New-GMP-ANVISA-Regulation---RDC16-2013---English-Version(1)-對(duì)照譯文.docx

醫(yī)療器械與體外診斷用品的良好生產(chǎn)技術(shù)規(guī)范TECHNICAL REGULATION OF GOOD MANUFACTURING PRACTICES FOR MEDICAL DEVICES ANDPRODUCTS FOR IN VITRO DIAGNOSTIC USE注：參考葡萄牙語(yǔ)-英語(yǔ)翻譯版本美國(guó)食品和藥物管理局質(zhì)量體系要求第21章第820節(jié)的基本術(shù)語(yǔ)。Note: The translation from Portuguese to English used as reference the basic terminology of the FDA QSR 21 Part 820.巴西國(guó)家衛(wèi)生監(jiān)督局聯(lián)合董事會(huì)決議第16號(hào)RDC2013年3月28日ANVISA - COLLEGIATE BOARD RESOLUTION RDC No.16 28 MAR 2013批準(zhǔn)醫(yī)療用品與體外診斷用品的良好生產(chǎn)技術(shù)規(guī)范及其他措施。Approves the Technical Regulation of Good Manufacturing Practice for Medical Products and Products for In Vitro Diagnostic Use and other measures.巴西國(guó)家衛(wèi)生監(jiān)督局在2013年3月7日召開(kāi)的會(huì)議上，根據(jù)第1999年4月16日3029號(hào)法令批準(zhǔn)的規(guī)范的第11條第4款規(guī)定，以及根據(jù)巴西國(guó)家衛(wèi)生監(jiān)督局的第354號(hào)法令附錄一批準(zhǔn)的附則的第54條第1款與第3款規(guī)定獲得授權(quán)行使權(quán)力，公布于2006年8月21日的公報(bào)上。參考1976年9月23日生效的6360號(hào)法案及其規(guī)定，以及1977年1月5日的79094號(hào)法令；The Board of the National Health Surveillance Agency, in exercise of the powers conferred upon him by section IV of article. 11 of the Regulation approved by Decree No. 3029 of April 16, 1999, and in view of the provisions of section II and in 1 and 3 of art. 54 of the Bylaws approved in accordance with Annex I of Ordinance No. 354 of ANVISA, of August 11, 2006, republished in the Official Gazette of August 21, 2006, at a meeting held March 7, 2013, considering the Law. 6360 of September 23, 1976 and its regulations, Decree No. 79094 of January 5, 1977;參考了內(nèi)在化決議南美共同市場(chǎng)/GMC/RES的需要。參考了內(nèi)在化20/11號(hào)南美共同市場(chǎng)/GMC/RES.決議，批準(zhǔn)了“南北共同市場(chǎng)醫(yī)療用品與體外診斷用品的良好生產(chǎn)技術(shù)規(guī)范”（廢除了第04/95、38/96、65/96與131/96號(hào)的GMC決議）；considering the need to internalize the Resolution MERCOSUR / GMC / RES. No. 20/11, which approved the MERCOSUR Technical Regulation of Good Manufacturing Practice for Medical Products and Products for In Vitro Diagnostic Use (repeal ofGMC Resolution No. 04/95, 38/96, 65/96 and 131/96) ;考慮到醫(yī)療用品與體外診斷用品的生產(chǎn)規(guī)范規(guī)則應(yīng)保證在巴西出售用品的質(zhì)量、安全與功效。considering that the rules of Good Manufacturing Practices relating to medical products and products for in vitro diagnostic use should seek to guarantee the quality, safety and efficacy of the products marketed in Brazil;因此，醫(yī)療用品與體外診斷用品監(jiān)管體制的優(yōu)化推動(dòng)工作至關(guān)重要；Whereas it is essential to promote the improvement of national systems aimed at the regulation and control of medical products and products for in vitro diagnostic use;基于以下董事會(huì)決議，本人作為總裁，宣布發(fā)表：adopts the following resolution of the Board and I, the Chairman, determine its publication:第1條規(guī)定，批準(zhǔn)“醫(yī)療用品與體外診斷用品的良好生產(chǎn)技術(shù)規(guī)范”。該規(guī)范作為附錄，是本決議的組成部分。Art 1st - Approve the Technical Regulation of Good Manufacturing Practice for Medical Products and Products for In Vitro Diagnostic Use, which is included as Annex and part of this resolution.單一段落。本規(guī)范含國(guó)家法律體制規(guī)范GMC MERCOSUR第20號(hào)2011年“南方共同市場(chǎng)醫(yī)療用品與體外醫(yī)療用品的良好生產(chǎn)技術(shù)規(guī)范（廢除第04/95、38/96、65/96與131/96號(hào)GMC決議）”。