Quality management system
質量管理體系
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.
組織應當依據本國際標準和相應的法律法規文件建立質量管理體系，并形成文件以維護質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.
組織應當確定、實施和維護任何本國家標準或適用的法規要求所需的要求、程序、活動或安排。（新增）
The organizationshall document the role(s) undertaken by the organization under the applicable regulatoryrequirements.
依據相應的法律法規，組織應當明確組織中的角色，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商、受托方（授權代表）、進口商或經銷商。（新增）
4.1.2 The organizationshall 組織應當：
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;
基于組織所承擔的角色，確定質量管理體系所需的過程以及在整個組織中應用的程序。（新增）
b) apply a riskbased approach to the control of the appropriate processes needed for thequality management system;
應用一個以風險為基礎的方法來控制質量管理體系所需的相應過程。（新增，強調風險管理）
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:
對于每個質量管理體系過程，組織應當：
a) determine criteria and methods needed toensure that both the operation and control of these processes are effective;
確定必要的標準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到預期的結果和維護這些過程的有效性。
d) monitor, measure as appropriate, and analysethese processes;
監測、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).
建立和維護用于證明符合本國際標準和適用的法律法規要求的符合性的記錄（參見4.2.5）。