ISO13485-2016中英文对照

（一）-一般要求 

Quality management system质量管理体系 

4.1 General requirements 一般要求 

4.1.1 The organizationshall document a quality management system and maintain its effectiveness in accordancewith the requirements of this International Standard and applicable regulatoryrequirements. 

组织应当依据本国际标准和相应的法律法规文件建立质量管理体系，并形成文件以维护质量管理体系的有效性。 

The organization shall establish, implement and maintain any requirement, procedure, activity activity arrangements required to be documented by this International Standard applicable regulatory requirements.

 组织应当确定、实施和维护任何本国家标准或适用的法规要求所需的要求、程序、活动或安排。（新增） The organization shall document the role(s) undertaken by the organization under the applicable regulatory requirements. 

依据相应的法律法规，组织应当明确组织中的角色，并形成文件。（新增）

NOTE Roles undertaken by the organization can include manufacturer, authorized representative,importer or distributor. 

组织中的角色可以包括生产商、受托方（授权代表）、进口商或经销商。（新增） 

4.1.2 The organization shall 组织应当：

 a) determine the processes needed for the quality management system and the application of these processes throughout the organization taking into account the roles undertaken by the organization; 

基于组织所承担的角色，确定质量管理体系所需的过程以及在整个组织中应用的程序。（新增） 

b) apply a risk based approach to the control of the appropriate processes needed for the quality management system; 

应用一个以风险为基础的方法来控制质量管理体系所需的相应过程。（新增，强调风险管理） 

c) determine the sequence and interaction of these processes. 

确定这些过程的顺序和相互作用。

 4.1.3 For each quality management system process, the organization shall: 

对于每个质量管理体系过程，组织应当： 

a) determine criteria and methods needed to ensure that both the operation and control of these processes are effective; 

确定必要的标准和方法从而保证这些过程的操作和控制都是有效的； 

b) ensure the availability of resources and information necessary to support the operation and monitoring of these processes; 

确保必须的信息和资源来支持这些过程的操作和控制； 

c) implement actions necessary to achieve planned results and maintain the effectiveness of these processes; 

实施必要的措施来达到预期的结果和维护这些过程的有效性。 

d) monitor, measure as appropriate, and analyse these processes; 

监测、测量和分析这些过程； 

e) establish and maintain records needed to demonstrate conformance to this International Standard and compliance with applicable regulatory requirements (see 4.2.5). 

建立和维护用于证明符合本国际标准和适用的法律法规要求的符合性的记录（参见4.2.5）。 

4.1.4 The organization shall manage these quality management system processes in accordance with the requirements of this International Standard and applicable regulatory requirements. Changes to be made to these processes shall be: 

组织应当依据本国际标准和适当的法规要求管理这些质量管理体系过程。这些过程的改变（变更）应当：（新增）

 a) evaluated for their impact on the quality management system; 

评价其对于质量管理体系的影响；（新增） 

b) evaluated for their impact on the medical devices produced under this quality management system; 评价其对于在此质量管理体系下生产的医疗器械的影响；（新增）

 c) controlled in accordance with the requirements of this International Standard and applicable regulatory requirements. 

依据本国际标准和适当的法规要求进行控制。（新增） 

4.1.5 When the organization chooses to outsource any process that affects product conformity to requirements, it shall monitor and ensure control over such processes. The organization shall retain responsibility of conformity to this International Standard and to customer and applicable regulatory requirements for outsourced processes. The controls shall be proportionate to the risk involved and the ability of the external party to meet the requirements in accordance with 7.4. The controls shall include written quality agreements. 

当组织选择外包（委托）任何影响产品符合要求的过程时，这些过程都应当被监控并确保这些过程控制。对于外包（委托）过程。组织应当具有符合国际标准、符合客户、符合适当法规要求的职责。 控制应当与所涉的风险以及外部组织的能力相适应，并且符合7.4项下的要求。控制应当包括书面的质量协议。（新增，委托） 

4.1.6 The organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application. 组织应当建议文件化的程序用于应用于质量管理体系计算机软件应用程序的验证。这类软件应用程序的验证应当在初始使用前进行验证，并在对该软件或其应用程序更改后进行验证。（新增，计算机系统验证） The specific approach and activities associated with software validation and re-validation shall be proportionate to the risk associated with the use of the software. Records of such activities shall be maintained (see 4.2.5). 

与软件验证和再验证相关的专门方法和措施应当使用该软件的风险相适应。这类措施的记录应当被保留》（见4.2.5）（新增） 

ISO 13485-2016中英文对照（二）-文件要求 

4.2 Documentation requirements 文件要求 

4.2.1 General 总则 

The quality management system documentation (see 4.2.4) shall include:

 质量管理体系文件（见4.2.4）应包括： 

a) documented statements of a quality policy and quality objectives; 

形成文件的质量方针和质量目标; 

b) a quality manual; 质量手册; 

c) documented procedures and records required by this International Standard; 

本国际标准所要求下的形成文件的程序和记录 

d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation, and control of its processes; 

组织确保其过程的有效策划、运行和控制所需的文件，包括记录

 e) other documentation specified by applicable regulatory requirements. 

