ISO13485：2016标准中英文对照整理版
合集下载
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
4.1.4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 th e quality management system;
a）评价其对于质量管理体系的影响；
（新增）
b) evaluated for their impact on th e medical devices produced under t his quality management system;
a）形成文件的质量方针和质量目标；
b) a quality manual;
b）质量手册；
c) documented procedures and reco rds required by this International S tandard;
c）本国际标准所要求下的形成文件的
程序和记录；
d)documents, including records, dete rmined by the organization to be n ecessary to ensure the effective pla nning, operation, and control of its processes;
e）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）。
4.1.4The organization shall manage these quality management system p rocesses in accordance withthe req uirements of this International Stan dard and applicable regulatory requ irements. Changes to bemade to th ese processes shall be:
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 orga nization can include manufacturer, a uthorized representative, importeror distributor.
b）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 applicableregulatory r equirements.
些过程的操作和控制都是有效的；
b)ensure the availability of resourc
es and information necessary to su pport the operation andmonitoring of these processes;
b）确保必须的信息和资源来支持这些
4.2.1 General
4.2.1总则U
The quality management system doc umentation (see4.2.4) shall include:
质量管理体系文件（见4.2.4）应包
括：
a) documented statements of a qual ity policy and quality objectives;
b）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 inte raction of these processes.
c）确定这些过程的JII顺序和相互作用。
4.1.3For each quality management system process, the organization sh all:
4.1.6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 revalidation shall beproportion ate to the risk associated with the use of the software.
ISO13485-2016
英文
中文
4.Quality management system
4.质量管理^系
4.1 General requirements
4.1一般要求
4.1.1The organization shall docume nt a quality management system an d maintain its effectiveness inaccor dance with the requirements of this International Standard and applica ble regulatory requirements.
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。
Records of such activities shall be maintained (see4.2.5).
这类措施的记录应当被保留》（见4.
2.5）（新增）
4.2 Documentation requirements
4.2^件要求
c）依据本国际标准和适当的法规要求
进行控制。（新增）
When the organization chooses to o utsource any process that affects pr oduct conformity torequirements, it shall monitor and ensure control ov er such processes. The organization shall retainresponsibility of conform ity to this International Standard an d to customer and applicable regula toryrequirements for outsourced pr ocesses. The controls shall be propo rtionate to the risk involved and th eability of the external party to me et the requirements in accordance with 7.4. The controls shall includ ewritten quality agreements.
d）监测、测量和分析这些过程；
e)establish and maintain records n eeded to demonstrate conformance to thice with applicable regulator y requirements (see 4.2.5).
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 organiza tion under the applicableregulatory requirements.
4.1.3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 ope ration and control of theseprocesse s are effective;
a）确定必要的标准和方法从而保证这
过程的操作和控制；
c)implement actions necessary to
achieve planned results and maintai n the effectiveness of theseprocesse s;
c）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;
注：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）
4.1.2The organization shall
4.1.2组织应当：
a) determine the processes needed for the quality management system and the application ofthese process es throughout the organization taki ng into account the roles undertake n by theorganization;
不一致。
4.2.2 Quality manual
4.2.2质量手册
The organization shall document a quality manual that includes:
a）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 t he control of the appropriate proce sses needed for the qualitymanage ment system;
4.1.5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（弹）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）
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, im plement and maintain any requirem ent, procedure, activity orarrangeme nt required to be documented by t his International Standard or applic able regulatoryrequirements.
4.1.6The organization shall docume nt procedures for the validation of the application of computersoftware used in the quality management sy stem. Such software applications sh all be validated prior toinitial use and, as appropriate, after changes t o such software or its application.
d）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.
e）相应法律法规要求下的其他文件。
与YY/T 0287-2003S本一致。注意
因为增加了器械文档，所以参引序号
程。这些过程的改变（变更）应当： （新增）
a) evaluated for their impact on th e quality management system;
a）评价其对于质量管理体系的影响；
（新增）
b) evaluated for their impact on th e medical devices produced under t his quality management system;
a）形成文件的质量方针和质量目标；
b) a quality manual;
b）质量手册；
c) documented procedures and reco rds required by this International S tandard;
c）本国际标准所要求下的形成文件的
程序和记录；
d)documents, including records, dete rmined by the organization to be n ecessary to ensure the effective pla nning, operation, and control of its processes;
e）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）。
4.1.4The organization shall manage these quality management system p rocesses in accordance withthe req uirements of this International Stan dard and applicable regulatory requ irements. Changes to bemade to th ese processes shall be:
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 orga nization can include manufacturer, a uthorized representative, importeror distributor.
b）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 applicableregulatory r equirements.
些过程的操作和控制都是有效的；
b)ensure the availability of resourc
es and information necessary to su pport the operation andmonitoring of these processes;
b）确保必须的信息和资源来支持这些
4.2.1 General
4.2.1总则U
The quality management system doc umentation (see4.2.4) shall include:
质量管理体系文件（见4.2.4）应包
括：
a) documented statements of a qual ity policy and quality objectives;
b）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 inte raction of these processes.
c）确定这些过程的JII顺序和相互作用。
4.1.3For each quality management system process, the organization sh all:
4.1.6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 revalidation shall beproportion ate to the risk associated with the use of the software.
ISO13485-2016
英文
中文
4.Quality management system
4.质量管理^系
4.1 General requirements
4.1一般要求
4.1.1The organization shall docume nt a quality management system an d maintain its effectiveness inaccor dance with the requirements of this International Standard and applica ble regulatory requirements.
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。
Records of such activities shall be maintained (see4.2.5).
这类措施的记录应当被保留》（见4.
2.5）（新增）
4.2 Documentation requirements
4.2^件要求
c）依据本国际标准和适当的法规要求
进行控制。（新增）
When the organization chooses to o utsource any process that affects pr oduct conformity torequirements, it shall monitor and ensure control ov er such processes. The organization shall retainresponsibility of conform ity to this International Standard an d to customer and applicable regula toryrequirements for outsourced pr ocesses. The controls shall be propo rtionate to the risk involved and th eability of the external party to me et the requirements in accordance with 7.4. The controls shall includ ewritten quality agreements.
d）监测、测量和分析这些过程；
e)establish and maintain records n eeded to demonstrate conformance to thice with applicable regulator y requirements (see 4.2.5).
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 organiza tion under the applicableregulatory requirements.
4.1.3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 ope ration and control of theseprocesse s are effective;
a）确定必要的标准和方法从而保证这
过程的操作和控制；
c)implement actions necessary to
achieve planned results and maintai n the effectiveness of theseprocesse s;
c）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;
注：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）
4.1.2The organization shall
4.1.2组织应当：
a) determine the processes needed for the quality management system and the application ofthese process es throughout the organization taki ng into account the roles undertake n by theorganization;
不一致。
4.2.2 Quality manual
4.2.2质量手册
The organization shall document a quality manual that includes:
a）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 t he control of the appropriate proce sses needed for the qualitymanage ment system;
4.1.5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（弹）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）
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, im plement and maintain any requirem ent, procedure, activity orarrangeme nt required to be documented by t his International Standard or applic able regulatoryrequirements.
4.1.6The organization shall docume nt procedures for the validation of the application of computersoftware used in the quality management sy stem. Such software applications sh all be validated prior toinitial use and, as appropriate, after changes t o such software or its application.
d）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.
e）相应法律法规要求下的其他文件。
与YY/T 0287-2003S本一致。注意
因为增加了器械文档，所以参引序号