Single paragraph. This regulation incorporates the national legal system Resolution GMC MERCOSUR No. 20/2011 MERCOSUR Technical Regulation of Good Manufacturing Practice for Medical Products and Products for Diagnostic Use In Vitro (repeal of GMC Resolution No. 04/95, 38/96, 65/96 and 131/96) .第2條：替代1998年8月27日的第686號(hào)法令，2000年6月27日發(fā)布的第59號(hào)RDC決議，以及2004年7月2日發(fā)布的第167號(hào)RDC決議。Article 2: - Repealing Ordinance No. 686, of August 27, 1998, the RDC Resolution No. 59, dated June 27, 2000, and Resolution RDC No. 167 of July 2, 2004.第3條適用時(shí)，醫(yī)療用品與體外診斷用品的經(jīng)銷(xiāo)商與存放/托管人應(yīng)符合決議要求。Article 3 - Distributors and storage/hosts of medical products and diagnostic products for use in vitro should meet the requirements of this Resolution, as applicable.第4條并入此法律文件后180日之內(nèi)可采取必要的措施落實(shí)本技術(shù)規(guī)范。Article 4 - It is granted within 180 days from the date of incorporation of the legislative instrument, to adopt the measures necessary for the implementation of the Technical Regulations.第5條該決議于公布之日生效。Article 5 - This Resolution shall enter into force on the date of its publication.DIRCEU BRS APARECIDO BARBANO=附件ANNEX醫(yī)療用品與體外診斷用品的良好生產(chǎn)技術(shù)規(guī)范TECHNICAL REGULATION OF GOOD MANUFACTURING PRACTICES FOR MEDICAL PRODUCTS ANDPRODUCTS FOR IN VITRO DIAGNOSTIC USE目錄CONTENT第1章總則CHAPTER 1 - GENERAL PROVISIONS第2章一般質(zhì)量體系要求 Part BCHAPTER 2 - GENERAL REQUIREMENTS OF QUALITY SYSTEM2.1. 總則2.1. General provisions 2.2.管理職責(zé)2.2. Managerial responsibility 2.3.雇員2.3. Staff 2.4.風(fēng)險(xiǎn)管理2.4. Risk Management 2.5.采購(gòu)控制2.5. Purchasing Control第3章文件和記錄 Part DCHAPTER 3 - DOCUMENTS AND RECORDS OF QUALITY3.1. 一般要求3.1. General requirements 3.2.器械歷史記錄3.2. Device History Record (DHR)3.3.檢測(cè)和試驗(yàn)記錄3.3. Records of inspections and tests第4章設(shè)計(jì)開(kāi)發(fā)文檔 Part CCHAPTER 4 - DESIGN CONTROL AND DEVICE MASTER RECORD (DMR)4.1.設(shè)計(jì)控制4.1. Design Control 4.2.器械主文檔4.2. Device Master Record (DMR)第5章產(chǎn)品過(guò)程控制 partGCHAPTER 5 - PROCESS AND PRODUCTION CONTROLS 5.1. 總則5.1. General Instructions5.2. 包裝，標(biāo)簽和使用說(shuō)明書(shū) partL5.2. Controls packaging, labeling and instructions for use5.3. 檢驗(yàn)和測(cè)試 Part H5.3. Inspection and testing5.4.檢測(cè)設(shè)備的要求 5.4. Inspection and test of measuring equipments.5.5. 確認(rèn)5.5. Validation 5.6.變更控制5.6. Change Control第6章搬運(yùn)、儲(chǔ)存、分銷(xiāo)的可追溯性 Part K搬運(yùn)、存儲(chǔ)、交付和安裝CHAPTER 6 - HANDLING, STORAGE, DISTRIBUTION AND TRACEABILITY6.1.處置6.1. Handling 6.2. 存貯6.2. Storage 6.3.分銷(xiāo)6.3. Distribution 6.4.可追溯性6.4. Identification and traceability 6.5.產(chǎn)品的符合性6.5. Non-compliant components and products第7章 糾正預(yù)防措施 Part J 糾正措施SECTION 7 - PREVENTIVE AND CORRECTIVE ACTIONS7.1.糾正和預(yù)防措施7.1. Corrective and Preventive Actions 7.2.投訴的管理7.2. Management of complaints7.3.質(zhì)量審核7.3. Quality audit 第8章安裝和服務(wù) Part K 搬運(yùn)、存儲(chǔ)、交付和安裝CHAPTER 8 - INSTALLATION AND SERVICING8.1.安裝8.1. Installation8.2.技術(shù)援助和服務(wù)8.2. Technical Assistance/Servicing第9章統(tǒng)計(jì)技術(shù) Part O CHAPTER 9 - STATISTICAL TECHNIQUES=第1章總則CHAPTER 1 - GENERAL PROVISIONS1.1適用性1.1 - Applicability1.1.1.本技術(shù)規(guī)范說(shuō)明了對(duì)醫(yī)療用品與體外診斷用品的制造要求。這些要求說(shuō)明了醫(yī)療用品與體外診斷用品的設(shè)計(jì)、采購(gòu)、制造、包裝、貼標(biāo)、存放、配送、安裝及維修方法與管理的良好生產(chǎn)規(guī)范(GMP)。本技術(shù)規(guī)范的要求旨在保證醫(yī)療用品與體外診斷用品的安全性與有效性。