相应法律法规要求下的其他文件。 【注：与 YY/T 0287-2003基本一致。注意因为增加了器械文档，所以参引序号不一致。】

 4.2.2 Quality manual 质量手册

 The organization shall document a quality manual that includes: 

组织应当起草一个质量手册，至少应包括： 

a) the scope of the quality management system, including details of and justification for any exclusion or non-application; 

质量管理体系的范围,包括任何删减和(或)不适用的细节与合理性; 

b) the documented procedures for the quality management system, or reference to them; 

为质量管理体系编制的形成文件的程序或对其引用;

 c) a description of the interaction between the processes of the quality management system. 

质量管理体系过程之间的相互作用的表述。 

The quality manual shall outline the structure of the documentation used in the quality management system. 

质量手册应概括质量管理体系中使用的文件的结构。 【注：与YY/T 0287-2003基本一致。】 

4.2.3 Medical device file 医疗器械文档（新增）

 For each medical device type or medical device family, the organization shall establish and maintain one or more files either containing or referencing documents generated to demonstrate conformity to the requirement of this International Standard and compliance with applicable regulatory requirements. The content of the file(s)shall include, but is not limited to: 对于每个医疗器械类型或系列医疗器械，组织应当确定和维护一个或多个文件，其中包括或引用所形成的文件，以证明符合国际标准和相应法规的要求。文件的内容应包括，但不限于：

 a) general description of the medical device,intended use/purpose, and labelling, including any instructions for use;specifications for product; 医疗器械的一般性描述、预期用途，标签，包括任何使用的说明；产品标准； 

c)specifications or procedures for manufacturing, packaging, storage, handling and distribution; 用于制造、包装、存储、处理、销售的标准或程序；

 d) procedures for measuring and monitoring; 

测量和控制程序； 

e) as appropriate, requirements for installation; 如果适用，安装的要求； 

f) as appropriate, procedures for servicing. 如果适用，服务的程序； 【注：ISO 13485-2016将医疗器械文档作为一个单独部分拿出来进行了描述，而不是YY/T0287-2003“组织应对每一类型或型号的医疗器械建立和保持一套文档，需包括或识别规定产品规范和质量管理体系要求的文件(见4.2.3)。这些文件应规定完整的生产过程，适用时，还包括安装和服务过程。”这样简单的进行了概述。】

 4.2.4 Control of documents 文件控制 

Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.5. 

质量体系所需的文件应当被控制。记录是一个特殊文件，应当依据4.2.5中的要求进行控制。

 A documented procedure shall define the controls needed to: 

应当用文件化的程序将这些控制明确下来，至少包括： 

a) review and approve documents for adequacy prior to issue; 下发前应当进行审核和批准，以确保文件的充分性和适宜性; 

b) review, update as necessary and re-approve documents; 必要时对文件进行评审、更新并重新批准文件； 

c) ensure that the current revision status of and changes to documents are identified; 

保证文件更改和现行修订状态得到识别； 

d) ensure that relevant versions of applicable documents are available at points of use; 

在应用文件的区域能够获得适用文件有关版本； 

e) ensure that documents remain legible and readily identifiable; 

确保文件保持清晰、易于识别；

 f) ensure that documents of external origin,determined by the organization to be necessary for the planning and operation of the quality management system, are identified and their distribution controlled; 确保外来文件得到识别、并控制其分发;这些文件是由组织确定的，对质量管理体系策划和运行来说都是必须的。

 g) prevent deterioration or loss of documents; 防止损坏或丢失文件。

 h) prevent the unintended use of obsolete documents and apply suitable identification to them. 防止作废文件的非预期使用，并对这些文件进行适当的标识。 

The organization shall ensure that changes to documents are reviewed and approved either by the original approving function or another designated function that has access to pertinent background information upon which to base its decisions. 

组织应保证文件的更改得到原审批部门或其他指定部门的审核和批准，该被指定的审批部门应能获取用于作出决定的相关背景信息。

 The organization shall define the period for which at least one copy of obsolete documents shall be retained. This period shall ensure that documents to which medical device shave been manufactured and tested are available for at least the lifetime of the medical device as defined by the organization, but not less than the retention period of any resulting record (see 4.2.5), or as specified by applicable regulatory requirements. 

组织应当规定一个期限来保留至少一份作废的受控文件。这个期限应确保至少在组织所规定的医疗器械寿命期内，可以得到此医疗器械的制造和试验的文件，但不要少于记录(见 4.2 .5 )或相关法规要求所规定的保存期限。 

4.2.5 Control of records 记录控制

 Records shall be maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. 

应当保留记录以便供符合法规要求和质量管理体系有效运行的证据。

 The organization shall document procedures to define the controls needed for the identification,storage, security and integrity, retrieval, retention time and disposition of records. 

组织应当建立文件化的程序，来规定记录的标识、贮存、保护、检索、保存期限和处置所需的控制 The organization shall define and implement methods for protecting confidential health information contained in records in accordance with the applicable regulatory requirements. 

组织应根据适用的法规要求，制定并实施记录中包含的机密健康信息的方法。（新增） 

Records shall remain legible, readily identifiable and retrievable. Changes to a record shall remain identifiable. 

记录应保持清晰、易于识别和检索。更改记录应保持可识别。（新增） 

The organization shall retain the records for at least the lifetime of the medical device as defined by the organization, or as specified by applicable regulatory requirements, but not less than two years from the medical device release by the organization. 

