標準編號:	YY/T 0287-2017
中文名稱:	醫(yī)療器械 質量管理體系 用于法規(guī)的要求
英文名稱:	Medical devices-Quality management systems- Requirements for regulatory purposes
中標分類:	C30    醫(yī)療器械綜合
行業(yè)分類:	YY    醫(yī)藥行業(yè)標準
發(fā)布機構:	國家食品藥品監(jiān)督管理局
發(fā)布日期:	2017-01-19
實施日期:	2017-5-1
標準狀態(tài):	valid
替代舊標準:	YY/T 0287-2003 醫(yī)療器械 質量管理體系 用于法規(guī)的要求
翻譯語言:	英文
文件格式:	PDF
中文字符數(shù):	37000 字
翻譯價格(元):	640.0
交付時間:	付款后 1 個工作日

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY/T 0287-2003 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes in whole, and the following technical deviations have been made with respect to YY/T 0287-2003: — the importance of regulatory requirements is highlighted; — the scope of application is expanded; — the requirements of risk management are strengthened; — the requirements for communicating with and reporting to regulators are added; — the requirements for post-listing supervision and management are added; — the requirements for documentation and record-keeping are added. This standard is identical with International Standard ISO 13485:2016 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights. This standard was proposed by the China Food and Drug Administration. This standard is under the jurisdiction of the National Technical Committee 221 on Quality Management of and General Requirements for Medical Devices of Standardization Administration of China (SAC/TC 221). The previous editions of this standard are as follows: — YY/T 0287-1996, YY/T 0287-2003. ? Introduction 0.1 General This standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support). The requirements in this standard can also be used by suppliers or other external parties providing product (e.g. raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to such organizations. The supplier or external party can voluntarily choose to conform to the requirements of this standard or can be required by contract to conform. Several jurisdictions have regulatory requirements for the application of quality management systems by organizations with a variety of roles in the supply chain for medical devices. Consequently, this standard expects that the organization: — identifies its role(s) under applicable regulatory requirements; — identifies the regulatory requirements that apply to its activities under these roles; — incorporates these applicable regulatory requirements within its quality management system. The definitions in applicable regulatory requirements differ from nation to nation and region to region. The organization needs to understand how the definitions in this standard will be interpreted in light of regulatory definitions in the jurisdictions in which the medical devices are made available. This standard can also be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements applicable to the quality management system and the organization’s own requirements. It is emphasized that the quality management system requirements specified in this standard are complementary to the technical requirements for product that are necessary to meet customer and applicable regulatory requirements for safety and performance. The adoption of a quality management system is a strategic decision of an organization. The design and implementation of an organization’s quality management system is influenced by the: a) organizational environment, changes in that environment, and the influence that the organizational environment has on the conformity of the medical devices; b) organization’s varying needs; c) organization’s particular objectives; d) product the organization provides; e) processes the organization employs; f) organization’s size and organizational structure; g) regulatory requirements applicable to the organization’s activities. It is not the intent of this standard to imply the need for uniformity in the structure of different quality management systems, uniformity of documentation or alignment of documentation to the clause structure of this standard. There is a wide variety of medical devices and some of the particular requirements of this standard only apply to named groups of medical devices. These groups are defined in Clause 3. 0.2 Clarification of concepts In this standard, the following terms or phrases are used in the context described below. — When a requirement is qualified by the phrase “as appropriate”, it is deemed to be appropriate unless the organization can justify otherwise. A requirement is considered appropriate if it is necessary for: — product to meet requirements; — compliance with applicable regulatory requirements; — the organization to carry out corrective action; — the organization to manage risks. — When the term “risk” is used, the application of the term within the scope of this standard pertains to safety or performance requirements of the medical device or meeting applicable regulatory requirements. — When a requirement is required to be “documented”, it is also required to be established, implemented and maintained. — When the term “product” is used, it can also mean “service”. Product applies to output that is intended for, or required by, a customer, or any intended output resulting from a product realization process. — When the term “regulatory requirements” is used, it encompasses requirements contained in any law applicable to the user of this standard (e.g. statutes, regulations, ordinances or directives). The application of the term “regulatory requirements” is limited to requirements for the quality management system and the safety or performance of the medical device. The following auxiliary verbs are used in this standard: — “shall” indicates a requirement; — “should” indicates a recommendation; — "may" indicates permission; — "can" indicates a possibility or a capability. "Note" is for guidance in understanding or clarifying the associated requirement. 0.3 Process approach This standard is based on a process approach to quality management. Any activity that receives input and converts it to output can be considered as a process. Often the output from one process directly forms the input to the next process. For an organization to function effectively, it needs to identify and manage numerous linked processes. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach.” When used within a quality management system, such an approach emphasizes the importance of: a) understanding and meeting requirements; b) considering processes in terms of added value; c) obtaining results of process performance and effectiveness; d) improving processes based on objective measurement. 0.4 Relationship with ISO 9001 While this is a stand-alone standard, it is based on GB/T 19001-2008, which has been replaced by GB/T 19001-2016. For the convenience of users, Annex B shows the correspondence between this standard and GB/T 19001-2016. ISO13485:2016 is intended to facilitate global alignment of appropriate regulatory requirements for quality management systems applicable to organizations involved in one or more stages of the life-cycle of a medical device. This standard includes some particular requirements for organizations involved in the life-cycle of medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this standard cannot claim conformity to ISO 9001 unless their quality management system meets all the requirements of ISO 9001. 0.5 Compatibility with other management systems This standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, or financial management. However, this standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this standard. Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes 1 Scope This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). This standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of this standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization. The processes required by this standard that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes. If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to this standard reflect any exclusion of design and development controls. If any requirement in Clauses 6, 7 or 8 of this standard is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2. 