rock_rock
第3楼2010/11/16
我最近要把资质认定的管理办法中译英,当中遇到不少困难,跟大伙分享一下
General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China (GAQSIQ) Order 86
(国家质量监督检验检疫总局令第86号)
“Laboratory and Inspection Organization Qualification Recognition Management Regulation”
实验室和检查机构资质认定管理办法
第一章 总则
Section 1 - General
1. To govern the qualification management of testing and inspection organizations, as well as improving the activities of testing and inspection organization to more scientific and effective, this Order is established base on PRC Metrology Law, PRC Standardization Law, PRC Product Quality Law and PRC Certification and Accreditation Ordinance.
第一条 为规范实验室和检查机构资质管理工作,提高实验室和检查机构资质认定活动的科学性和有效性,根据《中华人民共和国计量法》、《中华人民共和国标准化法》、《中华人民共和国产品质量法》、《中华人民共和国认证认可条例》等有关法律、行政法规的规定,制定本办法。
2. The Qualification of testing and inspection organizations in this Order refers to those organizations reporting data and results to the public with certification purpose, possess the necessary facilities and competences.
The Recognition in this Order refers to the activities of assessment and recognition, conducted by CNCA and the AQSIQ of provinces, autonomous regions and municipalities, of testing and inspection organizations with respect to the essential facilities and competences for the compliance with laws, regulations and relevant technical specifications.
第二条 本办法所称的实验室和检查机构资质,是指向社会出具具有证明作用的数据和结果的实验室和检查机构应当具有的基本条件和能力。
rock_rock
第4楼2010/11/16
3. In the territory of PRC, all testing and inspection organizations that report data and results to the public for certification purpose, and the qualification recognition activities to these organizations, shall comply with this Order.
第三条 在中华人民共和国境内,从事向社会出具具有证明作用的数据和结果的实验室和检查机构以及对其实施的资质认定活动应当遵守本办法。
4. CNCA centralizes the management, supervision and overall coordination of the qualification recognition activities for testing and inspection organizations.
The bureau of Quality and Technical Supervision (BQTS) of individual provinces, autonomous regions and municipalities are responsible for the qualification recognition activity within their respective areas.
各省、自治区、直辖市人民政府质量技术监督部门和各直属出入境检验检疫机构(以下统称地方质检部门)按照各自职责负责所辖区域内的实验室和检查机构的资质认定和监督检查工作。
第四条 国家认证认可监督管理委员会(以下简称国家认监委)统一管理、监督和综合协调实验室和检查机构的资质认定工作。
poorlittle
第7楼2010/11/17
“按照GMP规定,取样是质量部门的职责,是不能授权给其它部门的” Really?
If the warehouse personnel is impartial, qualified (trained and experienced) and the duty / responsibility have been properly assigned, I can’t see why he cannot be delegated to take sample.
Furthermore, there may have practical/operational need. For example, if the laboratory is in New York while the warehouse is in Cleveland, it is reasonable to set up an arrangement that the samples can be taken by the personnel in Cleveland, then sent to New York by express mail.
影子
第8楼2010/11/17
中国GMP上是这样说的:
第三节质量控制
第十四条 质量控制包括相应的组织机构、文件系统以及取样、检验等,确保物料或产品在放行前完成必要及相关的检验,确认其质量符合要求后,方可使用或发运。
第十五条 质量控制的基本要求:
3. 由经授权的人员按规定的方法对原辅料、包装材料、中间产品、待包装产品和成品取样;
第二十条 质量管理部门应参与所有与质量有关的活动和事务,负责审核所有与本规范有关的文件。质量管理部门人员的职责不得委托给其它部门的人员。