组织应当保存记录至少到组织规定的医疗器械寿命期，或是按相应的法律法规要求来实施，但从组织放行产品的日期起不少于2年。 【注：这部分新增内容一个亮点是器械文档（Medical device file），描述要比YY/T0287-2003内容充实的多。另外就是记录控制又增加了点内容。大家注意一下。 】

ISO 13485-2016中英文对照（三）-管理职责 

5 Management responsibility 5 管理职责 

5.1 Management commitment 管理承诺 

Top management shall provide evidence of its commitment to the development and implementation of the quality management system and maintenance of its effectiveness by:

 最高管理者应通过以下活动，对其开发、实施质量管理体系并维持其有效性的承诺提供证据:

 a) communicating to the organization the importance of meeting customer as well as applicable regulatory requirements; 

向组织传达满足顾客和法律法规要求的重要性; 

b) establishing the quality policy; 

确定质量方针; 

c) ensuring that quality objectives are established;

 确保质量目标的确定; 

d) conducting management reviews; 

进行管理评审; 

e) ensuring the availability of resources. 

确保资源的获得。 

5.2 Customer focus 客户关注 

Top management shall ensure that customer requirements and applicable regulatory requirements are determined and met. 

最高管理者应确保顾客和相应的法律法规要求得到确定并予以满足。 

5.3 Quality policy 质量方针 

Top management shall ensure that the quality policy: 最高管理者应确保质量方针： 

a) is applicable to the purpose of the organization; 

与组织的宗旨相适应； 

b) includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system; 包括一个符合要求和维持质量管理体系有效性的承诺; 

c) provides a framework for establishing and reviewing quality objectives; 

提供制定和评审质量目标的框架; 

d) is communicated and understood within the organization; 

在组织内得到沟通和理解; 

e) is reviewed for continuing suitability. 

为了保证持续适宜性应当进行评审。 

5.4 Planning 策划 

5.4.1 Quality objectives 质量目标

 Top management shall ensure that quality objectives, including those needed to meet applicable regulatory requirements and requirements for product, are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy. 

最高管理者应确保在组织的相关职能和层次上建立质量目标，质量目标包括满足适应的法律法规和产品要求所需的内容。质量目标应是可测量的，并与质量方针保持一致。

 5.4.2 Quality management system planning 质量管理体系策划 

Top management shall ensure that: 

高层管理者应当保证： 

a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives; 

质量管理体系的策划应当得到贯彻以符合4.1项下和质量目标的要求; 

b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 

经策划和实施质量管理体系发生变更时，应当保持质量管理体系的完整性。 

5.5 Responsibility, authority and communication 职责，权限和沟通 

5.5.1 Responsibility and authority 职责和权限 

Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization. 

最高管理者应当保证组织内的职责和权限清晰的被界定、文件化和沟通。 

Top management shall document the interrelation of all personnel who manage, perform and verify work affecting quality and shall ensure the independence and authority necessary to perform these tasks. 最高管理者应当文件化所有从事影响质量的管理、执行和验证工作的人员的相互关系。最高管理者还应当保证其完成这些任务所必须的独立性和权限。 其中没有YY/T0287的备注项目。（删减）

 5.5.2 Management representative 管理者代表 

Top management shall appoint a member of management who, irrespective of other responsibilities, has responsibility and authority that includes: 

最高管理者应当制定一名管理者，不管他是否有其他责任，他都应具有以下的职权：

 a) ensuring that processes needed for the quality management system are documented; 

保证质量管理体系所需的过程都被文件化； 

b) reporting to top management on the effectiveness of the quality management system and any need for improvement; 

向最高管理者报告质量管理体系的业绩和任何改进的需要； 

c) ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization. 

确保贯穿于组织内部的质量管理体系需求和适应的法规需求意识的提升。 【注：其中没有YY/T0287的备注项目。（删减）】 

5.5.3 Internal communication 内部沟通

 Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system. 

最高管理者应保证在组织内部建立适宜的沟通程序，并保证对质管理体系的有效性进行沟通。 5.6 Management review 管理评审 

5.6.1 General 总则

 The organization shall document procedures for management review. Top management shall review the organization’s quality management system at documented planned intervals to ensure its continuing suitability, adequacy and effectiveness. The review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.Records from management reviews shall be maintained (see 4.2.5).

 最高管理者应建立管理评审的程序。最高管理者应当在规定策划时间间隔内审核该组织的质量管理体系，从而保证质量管理体系持续的适宜性、充分性和有效性。评审应包括评估质量管理体系改进的机会和变更的需要，包括质量方针和质量目标。应保持管理评审的记录(见4.2.5)。 

5.6.2 Review input 审核输入 The input to management review shall include, but is not limited to, information arising from: 

管理评审的输入应当包括但不限于以下信息： 

a) feedback; 反馈 

b) complaint handling; 抱怨的处理 

c) reporting to regulatory authorities; 向药监部门报告 

d) audits; 审计 

e) monitoring and measurement of processes;过程的控制和测量； 

f) monitoring and measurement of product; 产品的控制和测量； （新增部分）

g) corrective action; 纠正措施； h) preventive action;预防措施； 

i) follow-up actions from previous management reviews; 以往管理评审的跟踪措施； 

j) changes that could affect the quality management system;可能影响质量管理体系的变更； 

k) recommendations for improvement;改进的建议； 

l) applicable new or revised regulatory requirements. 新的或修订的法规要求。 

5.6.3 Review output 评审输出 

The output from management review shall be recorded (see 4.2.5) and include the input reviewed and any decisions and actions related to: 

管理评审的输出应当被记录（见4.2.5），并且应当包括经审核输出和任何与下述有关的决定和措施： 

a) improvement needed to maintain the suitability, adequacy, and effectiveness of the quality management system and its processes; 