1.1.1. This Technical Regulation establishes requirements for the manufacture of medical products and products for in vitro diagnostic use. These requirements describe the Good Manufacturing Practices (GMP) for methods and controls used in the design, purchase, manufacturing, packaging, labeling, storage, distribution, installation and servicing of medical products and products for in vitro diagnostic use. The requirements of this Technical Regulation are intended to ensure that medical products and products for in vitro diagnostic use are safe and effective.1.1.1.2.本技術(shù)規(guī)范的要求適用于在巴西銷(xiāo)售的體外診斷用品的制造商與進(jìn)口商。1.1.1.2. The requirements of this Technical Regulation are applicable to manufacturers and importers of medical devices and diagnostic products for use in vitro that are commercialized in Brazil.1.1.3.制造商認(rèn)為本決議的任何要求不適用于自身情況的，應(yīng)提交相應(yīng)的書(shū)面理由說(shuō)明。1.1.3. Where the manufacturer understand that any of the requirements of this resolution does not apply to their cases, shall document justification for such understanding.1.1.1.4.適用時(shí)，醫(yī)療用品與體外診斷用品的進(jìn)口商應(yīng)符合決議要求。1.1.1.4. Importers of medical and diagnostic products for use in vitro should meet the requirements of this Resolution, as applicable.1.2.定義1.2. Definitions在本技術(shù)規(guī)范采用下列定義：For the purposes of this Technical Regulation the following definitions apply:1.2.1.技術(shù)協(xié)助/維修：為使成品達(dá)到規(guī)范要求而開(kāi)展的維護(hù)或維修。1.2.1. Technical Assistance/Servicing: Maintenance or repair of a finished product to return it to your specifications.1.2.2.質(zhì)量審查：一項(xiàng)定期以適當(dāng)頻率開(kāi)展的，獨(dú)立于制造商所有質(zhì)量體系的系統(tǒng)化審查，用于確認(rèn)質(zhì)量體系活動(dòng)或其結(jié)果是否符合貴方質(zhì)量體系程序的要求，確保有效落實(shí)程序，實(shí)現(xiàn)質(zhì)量體系目標(biāo)。質(zhì)量審查與本技術(shù)規(guī)范要求的其他質(zhì)量體系活動(dòng)不同。1.2.2. Audit quality: means an established examination, systematic and independent of all quality system from a manufacturer, performed at regular intervals and with sufficient frequency to ensure that either the activities of the quality system or their results satisfy the procedures specified in your quality system, and that these procedures are implemented efficiently and that are appropriate to achieve the objectives of the quality system. The quality audit is different from other activities of the quality system required by this Technical Regulation.1.2.3.組成部分：醫(yī)療用品與體外診斷用品的生產(chǎn)過(guò)程中使用的，作為成品組成部分的原材料、物質(zhì)、組件、零件、軟件、硬件、包裝、標(biāo)簽或使用說(shuō)明。1.2.3. Component: raw material, substance, piece, part, software, hardware, packaging, labeling or instructions for use which are used during the manufacture of a medical product and product for diagnostic use in vitro, to be included as part of the finished product.1.2.4.項(xiàng)目/設(shè)計(jì)輸入：作為貴方項(xiàng)目依據(jù)的物理特性、使用說(shuō)明、性能、兼容性、安全性、功效、人體工程學(xué)理論、可用性、先前項(xiàng)目信息與風(fēng)險(xiǎn)管理結(jié)果，以及醫(yī)療設(shè)備或體外診斷用品的其他要求。1.2.4. Project /Design Input : description of physical attributes, indication for use, performance, compatibility, security, efficiency, ergonomics, usability, information from previous projects and results of risk management, among other requirements of a medical device or diagnostic product use in vitro that are used as the basis for your project.1.2.5.項(xiàng)目/設(shè)計(jì)輸出：項(xiàng)目各階段成果及其最終結(jié)果。