被建立，並且對於品質管理系統的有效性進行溝通。 5.6 管理審查 5.6.1 通則 高階管理者應於事先計劃的間隔期間審查組織的品質管理系統，以確保其持續的適切性、正確性與有效性。管理審查應包括評估改善的機會與品質管理系統修正的必要性，包括品質政策與目標。 管理審查的紀錄需加以維持(見4.2.4)。 5.6.2 管理審查的輸入 管理審查的輸入應涵蓋下列資訊 a)稽核的結果， b)客戶的回饋， c)過程的績效及產品的符合性， d)各項矯正與預防措施的狀態， e)前次管理審查決議事項的跟催， f)可能影響品質管理系統的變化，和 g)改善的建議。 5.6.3 管理審查的輸出 管理審查的輸出應包括下列各項的決議與行動 a) 品質管理系統及其過程有效性的改善， b) 與客戶需求有關的產品改善， c) 資源的需求。 6.資源管理 6.1 資源的提供 組織應決定與提供必要的資源以 a)執行和維護品質管理系統及持續改善其有效性，和 b)藉由符合客戶需求以增進客戶滿意。 6.2 人力資源 6.2.1 通則 人員從事足以影響產品品質之工作，必須依其適當教育、訓練、技能和經歷以勝任其工作。 6.2.2 資格、認知與訓練 組織應： a)界定從事足以影響產品品質工作者之資格需求， b)提供訓練或其他措施以滿足這些需求， c)評估所採取措施的有效性， d)確保員工認知本身作業的相關性與重要性及其對達成品質目標的貢獻，和 e)維持適當的教育、訓練、技能及經驗的紀錄(見4.2.4)。 6.3 基礎設施 組織應決定、提供及維護為達成符合產品需求必要的基礎設施。基礎設施包括可行的下列 a)建築物、工作空間及附屬的設施； b)過程設備 (包括軟、硬體設備)，和 c)支援服務 (例如運輸、通訊)。 6.4 工作環境 組織應決定和管理為達到符合產品需求必要的工作環境。 7 產品實現 7.1 產品實現的規劃 組織應規劃與展開針對產品實現所需要的各項過程，產品實現過程的規劃必須與品質管理系統其他過程的要求相一致。 在規劃產品實現過程時，組織必須適當地決定下列要項： a)品質目標及產品的需求； b)針對產品所需過程、文件及資源的提供； c)針對產品必要的驗證、確認、監控、檢驗與測試的活動及產品的允收標準； d)必要的記錄以證明產品實現過程與最終產品符合要求 (見 4.2.4)。 大鱼海棠台词此項規劃產出的結果，其格式應適合其組織的運作方法。 備註 1 針對特定產品、專案或合約用以描述其品質管理系統所有過程(包括產品實現過程)及所需資源的書面文件，可被稱為品質計劃。 備註 2 組織亦可運用條文7.3的要求於產品實現過程的展開。 7.2 顧客相關的過程 7.2.1 決定產品相關的需求 組織應決定 a)顧客已指明的需求，包括對交貨與售後的需求， b)非顧客所明確指定，但對於已知特定或使用目的是必要的需求， c)與產品相關法令及法規的需求，和 d)組織自訂的任何額外需求。 7.2.2 產品相關需求的審查 組織應審查產品相關的需求。此項審查應該在向客戶承諾提供產品之前完成 (即：提出標單、接受合約或訂單、接受合約或訂單的變更)，並且確保 a)產品的需求已被定義， b)合約或其它需求與先前表達有所不同處已被解決，和 c)組織有能力滿足各項已定義之需求。 審查結果及後續措施的紀錄必須加以維持 (見4.2.4)。 當客戶提供非文件化的需求敘述時，組織在接受客戶需求前應加以確認。 當產品需求被改變時，組織應確保相關文件被修正，及相關人員都瞭解改變後的需求。 備註： 在某些情況下，例如網路行銷，對每一張訂單進行正式審查並不實際。取代的方式為對相關產品資訊，例如型錄、廣告素材等加以審查。 7.2.3 客戶溝通 組織應決定及實施有效的安排，以進行與客戶有關下列的溝通： a)產品資訊， b)詢價，合約或訂單的處理及修改，和 c)客戶回饋，包括客戶的抱怨。 7.3 設計與開發 7.3.1 設計與開發的規劃 組織須規劃和管制產品的設計與開發活動。 在設計與開發規劃時，組織必須決定 a)設計與開發過程的各階段， b)適合於各設計開發階段的審查,驗證和確認活動，和 c)設計與開發活動的責任與授權。 組織需管理參與設計開發不同群組間的界面，確保有效的溝通和責任的分配。 規劃的結果必須依據設計與開發的進展加以適當地更新。 7.3.2 設計與開發的輸入 有關產品需求的設計輸入必須加以決定和記錄(見4.2.4)，這些必須包括 a)功能與性能的需求， b)適用法規和法令的需求， c)可行時，得自先前類似設計的資訊，及 d)其它有關設計開發必要的需求。 這些設計輸入應被審查其正確性。需求必須完整、明確且不與其他需求相衝突。 7.3.3 設計與開發的輸出 設計與開發輸出的格式必須能和設計與開發輸入相驗証，且在發出前被核准。 