Nov 9 2009
Vision Technical Molding LLC, a manufacturer of precision injection molded components, announced it has achieved certification under ISO 13485: 2003. ISO 13485 provides internationally recognized guidelines pertaining to quality management systems (QMS). This achievement is the latest in a series of company milestones aimed at providing the highest-quality and most technologically sophisticated molding and post-molding operations for the medical device industry.
Vision has also updated its ISO 9001 certification to the 2008 standard, and recently added a 10,000-sq-ft certified ISO Class 8 clean room that includes space for secondary operations. Registration to both ISO standards was performed by QMI-SAI Global, a leading North American registrar.
"We proactively pursued ISO 13485 certification to demonstrate Vision's strong and continuing commitment to the medical device sector and our customers," said Steven Arnold, president, Vision Technical Molding. "As we grow, we are focused on understanding and anticipating the changing needs of the industry, particularly regarding quality and consistency. To support manufacturers, we achieved ISO 9001 registration for general quality management, and now have attained the key ISO certification for the device industry. We will continue to be forward thinking in our approach to attaining certifications that benefit our customers in the healthcare industry."
All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization. The steps to attaining ISO 13485 certification are similar to those for ISO 9001, including a documentation review and an in depth systems audit. After certification, an organization is subject to ongoing surveillance by its certification body.