Quality management system
質(zhì)量管理體系
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.
組織應(yīng)當(dāng)依據(jù)本國際標(biāo)準(zhǔn)和相應(yīng)的法律法規(guī)文件建立質(zhì)量管理體系，并形成文件以維護(hù)質(zhì)量管理體系的有效性。
The organizationshall establish, implement and maintain any requirement, procedure, activity orarrangement required to be documented by this International Standard orapplicable regulatory requirements.
組織應(yīng)當(dāng)確定、實施和維護(hù)任何本國家標(biāo)準(zhǔn)或適用的法規(guī)要求所需的要求、程序、活動或安排。（新增）
The organizationshall document the role(s) undertaken by the organization under the applicable regulatoryrequirements.
依據(jù)相應(yīng)的法律法規(guī)，組織應(yīng)當(dāng)明確組織中的角色，并形成文件。（新增）
NOTE Rolesundertaken by the organization can include manufacturer, authorized representative,importer or distributor.
組織中的角色可以包括生產(chǎn)商、受托方（授權(quán)代表）、進(jìn)口商或經(jīng)銷商。（新增）
4.1.2 The organizationshall 組織應(yīng)當(dāng)：
a) determine theprocesses needed for the quality management system and the application of theseprocesses throughout the organization taking into account the roles undertakenby the organization;
基于組織所承擔(dān)的角色，確定質(zhì)量管理體系所需的過程以及在整個組織中應(yīng)用的程序。（新增）
b) apply a riskbased approach to the control of the appropriate processes needed for thequality management system;
應(yīng)用一個以風(fēng)險為基礎(chǔ)的方法來控制質(zhì)量管理體系所需的相應(yīng)過程。（新增，強(qiáng)調(diào)風(fēng)險管理）
c) determine thesequence and interaction of these processes.
確定這些過程的順序和相互作用。
4.1.3 For each qualitymanagement system process, the organization shall:
對于每個質(zhì)量管理體系過程，組織應(yīng)當(dāng)：
a) determine criteria and methods needed toensure that both the operation and control of these processes are effective;
確定必要的標(biāo)準(zhǔn)和方法從而保證這些過程的操作和控制都是有效的；
b) ensure the availability of resources andinformation necessary to support the operation and monitoring of these processes;
確保必須的信息和資源來支持這些過程的操作和控制；
c) implement actions necessary to achieveplanned results and maintain the effectiveness of these processes;
實施必要的措施來達(dá)到預(yù)期的結(jié)果和維護(hù)這些過程的有效性。
d) monitor, measure as appropriate, and analysethese processes;
監(jiān)測、測量和分析這些過程；
e) establish and maintain records needed todemonstrate conformance to this International Standard and compliance withapplicable regulatory requirements (see 4.2.5).
建立和維護(hù)用于證明符合本國際標(biāo)準(zhǔn)和適用的法律法規(guī)要求的符合性的記錄（參見4.2.5）。