普立万成为中国首家获得ISO13485标准认证的色母粒工厂
PolyOne has become China's first to obtain ISO13485 certification standards of Masterbatch Factory
在2011年中国医疗设备技术展览会(Medtec China)上，特种聚合物材料、服务和解决方案的全球领先供应商普立万公司(纽约证券交易所：POL)宣布其位于上海的颜色和添加剂工厂已获ISO13485:2003标准认证。
In 2011 China Medical Equipment Technology Exhibition ( Medtec China ), special polymer materials, services and solutions, a leading global supplier of PolyOne Corporation ( New York Stock Exchange: POL ) announced that Shanghai is located in the color and additive factory has been ISO13485 : 2003 standard certification.
　　在位于中国的色母料生产商中，普立万是首家经ISO 13485认证的母粒工厂。目前，普立万在全球已拥有四家工厂获得该认证。取得这一认证，使普立万在医疗保健行业的客户能更快地符合国家食品药品监督管理局(SFDA)的有关法规，从而节省客户的精力和相关费用。
Located in China 's Masterbatch manufacturers, PolyOne was the first ISO 13485 certified masterbatch factory. At present, PolyOne has four factories in the world to receive this certification. To obtain this certification, the Pulitzer million in the health care industry customers can quickly meet the State Food and Drug Administration ( SFDA ) of the relevant laws and regulations, thus saving customer's energy and related expenses.
　　“普立万致力于为全球医疗OEM提供最高性能和最先进的颜色和添加剂解决方案，”普立万颜色和添加剂业务总裁John Van Hulle说。“该认证进一步体现和强化了普立万对医疗保健行业客户的承诺，即提供全球一致高质量的医疗级母料，让客户用得放心。”
" PolyOne is committed to providing global medical OEM provides maximum performance and the most advanced color and additive solution," PolyOne color and additive business CEO John Van said Hulle. " The authentication embodiment further and aggrandizement PolyOne to the health care industry customer commitment, i.e. with a globally consistent high quality medical grade masterbatch, to reassure customers use."
　　ISO 13485:2003是针对设计和生产医疗设备的综合性管理体系满足法规要求而制定的标准。此前，普立万上海工厂于1998年首次获得ISO 9001国际标准体系认证。
ISO 13485: 2003 is for the design and production of medical equipment integrated management system to meet the regulatory requirements and standards. Previously, PolyOne Shanghai factory in 1998 for the first time ISO 9001 international standards certification system.
　　与ISO 9001标准相比，ISO 13485主要强调的是医疗保健行业满足法规的要求，主要包括以下几个方面：•在质量管理责任中包含对医疗监管要求的推广和认知
With the ISO 9001 standard, ISO 13485 the main emphasis is on the health care industry to meet regulatory requirements, mainly includes the following aspects: quality management responsibility of medical regulatory requirements contained in the promotion and cognition
　　•控制工作环境以保证产品安全
Control of the working environment, in order to ensure product safety
　　•对检测和记录追踪有明确规定
The detection and recording track, there are clear provisions
　　•保证纠正措施及预防措施的有效性
" To ensure corrective and preventive measures
　　普立万位于苏州的吉力士热塑性弹性体工厂和普立万工程材料苏州工厂已分别于2009年和2010年获得ISO 13485标准认证。今年年初，位于美国McHenry的吉力士热塑性弹性体工厂成为普立万第三个获得ISO13485认证的生产设施。
PolyOne Suzhou Guinness thermoplastic elastomer factory and PolyOne engineering materials plant in Suzhou has been respectively in 2009 and 2010 13485 ISO standard certification. At the beginning of this year, is located in the United States of America McHenry Guinness thermoplastic elastomer factory become PolyOne third ISO13485 certified production facilities.
　　“该认证彰显了普立万立志成为世界级领先生产商的承诺，我们致力于满足医疗保健行业的苛刻要求，包括清洁度、详细记录保存、批次间的品质一致性以及原材料的追踪和加工处理。这一切都意味着客户可以相信普立万开发的配方产品能够以最高的标准满足各种苛刻应用的要求，”Van Hulle补充道。
" The certification shows Pulitzer Wan Lizhi become a world leading manufacturer of commitment, we are committed to meet the demanding requirements of medical care industry, including cleanliness, detailed record keeping, batch-to-batch consistency of the quality of raw materials and the tracking and processing. All this means that the customer can trust Pulitzer Wan Kaifa formula products to the highest standards to meet a variety of demanding applications," Van added Hulle.