2 Normative References The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 19000-2016 Quality Management Systems — Fundamentals and Vocabulary (ISO 9000: 2015, IDT) 3 Terms and Definitions For the purposes of this document, the terms and definitions given in GB/T 19000-2016 and the following apply. 3.1 advisory notice notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary information or to advise on action to be taken in the: — use of a medical device; — modification of a medical device; — return of the medical device to the organization that supplied it; or — destruction of a medical device. Note: Issuance of an advisory notice can be required to comply with applicable regulatory requirements. 3.2 authorized representative natural or legal person established within a country or jurisdiction who has received a written mandate from the manufacturer to act on his behalf for specified tasks with regard to the latter’s obligations under that country or jurisdiction’s legislation [Source: GHTF/SG1/N055:2009, 5.2] 3.3 clinical evaluation assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer [Source: GHTF/SG5/N4:2010, Clause 4] 3.4 complaint written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization’s control or related to a service that affects the performance of such medical devices Note: This definition of “complaint” differs from the definition given in GB/T 19000-2016. ? 3.5 distributor natural or legal person in the supply chain who, on his own behalf, furthers the availability of a medical device to the end user Note 1: More than one distributor may be involved in the supply chain. Note 2: Persons in the supply chain involved in activities such as storage and transport on behalf of the manufacturer, importer or distributor, are not distributors under this definition. [Source: GHTF/SG1/N055, 5.3] 3.6 implantable medical device medical device which can only be removed by medical or surgical intervention and which is intended to: — be totally or partially introduced into the human body or a natural orifice; or replace an epithelial surface or the surface of the eye; — remain after the procedure for at least 30 days. Note: This definition of implantable medical device includes active implantable medical device. 3.7 importer natural or legal person in the supply chain who is the first in a supply chain to make a medical device, manufactured in another country or jurisdiction, available in the country or jurisdiction where it is to be marketed [Source: GHTF/SG1/N055:2009, 5.4] 3.8 labelling label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents [Source: GHTF/SG1/N70:2011, Clause 4] 3.9 life-cycle all phases in the life of a medical device, from the initial conception to final decommissioning and disposal [Source: YY/T 0316-2016, 2.7] 3.10 manufacturer natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s) Note 1: This “natural or legal person” has ultimate legal responsibility for ensuring compliance with all applicable regulatory requirements for the medical devices in the countries or jurisdictions where it is intended to be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory Authority (RA) within that jurisdiction. Note 2: The manufacturer’s responsibilities are described in other GHTF guidance documents. These responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse event reporting and notification of corrective actions. Note 3: “Design and/or manufacture”, as referred to in the above definition, may include specification development, production, fabrication, assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or remanufacturing of a medical device; or putting a collection of devices, and possibly other products, together for a medical purpose. Note 4: Any person who assembles or adapts a medical device that has already been supplied by another person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided the assembly or adaptation does not change the intended use of the medical device. Note 5: Any person who changes the intended use of, or modifies, a medical device without acting on behalf of the original manufacturer and who makes it available for use under his own name, should be considered the manufacturer of the modified medical device. Note 6: An authorized representative, distributor or importer who only adds its own address and contact details to the medical device or the packaging, without covering or changing the existing labelling, is not considered a manufacturer. Note 7: To the extent that an accessory is subject to the regulatory requirements of a medical device, the person responsible for the design and/or manufacture of that accessory is considered to be a manufacturer. [Source: GHTF/SG1/N055:2009, 5.1] 3.11 medical device instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of: — diagnosis, prevention, monitoring, treatment or alleviation of disease; — diagnosis, monitoring, treatment, alleviation of or compensation for an injury; — investigation, replacement, modification, or support of the anatomy or of a physiological process; — supporting or sustaining life; — control of conception; — disinfection of medical devices; — providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means Note: Products which may be considered to be medical devices in some jurisdictions but not in others include: — disinfection substances; — aids for persons with disabilities; — devices incorporating animal and/or human tissues; — devices for in vitro fertilization or assisted reproduction technologies. [Source: GHTF/SG1/N071:2012, 5.1] 3.12 medical device family group of medical devices manufactured by or for the same organization and having the same basic design and performance characteristics related to safety, intended use and function 3.13 performance evaluation assessment and analysis of data to establish or verify the ability of an in vitro diagnostic medical device to achieve its intended use 3.14 post-market surveillance systematic process to collect and analyse experience gained from medical devices that have been placed on the market 3.15 product result of a process Note 1: There are four generic product categories, as follows: — services (e.g. transport); — software (e.g. computer program, dictionary); — hardware (e.g. engine mechanical part); — processed materials (e.g. lubricant). Many products comprise elements belonging to different generic product categories. Whether the product is then called service, software, hardware or processed material depends on the dominant element. For example, the offered product “automobile” consists of hardware (e.g. tyres), processed materials (e.g. fuel, cooling liquid), software (e.g. engine control software, driver’s manual), and service (e.g. operating explanations given by the salesman). Note 2: Service is the result of at least one activity necessarily performed at the interface between the supplier and customer and is generally intangible. Provision of a service can involve, for example, the following: — an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired); — an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return); — the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission); — the creation of ambience for the customer (e.g. in hotels and restaurants). Software consists of information and is generally intangible and can be in the form of approaches, transactions or procedures. Hardware is generally tangible and its amount is a countable characteristic. Processed materials are generally tangible and their amount is a continuous characteristic. Hardware and processed materials often are referred to as goods. Note 3: This definition of “product” differs from the definition given in GB/T 19000-2016. [Source: GB/T 19000-2008 , 3.4.2, modified] 3.16 purchased product product provided by a party outside the organization’s quality management system Note: The provision of product does not necessarily infer a commercial or financial arrangement.