维持质量管理系和其过程适宜性、有效性和充分性所需的改进； 

b) improvement of product related to customer requirements; 

与顾客要求有关的产品的改进； 

c) changes needed to respond to applicable new or revised regulatory requirements; 

适应新的和修订的法规所需的变更；（新增） 

d) resource needs. 资源需求。 总结：管理职责变化不大，只是略微调整。其中5.5.1和5.5.2去掉了注意项；5.6.2管理评审输入增加了几个输入内容；5.6.3管理评审输出增加了一项输出内容。 

ISO 13485-2016中英文对照（四）-资源管理 

6 Resource management 

6 资源管理 

6.1 Provision of resources 资源供给 

The organization shall determine and provide the resources needed to: 

组织应当确定并提供以下所需资源: 

a) implement the quality management system and to maintain its effectiveness; 

实施质量管理体系和维护其有效的资源; 

b) meet applicable regulatory and customer requirements. 符合相应法规和客户要求的资源。 

6.2 Human resources 人力资源 

Personnelperforming work affecting product quality shall be competent on the basis ofappropriate education, training, skills and experience. 

对于从事影响产品质量的工作人员应当具有与其工作相适应的教育、培训、技能和经验，并且胜任。 

The organizationshall document the process(es) for establishing competence, providing needed training,and ensuring awareness of personnel. 

组织应当建立程序来促使这些能力的形成、并提供必要的培训和确保人员的认知。（新增） The organizationshall: 组织应当 

a) determine thenecessary competence for personnel performing work affecting product quality; 确定从事影响产品质量工作的人员所必要的能力;

 b) provide trainingor take other actions to achieve or maintain the necessary competence; 

提供培训或采取其他措施来达到或维持必要的能力；

 c) evaluate theeffectiveness of the actions taken;

 评估采取措施的有效性； 

d) ensure thatits personnel are aware of the relevance and importance of their activities andhow they contribute to the achievement of the quality objectives; 

确保员工认识到所从事活动的相关性和重要性，以及如何为实现质量目标作出贡献; 

e) maintainappropriate records of education, training, skills and experience (see 4.2.5). 

持续教育、培训、技能和经验的适当记录(见 4.2.5). 

NOTE The methodology used to check effectiveness isproportionate to the risk associated with the work for which the training orother action is being provided. 

注意：评估用于检查有效性的方法学应当风险相适应，这些风险与从事培训或提供其他措施有关。（新增） 

6.3 Infrastructure 基础设施

 The organizationshall document the requirements for the infrastructure needed to achieveconformity to product requirements, prevent product mix-up and ensure orderlyhandling of product. Infrastructure includes, as appropriate: 

组织应当建立形成文件化的基础设施需求，来符合产品需求、防止产品混淆以及确保产品的正确处理。（新增）

 a) buildings,workspace and associated utilities; 

建筑物，工作场所和相关的设施；

 b) processequipment (both hardware and software); 

工艺设备（包括软硬件）； 

c) supportingservices (such as transport, communication, or information systems). 

支持性服务（比如运输、通讯或信息系统（新增））

 The organizationshall document requirements for the maintenance activities, including theinterval of performing the maintenance activities, when such maintenanceactivities, or lack thereof, can affect product quality. As appropriate, therequirements shall apply to equipment used in production, the control of thework environment and monitoring and measurement. Records of such maintenanceshall be maintained (see 4.2.5). 

组织应建立和和形成文件化的维护措施需求，包括内部维护措施实施，当这样的维护措施实施时，或缺乏时，都会影响产品质量。如果可以，这些要求应当应用到生产、控制工作环境、检测和测量的设备上。（新增）应保持此类维护记录(见 4.2 .5) 

6.4 Workenvironment and contamination control 

6.4.1 Workenvironment 工作环境 

The organizationshall document the requirements for the work environment needed to achieve conformityto product requirements. 

组织应建立文件化的工作环境需求，来达到产品符合要求。

 If theconditions for the work environment can have an adverse effect on productquality, the organization shall document the requirements for the workenvironment and the procedures to monitor and control the work environment. 

如果用于工作环境的条件对产品质量有不良影响，组织应当建立工作环境的文件化需求和程序来监控和控制工作环境。（ YY/T6.4 b）） 

The organizationshall: 组织应当 

a) documentrequirements for health, cleanliness and clothing of personnel if contactbetween such personnel and the product or work environment could affect medicaldevice safety or performance; 

若人员与产品或工作环境的接触可能影响医疗器械的安全和性能；（新增），则组织应建立人员的健康、人员卫生和人员着装的文件化要求;

 b) ensure thatall personnel who are required to work temporarily under special environmental conditionswithin the work environment are competent or supervised by a competent person.

确保在特殊技环境条件下工作的所有的临时人员都能胜任相应的工作或在一个胜任人员的监督下。 NOTE Furtherinformation can be found in ISO 14644 and ISO 14698. 【注：更多信息请见ISO14644和ISO 14698。（新增） 】

6.4.2 Contamination control As appropriate,the organization shall plan and document arrangements for the control ofcontaminated or potentially contaminated product in order to preventcontamination of the work environment, personnel, or product. 