完成項(xiàng)目的輸出數(shù)據(jù)是產(chǎn)品主記錄(PMR)/器械主記錄(DMR)的依據(jù)。1.2.5. Project/Design Output : outcome of the work in each phase of the project and its final result. The output data of finished project is the basis for the product master record (PMR)/Device Master Record (DMR) .1.2.6.損害：對(duì)人員健康的物理傷害，或者財(cái)產(chǎn)或環(huán)境的損壞。1.2.6. Damage: physical injury or harm to the health of the person, or damage to property or the environment.1.2.7.規(guī)范：各種產(chǎn)品、成分、生產(chǎn)活動(dòng)、技術(shù)協(xié)助服務(wù)、質(zhì)量體系或其他活動(dòng)必須符合的要求。1.2.7. Specifications: requirements that products, components, production activities, technical assistance services, quality system or any other activity must conform.1.2.8.確立：定義、記錄（通過(guò)書(shū)面或電子手段）與實(shí)施。1.2.8. Establish: define, document (through written or electronic) and implement.1.2.9.廠商：負(fù)責(zé)設(shè)計(jì)、制造、組裝或處理成品的任何人，包括消毒、貼標(biāo)與包裝人。1.2.9. Manufacturer: means any person who designs, manufactures, assembles or processes a finished product, including those who perform contract sterilization, labeling, packaging.1.2.10.行政管理層：負(fù)責(zé)提供資源與授權(quán)變更政策與質(zhì)量體系的高層管理人員。1.2.10. Executive management: top management responsible for providing resources and authority to establish or change policy and quality system of the company.1.2.11.風(fēng)險(xiǎn)管理：各種分析、評(píng)估、控制與管理特定產(chǎn)品或流程相關(guān)風(fēng)險(xiǎn)的政策、程序與管理規(guī)范的系統(tǒng)化應(yīng)用。1.2.11. Risk Management: the systematic application of policies, procedures and management practices to the tasks of analyzing, evaluating, controlling and monitoring risks associated with a particular product or process.1.2.12.批次：來(lái)自同一生產(chǎn)或消毒周期的，關(guān)鍵特性相同的產(chǎn)品之?dāng)?shù)量。1.2.12. Lot or batch: quantity of a product produced in a cycle of manufacturing or sterilization, whose essential characteristic is homogeneity.1.2.13.原材料：用于生產(chǎn)或促進(jìn)生產(chǎn)的材料或物質(zhì)，包括清潔劑、脫模劑、潤(rùn)滑劑、消毒劑或生產(chǎn)流程中的其他副產(chǎn)品。原材料：1.2.13. Manufacturing Material: material or substance used in the manufacturing process or to facilitate this process, including cleaning agents, mold release agents, lubricants, sterilizing, or other byproducts of the manufacturing process.1.2.14.不合格: 未滿足事先規(guī)定的各項(xiàng)要求。1.2.14. Nonconformity: non-fulfillment of requirements specified in advance.1.2.15.序號(hào)或批號(hào)：可追溯采購(gòu)、制造、包裝、貼標(biāo)及成品分銷(xiāo)信息的唯一字母/數(shù)字/字母+數(shù)字組合。1.2.15. Serial Number or Lot: distinctive combination of letters or numbers, or both, which can be given a complete history of purchasing, manufacturing, packaging, labeling and distribution of finished products.1.2.16.危害：潛在風(fēng)險(xiǎn)。1.2.16. Hazard: Potential source of harm.1.2.17.質(zhì)量政策：行政管理人員明示的組織關(guān)于質(zhì)量的一切目的與指示。1.2.17. Quality Policy: all the intentions and directives of an organization with regard to quality, expressed by executive management.1.2.18. 特殊工藝：無(wú)法通過(guò)后續(xù)檢查與測(cè)試充分核實(shí)結(jié)果的任何流程。1.2.18. Special Process: any process whose results cannot be fully verified by subsequent inspection and testing.1.2.19.生產(chǎn)：制造產(chǎn)品所涉及的所有運(yùn)作，從接收成分、處理、包裝，到實(shí)現(xiàn)成品。1.2.19. Production: all operations involved in the manufacture of a product, from receipt of components, through processing and packaging, to obtain the finished product.1.2.20.