Foreword IV Introduction V 1 Scope 2 Normative References 3 Terms and Definitions 4 Quality Management System 4.1 General requirements 4.2 Documentation requirements 4.2.1 General 4.2.2 Quality manual 4.2.3 Medical device documents 4.2.4 Control of documents 4.2.5 Control of records 5 Management Responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.4.1 Quality objectives 5.4.2 Quality management system planning 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority 5.5.2 Management representative 5.5.3 Internal communication 5.6 Management review 5.6.1 General 5.6.2 Review input 5.6.3 Review output 6 Resource Management 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment and contamination control 6.4.1 Work environment 6.4.2 Contamination control 7 Product Realization 7.1 Planning of product realization 7.2 Customer-related processes 7.2.1 Determination of requirements related to products 7.2.2 Review of requirements related to products 7.2.3 Communication 7.3 Design and development 7.3.1 General 7.3.2 Design and development planning 7.3.3 Design and development inputs 7.3.4 Design and development outputs 7.3.5 Design and development review 7.3.6 Design and development verification 7.3.7 Design and development validation 7.3.8 Design and development transfer 7.3.9 Control of design and development changes 7.3.10 Design and development files 7.4 Purchasing 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of purchased product 7.5 Production and service provision 7.5.1 Control of production and service provision 7.5.2 Cleanliness of product 7.5.3 Installation activities 7.5.4 Service activities 7.5.5 Particular requirements for sterile medical devices 7.5.6 Validation of processes for production and service provision 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier system 7.5.8 Identification 7.5.9 Traceability 7.5.10 Customer property 7.5.11 Preservation of product 7.6 Control of monitoring and measuring equipment 8 Measurement, Analysis and Improvement 8.1 General 8.2 Monitoring and measurement 8.2.1 Feedback 8.2.2 Complaint handling 8.2.3 Reporting to regulatory authorities 8.2.4 Internal audit 8.2.5 Monitoring and measurement of processes 8.2.6 Monitoring and measurement of product 8.3 Control of nonconforming product 8.3.1 General 8.3.2 Actions in response to nonconforming product detected before delivery 8.3.3 Actions in response to nonconforming product detected after delivery 8.3.4 Rework 8.4 Analysis of data 8.5 Improvement 8.5.1 General 8.5.2 Corrective action 8.5.3 Preventive action Annex A (Informative) Comparison of content between YY/T 0287-2017 and YY/T 0287- Annex B (Informative) Correspondence between YY/T 0287-2017 and GB/T 19001- Bibliography