如果可以，组织应当策划和形成文件化的安排来进行污染和潜在污染产品的控制，从而预防工作环境、人员或产品的污染。（YY/T6.4d）） 

For sterilemedical devices, the organization shall document requirements for control ofcontamination with microorganisms or particulate。 

对于无菌医疗器械而言，组织应当建立与微生物和颗粒有关的污染控制的文件化要求。（新增） 总结：资源管理这部分，增添的内容还是相对较多的。然后是内容章节的略微的调整。6.2 Human resources 人力资源总则多了一段内容。并且最后部分多了一个注意项，再次提到风险管理（评估用于检查有效性的方法学应当风险相适应）；6.3基础设施部分增加的内容要格外关注了，一个是增加混淆的概念（mix-up）、一个增加了信息系统（information systems）、再就是最后部分的维护措施，应用到生产、检测、厂房控制的所有设备；

6.4是章节性的内容变化，另外增加了备注信息，关于环境标准和环境监测的，最后增加了无菌医疗器械环境控制的内容。

 ISO 13485-2016中英文对照（五）-产品实现  Product realization 

7 产品实现 

 7.1 Planning of product realization 产品实现策划 

The organizationshall plan and develop the processes needed for product realization. Planningof product realization shall be consistent with the requirements of the otherprocesses of the quality management system. 

组织应当策划和设计产品实现所需的过程。产品实现策划应当与质量管理体系其他的过程要有相一致。 

The organizationshall document one or more processes for risk management in productrealization. Records of risk management activities shall be maintained (see 4.2.5). 

基于风险管理，组织应在产品实现中应当建立一个或多个过程。风险管理措施的记录应当予以保留。（见4.2.5）类似于YY/T 0287的组织应在产品实现全过程中，建立风险管理的形成文件的要求。应保持风险管理引起的记录(见4. 2.4)

 In planningproduct realization, the organization shall determine the following, asappropriate: 

在产品实现策划中，组织应当确定以下适当内容： 

a) qualityobjectives and requirements for the product; 

产品的质量目标和要求 

b) the need toestablish processes and documents (see 4.2.4) and to provideresources specific to the product, including infrastructure and workenvironment; 

确定过程和文件（见4.2.4）以及为产品提供特定资源的需求，包括资源和工作环境。（新增） 

c) requiredverification, validation, monitoring, measurement, inspection and test,handling, storage, distribution and traceability activities specific to theproduct together with the criteria for product acceptance; 

产品所需要的确认、验证、监控、测量、检查和测试、处理，存储、分配（销售）和可追溯性措施（新增）；以及专门针对于产品的产品验收标准； 

d) recordsneeded to provide evidence that the realization processes and resulting productmeet requirements (see 4.2.5). 产品实现和产品符合要求的结果得以证实所需的记录（见4.2.5）； 

The output ofthis planning shall be documented in a form suitable for the organization’s methodof operations. 

策划输出应当文件化（新增）并适于组织的运作方式。 NOTE Furtherinformation can be found in ISO 14971. 注：更多的信息见ISO14971。（新增） 

7.2 Customer-related processes 与顾客有关的过程 

7.2.1 Determination of requirements related to product 与产品有关的要求的确定 

The organizationshall determine: 

组织应当确定 

a) requirementsspecified by the customer, including the requirements for delivery andpost-delivery activities; 

顾客规定的要求，包括对交付及交付后活动的要求; 

b) requirementsnot stated by the customer but necessary for specified or intended use, asknown; 顾客虽然没有明示，但规定的用途或已知的预期用途所必需的要求; 

c) applicableregulatory requirements related to the product; 与产品有关的法律法规要求; 

d) any usertraining needed to ensure specified performance and safe use of the medicaldevice; 任何用于保证医疗器械安全使用和特定性能的用户培训需求；（新增） 

e) anyadditional requirements determined by the organization. 

确定的任何附加要求。 

7.2.2 Review of requirements related to product 与产品相关的需求的审核 

The organizationshall review the requirements related to product. This review shall beconducted prior to the organization’s commitment to supply product to thecustomer (e.g. submission of tenders, acceptance of contracts or orders,acceptance of changes to contracts or orders) and shall ensure that: 

组织应当审核与产品有关的要求。审核应在组织向顾客作出提供产品的承诺之前进行（如:提交标书、接受合同或订单及接受合同或订单的更改），并应确保: 

a) productrequirements are defined and documented; 产品需求必须得到明确并形成文件； 

b) contract ororder requirements differing from those previously expressed are resolved; 与以前表述不一致的合同或订单的要求得到解决； 

c) applicableregulatory requirements are met; 符合相应的法律法规要求； 

d) any usertraining identified in accordance with 7.2.1 is available orplanned to be available; 按照7.2.1项要求确定的任何用户培训是可行的或是计划可行。（新增） 

e) theorganization has the ability to meet the defined requirements. 

组中有能力符合确定的需求； Records of theresults of the review and actions arising from the review shall be maintained(see 4.2.5). 审核结果和因审核而产生措施的记录应当予以保留（见4.2.5） When the customerprovides no documented statement of requirement, the customer requirements shallbe confirmed by the organization before acceptance. 

若顾客提供的要求没有形成文件，组织在接受顾客要求前应对顾客要求进行确认。 When productrequirements are changed, the organization shall ensure that relevant documentsare amended and that relevant personnel are made aware of the changedrequirements. 

若产品要求发生变更，组织应确保相关文件得到修改。并确保相关人员知道已变更的要求。【注： YY/0287备注项目（删除）】

 7.2.3Communication 沟通 

The organizationshall plan and document arrangements for communicating with customers in relationto: 

组织应对以下有关方面确定并实施与顾客沟通的有效安排: 

a) productinformation; 

产品信息；

 b) enquiries,contracts or order handling, including amendments; 

问询、合同或订单处理、包括修订； 

c) customerfeedback, including complaints;

 顾客反馈，包括抱怨； 

d) advisorynotices.

