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4.2.4）應(yīng)包括：

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;

c) documentedprocedures and records required by this International Standard;

本國際標(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，所以參引序號不一致。

4.2.2 Quality manual

質(zhì)量手冊

The organizationshall document a quality manual that includes:

組織應(yīng)當(dāng)起草一個(gè)質(zhì)量手冊，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)部分拿出來進(jìn)行了描述，而不是YY/T0287-2003“組織應(yīng)對每一類型或型號的醫(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4.2.3)。這些文件應(yīng)規(guī)定完整的生產(chǎn)過程，適用時(shí)，還包括安裝和服務(wù)過程。”這樣簡單的進(jìn)行了概述。