醫(yī)療器械 質量管理體系 用于法規(guī)的要求 1 范圍 本標準為需要證實自身有能力提供持續(xù)滿足顧客要求和適用的法規(guī)要求的醫(yī)療器械和相關服務的組織規(guī)定了質量管理體系要求。這類組織能涉及醫(yī)療器械生命周期的一個或多個階段，包括醫(yī)療器械的設計和開發(fā)、生產(chǎn)、貯存和流通、安裝或服務，以及相關活動(例如技術支持)的設計和開發(fā)或提供。本標準也能用于向這類組織提供產(chǎn)品(包括與質量管理體系相關的服務)的供方或外部方。 除非明確規(guī)定，本標準的要求適用于各種規(guī)模和類型的組織。本標準中應用于醫(yī)療器械的要求同樣適用于組織提供的相關服務。 對于本標準所要求的適用于組織但不是由組織實施的過程，在質量管理體系中組織通過監(jiān)視、維護和控制這些過程對其負有責任。 如果適用的法規(guī)要求允許對設計和開發(fā)控制進行刪減，則能作為在質量管理體系中將其刪減的理由。若這些法規(guī)要求能提供其他方法，這些方法要在質量管理體系中予以說明。組織有責任確保在符合本標準的聲明中明確對設計和開發(fā)控制的任何刪減。 本標準第6、7或8章中的任何要求，如果因組織開展的活動或質量管理體系所涉及的醫(yī)療器械的特點而不適用時，組織不需要在其質量管理體系中包含這樣的要求。對于經(jīng)確定不適用的任何條款，組織按照4.2.2的要求記錄其理由。 2 規(guī)范性引用文件 下列文件對于本文件的應用是必不可少的。凡是注日期的引用文件，僅注日期的版本適用于本文件。凡是不注日期的引用文件，其最新版本(包括所有的修改單)適用于本文件。 GB／T 19000—2016質量管理體系 基礎和術語(ISO 9000：2015，IDT) 3 術語和定義 GB／T 19000—2016界定的以及下列術語和定義適用于本文件。 3.1 忠告性通知 advisory notice 在醫(yī)療器械交付后由組織發(fā)布的旨在以下方面給出補充信息或建議要采取措施的通知： ——醫(yī)療器械的使用； ——醫(yī)療器械的改動； ——醫(yī)療器械返回組織；或 ——醫(yī)療器械的銷毀。 注：忠告性通知的發(fā)布可能要求符合適用的法規(guī)要求。 3.2 授權代表 authorized representative 在國家或管轄區(qū)內確定了的，接受制造商書面授權、按照該國家或管轄區(qū)的法律，代表制造商行使與其義務有關的指定任務的自然人或法人。 [來源：GHTF／SG1／N055：2009，定義5.2] 3.3 臨床評價 clinical evaluation 評定和分析與醫(yī)療器械有關的臨床數(shù)據(jù)以驗證該器械按制造商的預期使用時的臨床安全和性能。 [來源：GHTF／SG5／N4：2010，第4章] 3.4 投訴 complaint 宣稱已從組織的控制中放行的醫(yī)療器械存在與標識、質量、耐用性、可靠性、可用性、安全或性能有關的缺陷或宣稱影響這些醫(yī)療器械性能的服務存在不足的書面、電子或口頭的溝通。 注：“投訴”的此定義不同于GB／T 19000—2016界定的定義。 3.5 經(jīng)銷商 distributor 供應鏈中代表其自身將醫(yī)療器械推銷給最終用戶的自然人或法人。 注1：供應鏈中可涉及多個經(jīng)銷商。 注2：供應鏈中代表制造商、進口商或經(jīng)銷商的涉及諸如貯存和運輸活動的人員不是本定義中的經(jīng)銷商。 [來源：GHTF／SG1／N055，定義5.3] 3.6 植入性醫(yī)療器械 implantable medical device 只能通過醫(yī)療或外科手術去除的醫(yī)療器械，預期其： ——被全部或部分插入人體或自然腔道中，或替代上表皮或眼表面； ——并且存留至少30天。 注：植入性醫(yī)療器械的定義包含有源植入性醫(yī)療器械。 3.7 進口商 importer 在供應鏈中使其他國家或管轄區(qū)制造的醫(yī)療器械在所要上市的國家或管轄區(qū)可銷售的第一個自然人或法人。 [來源：GHTF／SG1／N055：2009，定義5.4] 3.8 標記 labelling 與醫(yī)療器械的識別、技術說明、預期用途和正確使用有關的標簽、使用說明書和任何其他信息，但不包括貨運文件。 [來源：GHTF／SG1／N70：2011，第4章] 3.9 生命周期 life-cycle 在醫(yī)療器械生命中，從初始概念到最終停用和處置的所有階段。 [來源：YY／T 0316—2016，定義2.7] 3.10 制造商 manufacturer 以其名義制造預期可用的醫(yī)療器械并負有醫(yī)療器械設計和／或制造責任的自然人或法人，無論此醫(yī)療器械的設計和／或制造是由該自然人或法人進行或由另外的一個或多個自然人或法人代表其進行。 注1：此“自然人或法人”對確保符合醫(yī)療器械預期可用或銷售的國家或管轄區(qū)的所有適用的法規(guī)要求負有最終法律責任，除非該管轄區(qū)的監(jiān)管機構(RA)明確將該責任強加于另一自然人或法人。 注2：在其他GHTF指南文件中說明了制造商的責任。這些責任包括滿足上市前要求和上市后要求，比如不良事件報告和糾正措施通知。 注3：上述定義中所指的“設計和／或制造”可包括醫(yī)療器械的規(guī)范制定、生產(chǎn)、制造、組裝、加工、包裝、重新包裝、標記、重新標記、滅菌、安裝或再制造；或為了醫(yī)療目的而將多個器械(可能包括其他產(chǎn)品)組合在一起。 注4：假如組裝或修改不改變醫(yī)療器械的預期用途，該醫(yī)療器械已經(jīng)由另一自然人或法人按照使用說明書提供給個體患者，組裝或修改醫(yī)療器械的任何自然人或法人不是制造商。 