21 CFR § 820Quality System Regulation質(zhì)量體系手冊Reprinted from the Federal Register/Vol. 61, No. 195/Monday, October 7, 1996/Rules and Regulations聯(lián)邦注冊局出版，法規(guī)與準則，61冊，第195號，1996年10月7日Page 41 of 41Subpart AGeneral ProvisionsA部分總則820.1 Scope.820.1范圍820.3 Definitions. 定義820.5 Quality system. 質(zhì)量體系Subpart BQuality System RequirementsB部分質(zhì)量體系要求820.20 Management responsibility. 管理者職責820.22 Quality audit. 質(zhì)量審核820.25 Personnel. 職員Subpart CDesign ControlsC部分設計控制820.30 Design controls. 設計控制Subpart DDocument ControlsD部分文件控制820.40 Document controls. 文件控制Subpart EPurchasing ControlsE部分采購控制820.50 Purchasing controls. 采購控制Subpart FIdentification and TraceabilityF部分標識和可追溯性820.60 Identification. 標識820.65 Traceability. 可追溯性Subpart GProduction and Process ControlsG部分生產(chǎn)和過程控制820.70 Production and process controls. 產(chǎn)品和過程控制820.72Inspection,measuring, and test equipment. 檢查、測量，測試儀器 820.75 Process validation. 過程確認Subpart HAcceptance ActivitiesH部分接收活動820.80 Receiving, in-process, and finished device acceptance.接收設備準則，過程設備準則，最終設備準則820.86 Acceptance status. 接收狀態(tài)Subpart INonconforming ProductI部分不合格產(chǎn)品820.90 Nonconforming product. 不合格產(chǎn)品Subpart JCorrective and Preventive ActionJ部分糾正預防措施820.100 Corrective and preventive action. 糾正預防措施Subpart KLabeling and Packaging ControlK部分標簽與包裝控制820.120 Device labeling. 產(chǎn)品標識820.130 Device packaging. 產(chǎn)品包裝Subpart LHandling, Storage, Distribution, and Installation L部分操作、存儲、分配以及安裝820.140 Handling. 操作820.150 Storage. 存儲820.160 Distribution. 分配820.170 Installation. 安裝Subpart MRecordsM部分記錄820.180 General requirements. 總要求820.181 Device master record. 產(chǎn)品控制記錄820.184 Device history record. 產(chǎn)品歷史記錄820.186 Quality system record. 質(zhì)量體系記錄820.198 Complaint files. 客戶抱怨文件Subpart NServicing820.200 Servicing.Subpart OStatistical Techniques820.250 Statistical techniques.Authority: Secs. 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383).Subpart AGeneral Provisions4§ 820.1 Scope.4Subpart AGeneral Provisions§ 820.1 Scope. 820.1范圍(a) Applicability. 適用性(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. 在本質(zhì)量體系法規(guī)（QSR）中闡述了CGMP的要求。本部分中的要求規(guī)定了在下列情況下使用的方法：所有的預期用于人類的最終器械產(chǎn)品的設計、制造、包裝、標記、儲存、安裝和服務中使用的方法。本部分的要求可確保最終器械的安全有效，并符合聯(lián)邦食品、藥品和化妝品法案。本部分內(nèi)容確定了適用于最終器械的制造商的基本要求。如果制造商從事的一些操作符合本部分的要求，而不是其他部分的要求，則該制造商只需符合那些用于這些操作上的要求。對于I類醫(yī)療器械，設計控制僅適用于820.3（a）（2）部分列出的那些器械。本法規(guī)不適用于最終器械的組件和部件的制造商，但鼓勵這樣的制造商使用本法規(guī)中的適宜條款做指南。生產(chǎn)人體血液和血液組件的制造商可不遵守本部分的要求，但要遵守本章606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.本部分條款可適用于任何本部分規(guī)定的、預期用于人類的最終器械，這樣的器械可在美國、哥倫比亞地區(qū)和波多黎各共和國生產(chǎn)或進口到這些國家。(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. 本法規(guī)中使用幾次詞語“適當處”。當一個要求被“適當處”修飾時，這一要求就被認為是“適當?shù)摹?，除非制造商能以文件的形式提出其它的正當理由。如果不實施某個要求就會導致產(chǎn)品不滿足其規(guī)定的要求或制造商不能開展必要的糾正措施，則可認為這一要求是“適當?shù)摹薄?b) Limitations. The quality system regulation in this part supplements regulations in other parts of this chapter except where explicitly stated otherwise. In the event that it is impossible to comply with all applicable regulations, both 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.局限性。除非明確聲明有其他情況，否則本部分中質(zhì)量體系法規(guī)是對本章其他部分的法規(guī)的補充。如果遵守所有適用法規(guī)（包括本部分的法規(guī)和本章其他部分的法規(guī)）是不可能的，則指定應用于討論中器械的法規(guī)應代替其他通用的要求。(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.權(quán)威性。820部分內(nèi)容的是參照權(quán)威法案501，502，510，513，514，515，518，519，520，522，701，704，801，803（21U.S.C.351，352，360，360c,360d,360e,360h,360i,360j,360l,371,374,381,383 ）而制定和發(fā)布的。