成品：適合使用的已包裝或已貼標(biāo)的產(chǎn)品或配件。1.2.20. Finished product: any product or accessory suitable for use, packed, labeled.1.2.21.質(zhì)量：使某一醫(yī)療用品或體外診斷用品符合使用要求（包括安全與性能）的全體功能與特點(diǎn)。1.2.21. Quality: the totality of features and characteristics that enable a medical product or product for diagnostic use in vitro meet the requirements of fitness for use, including safety and performance.1.2.22.投訴：否定產(chǎn)品特性、質(zhì)量、耐用性、安全性、效果或性能的書(shū)面、口頭或電子溝通。1.2.22. Complaint: written communication, oral or electronic on the rejection of identity, quality, durability, reliability, safety, effectiveness, or performance of a product.1.2.23.記錄：符合標(biāo)準(zhǔn)與質(zhì)量系統(tǒng)程序要求的，展示數(shù)據(jù)、事實(shí)、特定情況及成果的紙質(zhì)或電子文件。1.2.23. Records: physical or electronic document, which shows data, facts, specific events and achievements in relation to compliance with standards and procedures of the quality system.1.2.24.產(chǎn)品歷史記錄/設(shè)備歷史記錄(DHR)：成品制造完整歷史信息的記錄。1.2.24. Historical record of the product/Device History Record (DHR): compilation of records containing the complete history of producing a finished product.1.2.25.項(xiàng)目歷史記錄/設(shè)計(jì)歷史文件(DHF)：從項(xiàng)目到成品的完整歷史信息的文件。1.2.25. Historical record of the project/Design History File (DHF): compilation of documents containing the complete history of the project to a finished product.1.2.26.產(chǎn)品主記錄(PMR)/設(shè)備主記錄(DMR)：含實(shí)現(xiàn)成品、安裝、維修與服務(wù)的規(guī)范、指示與程序的文件。1.2.26. Product Master Record (PMR)/Device Master Record (DMR): compilation of documents containing specifications, instructions and procedures to obtain a finished product as well as installation, service and maintenance.1.2.27.返工：用于整改某一不合格成分、中間產(chǎn)品或成品，使其符合產(chǎn)品主記錄/設(shè)備主記錄規(guī)范的部分或全部制造活動(dòng)。1.2.27. Rework: part or all of the manufacturing operation designed to correct non-conformity of a component, the intermediate product or a finished product, so that it meets the specifications set out in PMR/DMR.1.2.28.項(xiàng)目/設(shè)計(jì)審查：項(xiàng)目開(kāi)發(fā)過(guò)程中實(shí)施的配有文件、系統(tǒng)化且完整實(shí)施的檢查，用于評(píng)估規(guī)劃與目標(biāo)的適當(dāng)性。1.2.28. Project/Design review: examination documented, systematic and complete performed during the development of the project to assess the adequacy of the same planning and objectives.1.2.29.風(fēng)險(xiǎn)：發(fā)生概率與破壞程度的結(jié)合。1.2.29. Risk: Combination of the probability of occurrence and severity of damage.1.2.30.質(zhì)量體系：質(zhì)量管理的組織化結(jié)構(gòu)、職責(zé)、程序、規(guī)范、流程及資源。1.2.30. Quality system: organizational structure, responsibilities, procedures, specifications, processes and resources for quality management.1.2.31.確認(rèn)：通過(guò)檢查與客觀證明，驗(yàn)證針對(duì)特定目的提出的要求持續(xù)獲得預(yù)期結(jié)果。就項(xiàng)目而言，確認(rèn)指確立并記錄客觀證據(jù)，證明產(chǎn)品規(guī)范符合用戶需求及其目標(biāo)用途。就流程而言，確認(rèn)指確立并記錄客觀證據(jù)，證明流程將持續(xù)產(chǎn)生符合既定規(guī)范的結(jié)果。1.2.31. Validation: Confirmation by examination and objective evidence that the requirements defined for a particular purpose lead, consistently, the expected result. With respect to a project, means to establish and document objective evidence that the product specifications meet user needs and its intended use. With respect to a process means to establish and document objective evidence that the process will consistently produce a result that meets the predetermined specifications.1.2.32.