 忠告性通知。 

The organizationshall communicate with regulatory authorities in accordance with applicable regulatoryrequirements. 

组织依据相应的法规要求与药监局进行沟通。 总结:风险管理描述略有差异。 

7.1产品实现策划 b）项中强调了资源和环境； c）中强调了处理，存储、分配（销售）和可追溯性措施；新增注意事项。 7.2.1中d）项新增培训、7.2.2中d）项新增培训，且备注项删剪。

 ISO13485-2016中英文对照（六）-产品实现 Product realization 

7 产品实现 

7.3 Design and development 设计和开发

 7.3.1 General 总则 

The organizationshall document procedures for design and development. 

组织应当建立设计和开发程序文件。 章节性变化，YY/T0287原文在7.3.1项下。 

7.3.2Design and development planning 设计和开发策划 

The organizationshall plan and control the design and development of product. As appropriate,design and development planning documents shall be maintained and updated asthe design and development progresses. 组织应当策划和控制产品的设计和开发。

随着设计和开发的开展，设计和开发的计划文件应适当的进行维护和更新。（新增） During designand development planning, the organization shall document: 在设计和开发策划期间，组织应当文件化： 

a) the design anddevelopment stages; 

设计和开发的阶段 

b) the review(s)needed at each design and development stage;

 每个设计和开发阶段所需的审核; 

c) theverification, validation, and design transfer activities that are appropriateat each design and development stage; 

适用于每个设计和开发阶段的确认、验证和设计转换活动； 

b)和c)等同于YY/T0287的b)。 

d) theresponsibilities and authorities for design and development; 

设计和开发的职责和权限。 

e) the methodsto ensure traceability of design and development outputs to design and developmentinputs; 

保证设计和开发输入和输出的追溯性的方法。（新增） 

f) the resourcesneeded, including necessary competence of personnel. 

所学的资源，包括必须的有经验的人员。（新增） 删剪掉YY/T0287的c)项后所有内容。 

7.3.3Design and development inputs 设计开发的输入

 Inputs relatingto product requirements shall be determined and records maintained (see 4.2.5). These inputsshall include: 

与产品需求相关的输入应当被确定，记录应当被保留。输入应当包括：

 a) functional,performance, usability and safety requirements, according to the intended use; 

功能性、操作性、可用性和安全性需求，依据预期的用途。 

b) applicableregulatory requirements and standards; 

适用的法律法规要求和标准；

 c) applicable output(s)of risk management; 

风险管理适用的输出 

d) asappropriate, information derived from previous similar designs; 

如果适用，来源于以往相同设计的信息； 

e) otherrequirements essential for design and development of the product and processes. 针对产品和过程设计和开发所需的其他必要需求；（新增） 

These inputsshall be reviewed for adequacy and approved. 

应对这些输入的充分性进行审核，并批准。

 Requirementsshall be complete, unambiguous, able to be verified or validated, and not inconflict with each other. 

要求必须完整，明确，能够确认或验证，并不相互产生冲突。 

NOTE Furtherinformation can be found in IEC 62366–1. 注：详细信息见IEC62366–1. 7.3.4Design and development outputs 设计和开发输出 Design anddevelopment outputs shall: 设计和开发输出应当包括： 

a) meet theinput requirements for design and development; 

符合设计和开发输入的要求； 

b) provideappropriate information for purchasing, production and service provision; 

提供适应的采购、生产和服务信息 

c) contain orreference product acceptance criteria; 包含或涉及引用的可接收标准； 

d) specify thecharacteristics of the product that are essential for its safe and proper use. 

描述产品安全和正常使用所必须的产品特性。 

The outputs ofdesign and development shall be in a form suitable for verification against thedesign and development inputs and shall be approved prior to release. 

设计和开发的输出应当符合设计和开发的输入要求，并在最后放行前得到批准。（新增） Records of thedesign and development outputs shall be maintained (see 4.2.5). 应保留设计和开发输出的记录。（详见4.2.5） 

7.3.5 Design and development review 设计和开发审核 

At suitablestages, systematic reviews of design and development shall be performed inaccordance with planned and documented arrangements to: 

在适当的阶段，应当根据策划和文件化的安排实施系统的设计和开发审核。以便： 

a) evaluate theability of the results of design and development to meet requirements; 

评估设计和开发结果符合需求的能力； 

b) identify andpropose necessary actions. 

识别并提出必要的措施。

 Participants insuch reviews shall include representatives of functions concerned with thedesign and development stage being reviewed, as well as other specialistpersonnel. 

审核人员应当包括设计和开发阶职能部门人员和其他专业人员。 

Records of theresults of the reviews and any necessary actions shall be maintained andinclude the identification of the design under review, the participantsinvolved and the date of the review (see 4.2.5) 

审核结果和任何必要的措施的相关记录应当予以保留，记录中包括审核下的设计识别、相关人员、审核的日期。（新增）（见4.2.5） 

7.3.6 Design and development verification 设计和开发的确认【注：YY/T0287翻译成验证 】

Design anddevelopment verification shall be performed in accordance with planned anddocumented arrangements to ensure that the design and development outputs havemet the design and development input requirements. 