如果器械沒有符合本部分的任何適用條款會，按照501法案，可認為該種器械為偽劣產(chǎn)品，造成器械不符合性的人員都要負一定責任。(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.國外制造商：如果將器械進口到美國的制造商拒絕接受FDA對其國外設施的檢查，以確定是否符合本部分801法案的內(nèi)容，則可認為生產(chǎn)該器械所使用的方法，設施、設備以及在該場地下生產(chǎn)的、將要進口到美國的器械的設計、生產(chǎn)、包裝、標記、貯存、安裝或服務不符合520（f）法案和本部分內(nèi)容的要求，并且按照501（h）法案的規(guī)定，該場地下生產(chǎn)的器械為偽劣產(chǎn)品。(e) Exemptions or variances. 豁免或特殊許可：(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 Center for Devices and Radiological Health, Division of Small Manufacturers Assistance, (HFZ220), 1350 Piccard Dr., Rockville, MD 20850, U.S.A., telephone 18006382041 or 1301 4436597, FAX 3014438818. （1）任何申請對器械質(zhì)量體系要求豁免或特殊許可的人員都要遵守法案520(f)(2)的要求。按照本章10.30中闡述的程序要求（FDA的管理程序），將豁免或特殊許可的申請?zhí)峤唤oFDA。 可從器械與輻射健康中心，小型制造商服務部（HFZ-220）獲得指南。(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. 當代理商確定這樣的特殊許可是為了公眾健康的利益，F(xiàn)DA可鼓勵并允許器械的質(zhì)量體系要求有一些特殊許可。而且這樣的許可只有在保持器械一直有利于公眾的健康時才能保持其有效性，在沒有特殊許可的情況下不能大量的制造器械。1. § 820.3 Definitions. 定義(a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201903, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321394). All definitions in section 201 of the act shall apply to the regulations in this part.法案是指聯(lián)邦食品、藥品和化裝品法案。法案中201部分中規(guī)定的所有定義都適用于本部分的法規(guī)。(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.抱怨：抱怨是指任何以書面、口頭、電訊的形式宣稱，已放行銷售的醫(yī)療器械在其特性、質(zhì)量、耐用性、可靠性、安全性、有效性及性能等方面存在不足的行為。(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.組件：組件是指任何原材料、物質(zhì)、零件、部件、軟件、固件（軟件硬件相結(jié)合）、標記或裝配件，可作為最終器械、包裝器械和標記器械的一部分。(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.控制號碼是指任何有特色的符號，如：字母或數(shù)字的有特色的組合，或者兩者的結(jié)合，從中可以確定最終產(chǎn)品批或單元的生產(chǎn)、包裝、標記和銷售的歷史。(e) Design history file (DHF) means a compilation of records which describes the design history of a finished device.設計歷史文件（DHF）是指記錄的匯編，描述了一個最終器械的設計歷史。(f) Design input means the physical and performance requirements of a device that are used as a basis for device design.設計輸入是指器械的物理要求和性能要求，其可作為器械的設計基礎(chǔ)。(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.設計輸出是指每一設計階段和總體設計的設計努力的結(jié)果。最終器械的設計輸出是由器械、器械的包裝、標簽和器械主記錄構(gòu)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.設計評審是指對設計的形成文件的、全面的、系統(tǒng)的檢查以便評價設計要求的充分性，設計滿足要求的能力以及識別問題。(i) Device history record (DHR) means a compilation of records containing the production history of a finished device.設備歷史記錄（DHR）是指包含最終器械生產(chǎn)歷史的記錄匯編(j) Device master record (DMR) means a compilation of records containing the procedures and specifications for a finished device.器械主記錄（DMR）是指包含最終器械的程序和規(guī)范的記錄匯編。(k) Establish means define, document (in writing or electronically), and implement.建立是指規(guī)定、形成文件（手寫的、電子的）和實施。(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.最終器械是指任何適于使用或能夠運行的器械或器械的附件，無論其是否經(jīng)包裝、標記或滅菌。(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.批是指最終器械、一個或多個組件，其可由唯一的型號、規(guī)格、類型、尺寸、結(jié)構(gòu)或軟件版本構(gòu)成，這些器械和組件是在相同的條件下生產(chǎn)的，在規(guī)定的范圍內(nèi)有相同的特性和質(zhì)量。(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.有行政職責的管理者是指有權(quán)確定質(zhì)量方針和質(zhì)量體系或?qū)|(zhì)量方針和質(zhì)量體系作出更改的制造商的高級雇員。(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.制造商是指任何對最終器械進行設計、生產(chǎn)、制作、組裝或加工的人。制造商包括但并不僅僅只限于是那些完成滅菌、安裝、重新標記、重新制造、重新包裝、制定規(guī)范的人，或者完成上述操作的境外初始銷售商(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.制造材料是指任何使用的材料或物質(zhì)，這些材料的使用可便于生產(chǎn)加工，或在生產(chǎn)過程中產(chǎn)生的伴隨物或副產(chǎn)物，這些物質(zhì)的是作為殘留物或雜質(zhì)存在于最終器械上，它的產(chǎn)生不是設計出來的，也不是制造商想要的。(q) Nonconformity means the nonfulfillment of a specified requirement.不合格是指不滿足規(guī)定要求(r) Product means components, manufacturing materials, in- process devices, finished devices, and returned devices.