設計與開發的輸出必須 a)符合設計與開發的輸入， b)提供採購、生產及服務提供的適當資訊， c)包含或引述產品的允收標準，和 d)明定對安全及正當使用必備的產品特性。 7.3.4設計與開發的審查 於適當階段，應依規劃的安排(見7.3.1)執行系統化的設計與開發的審查 a)評估設計與開發結果符合需求的能力，和 b)指出問題並提出必要的措施。 參與此類審查者，應包含與該階段審查有關功能的代表人員。必須維持設計審查其結果及任何必要措施的記錄(見4.2.4) 7.3.5 設計與開發的驗證 設計與開發的驗證應依規劃的安排執行(見7.3.1)以確保設計與開發的輸出符合設計與開發的輸入。必須維持設計驗證其結果及任何必要措施的記錄(見4.2.4) 7.3.6 設計與開發的確認 設計與開發的確認應依規劃的安排執行(見7.3.1)以確保最終產品能符合已知的特定應用或預期使用的需求。可行時，確認必須在產品交貨或執行前被完成。必須維持確認的結果及任何必要措施的記錄(見4.2.4)。 7.3.7 設計與開發變更的管制 必須鑑別設計與開發的變更並維持紀錄。此等變更必須被適當地審查、驗證及確認且於執行前獲得核准。設計與開發變更的審查必須包括對其組成零件和已交貨產品的影響評估。 必須維持變更審查的結果及任何必要措施的記錄(見4.2.4)。 7.4 採購 7.4.1 採購過程 組織須確保採購品符合規定的要求。對於供應商及採購品的管制方式及範圍，應依採購品對後續產品的實現或最終產品影響的程度而定。 組織應根據供應商提供符合組織需求產品的能力來評估及選擇供應商。用以選擇、評估及定期評估供應商的標準應被建立。必須維持評估結果及任何後續必要措施的記錄(見4.2.4)。 7.4.2 採購資訊 採購資訊必須清楚描述採購品，適當時，包括 a)對產品、程序、過程及設備的要求， b)人員資格的要求，和 c)品質管理系統的要求。 組織與供應商溝通前，應確保所規定需求內容的適當性。 7.4.3 採購品的驗証 組織應建立及實施為確保採購品符合規定要求所需之檢驗及其他活動。 當組織或其客戶準備於供應商處進行驗証時，組織應於採購資訊中說明計劃驗証的安排及產品放行的方法。 7.5 生產及服務提供 7.5.1 生產及服務提供之管制 組織應在管制狀態下計劃及進行生產及服務的提供。管制狀態包括下列可行的項目 a)提供描述產品特性的資訊， b)必要時，提供工作說明書， c)使用適當的設備， d)具備及使用量測與監控設備， e)實施監控與量測，和 f)實施放行、交貨與售後之活動。 7.5.2 生產與服務提供過程的確認 當過程其結果輸出無法被隨後之監控或量測所驗證時，組織應確認生產及服務過程。這包括過程的缺陷唯有在產品使用或是服務已提供後才會顯現的任何過程。 過程的確認必須展現該等過程具有達成計劃結果的能力。 組織應建立此等過程確認的安排，可行時，應包括以下各項 a)定義過程審核與核准的準則， b)設備與人員的資格的核准， c)使用規定的方法與程序， d)記錄的需求(見4.2.4)，和 e)再確認。 7.5.3 鑑別與追溯 適當時，組織於產品實現所有過程中應以適當的方式來鑑別產品。 組織應針對量測與監控要求的結果鑑別產品的狀態。 當追溯為一項要求時，組織應管制及記錄產品鑑別的特定方式(見4.2.4)。 備註 在某些產業中，型態管理為達到識別與追溯的一種方式。 7.5.4 客戶財產 組織應注意被組織控管或使用的客戶財產。組織須鑑別、驗證、保護和維護客戶所提供使用於或組裝於產品之財產。任何客戶財產如發生遺失、損壞或發現不適用時，須向客戶報告並維持記錄(見4.2.4)。 備註 客戶財產可包含智慧財產。 7.5.4 產品保存 在內部實現過程及交運至指定地點中，組織應保存產品符合需求。此處的保存應包括鑑別、搬運、包裝、儲存及保護。此項要求亦適用於產品的零組件。 7.6 量測與監控設備的管制 組織應決定必需執行的監控與量測，以及用以證明產品符合規定要求所需的量測與監控設備(見7.2.1)。 組織應建立過程以確保監控與量測被執行，且其執行的方式相對監控與量測的需求是一致的。 當監控與量測的結果需確保正確時，量測的設備必須 a)依規定週期或使用前加以校正或驗證，比對的基準應可追溯至國際或國家的量測基準；如無此類標準存在時，應記錄校正或驗證所使用之基準； b)必要的調整或重複調整； c)足以識別其校正狀態的標識； d)妥善防護免於不當調整而致量測結果失效； e)於搬運、維護與儲存過程中加以保護以免造成損壞及劣化。 除此之外，當發現設備不符其要求時，組織應評估及紀錄先前量測結果的有效性。組織應對該設備及受影響之任何產品採取適當之措施。