Americhem Announces ISO 13485 Certification to Serve Medical Plastics Markets
The manufacturing operation of Americhem Group in Suzhou, China, is certified to the ISO 13485:2003 quality management system. The company is one of a select few engineering thermoplastic compounders in China with this distinction, required by many medical and healthcare manufacturers.
The ISO 13485 standard represents the requirements for regulatory compliance in the design and manufacture of medical and healthcare devices. It focuses on risk management activities during product development and guides specific requirements for verification of effectiveness of corrective and preventive actions.
Americhem underwent a thorough evaluation process that included quality management system development, a management system documentation review, pre-audit, initial assessment, and certification to the quality management standard. Americhem received its ISO 13485 certificate of registration on April 27, 2015.
The certification mirrors the ISO 13485 accreditation held by Infinity LTL Engineered Compounds, part of the Americhem Group of companies, in the United States. Our efforts to obtain this important medical certification for our engineered compound products ensure that we place identical emphasis on quality around the globe,” said Carlos Carreno, president of Infinity LTL.
“The certification of compliance with ISO 13485 recognizes that the policies, practices and procedures of our plant ensure consistent quality in the services and products we provide our customers,” said Stanley Teoh, Americhem‘s vice president and managing director for the Asia Pacific region.
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