设计和开发确认应当依据策划好的和文件化的方案来实施，从而保证设计和确认的输出能够符合设计和确认输入的要求。 

The organizationshall document verification plans that include methods, acceptance criteriaand, as appropriate, statistical techniques with rationale for sample size. 

组织应当建立确认计划，包括方法、接受标准、如果可以，样本大小的统计技术。（新增） 

If the intendeduse requires that the medical device be connected to, or have an interfacewith, other medical device(s), verification shall include confirmation that thedesign outputs meet design inputs when so connected or interfaced. 

如果医疗器械的预期用途与其他医疗器械相连或有接口，当这样相连或接口时，确认应当包括设计输出满足设计输入的证明。（新增） 

Records of theresults and conclusions of the verification and necessary actions shall bemaintained (see4.2.4 and 4.2.5). 

所有确认结论和结果以及必要的措施的记录都应当予以保留。（见4.2.4和4.2.5）

 7.3.7 Design and development validation 设计和开发的验证【注： YT/T0287翻译成确认   】（Design anddevelopment validation shall be performed in accordance with planned anddocumented arrangements to ensure that the resulting product is capable ofmeeting the requirements for the specified application or intended use. 

设计和开发验证应当依据策划好的和文件化的方案来实施，从而保证产品能够满足规适用要求或预期用途的要求。 The organizationshall 

document validation plans that include methods, acceptance criteria and,as appropriate, statistical techniques with rationale for sample size. 组

织应当建立验证计划包括方法、接受标准、如果可以，样本大小的统计技术。（新增） 

Design validation shall beconducted on representative product. Representative product includes initial production units, batches or their equivalents.The rationale for the choice of product used for validation shall be recorded(see 4.2.5). 

设计验证应当用代表性的产品加以实施。代表性的产品包括初始产品单位、批量或其等价物。应当记录选择用于验证产品的统计技术。（见4.2.5） 

As part ofdesign and development validation, the organization shall perform clinicalevaluations or performance evaluations of the medical device in accordance withapplicable regulatory requirements. 

作为设计和开发验证的一部分，组织应当一句相应的法律法规实施临床评价或性能评价。 

A medical deviceused for clinical evaluation or performance evaluation is not considered to bereleased for use to the customer. 

用于临床评价或性能评价的医疗器械不可以放行为客户使用。 

If the intendeduse requires that the medical device be connected to, or have an interfacewith, other medical device(s), validation shall include confirmation that therequirements for the specified application or intended use have been met whenso connected or interfaced. 

如果医疗器械的预期用途与其他医疗器械相连或有接口，当这样相连或接口时，验证应当包括使用要求和预期用途已经得到符合的证明。（新增） 

Validation shallbe completed prior to release for use of the product to the customer. Records of theresults and conclusion of validation and necessary actions shall be maintained(see 4.2.4 and4.2.5).

 在产品交付使用者之前验证应当实施完，验证的结果及任何必要措施的记录应予保留（见4.2.4和4.2.5）。 

7.3.8 Design and development transfer 设计和开发的转换 

The organizationshall document procedures for transfer of design and development outputs to manufacturing.These procedures shall ensure that design and development outputs are verified assuitable for manufacturing before becoming final production specifications andthat production capability can meet product requirements. 

组织应当建立设计和开发输出到实现产品之间的转换程序。这些程序应当保证设计和开发输出得以证实，并在产品成为最终产品规格时适合于生产制造，并且产能与产品要求相适应。 

Results andconclusions of the transfer shall be recorded (see 4.2.5).

 转换的结论和结果应当予以记录（见4.2.5）。（新增） 

7.3.9 Control of design and development changes 设计和开发变更的控制 

The organizationshall document procedures to control design and development changes. The organizationshall determine the significance of the change to function, performance,usability, safety and applicable regulatory requirements for the medical deviceand its intended use. 

组织应当建立程序来控制设计和开发的变更。组织应当确定医疗器械的功能、操作、可用性、安全性和适当的法规要求和它的预期用途变更的重要性。 Design anddevelopment changes shall be identified. Before implementation, the changesshall be: 设计和开发变更应当被确定。在实施前，变更应当： 

a) reviewed; 再审核 

b) verified;确认 

c) validated, asappropriate;适当的验证； 

d) approved.批准。 

The review ofdesign and development changes shall include evaluation of the effect of thechanges on constituent parts and product in process or already delivered,inputs or outputs of risk management and product realization processes. 设计和开发变更的审核应当包括这些变更所产生的影响。这些变更包括过程中和已经交付产品和组件的变更、风险管理的输入和输出以及产品实现过程的变更。 Records ofchanges, their review and any necessary actions shall be maintained (see 4.2.5). 

变更，变更的审核和任何必须的措施的记录都应当予以保留（见4.2.5） 

7.3.10 Design and development files 设计和开发文档 The organizationshall maintain a design and development file for each medical device type ormedical device family. This file shall include or reference records generatedto demonstrate conformity to the requirements for design and development and records for design anddevelopment changes. 