產(chǎn)品是指組件、制造材料、過程中的器械、最終器械和返回器械。(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.質(zhì)量是指器械滿足良好使用性能的總體的特性和性能，包括安全和性能。(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. 質(zhì)量審核是指按照規(guī)定的時間間隔對制造商的質(zhì)量體系進行的系統(tǒng)的、獨立的檢查，以確定質(zhì)量體系活動和活動的結(jié)果符合質(zhì)量體系程序，并確保質(zhì)量體系程序得到有效的實施并適合于實現(xiàn)質(zhì)量體系的目標。(u) Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility.質(zhì)量方針是指與組織質(zhì)量有關(guān)的總的意圖和方向，質(zhì)量方針是由最高管理層制定的。(v) Quality system means the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.質(zhì)量體系是指完成組織的質(zhì)量管理所需的組織結(jié)構(gòu)、職責、程序、過程和資源。(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.二手制造商是指加工、改造、翻修、再次包裝、修復或?qū)ψ罱K器械采取其他措施來對器械的性能或安全規(guī)范或預期用途做重要更改的人。(x) Rework means action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution. 返工是指對不合格產(chǎn)品采取的措施以便使其在放行和銷售前滿足規(guī)定的器械主記錄的要求。(y) Specification means any requirement with which a product, process, service, or other activity must conform.規(guī)范是指產(chǎn)品、過程、服務或其他活動必須滿足的任何要求。(z) Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.確認是指通過檢查和提供客觀證據(jù)確認能夠持續(xù)的滿足指定用途的特殊要求。(1)Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.過程確認是指通過客觀證據(jù)確定過程能持續(xù)生產(chǎn)出滿足其預先確定的規(guī)范要求。(2) Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).設計確認是指通過客觀證據(jù)來確定器械規(guī)范符合用戶需求和預期使用用途。(aa) Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.驗證是指通過檢查和提供客觀證據(jù)以確認規(guī)定的要求是否得到滿足。1. § 820.5 Quality systems質(zhì)量體系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.每一個制造商應建立和保持一個適用于指定醫(yī)療器械設計和生產(chǎn)的質(zhì)量體系并滿足本部分的要求。Subpart BQuality System RequirementsB部分：質(zhì)量體系要求§ 820.20 Management responsibility 管理職責(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.質(zhì)量方針：最高管理者應制定企業(yè)的質(zhì)量方針和目標和對質(zhì)量的承諾。最高管理者應確保質(zhì)量方針在組織內(nèi)各層次得到理解、實施和保持。(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.組織：每一個制造商應建立和保持適宜的組織結(jié)構(gòu)以確保器械的設計和生產(chǎn)按照本部分的要求進行。(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.職責和權(quán)限：每一個制造商應確定人員的職責、權(quán)限和相互關(guān)系，這些人員負責管理、執(zhí)行和評價對質(zhì)量有影響的工作。(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.資源：每一個制造商應提供充足的資源以滿足本部分的要求，包括指定培訓管理人員，操作人員 的人員，以及評價活動（包括內(nèi)部審核）。(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:管理者代表：最高管理者應任命一名管理者并記錄這樣的任命，不管在其他方面的職責如何，他應該具有以下方面的職責和權(quán)限：（i） Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and確保質(zhì)量管理體系要求能按照本部分的要求得到有效的建立和保持。(ii) Reporting on the performance of the quality system to management with executive responsibility for review. 向最高管理者匯報質(zhì)量體系的業(yè)績。(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 manufacturer's established quality policy and objectives. The results of quality system reviews shall be documented. 管理評審：最高管理者按照規(guī)定的時間間隔和按照規(guī)定程序所確立的有效頻率評價質(zhì)量管理體系的適宜性和有效性，以確保質(zhì)量體系滿足本部分的要求和制造商的質(zhì)量方針和目標。質(zhì)量體系評審的日期和結(jié)果應形成文件。(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. 質(zhì)量策劃：每一個制造商應建立一個質(zhì)量計劃以規(guī)定與所設計和生產(chǎn)的器械有關(guān)的質(zhì)量規(guī)范，資源和活動。制造商應確定質(zhì)量要求是如何得到滿足的。(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.質(zhì)量體系程序：每一個制造商應建立質(zhì)量體系程序和說明。適當時，應確定質(zhì)量體系中所使用的文件的結(jié)構(gòu)。1. § 820.22 Quality audit 質(zhì)量審核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 where necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters being audited. The dates and results of quality audits and reaudits shall be documented.每一個制造商應建立質(zhì)量審核的程序并完成這樣的審核以確保質(zhì)量體系符合經(jīng)確定的質(zhì)量體系要求并保持其有效性。進行質(zhì)量審核的人員應不能直接負責受審核的事項。必要時要采取糾正措施包括對不合格的再次審核。應報告每次質(zhì)量審