IECQQC080000中英文对照表(DOC15)

IECQ QC 080000 中英文对照表
IECQ QC 080000
IECQ QC 080000 中译本
4 General requirements
4. 一般要求事项
4.1 Quality Management System
4.1 质量管理系统
The requirements of ISO 9001 shall apply
along with the additional requirements below:
ISO 9001 的要求事项应适用，并增加下列要求
4.1.1 General
4.1.1 概述
Each organization shall include in its ISO
9001:2000 mandated quality management
system the procedures, documentation, and
process management practices necessary to
achieve HSF product and production
processes.
组织应在其 ISO 9001:2000指定质量管理系统
中，加入达成 HSF 产品与作业流程所需之
程序、文件与流程管理实务。
The organization shall
组织应
a) Identify and document all hazardous
substances in use in the organization.
a) 确认与记录组织使用的所有有害物质。
b) identify the specific processes to be
managed relevant to its HSF goals.
b) 确认与 HSF 目标相关且待管理的特定流
程。
c) determine the interdependence and
interaction of these processes and develop an
appropriate HSF process management plan.
c) 决定这些流程的相互依赖关系与交互作
用，并发展适当之 HSF 流程管理计划。
d) establish criteria upon which to objectively
determine the effectiveness of the
organization’s HSF process management.
d) 建立能客观决定组织 HSF 流程管理功效
的条件。
e) ensure the availability of resources and
information needed to support effective HSF
process management.
e) 确保支持有效 HSF 流程管理所需之资源
与信息容易取得
f) monitor, measure and analyze these
processes, and
f) 监督、量测与分析这些流程。
g) implement actions to ensure continuous
process improvement in achieving HSF.
g) 采取行动以确保流程之持续改善以达成
HSF。
h) have a process established to restrict and/or
eliminate the use of hazardous substances from
products and processes.
h) 建立流程，以限制及（或）中止对产品与
在流程中使用有害物质。
4.1.2 Relationship with ISO 9001
4.1.2 与 ISO 9001:2000 的关连
The intention of this document is that HSF
process management is to be congruent with
the elements of ISO 9001:2000 international
Standard.
本文件的目的是要让 HSF 流程管理符合
ISO 9001:2000 国际标准的要项。
4.1.3 Outsourcing
4.1.3 委外
Where an organization chooses to outsource
any process that affects its products’ HSF
若组织选择将任何会影响其产品 HSF 特性
的流程外包出去，并将外包流程之产品引进其
IECQ QC 080000
IECQ QC 080000 中译本
characteristics, and accept into its operations
the product of processes outside its own
operations, the organization shall ensure
management of and control over such
processes.
本身的作业，则该组织应确保此等流程之管理
与管制。
4.2 Documentation requirements
4.2 文件要求
The requirements of ISO 9001 shall apply
along with the additional requirements below:
ISO 9001 的要求事项应适用，并增加下列要求
4.2.1 General
4.2.1 概述
The quality management system
documentation shall include
质量管理系统文件化应包括
a) The HSF requirements shall be an integral
part of the organization’s quality management
system and shall include
a) HSF 要求应为组织质量管理系统中不可或
缺的部份，并应包含下列各项：
b) a list of all hazardous substances used
within the organization.
b) 组织内使用之所有有害物质清单。
c) statements of HSF policy and objectives
with inclusion of a timeline for elimination of
use of all hazardous substances, as appropriate
c) HSF 政策与目标之声明。若适当的话，包
含停止使用所有有害物质之时程。
d) in the organization’s quality manual a
section on the HSF process management plan
and objectives and reference to HSF
documented procedures
d) 组织的质量手册中应说明 HSF 流程管理
计划与目标、以及 HSF 文件化程序之参考
章节
e) documented procedures as required by the
organization’s HSF process management plan
with control of all such documents executed as
required by section 4.2.4 of the ISO 9001:2000
international Standard.
e) 按照组织 HSF 流程管理计划要求之文件
化程序，并按 ISO 9001:2000 国际标准第 4.2.4
节之规定控管所有此类文件。
f) records of the organization’s HSF process
management performance.
f) 组织 HSF 流程管理绩效之记录，
Note: Consistent with the ISO 9001:2000
international Standard, “documented
procedures” means that the procedure is
established, documented, implemented and
maintained. Additionally, the extent of
documentation required is specific to the size
of the organization, complexity of processes,
and the competence of personnel.
说明：与 ISO 9001:2000 国际标准一致，「文
件化程序」指程序应建立、记录、执行与维护。
此外，文件记录的程序应按照组织规模、流程
复杂度与人员的能力而定
5. Management Responsibility
5. 管理责任
5.1 Management Commitment
5.1．承诺证据
The requirements of ISO 9001 shall apply
ISO 9001 的要求事项应适用，并增加下列要求