国家实验室认可：药明康德圣保罗及亚特兰大实验室获ISO/IEC 17025:2005标准认证
The National Laboratory Accreditation: Wuxi St Paul and Atlanta laboratory by ISO / IEC 17025 : 2005 standard certification
中国上海——在中美两国均有运营实体，全球领先的医药、生物制药以及医疗器械研发服务企业药明康德（NYSE:WX），今日宣布其圣保罗及亚特兰大测试实验室获ISO/IEC17025:2005标准认证，认可其在包括生物相容性及微生物学的一系列特定生物测试方面的技术能力。美国实验室认可协会（AmericanAssociationforLaboratoryAccreditation）指派两位此实验室测试技术方面的专家对两个实验室进行了检查及审核，并颁发此认证。
China Shanghai -- in the United States are operating entities, the leading global pharmaceutical, biotechnology and medical equipment research and development services company 's ( NYSE: WX ), today announced that its St Paul and Atlanta testing laboratory by ISO / IEC17025: 2005 standard certification, accreditation in include biocompatibility and microbiology of a series of specific biological test of technical capability. American Association for Laboratory Accreditation ( AmericanAssociationforLaboratoryAccreditation ) assignment two this laboratory testing technology experts in the field of two laboratories for inspection and audit, and presented this certification.
ISO标准由国际标准化组织（InternationalOrganizationforStandardisation）设立，其标准化范围已覆盖157个国家。国际电工委员会（InternationalElectrotechnicalCommission）设立应用于电力、电子等相关领域的标准。这些标准覆盖诸多领域，并且基于权威的国际化行为准则。此次圣保罗及亚特兰大实验室所获得的ISO/IEC17025标准认证，涵盖了测试及标准实验室的能力要求。
The ISO standard developed by the international organization for Standardization ( InternationalOrganizationforStandardisation ) set up, its standardization scope has covered 157 countries. The International Electrotechnical Commission ( InternationalElectrotechnicalCommission ) set used in electric power, electronics and other related fields of the standard. These standards cover many fields, and based on the authority of the international code of conduct. The St Paul and Atlanta laboratory obtained ISO / IEC17025 certification standards, covers the test and standard laboratory capability requirements.
实验室必须证明其在管理以及技术要求上的能力，才能获此认证。管理要求包括高质量管理系统的有效运作。技术要求指的是操作人员的能力，测试方法的正确性，设备的充足性，以及实验结果的准确性。为了获此认证，实验室必须接受实验流程及步骤的全面审核，包括对现场进行的实验操作的审察。实验室必须使用最新的科研及技术知识，进行内部审核，不断完善，并与客户进行有效的沟通。药明康德此次获得的ISO/IEC17025:2005标准认证有效期为两年，两年后可续获。
The laboratory must prove the management and technical requirements of the ability, can obtain this certification. Management requirements include high quality management system effective operation. Technical requirements of refers to the staff's ability to operate, test the validity of the methods, equipment, adequacy, and the accuracy of experimental results. In order to obtain this certification, the laboratory must accept the experimental processes and procedures of comprehensive audit, including field experiment observation. The laboratory must use the latest scientific and technical knowledge, internal audit, continuous improvement, and effective communication with customers. Wuxi is obtained this ISO / IEC17025: 2005 standard certification is valid for two years, two years later to be continued by the.
“获得ISO/IEC17025标准认证进一步证明了我们实验室的测试服务质量及我们技术人员的能力，”药明康德首席运营官胡正国评论道。“我们最初取得ISO/IEC17025:2000标准认证（颁发于2000年）是为了满足一家医疗器械客户的特定要求。之后我们主动要求获得ISO/IEC17205:2005标准认证（颁发于2005年）以继续更好地满足我们尊贵的客户。公司如此响应客户需求，并不在于仅仅满足某家客户，而是通过这项认证向新老客户证明药明康德的测试服务实验流程符合最高标准。我们的竞争者中极少有获此ISO/IEC17025标准认证的。”
" ISO / IEC17025 certification standards to further demonstrate our laboratory testing services and the quality of our technical staff capacity," our chief operating officer Hu Zhengguo commented. " We initially achieved ISO / IEC17025: 2000 standard certification ( issued in 2000 ) is a medical equipment to meet the specific requirements of customers. We asked for ISO / IEC17205: 2005 standard certification ( issued in 2005 ) in order to better meet the needs of our valued customers. The company so in response to customer demand, a customer is not only meet, but through the certification of new and old customers to prove our testing services to meet the highest standards of experimental process. Our competitors are very rarely received the ISO / IEC17025 standard certification."