應維持校正及驗證結果的記錄(見4.2.4)。 用於量測與監控規定需求的電腦軟體，應於首次使用前確認其具備足夠之能力滿足預期之運用，且於必要時進行再確認。 備註 見ISO10012-1及ISO10012-2指導綱要 8 量測、分析與改善 8.1 通則 組織應規劃與執行用以滿足下列要求之監控、量測、分析及改善所需的過程： a)展現產品的符合， b)確保品質管理系統的符合， c)持續改善品質管理系統的有效性。 這應包括決定可行的方法，含統計技術，及其使用的範圍。 8.2監控與量測 8.2.1 客戶滿意 作為品質管理系統成效的量測之一，組織應監控客戶所認知組織是否滿足其需求的資訊。取得及運用此等資訊的方法應被決定。 8.2.2 內部稽核 組織應於規劃的期間執行內部稽核以決定品質管理系統是否 a)符合計畫的安排(見7.1)，符合本國際標準的要求及組織所建立的品質管理系統要求，和 b)有效地被執行與維持 稽核計劃的規劃應考量被稽核過程與區域的狀態及其重要性和前次稽核的結果。稽核的準則、範圍、頻率與方法必須加以定義。稽核人員的指派及稽核工作的執行必須確保稽核過程的客觀與公平。稽核員不得稽核自身的工作。 規劃稽核與執行及報告結果與維持紀錄(見4.2.4)的責任與要求應被定義於文件化的程序。 被稽核區域的管理者應確保採取立即的矯正措施以消除所發現的不符合事項及其原因。後續追蹤應包括矯正措施執行結果的驗證及驗證結果的提報(見8.5.2) 備註 見ISO10011-1，ISO10011-2及ISO10011-3指導綱要 8.2.3 過程的監控與量測 組織應對品質管理系統的各項過程運用適當方法加以監控及可行的量測。此等方法必須展現每項過程滿足其預期結果的能力。當預期結果未達成時，必須採取糾正及矯正措施以確保產品的符合性。 8.2.4 產品的監控與量測 組織應監控與量測產品特性以驗證產品的要求已被達成。此監控與量測應根據計畫的安排(見7.1)於產品實現的適當過程中執行。 符合允收準則的證據必須被維持。記錄應包括產品放行的權責人員(見4.2.4) 除非獲得相關權責及可行時客戶的准許，否則產品放行及服務的提供必須等到所有計畫的安排(見7.1)均已完成且符合要求。 8.3. 不合格品管制 組織應確保不合格產品被識別與管制以防止非預期的使用或交貨。不合格品的管制及處理的責任與授權，應被定義於文件化程序中。 針對不合格品，組織應該採取下列一項或多項措施： a)採取行動以消除所發現的不符合； b)獲相關權責及可行時客戶的特准其使用、放行或接收； c)採取行動以排除其預期之使用與運用。 應維持不符合的特性及其後續的任何措施，包括特採取得的紀錄(見4.2.4)。 不合格品在糾正後應該再次驗證以展現其符合各項要求。 當不合格品在交運後或開始使用才被發現，組織應相對不符合的影響或其潛在影響採取適當的行動。 8.4 資料分析 組織應決定、收集與分析適當的資料，以展現品質管理系統的適切性與有效性，並評估持續改善品質管理系統有效性的機會。這包括監控與量測結果及其他相關來源所產生之資料。 資料分析應提供下列相關資訊 a)客戶滿意(見8.2.1)， b)產品符合需求的程度(見7.2.1)， c)過程及產品的特性及趨勢，包括預防措施的機會，和 d)供應商 8.5 改善 8.5.1 持續改善 組織應透過品質政策、品質目標、稽核結果、資料分析、矯正與預防措施及管理審查的運用，以持續改善品質管理系統的有效性。 8.5.2 矯正措施 組織應採取矯正措施消除不符合的原因以防止再度發生。矯正措施應適切於所遇不符合的影響程度。 應建立矯正措施的文件化程序以定義下列 a)審查不符合事項 (含客戶抱怨)， b)決定不符合事項的原因， c)評估為確保不符合事項不會再度發生必要的措施， d)決定及執行必要的矯正措施， e)記錄矯正措施執行結果(見4.2.4)，和 f)審查已執行的矯正措施。 8.5.3 預防措施 組織應決定預防措施以消除潛在不符合的原因，以防止其發生。預防措施應適切於潛在問題的影響程度。 應建立預防措施的文件化程序以定義下列 a)決定潛在不符合事項及其原因， b)評估預防不符合事項發生的必要措施， c)決定及執行必要的預防措施， d)記錄預防措施執行結果(見4.2.4)，和 e)審查已執行的預防措施。 | |
本文发布于:2023-07-16 10:45:14，感谢您对本站的认可！
本文链接：https://www.wtabcd.cn/fanwen/fan/82/1099484.html
版权声明：本站内容均来自互联网，仅供演示用，请勿用于商业和其他非法用途。如果侵犯了您的权益请与我们联系，我们将在24小时内删除。
| 留言与评论（共有 0 条评论） |
