4.2Documentation requirements 文件要求
4.2.1General 总则
The qualitymanagement system documentation (see 4.2.4) shall include:
质量管理体系文件（见4.2.4）应包括：
a) documentedstatements of a quality policy and quality objectives;
形成文件的质量方针和质量目标;
b) a qualitymanual;
质量手册;
c) documentedprocedures 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, includingrecords, determined by the organization to be necessary to ensure the effectiveplanning, 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) otherdocumentation specified by applicable regulatory requirements.
相应法律法规要求下的其他文件。
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。
4.2.2Quality manual
质量手册
The organizationshall 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 ofthe quality management system, including details of and justification for any exclusionor 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) thedocumented 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 descriptionof 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 qualitymanual shall outline the structure of the documentation used in the qualitymanagement system.
质量手册应概括质量管理体系中使用的文件的结构。
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 medicaldevice type or medical device family, the organization shall establish andmaintain one or more files either containing or referencing documents generatedto demonstrate conformity to the requirement of this International Standard andcompliance 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, handlingand distribution;
用于制造、包装、存储、处理、销售的标准或程序；
d) proceduresfor measuring and monitoring;
测量和控制程序；
e) asappropriate, requirements for installation;
如果适用，安装的要求；
f) asappropriate, procedures for servicing.
如果适用，服务的程序；
ISO13485-2016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。
4.2.4Control of documents 文件控制
Documentsrequired by the quality management system shall be controlled. Records are aspecial type of document and shall be controlled according to the requirementsgiven 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 documentedprocedure 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 adequacyprior 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-approvedocuments;
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 ofand 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 applicabledocuments 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 andreadily 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 operationof 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 theunintended 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 organizationshall ensure that changes to documents are reviewed and approved either by the originalapproving function or another designated function that has access to pertinentbackground 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 organizationshall define the period for which at least one copy of obsolete documents shallbe retained. This period shall ensure that documents to which medical deviceshave been manufactured and tested are available for at least the lifetime ofthe medical device as defined by the organization, but not less than theretention period of any resulting record (see 4.2.5), or asspecified 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。
4.2.5Control of records 记录控制
Records shall bemaintained to provide evidence of conformity to requirements and of theeffective 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 organizationshall document procedures to define the controls needed for the identification,storage, security and integrity, retrieval, retention time and disposition ofrecords.
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 organizationshall define and implement methods for protecting confidential healthinformation contained in records in accordance with the applicableregulatoryrequirements.
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 shallremain legible, readily identifiable and retrievable. Changes to a record shallremain 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 organizationshall retain the records for at least the lifetime of the medical device asdefined by the organization, or as specified by applicable regulatoryrequirements, but not less than two years from the medical device release bythe 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 devicefile），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。
(责任编辑：ysbadmin)