注5：不是以原制造商的名義更改醫(yī)療器械的預期用途或改進醫(yī)療器械的任何自然人或法人，使器械以其名義提供使用，宜認為是改進后的醫(yī)療器械的制造商。 注6：不覆蓋或改變現(xiàn)有標記，只將自己的地址和聯(lián)系方式加在醫(yī)療器械上或包裝上的授權代表經(jīng)銷商或進口商，不被認為是制造商。 注7：納入醫(yī)療器械法規(guī)要求的附件，負責設計和／或制造該附件的自然人或法人被認為是制造商。 [來源：GHTF／SG1／N055：2009，定義5.1] 3.11 醫(yī)療器械 medical device 用于人類的儀器、設備、工具機械、器具、植入物、體外試劑、軟件、材料或其他類似或相關物品，其預期使用由制造商確定，不論單獨使用或組合使用，以達到下列一個或多個特定的醫(yī)療目的： ——疾病的診斷、預防、監(jiān)護、治療或緩解； ——損傷的診斷、監(jiān)護、治療、緩解或補償； ——生理結構或生理過程的查驗、替代、調節(jié)或支持； ——生命的支持或維持； ——妊娠控制； ——醫(yī)療器械的消毒； ——通過對取自人體的樣本進行體外檢查的方式來提供信息。 其作用于人體體內或體表，主要預期功能不是通過藥理學、免疫學或代謝的方式實現(xiàn)，但這些方式可有助于實現(xiàn)預期功能。 注：在一些國家或地區(qū)可認為是醫(yī)療器械但在另一些國家或地區(qū)不認為是醫(yī)療器械的產(chǎn)品包括但不限于： ——消毒物； ——殘障人士的輔助器具； ——包含動物和／或人體組織的器械； ——用于體外受精或輔助生殖技術的器械。 —[來源：GHTF／SG1／N071：2012，定義5.1] 3.12 醫(yī)療器械族 medical device family 由同一組織或為同一組織制造的具有有關安全、預期用途和功能的相同的基本設計和性能特性的成組醫(yī)療器械。 3.13 性能評價 performance evaluation 評定和分析數(shù)據(jù)以確立或驗證體外診斷醫(yī)療器械實現(xiàn)其預期用途的能力。 3.14 上市后監(jiān)督 post-market surveillance 收集和分析從已經(jīng)上市的醫(yī)療器械獲得的經(jīng)驗的系統(tǒng)過程。 3.15 產(chǎn)品 product 過程的結果。 注1：有下列四種通用的產(chǎn)品類別： ——服務(如運輸)； ——軟件(如計算機程序、字典)； ——硬件(如發(fā)動機機械零件)； ——流程性材料(如潤滑油)。 許多產(chǎn)品由分屬于不同產(chǎn)品類別的成分構成，其屬性是服務、軟件、硬件或流程性材料取決于產(chǎn)品的主導成分。例如：產(chǎn)品“汽車”是由硬件(如輪胎)、流程性材料(如：燃料、冷卻液)、軟件(如：發(fā)動機控制軟件、駕駛員手冊)和服務(如銷售人員所做的操作說明)所組成。 注2：服務通常是無形的，并且是在供方和顧客接觸面上需要完成至少一項活動的結果。服務的提供可涉及，例如： ——在顧客提供的有形產(chǎn)品(如需要維修的汽車)上所完成的活動； ——在顧客提供的無形產(chǎn)品(如為準備納稅申報單所需的損益表)上所完成的活動； ——無形產(chǎn)品的交付(如知識傳授方面的信息提供)； ——為顧客創(chuàng)造氛圍(如在賓館和飯店)。 軟件由信息組成，通常是無形產(chǎn)品，并可以方法、報告或程序的形式存在。 硬件通常是有形產(chǎn)品，其量具有計數(shù)的特性。流程性材料通常是有形產(chǎn)品，其量具有連續(xù)的特性。硬件和流程性材料經(jīng)常被稱為貨物。 注3：“產(chǎn)品”的此定義不同于GB／T 19000—2016界定的定義。 [來源：改寫GB／T 19000—2008)，定義3.4.2] 3.16 采購產(chǎn)品 purchased product 由組織質量管理體系以外的一方提供的產(chǎn)品。 注：提供產(chǎn)品不一定能推斷出商業(yè)或財務安排。 3.17 風險 risk 傷害發(fā)生的概率和該傷害嚴重度的組合。 注：“風險”的此定義不同于GB／T 19000—2016界定的定義。 [來源：YY／T 0316—2016，定義2.16] 3.18 風險管理 risk management 用于風險分析、評價、控制和監(jiān)視工作的管理方針、程序及其實踐的系統(tǒng)運用。 [來源：YY／T 0316—2016，定義2.22] 3.19 無菌屏障系統(tǒng) sterile barrier system 防止微生物進入并能使產(chǎn)品在使用地點無菌取用的最小包裝。 [來源：GB／T 19633.1—2015，定義3.22] 3.20 無菌醫(yī)療器械 sterile medical device 預期滿足無菌要求的醫(yī)療器械。 注1：對醫(yī)療器械無菌的要求，可按照適用的法規(guī)要求或標準執(zhí)行。 4 質量管理體系 4.1 總要求 4.1.1 組織應按照本標準的要求和適用的法規(guī)要求將質量管理體系形成文件并保持其有效性。 1) 被GB／T 19000—2016代替。 組織應按照本標準或適用的法規(guī)要求建立、實施和保持需要形成文件的所有要求、程序、活動或安排。 組織應將其在適用的法規(guī)要求下所承擔的一個或多個角色形成文件。 注：組織所承擔的角色可能包括制造商、授權代表、進口商或經(jīng)銷商。 4.1.2 組織應： a) 考慮組織承擔的角色來確定質量管理體系所篅的過程及這些過程在整個組織中的應用； b) 應用基于風險的方法控制質量管理體系所需的適當過程； c) 確定這些過程的順序和相互作用。 