驗(yàn)證：檢查并提供客觀證據(jù)，證明滿足特定要求。驗(yàn)證流程包括檢查某一活動(dòng)的記錄，確定符合確立的規(guī)范。1.2.32. Verification: confirmation by examination and presentation of objective evidence that specified requirements have been met. The verification process includes examining the results of an activity to determine compliance with established specifications.1.2.33.生命周期：廠商預(yù)計(jì)產(chǎn)品可正常發(fā)揮設(shè)計(jì)功能的時(shí)長(zhǎng)。1.2.33. Life time: time estimated by the manufacturer that a product complies correctly functions for which it was designed.第2章質(zhì)量體系一般要求CHAPTER 2 - GENERAL REQUIREMENTS OF QUALITY SYSTEM2.1.總則2.1. General Provisions2.1.1.每個(gè)廠商應(yīng)建立并維護(hù)一個(gè)質(zhì)量體系，確保滿足本技術(shù)規(guī)范的要求，并保證生產(chǎn)的產(chǎn)品安全、有效，適合預(yù)期用途。對(duì)于質(zhì)量體系，每個(gè)廠商需要開(kāi)展下列活動(dòng)：2.1.1. Each manufacturer shall establish and maintain a quality system to ensure that the requirements of this Technical Regulation are met and that the products manufactured are safe, effective and appropriate for the intended use. As part of its activities on the quality system, each manufacturer must:2.1.1.1.根據(jù)本技術(shù)規(guī)范的要求，建立并維護(hù)使用說(shuō)明和有效質(zhì)量體系程序，并2.1.1.1. Establish and maintain instructions and effective quality system procedures in accordance with the requirements of this Technical Regulation, and2.1.1.2.建立符合當(dāng)前健康法/衛(wèi)生法/監(jiān)督法的規(guī)定的程序。2.1.1.2. Establish procedures for compliance with the legal provisions contained in current health/sanitary surveillance laws.2.2.管理責(zé)任2.2. Managerial responsibility2.2.1.質(zhì)量政策。每個(gè)廠商的行政管理層的任務(wù)包括建立與已有政策一致的可量化政策和目標(biāo)，以實(shí)現(xiàn)質(zhì)量承諾。行政管理層負(fù)責(zé)維護(hù)組織內(nèi)各個(gè)層級(jí)的政策。行政管理層負(fù)責(zé)確保上述政策包含于質(zhì)量手冊(cè)之中，并且所有影響產(chǎn)品質(zhì)量的員工都理解掌握這些政策。2.2.1. Quality Policy. The executive management of each manufacturer shall establish its policy and objectives of commitment to quality, which should be measurable and consistent with the established policy. Executive management should maintain the policy at all levels of the organization. Executive management should ensure that this policy is described in a quality manual and understood by all employees who may affect or influence the quality of a product.2.2.2.組織每個(gè)廠商應(yīng)根據(jù)組織系統(tǒng)圖，建立并維護(hù)適當(dāng)?shù)慕M織結(jié)構(gòu)，任命有效率的員工，確保生產(chǎn)的產(chǎn)品符合本技術(shù)規(guī)范的要求。2.2.2. Organization. Each manufacturer shall establish and maintain an appropriate organizational structure, represented by the organization chart, with sufficient staff to ensure that products are manufactured in accordance with the requirements of this Technical Regulation.2.2.3.職責(zé)及權(quán)限每個(gè)廠商應(yīng)根據(jù)本規(guī)范中每一章節(jié)的要求，落實(shí)管理、執(zhí)行并驗(yàn)證質(zhì)量相關(guān)工作的所有員工的職責(zé)、權(quán)限和相互關(guān)系，并確保員工擁有必要的獨(dú)立性去完成各自職責(zé)。2.2.3. Responsibility and Authority. Each manufacturer shall establish, for each chapter of this Technical Regulation, responsibility, authority and interrelation of all personnel who manage, perform and verify work relating to quality, with the necessary independence to perform its responsibilities.2.2.4.待驗(yàn)證的資源與人員每個(gè)廠商應(yīng)確定驗(yàn)證職能，提供充足的資源，任命經(jīng)培訓(xùn)的人員開(kāi)展驗(yàn)證活動(dòng)。2.2.4. Resources and personnel for v