组织应当为每一个医疗器械或系列医疗器械保留一份设计和开发文档。该文档应当包括或涉及相应的记录。这些记录包含符合设计和开发要求的证明文件以及设计和开发变更的相关记录。（新增）【注： 备注：翻译有不到的地方请见谅，针对Design and development verification and Designand development validation笔者一直认为两个定义部分中“verification”应当翻译为确认而“validation”应当翻译为验证。但由于这两个词又都有确认和验证之意，所以还望以最后的官方译文为准，谢谢。 总结：产品实现7.3设计和开发控制变化还是比较明显的。其中几个重要的部分是。增加了7.3.8设计转换（设计和开发的转换）和7.3.10设计和开发文档（Design and developmentfiles）】

7.3.9设计和开发变更，有大篇幅的更改。7.3.6和7.3.7设计开发确认和验证部分也都有明显的增加内容。7.3.2-7.3.5都有一点新增内容，希望大家多关注。

 ISO 13485-2016中英文对照（七）-产品实现

7 Product realization 7 产品实现 

 7.4 Purchasing 采购 

7.4.1 Purchasing process 采购过程 

The organizationshall document procedures (see 4.2.4) to ensure thatpurchased product conforms to specified purchasing information. 

组织应当建立采购程序（见4.2.4）来保证采购的产品符合特定采购要求。 

The organization shall establishcriteria for the evaluation and selection of suppliers. The criteria shall be: 

组织应当确定用于评估和选择供应商的标准，标准应当包括： 

a) based on the supplier’s abilityto provide product that meets the organization’s requirements; 

供应商供应产品的能力，且产品要满足组织要求； 

b) based on the performance of thesupplier; 

供应商的业绩； 

c) based on the effect of thepurchased product on the quality of the medical device; 

供应的产品在医疗器械质量上影响。

 d) proportionate to the riskassociated with the medical device. 

与医疗器械风险相适应。 

The organization shall plan the monitoring and re-evaluation of suppliers. Supplier performance in meeting requirements for the purchased product shall be monitored. The results of the monitoring shall provide an input into the supplier re-evaluation process. 

组织应当制定监控和再评估供应商的计划。

针对采购的产品,应当控符合需求的供应商业绩。监控的结果应当作为供应商在评估过程的输入。 Non-fulfilment of purchasingrequirements shall be addressed with the supplier proportionate to the riskassociated with the purchased product and compliance with applicable regulatoryrequirements. 

非履行的采购需求应当依据与供应商采购产品相适应的风险进行登记，并且符合相应的法律法规。（新增）

 Records of the results of evaluation, selection, monitoring and re-evaluation of suppliercapability or performance and any necessary actions arising from theseactivities shall be maintained (see 4.2.5). 

评估、选择、控制和供应商能力或业绩的再评估以及由这些活动所引出的任何必要措施的记录都应当予以保留（见4.2.5） 

7.4.2 Purchasing information 采购信息 Purchasing information shall describe or reference the product to be purchased, includingas appropriate: 采购信息应当描述或涉及拟采购的产品，适当时应包括： a) productspecifications; 产品标准 b) requirementsfor product acceptance, procedures, processes and equipment; 产品接收、程序、过程和设备的需求； c) requirementsfor qualification of supplier personnel; 供应商人员资质的需求； d) qualitymanagement system requirements. 质量管理体系需求。 The organizationshall ensure the adequacy of specified purchasing requirements prior to their communicationto the supplier. 组织在与供应商沟通前应当确保有足够的有针对性的采购要求。 Purchasing information shallinclude, as applicable, a written agreement that the supplier notify the organizationof changes in the purchased product prior to implementation of any changes thataffect the ability of the purchased product to meet specified purchaserequirements. 采购信息应当包括，如适用，书面的批准，在任何拟采购产品的变更实施之前供应商应当向组织进行告知，这些变更可能会影响到拟采购产品符合特定采购要求的性能。（新增） To the extentrequired for traceability given in 7.5.9, theorganization shall maintain relevant purchasing information in the form ofdocuments (see 4.2.4) and records (see 4.2.5). 在7.5.9中规定了可追溯性要求的程度，组织应当以文档（见4.2.4）和记录（见4.2.5）的形式保存这些采购信息。 7.4.3Verification of purchased product 采购产品的确认 The organizationshall establish and implement the inspection or other activities necessary forensuring that purchased product meets specified purchasing requirements. The extent of verification activities shall be based on the supplierevaluation results and proportionate to the risks associated with the purchasedproduct. 组织应当确定和实施检查或其他的必要措施来保证所采购产品符合特定的采购需求。确认活动的范围应当基于供应商评估结果并且与采购产品有关的风险相适应。（新增） When theorganization becomes aware of any changes to the purchased product, theorganization shall determine whether these changes affect the product realizationprocess or the medical device. the organization shall state the intendedverification activities and method of product release in the purchasinginformation. 当组织发现采购产品任何变更时，组织应当确定这些变化是否影响产品的实现过程或影响到医疗器械。组织应当在采购信息中陈述产品放行的方法和意图的确认措施。（新增） Records of theverification shall be maintained (see 4.2.5). 确认的记录应予以保留（见4.2.5） 

7.6 Controlof monitoring and measuring equipment 监控和测量设备的控制 The organizationshall determine the monitoring and measurement to be undertaken and the monitoringand measuring equipment needed to provide evidence of conformity of product to determinedrequirements. 组织应当确定所需实施监控和测量，以及应用的设备以便于提供符合产品特定要求的证据。 The organizationshall document procedures to ensure that monitoring and measurement can be carriedout and are carried out in a manner that is consistent with the monitoring andmeasurement requirements. 组织应当形成程序文件来保证监控和测量的实施，并与监控和测量需求相一致的方式进行。 As necessary toensure valid results, measuring equipment shall: 为了保证结果有效，测量设备应当： 

a) be calibratedor verified, or both, at specified intervals, or prior to use, againstmeasurement standards traceable to international or national m