4.1.3 對于每個質量管理體系過程，組織應： a) 確定所需的準則和方法，以確保這些過程的有效運行和控制； b) 確保可獲得必要的資源和信息，以支持這些過程的運行和對這些過程的監(jiān)視； c) 實施必要的措施，以實現(xiàn)這些過程策劃的結果并保持這些過程的有效性； d) 監(jiān)視、測量(適當時)和分析這些過程； e) 建立和保持所需的記錄以證實符合本標準并滿足適用的法規(guī)要求(見4.2.5)。 4.1.4 組織應按照本標準要求和適用的法規(guī)要求管理這些質量管理體系過程。更改這些過程應： a) 評價過程更改對質量管理體系的影響； b) 評價過程更改對該質量管理體系中所生產(chǎn)的醫(yī)療器械的影響； c) 按照本標準的要求和適用的法規(guī)要求進行控制。 4.1.5 若組織選擇將影響產(chǎn)品符合要求的任何過程外包，組織應監(jiān)視這類過程并確保對其進行控制。組織應保留外包過程符合本標準要求、顧客要求和適用的法規(guī)要求的責任。控制應與所涉及的風險和外部方滿足7.4中要求的能力相適應。控制應包括書面質量協(xié)議。 4.1.6 組織應將用于質量管理體系的計算機軟件應用的確認程序形成文件。在軟件首次使用前應對軟件應用進行確認，適當時，軟件或其應用更改后也應對軟件應用進行確認。 與軟件確認和再確認有關的特定方法和活動應與軟件使用有關的風險相適應。 應保留這些活動的記錄(見4.2.5)。 4.2 文件要求 4.2.1 總則 質量管理體系文件(見4.2.4)應包括： a) 形成文件的質量方針和質量目標； b) 質量手冊； c) 本標準所要求的形成文件的程序和記錄； d) 組織確定的為確保其過程有效策劃、運行和控制所需的文件，包括記錄； e) 適用的法規(guī)要求規(guī)定的其他文件。 4.2.2 質量手冊 組織應編制質量手冊，質量手冊包括： a) 質量管理體系的范圍，包括任何刪減或不適用的詳細說明和理由； b) 質量管理體系的形成文件的程序或對其引用； c) 質量管理體系過程之間的相互作用的表述。 質量手冊應概述質量管理體系的文件結構。 4.2.3 醫(yī)療器械文檔 組織應為每個醫(yī)療器械類型或醫(yī)療器械族建立并保持一個或多個文檔，文檔包含或引用形成的文件以證明符合本標準要求和適用的法規(guī)要求。 文檔的內容應包括但不限于： a) 醫(yī)療器械的概述、預期用途／預期目的和標記，包括所有使用說明； b) 產(chǎn)品規(guī)范； c) 制造、包裝、貯存、處置和流通的規(guī)范或程序； d) 測量和監(jiān)視程序； e) 適當時，安裝要求； f) 適當時，服務程序。 4.2.4 文件控制 質量管理體系所要求的文件應予控制。記錄是一種特殊類型的文件，應依據(jù)4.2.5的要求進行控制。 形成文件的程序應規(guī)定以下方面所需的控制： a) 為使文件充分和適宜，文件發(fā)布前得到評審和批準； b) 必要時對文件進行評審與更新，并再次批準； c) 確保文件的現(xiàn)行修訂狀態(tài)和更改得到識別； d) 確保在使用處可獲得適用文件的有關版本； e) 確保文件保持清晰、易于識別； f) 確保組織所確定的策劃和運行質量管理體系所需的外來文件得到識別，并控制其分發(fā)； g) 防止文件的損壞或丟失； h) 防止作廢文件的非預期使用，對這些文件進行適當?shù)臉俗R。 組織應確保文件的更改得到原審批部門或指定的其他審批部門的評審和批準，被指定的審批部門應能獲取用于做出決定的相關背景資料。 對于至少應保存一份的作廢文件，組織應規(guī)定其保存期限。此期限應確保至少在組織所規(guī)定的醫(yī)療器械壽命期內，可得到這些醫(yī)療器械的制造和試驗的文件，而且還應不少于記錄(見4.2.5)或適用的法規(guī)要求所規(guī)定的保存期限。 4.2.5 記錄控制 應保持記錄以提供符合要求和質量管理體系有效運行的證據(jù)。 組織應建立程序并形成文件，以規(guī)定記錄的標識、存儲、安全和完整性檢索、保留時間和處置所需的控制。 按照適用的法規(guī)要求，組織應對記錄中包含的保密健康信息規(guī)定并實施保護方法。 記錄應保持清晰、易于識別和檢索。記錄的更改應保持可識別。 組織應保存記錄的期限至少為組織所規(guī)定的或適用的法規(guī)要求所規(guī)定的醫(yī)療器械的壽命期，而且還應從組織放行醫(yī)療器械起不少于兩年。 5 管理職貴 5.1 管理承諾 最高管理者應通過以下活動，對其建立、實施質量管理體系并保持其有效性的承諾提供證據(jù)： a) 向組織傳達滿足顧客要求以及適用的法規(guī)要求的重要性； b) 制定質量方針； c) 確保制定質量目標； d) 進行管理評審； e) 確保資源的可獲得性。 5.2 以顧客為關注焦點 最高管理者應確保顧客要求和適用的法規(guī)要求得到確定和滿足。 5.3 質量方針 最高管理者應確保質量方針： a) 適應組織的宗旨； b) 包括對滿足要求和保持質量管理體系有效性的承諾； c) 為制定和評審質量目標提供框架； d) 在組織內得到溝通和理解； e) 在持續(xù)適宜性方面得到評審。 5.4 策劃 5.4.1 質量目標 最高管理者應確保在組織的相關職能和層次上建立質量目標，質量目標包括滿足適用的法規(guī)要求和產(chǎn)品要求所需的內容。質量目標應是可測量的，并與質量方針保持一致。 5.4.2 質量理體系策劃 最高管理者應確保： a) 對質量管理體系進行策劃，以滿足4.1的要求以及質量目標； b) 在策劃和實施質量管理體系變更時保持其完整性。 5.5 職責、權限與溝通 5.5.1 職責和權限 最高管理者應確保職責和權限得到規(guī)定、形成文件并在組織內溝通。 最高管理者應將所有從事對質量有影響的管理、執(zhí)行和驗證工作的人員的相互關系形成文件，并應確保其完成這些任務所必要的獨立性和權限。 5.5.2 管理者代表 最高管理者應在管理層中指定一名成員，無論該成員在其他方面的職責如何，應使其具有以下方面的職責和權限： a) 確保將質量管理體系所需的過程形成文件； b) 向最高管理者報告質量管理體系的有效性和任何改進的需求； c) 確保在整個組織內提高滿足適用的法規(guī)要求和質量管理體系要求的意識。 5.5.3 內部溝通 最高管理者應確保在組織內建立適當?shù)臏贤ㄟ^程，并確保對質量管理體系的有效性進行溝通。 5.6 管理評審 5.6.1 總則 組織應將管理評審程序形成文件。最高管理者應按照形成文件的策劃的時間間隔對組織的質量管理體系進行評審，以確保其持續(xù)的適宜性、充分性和有效性。評審應包括評價改進的機會和質量管理體系變更的篅求，包括質量方針和質量目標變更的需求。 應保留管理評審的記錄(見4.2.5)。 5.6.2 評審輸入 管理評審的輸入應包括但不限于由以下方面產(chǎn)生的信息： a) 反饋； b) 投訴處置； c) 給監(jiān)管機構的報告； d) 審核； e) 過程的監(jiān)視和測量； f) 產(chǎn)品的監(jiān)視和測量； g) 糾正措施； h) 預防措施； i) 以往管理評審的跟蹤措施； j) 可能影響質量管理體系的變更； k) 改進的建議； l) 適用的新的或修訂的法規(guī)要求。 5.6.3 評審輸出 管理評審的輸出應予記錄(見4.2.5)并包括經(jīng)評審的輸入和與以下方面有關的任何決定和措施： a) 保持質量管理體系及其過程適宜性、充分性和有效性所需的改進； b) 與顧客要求有關的產(chǎn)品的改進； c) 響應適用的新的或修訂的法規(guī)要求所需的變更； d) 資源需求。 6 資源管理 6.1 資源提供 組織應確定并提供所需的資源，以： a) 實施質量管理體系并保持其有效性； b) 滿足適用的法規(guī)要求和顧客要求。 6.2 人力資源 基于適當?shù)慕逃⑴嘤枴⒓寄芎徒?jīng)驗，從事影響產(chǎn)品質量工作的人員應是勝任的。 組織應將確立能力、提供所需的培訓和確保人員的意識等一個或多個過程形成文件。 組織應： a) 確定從事影響產(chǎn)品質量工作的人員所需具備的能力； b) 提供培訓或采取其他措施以獲得或保持所需的能力； c) 評價所采取措施的有效性； d) 確保組織的人員知曉所從事活動的關聯(lián)性和重要性，以及如何為實現(xiàn)質量目標做出貢獻； e) 保留教育、培訓、技能和經(jīng)驗的適當記錄(見4.2.5)。 注：對于提供培訓或采取其他措施的有效性的檢查方法應與工作相關的風險相適應。 6.3 基礎設施 為達到符合產(chǎn)品要求、防止產(chǎn)品混淆和確保產(chǎn)品有序處置，組織應將所需的基礎設施的要求形成文件。適當時，基礎設施包括： a) 建筑物、工作場所和相關設施； b) 過程設備(硬件和軟件)； c) 支持性服務(如運輸、通訊或信息系統(tǒng))。 若維護活動或缺少維護活動可能影響產(chǎn)品質量，組織應將此類維護活動的要求包括執(zhí)行維護活動的時間間隔形成文件。適當時，要求應適用于生產(chǎn)設備、工作環(huán)境控制設備和監(jiān)視測量設備。 應保留此類維護的記錄(見4.2.5)。 6.4 工作環(huán)境和污染控制 6.4.1 工作環(huán)境 組織應將為達到符合產(chǎn)品要求所需工作環(huán)境的要求形成文件。 如果工作環(huán)境條件可能對產(chǎn)品質量有不良影響，組織應將工作環(huán)境要求以及監(jiān)視和控制工作環(huán)境的程序形成文件。 組織應： a) 將對特定人員的健康、清潔和著裝要求形成文件，此類人員與產(chǎn)品或工作環(huán)境的接觸可能影響醫(yī)療器械的安全或性能； b) 確保需要在工作環(huán)境內的特殊環(huán)境條件下臨時工作的所有人員是勝任的或在勝任人員監(jiān)督下工作。 注：更多信息見ISO 14644和ISO 14698。 6.4.2 污染控制 適當時，為了防止對工作環(huán)境人員或產(chǎn)品的污染，組織對受污染或易受污染產(chǎn)品的控制應進行策劃并將安排形成文件。 對于無菌醫(yī)療器械，組織應將控制微生物或微粒物污染的要求形成文件，在組裝或包裝過程中保持所要求的潔凈度。 7 產(chǎn)品實現(xiàn) 7.1 產(chǎn)品實現(xiàn)的策劃 組織應策劃和開發(fā)產(chǎn)品實現(xiàn)所需的過程。產(chǎn)品實現(xiàn)的策劃應與質量管理體系其他過程的要求相一致。 組織應在產(chǎn)品實現(xiàn)過程中，將風險管理的一個或多個過程形成文件。應保留風險管理活動的記錄(見4.2.5)。 在策劃產(chǎn)品實現(xiàn)的過程中，適當時，組織應確定以下方面的內容： a) 產(chǎn)品的質量目標和要求； b) 針對產(chǎn)品建立過程、文件(見4.2.4)和提供資源的需求，包括基礎設施和工作環(huán)境； c) 針對產(chǎn)品所要求的驗證、確認、監(jiān)視、測量、檢驗和試驗、處置、貯存、流通和可追溯性活動以及產(chǎn)品接收準則； d) 為實現(xiàn)過程及其產(chǎn)品滿足要求提供證據(jù)所需的記錄(見4.2.5)。 此策劃的輸出應以適合于組織運行方式的形式形成文件。 注：更多信息見ISO 14971。 7.2 與顧客有關的過程 7.2.1 產(chǎn)品要求的確定 組織應確定： a) 顧客規(guī)定的要求，包括對交付及交付后活動的要求； b) 顧客雖然沒有明示，但規(guī)定的用途或已知的預期用途所必需的要求； c) 與產(chǎn)品有關的適用的法規(guī)要求； d) 確保醫(yī)療器械的特定性能和安全使用所需的任何用戶培訓； e) 組織確定的任何附加要求。 7.2.2 產(chǎn)品要求的評審 組織應評審與產(chǎn)品有關的要求。評審應在組織向顧客做出提供產(chǎn)品的承諾(如提交投標書、接受合同或訂單以及接受合同或訂單的更改)前進行并應確保： a) 產(chǎn)品要求已得到規(guī)定并形成文件； b) 與以前表述不一致的合同或訂單要求已得到解決； c) 滿足適用的法規(guī)要求； d) 依照7.2.1識別的任何用戶培訓是可獲得的或按計劃是可獲得的； e) 組織有能力滿足規(guī)定的要求。 