Clearwater, FL (PRWEB) February 07, 2013
American Tool & Mold, a leader in the design and construction of complex, precision, multi-cavity molds for the plastic injection molding industry, announced today that it has achieved certification to the ISO9001 and ISO13485 standards.
Over the past 16 months, the company has gone through a rigorous process of upgrading their quality control system, which had not changed over the past several years. The company has implemented a series of procedures based on ISO requirements covering all internal processes from quoting to final inspection. ATM underwent the phase 1 and phase 2 processes in December 2012.
The ISO13485 standard specifically relates to the manufacture of medical devices, an important segment of ATMs business. The ISO13485 standard requires awareness and promotion of regulatory requirements for medical devices, specific requirements for inspection and traceability, and documentation and validation of processes for sterile medical devices.
The ISO9001 standard is a general manufacturing standard for quality management systems, which calls not only for implementing and maintaining a quality program, but also for showing continuous improvement.
With the implementation of ISO procedures, we have significantly reduced, and in some cases eliminated, the variability in our processes. This ensures that the customer receives products on time and to specifications stated ATM CEO Emilia Loulourgas. The impact this has had internally has been significant.