FDA质量体系规范-QSR820（中英对照）

Subpart A-General Provisions A分部-通则Sec. 820.1 Scope.范围 (a)Applicability. (1) Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements applicable to manufacturers of finished medical devices. If a manufacturer engages in only some operations subject to the requirements in this part, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged. With respect to class I devices, design controls apply only to those devices listed in 820.30(a)(2). This regulation does not apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance. Manufacturers of human blood and blood components are not subject to this part, but are subject to part 606 of this chapter. Manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), as defined in 1271.3(d) of this chapter, that are medical devices (subject to premarket review or notification, or exempt from notification, under an application submitted under the device provisions of the act or under a biological product license application under section 351 of the Public Health Service Act) are subject to this part and are also subject to the donor-eligibility procedures set forth in part 1271 subpart C of this chapter and applicable current good tissue practice procedures in part 1271 subpart D of this chapter. In the event of a conflict between applicable regulations in part 1271 and in other parts of this chapter, the regulation specifically applicable to the device in question shall supersede the more general.适用性. 本质量体系规范提出了CGMP的要求。本（规范）要求管理所有医疗器械产品在设计，制造，包装，标签，贮存，安装和服务中使用的方法，以及为此所使用的设施和控制（措施/方法）。本（规范）要求意在确保器械成品安全有效，并遵守联邦食品，药品，化妆品法案（本法案）。本规范确定/提出了适用于医疗器械成品制造商的基本要求。假如某制造商（的活动）仅涉及从属于本规范规定的部分要求，并不涉及其他的要求，那么仅需要遵守适用于其操作所涉及部分的要求。关于I类医疗，设计控制仅适用于那些列于820.30（a）（2）（项下）的器械。本法规不适用于成品组件或部件制造商，但鼓励其使用本法规的适当的条款作为指导。人类血液和血液制品不受此规范管辖，而是从属于本法案606部分。制造人类细胞、组织，和以人类细胞、组织为基础的产品（HCT/Ps），定义于本法案1271.3（d）（部分），是指医疗器械从属于上市前评审或通知，或豁免，在本法案器械条款下，或（本法案）351（部分）（公共健康服务）生物产品许可证申报下递交的申请。从属于此部分（820），也从属于本法案1271C donor-eligibility程序，同时适用于本法案1271D现行的良好组织实践。如果发生应用本法案1271部分和其他部分相冲突时，特别地适用于器械的规范代替更通用的（要求）。(2) The provisions of this part shall be applicable to any finished device as defined in this part, intended for human use, that is manufactured, imported, or offered for import in any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.本规范的条款/规定应适用于本规范定义的任何器械成品。即供人类使用，在美国的任何州或领土，哥伦比亚特区，或美属波多黎哥联邦，制造，进口或为进口提供的（器械成品）。(3) In this regulation the term where appropriate is used several times. When a requirement is qualified by where appropriate, it is deemed to be appropriate unless the manufacturer can document justification otherwise. A requirement is appropriate if nonimplementation could reasonably be expected to result in the product not meeting its specified requirements or the manufacturer not being able to carry out any necessary corrective action.在本规范中数次使用术语“适当的情况下/地方”。当一个要求被冠以“适当的地方/情况下”，其被认为是“适当的”。除非制造商能证明其理由得当除外。假如不执行“适当的”要求，将可以有理由预期其会导致产品不能达到规定要求或制造商不能采取任何纠正措施。(b) The quality system regulation in this part supplements regulations in other parts of this chapter except where explicitly stated otherwise. In the event of a conflict between applicable regulations in this part and in other parts of this chapter, the regulations specifically applicable to the device in question shall supersede any other generally applicable requirements.此规范的质量系统法规补充法案本章其他部分的法规，有明确地规定的地方除外。如果发生应使用本规范和本法案其他部分相冲突时，正在被讨论的明确地适用于器械的要求将取代任何其他通用要求。(c)Authority. Part 820 is established and issued under authority of sections 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803 of the act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383). The failure to comply with any applicable provision in this part renders a device adulterated under section 501(h) of the act. Such a device, as well as any person responsible for the failure to comply, is subject to regulatory action.权威性/法律来源.在的授权下建立和发行本规范（820）。根据法规501（h），不能遵守本规范的任何应用条款致使（出现）的劣质器械，此器械及其负责人会遭受法律制裁。