應保留評審結果及評審所引起的措施的記錄(見4.2.5)。 若顧客沒有提供形成文件的要求，組織在接受顧客要求前應對顧客要求進行確認。 若產(chǎn)品要求發(fā)生更改，組織應確保相關文件得到修改，并確保相關人員知道已更改的要求。 7.2.3 溝通 組織應就以下方面與顧客的溝通進行策劃并將安排形成文件： a) 產(chǎn)品信息； b) 處理問詢、合同或訂單，包括更改； c) 顧客反饋，包括投訴； d) 忠告性通知。 組織應按照適用的法規(guī)要求與監(jiān)管機構溝通。 7.3 設計和開發(fā) 7.3.1 總則 組織應將設計和開發(fā)程序形成文件。 7.3.2 設計和開發(fā)策劃 組織應對產(chǎn)品的設計和開發(fā)進行策劃和控制。適當時，隨著設計和開發(fā)的進展，應保持并更新設計和開發(fā)策劃文件。 在設計和開發(fā)策劃期間，組織應將以下方面形成文件： a) 設計和開發(fā)的各個階段； b) 每個設計和開發(fā)階段所需的一個或多個評審； c) 適合于每個設計和開發(fā)階段的驗證確認和設計轉換活動； d) 設計和開發(fā)的職責和權限； e) 確保設計和開發(fā)輸出到設計和開發(fā)輸入的可追溯的方法； f) 所需的資源，包括必要的人員能力。 7.3.3 設計和開發(fā)輸入 應確定與產(chǎn)品要求有關的輸入，并保留記錄(見4.2.5)，這些輸入應包括： a) 根據(jù)預期用途所確定的功能、性能、可用性和安全要求； b) 適用的法規(guī)要求和標準； c) 適用的風險管理的一個或多個輸出； d) 適當時，來源于以前類似設計的信息； e) 產(chǎn)品和過程的設計和開發(fā)所必需的其他要求。 應對這些輸入進行評審，以確保輸入是充分和適宜的，并經(jīng)批準。 這些要求應完整、清楚，能夠被驗證或確認，并且不能互相矛盾。 注：更多信息見IEC 62366-1。 7.3.4 設計和開發(fā)輸出 設計和開發(fā)輸出應： a) 滿足設計和開發(fā)輸入的要求； b) 給出采購生產(chǎn)和服務提供的適當信息； c) 包括或引用產(chǎn)品接收準則； d) 規(guī)定產(chǎn)品特征，該特性對于產(chǎn)品的安全和正確使用是必需的。 設計和開發(fā)輸出的方式應適合于對照設計和開發(fā)輸入進行驗證，設計和開發(fā)輸出應在發(fā)布前得到批準。 應保留設計和開發(fā)輸出的記錄(見4.2.5)。 7.3.5 設計和開發(fā)評審 應依據(jù)所策劃并形成文件的安排，在適宜的階段對設計和開發(fā)進行系統(tǒng)評審，以： a) 評價設計和開發(fā)的結果滿足要求的能力； b) 識別并提議必要的措施。 評審的參加者應包括與所評審的設計和開發(fā)階段有關的職能的代表以及其他專業(yè)人員。 應保留評審結果和任何必要措施的記錄，包括所評審的設計、涉及的參加者和評審日期(見4.2.5)。 7.3.6 設計和開發(fā)驗證 為確保設計和開發(fā)輸出滿足設計和開發(fā)輸入的要求，應依據(jù)所策劃并形成文件的安排對設計和開發(fā)進行驗證。 組織應將驗證計劃形成文件，驗證計劃包括方法、接收準則，適當時包括包含樣本量原理的統(tǒng)計技術。 如果預期用途要求醫(yī)療器械連接至或通過接口連接至其他的一個或多個醫(yī)療器械，驗證應包括證實當這樣連接或通過接口連接時設計輸出滿足設計輸入的要求。 應保留驗證結果和結論及必要措施的記錄(見4.2.4和4.2.5)。 7.3.7 設計和開發(fā)確認 為確保產(chǎn)品能夠滿足規(guī)定的應用要求或預期用途要求，應依據(jù)策劃并形成文件的安排對設計和開發(fā)進行確認。 組織應將確認計劃形成文件，確認計劃包括方法、接收準則，適當時包括包含樣本量原理的統(tǒng)計技術。 設計確認應選擇有代表性產(chǎn)品進行。有代表性產(chǎn)品包括最初的生產(chǎn)單元批次或其等同品。應記錄用于確認的產(chǎn)品選擇的理由說明(見4.2.5)。 作為設計和開發(fā)確認的一部分，組織應按照適用的法規(guī)要求進行醫(yī)療器械臨床評價或性能評價。用于臨床評價或性能評價的醫(yī)療器械不視為放行給顧客使用。 如果預期用途要求醫(yī)療器械連接至或通過接口連接至其他的一個或多個醫(yī)療器械，確認應包括證實當這樣連接或通過接口連接時已滿足規(guī)定的應用要求或預期用途。 確認應在向顧客放行產(chǎn)品使用前完成。 應保留確認結果和結論及必要措施的記錄(見4.2.4和4.2.5)。 7.3.8 設計和開發(fā)轉換 組織應將設計和開發(fā)輸出向制造轉換的程序形成文件。這些程序應確保設計和開發(fā)輸出在成為最終生產(chǎn)規(guī)范前經(jīng)驗證適合于制造并確保生產(chǎn)能力能滿足產(chǎn)品要求。 應記錄轉換的結果和結論(見4.2.5)。 7.3.9 設計和開發(fā)更改的控制 組織應將控制設計和開發(fā)更改的程序形成文件。組織應確定更改對于醫(yī)療器械功能、性能、可用性、安全、適用的法規(guī)要求及其預期用途等的重要程度。 應識別設計和開發(fā)的更改。更改在實施前應經(jīng)： a) 評審； b) 驗證； c) 適當時，確認； d) 批準。 設計和開發(fā)更改的評審應包括評價更改對在制的或已交付的組成部件和產(chǎn)品的影響，以及對風險管理的輸入或輸出和產(chǎn)品實現(xiàn)過程的影響。 應保留更改及其評審和任何必要的措施的記錄(見4.2.5)。 7.3.10 設計和開發(fā)文檔 組織應為每個醫(yī)療器械類型或醫(yī)療器械族保留設計和開發(fā)文檔。該文檔應包含或引用形成的記錄以證明符合設計和開發(fā)要求，該文檔還應包含設計和開發(fā)更改的記錄。