ISO13485中英文文件要求（4.21-4.25）

4.2.1 General 總則

The qualitymanagement system documentation (see 4.2.4) shall include:

質(zhì)量管理體系文件（見(jiàn)4.2.4）應(yīng)包括：( 了解詳情可咨詢?cè)诰€客服或撥打電話400-6138-123咨詢）

a) documentedstatements of a quality policy and quality objectives;

形成文件的質(zhì)量方針和質(zhì)量目標(biāo);

b) a qualitymanual;

質(zhì)量手冊(cè);

c) documentedprocedures and records required by this International Standard;

本國(guó)際標(biāo)準(zhǔn)所要求下的形成文件的程序和記錄

d) documents, includingrecords, determined by the organization to be necessary to ensure the effectiveplanning, operation, and control of its processes;

組織確保其過(guò)程的有效策劃、運(yùn)行和控制所需的文件，包括記錄

e) otherdocumentation specified by applicable regulatory requirements.

相應(yīng)法律法規(guī)要求下的其他文件。

與YY/T 0287-2003基本一致。注意因?yàn)樵黾恿似餍滴臋n，所以參引序號(hào)不一致。

4.2.2 Quality manual

質(zhì)量手冊(cè)

The organizationshall document a quality manual that includes:

組織應(yīng)當(dāng)起草一個(gè)質(zhì)量手冊(cè)，至少應(yīng)包括：

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

質(zhì)量管理體系的范圍,包括任何刪減和(或)不適用的細(xì)節(jié)與合理性;

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

為質(zhì)量管理體系編制的形成文件的程序或?qū)ζ湟?

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

質(zhì)量管理體系過(guò)程之間的相互作用的表述。

The qualitymanual shall outline the structure of the documentation used in the qualitymanagement system.

質(zhì)量手冊(cè)應(yīng)概括質(zhì)量管理體系中使用的文件的結(jié)構(gòu)。

與YY/T 0287-2003基本一致。

4.2.3 Medical device file 醫(yī)療器械文檔（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:

對(duì)于每個(gè)醫(yī)療器械類型或系列醫(yī)療器械，組織應(yīng)當(dāng)確定和維護(hù)一個(gè)或多個(gè)文件，其中包括或引用所形成的文件，以證明符合國(guó)際標(biāo)準(zhǔn)和相應(yīng)法規(guī)的要求。文件的內(nèi)容應(yīng)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;

醫(yī)療器械的一般性描述、預(yù)期用途，標(biāo)簽，包括任何使用的說(shuō)明；產(chǎn)品標(biāo)準(zhǔn)；

c)specifications or procedures for manufacturing, packaging, storage, handlingand distribution;

用于制造、包裝、存儲(chǔ)、處理、銷售的標(biāo)準(zhǔn)或程序；

d) proceduresfor measuring and monitoring;

測(cè)量和控制程序；

e) asappropriate, requirements for installation;

如果適用，安裝的要求；

f) asappropriate, procedures for servicing.

如果適用，服務(wù)的程序；

ISO13485-2016將醫(yī)療器械文檔作為一個(gè)單獨(dú)部分拿出來(lái)進(jìn)行了描述，而不是YY/T0287-2003“組織應(yīng)對(duì)每一類型或型號(hào)的醫(yī)療器械建立和保持一套文檔，需包括或識(shí)別規(guī)定產(chǎn)品規(guī)范和質(zhì)量管理體系要求的文件(見(jiàn)4.2.3)。這些文件應(yīng)規(guī)定完整的生產(chǎn)過(guò)程，適用時(shí)，還包括安裝和服務(wù)過(guò)程。”這樣簡(jiǎn)單的進(jìn)行了概述。

4.2.4 Control 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.

質(zhì)量體系所需的文件應(yīng)當(dāng)被控制。記錄是一個(gè)特殊文件，應(yīng)當(dāng)依據(jù)4.2.5中的要求進(jìn)行控制。

A documentedprocedure shall define the controls needed to:

應(yīng)當(dāng)用文件化的程序?qū)⑦@些控制明確下來(lái)，至少包括：

a) review and approve documents for adequacyprior to issue;

下發(fā)前應(yīng)當(dāng)進(jìn)行審核和批準(zhǔn)，以確保文件的充分性和適宜性;

b) review, update as necessary and re-approvedocuments;

必要時(shí)對(duì)文件進(jìn)行評(píng)審、更新并重新批準(zhǔn)文件；

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

保證文件更改和現(xiàn)行修訂狀態(tài)得到識(shí)別；

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

在應(yīng)用文件的區(qū)域能夠獲得適用文件有關(guān)版本；

e) ensure that documents remain legible andreadily identifiable;

確保文件保持清晰、易于識(shí)別；

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;

確保外來(lái)文件得到識(shí)別、并控制其分發(fā);這些文件是由組織確定的，對(duì)質(zhì)量管理體系策劃和運(yùn)行來(lái)說(shuō)都是必須的。

g) prevent deterioration or loss of documents;

防止損壞或丟失文件。

h) prevent theunintended use of obsolete documents and apply suitable identification to them.

防止作廢文件的非預(yù)期使用，并對(duì)這些文件進(jìn)行適當(dāng)?shù)臉?biāo)識(shí)。

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.

組織應(yīng)保證文件的更改得到原審批部門或其他指定部門的審核和批準(zhǔn)，該被指定的審批部門應(yīng)能獲取用于作出決定的相關(guān)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.

組織應(yīng)當(dāng)規(guī)定一個(gè)期限來(lái)保留至少一份作廢的受控文件。這個(gè)期限應(yīng)確保至少在組織所規(guī)定的醫(yī)療器械壽命期內(nèi)，可以得到此醫(yī)療器械的制造和試驗(yàn)的文件，但不要少于記錄(見(jiàn) 4.2 .5 )或相關(guān)法規(guī)要求所規(guī)定的保存期限。

4.2.5 Control of records 記錄控制

Records shall bemaintained to provide evidence of conformity to requirements and of theeffective operation of the quality management system.

應(yīng)當(dāng)保留記錄以便供符合法規(guī)要求和質(zhì)量管理體系有效運(yùn)行的證據(jù)。

The organizationshall document procedures to define the controls needed for the identification,storage, security and integrity, retrieval, retention time and disposition ofrecords.

組織應(yīng)當(dāng)建立文件化的程序，來(lái)規(guī)定記錄的標(biāo)識(shí)、貯存、保護(hù)、檢索、保存期限和處置所需的控制

The organizationshall define and implement methods for protecting confidential healthinformation contained in records in accordance with the applicable regulatoryrequirements.

組織應(yīng)根據(jù)適用的法規(guī)要求，制定并實(shí)施記錄中包含的機(jī)密健康信息的方法。（新增）

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

記錄應(yīng)保持清晰、易于識(shí)別和檢索。更改記錄應(yīng)保持可識(shí)別。（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.

組織應(yīng)當(dāng)保存記錄至少到組織規(guī)定的醫(yī)療器械壽命期，或是按相應(yīng)的法律法規(guī)要求來(lái)實(shí)施，但從組織放行產(chǎn)品的日期起不少于2年。

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