(d)Foreign manufacturers. If a manufacturer who offers devices for import into the United States refuses to permit or allow the completion of a Food and Drug Administration (FDA) inspection of the foreign facility for the purpose of determining compliance with this part, it shall appear for purposes of section 801(a) of the act, that the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, or servicing of any devices produced at such facility that are offered for import into the United States do not conform to the requirements of section 520(f) of the act and this part and that the devices manufactured at that facility are adulterated under section 501(h) of the act.外国制造商。假如某制造商提供进口给美国的器械，但拒绝允许或同意FDA为了完成以确定其符合本规范对其国外设施的检查，将会出现本法案801（a）部分的后果用此设施生产出的任何（提供进口给美国的）器械，其设计，制造，包装，标签，贮存，安装，或服务使用的方法，设施和控制是不符合520（f）和本规范的要求。按照501（h）属于劣质产品。(e)Exemptions or variances . (1) Any person who wishes to petition for an exemption or variance from any device quality system requirement is subject to the requirements of section 520(f)(2) of the act. Petitions for an exemption or variance shall be submitted according to the procedures set forth in 10.30 of this chapter, the FDAs administrative procedures. Guidance is available from the Food and Drug Administration, Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance.豁免后更改。任何希望请求豁免或更改器械质量体系的请求，都要遵守本法案520（f）（2）的要求。豁免或变更应按照本规范10.30提出的程序递交请求，即FDA管理程序。可从FDA，CDRH，DSM，ICA等处获得指南。(2) FDA may initiate and grant a variance from any device quality system requirement when the agency determines that such variance is in the best interest of the public health. Such variance will remain in effect only so long as there remains a public health need for the device and the device would not likely be made sufficiently available without the variance.（2）当FDA确定使用某种来自任何器械质量体系要求的更改是最有益于公众健康时，可能发起和同意更改。此更改仅只有公众健康需，并且在不采取更改情况下器械不能被制造的十分可取时有效。Sec. 820.3 Definitions.定义 (a)Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-903, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-394). All definitions in section 201 of the act shall apply to the regulations in this part.（a）法案是指联邦食品，药品和化妆品法修正案(secs. 201-903, 52 Stat. 1040 et seq., 修订的(21 U.S.C. 321-394)。所有在法案201部分的定义均适用于本规范。(b)Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.（b）投诉是指任何书面的，电子的或口头的交流声称在放行分发后某一器械相关的鉴定，质量，耐久性，可靠性，安全，效力或性能不足（的一种活动）。(c)Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.组件是指任何原料，物质，小件，零件，软件，固件，标签，或被预期包括在一部分用于完成的，包装的，贴标签的器械的装配（组件）内的（物质）。(d)Control number means any distinctive symbols, such as a distinctive combination of letters or numbers, or both, from which the history of the manufacturing, packaging, labeling, and distribution of a unit, lot, or batch of finished devices can be determined.控制号是指任何可区别的符号，如可区分的由数字或字母或二者组成的组合体。以此可确定制造，包装，标签，和发放的单个或一批器械的历史。(e)Design history file (DHF ) means a compilation of records which describes the design history of a finished device.设计历史文件（DHF）是指一份编辑的描述某器械成品设计历史/来历的记录。(f)Design input means the physical and performance requirements of a device that are used as a basis for device design.设计输入是指以某器械物理和性能要求为设计基础的（活动）。(g)Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.设计输出指在每个设计阶段的成果和最终总的设计成果。完成的设计输出是以器械主记录为基础（来体现的），最终完成的设计输出由器械，其包装，标签和主记录组成。(h)Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.设计评审是指文件的，全面的，系统的检查某设计，评价（输出）对于设计要求满足的充分性，和设计满足要求的能力和识别问题（所在）。(i)Device history record (DHR ) means a compilation of records containing the production history of a finished device.设计历史记录（DHR）是指编辑的包括某器械成品的历史/来历/制造的记录。(j)Device master record (DMR ) means a compilation of records containing the procedures and specifications for a finished device.器械主记录（DMR）是指编辑的包含某器械成品的程序和规范的记录。(k)Establish means define, document (in writing or electronically), and implement.建立是指定义，文件化（书面或电子的），并执行（的活动）。(l)Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.器械成品指任何适于使用或可以运行的器械或器械附件，无论包装，标识，灭菌与否。(m)Lot or batch means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.批是指在本质上相同条件下制造的，在规定的限度内预期有统一的特性和质量的一种或几种组件或器械成品构成的某单个类型，样式，类别，型号，成分，或软件版本。 (n)Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturers quality policy and quality system.最高管理层（为了同ISO9001统一）是指那些拥有权限去建立或改变器械制造商的质量方针和质量体系的高级雇员。(o)Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.制造商是指任何设计，制造，构造，组装，或加工器械的人。制造商包括但不限于那些从事（合同）灭菌，安装，再贴标，再加工，再包装，或规范开发活动（的人）和从事这些（工作内容）的国外实体的原始经销商。(p)Manufacturing material means any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or impurity not by design or intent of the manufacturer.制造物料是指任何用于生产或便于生产过程（运作）而使用的物料或物质，或制造过程产生的（而不是制造商设计或预期的）以残留物或杂质（的形式）存在于器械成品内或上的伴随物或副产品。(q)Nonconformity means the nonfulfillment of a specified requirement.不合格是指未执行/满足规定的要求。(r)Product means components, manufacturing materials, in- process devices, finished devices, and returned devices.产品是指组件，生产/制造物料，过程中器械，器械成品和退回的器械。(s)Quality means the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance.质量是指器械适于使用的整体特征和特性的能力，包括安全性和性能（方面）。(t)Quality audit means a systematic, independent examination of a manufacturers quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.质量审核是指系统的，独立的考核制造商的质量体系，即按照定义的时间间隔和在足够的频率下去确定质量体系活动和其结果是否都符合质量体系程序规定（的活动），因而（证明）程序被有效地执行，并且质量体系目标可达。(u)Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility.质量方针是指由最高管理层建立的组织关于质量总的期望和方向。(v)Quality system means the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.质量体系是指执行质量管理（活动）的组织结构，职责，程序，过程和资源。(w)Remanufacturer means any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished devices performance or safety specifications, or intended use.再加工商是指任何加工，调节，革新，再包装，修复/再贮存？，或做其他对器械成品性能，安全规范或预期用途大大地/显著地变更（动作）的人。(x)Rework means action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution.返工是指实施在不合格产品上，使其在放行发送前，能满足规定的DMR要求的动作。(y)Specification means any requirement with which a product, process, service, or other activity must conform.规范是指一个产品，过程，服务或其他活动必须遵守的任何要求。(z)Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.确认是指用考核和提供客观证据（的方式）来为特定的预期用途能始终如一地被满足提供（证明）的活动。(1)Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.工艺验证是指由一个过程产生的结果或产品能始终如一的满足预先确定的规范要求建立的客观证据。(2)Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).设计确认是指用客观证据建立器械规范同用户需求和（产品）预期用途相一致（的证明活动）。(aa)Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.验证是指用考核和提供客观证据证明规定要求已被满足的活动。Sec. 820.5 Quality system.质量体系 Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.各制造商应建立并保持质量体系。体系应适合于（制造商）特定的医疗器械的设计或制造，并满足本部分要求。Subpart B-Quality System Requirements 质量体系要求Sec. 820.20 Management responsibility.管理职责 (a)Quality policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.质量方针.最高管理层应建立组织的质量方针和目标，并承诺（执行）。最高管理层应确保质量方针在组织内各层面上得到理解，贯彻和保持。(b)Organization. Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part.组织.各制造商应建立并保持一个适当的组织结构，以确保器械的设计和生产符合本规范的要求。(1)Responsibility and authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.职责和权限.各制造商应为（从事）影响质量的管理，执行和评估工作的人员建立适当的职责，权限和相互关系，并保证（他们）执行这些工作所必需的独立性和权威性。(2)Resources. Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part.资源.各制造商应提供足够的资源，包括安排经培训的人员（从事）管理，执行，评价（包括内审）（体系）满足本规范要求的工作。(3)Management representative. Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for:(i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and(ii) Reporting on the performance of the quality system to management with executive responsibility for review.管理者代表.最高管理层应以文件的形式任命/指定管理层中的一员（为管理者代表）。无论该成员在其他方面的职责如何，他应具有以下方面有权限和职责：确保质量体系的要求按照此规范得到有效的建立并保持；向管理层报告质量体系的表现供其评审。(c)Management review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturers established quality policy and objectives. The dates and results of quality system reviews shall be documented.管理评审.最高管理层应按照建立的程序，在规定的时间间隔和充分的频率下评审质量体系的适宜性和有效性。确保质量体系满足本规范和制造商建立的质量方针和目标要求。评审时间和结果应记录。(d)Quality planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.质量策划.各制造商应建立一个质量计划，规定/祥述与设计和制造器械有关的质量实践，资源和活动，并建立质量要求将如何被满足（的计划）。(e)Quality system procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate.质量体系程序.各制造商应建立质量体系程序和指导书。适当情况下应在质量体系中建立文件的结构大纲。Sec. 820.22 Quality audit.质量审核 Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewe