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关于设计的供应商过程控制方面的中英翻译文件 |
7.9.2 设计的供应商过程控制（EN50128 15.4.8，15.4.9）
Process control for suppliers of design (EN50128 15.4.8, 15.4.9)
1）应建立和维护外部供应商控制的程序，包括：
Control procedures for exterior suppliers shall be established and maintained, including:
? 确保外部供应商提供的软件满足已有需求的方法。应保证前期开发的软件符合软件安全完整性等级和可信性。新软件应按供应商的软件质量保证计划或与供应商的软件质量保证计划协调一致的外部供应商的特定软件质量保证计划来进行开发和维护。
Methods making sure software provided by exterior suppliers meet existing requirements. It shall be made sure that the software developed formerly complies with software safety integrality level and dependability. New software shall be developed and maintained according to the suppliers’ software quality assurance plan or exterior suppliers’ special software quality assurance plan consistent with the suppliers’ software quality assurance plan.
? 确保提供给软件外部供应商的需求是充分的而完备的。
It shall be made sure that the requirements provided for exterior software suppliers are sufficient and complete.
华译网上海翻译公司曾经翻译过大量有关设计的供应商过程控制的资料文件。
2）应建立和维护问题报告和纠正行为的程序。这些程序作为质量保障系统的一部分，应实施EN ISO 9001的相关部分，特别至少应覆盖以下几个方面：
Procedures for problems reporting and behavior rectifying shall be established and maintained. As a part of quality assurance system, these procedures shall implement related part of EN ISO 9001, especially shall cover at least the following aspects:
? 为了反馈给负责的管理部分，规定问题报告和或纠正行为所需的文档。
Prescribing documents necessary for problems reporting or behavior rectifying in order to give feedback to management.
? 规定在问题报告中收集到的信息的分析方法，以判断出其原因。
Prescribing analysis method for information collected in problems reports in order to judge the causes.
? 规定在开发阶段和软件维护过程中报告、追踪和问题解决应遵循的措施。
Prescribing the measures followed in reporting, tracing and problem solutions in development phase and during software maintenance.
? 规定根据与所要求的软件安全完整性等级相对应的等级处理问题的预防行为。
Prescribing preventive behaviors to handle problems according to the level corresponding to software safety integrality level.
? 规定有关开发和软件维护的特定组织的职责。
Prescribing the responsibilities of special organizations relating to development and software maintenance.
? 规定如何实施控制，以确报纠正行为已被采取并有效。
Prescribing how to implement control to make sure corrected behaviors have been taken and in effect.
? 规定再测试、再验证、再确认和再评估的需求。
Prescribing the requirements for re-testing, re-verification, re-assessment and re-evaluation.
在紧接软件集成之后、正式的软件确认开始之前的软件生存周期中，至少应实施问题报告和纠正行为管理，而且要覆盖软件维护整个阶段。
In the life cycle after software integration and before official software verification, at least the management for problems reporting and behavior rectifying shall be implemented, covering the whole stage of software maintenance.
3）供应者和/或开发者以及客户最低限度都应执行EN ISO 9001的相关部分，以保持和EN ISO 9000—3一致。（EN50128 6.2.1）
Suppliers and/or developers as well as customers shall all execute at least related part of EN ISO 9001 in order to keep consistent with EN ISO 9000-3. (EN50128 6.2.1)
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