February 7, 2014 — After several months of intense review and assessment of its specialized worker training program by an independent agency, Operon Resource Management of Lowell, Mass. received ISO 13485 certification.
ISO 13485 Quality Management Systems Standard for Medical Devices Manufacturers and Related Services was awarded by BSI Inc., a global independent business conformity assessment organization. Health care product manufacturers typically attain this standard of certification for management systems rather than staffing firms.
Operon has developed a customized on-boarding program, called the Operon Gate, that includes rigorous screening and ISO-compliant job training for entry-level workers. This training program puts inexperienced job candidates through an extensive course of training and gives them the necessary background to succeed on the manufacturing floor. Operon provides skills and knowledge to these workers that can be used to gain permanent and good-paying employment for life.
These workers are now helping several medical device and health care product firms in Massachusetts cope with surges in demand for their products. Among other skills, Operon’s trainings teach workers how to function in “clean room” environments required to manufacture many medical devices such as those for endovascular, graft, cardio thoracic, wound/reconstruction, blood/fluid flow, diagnostics, drug delivery, disposables and other products.
During 2013, Operon trained and employed over 1,200 workers in health care product manufacturing companies in Massachusetts. Operon was chosen to represent the Northeast in the Community College Consortium for Biosciences Credentials (c3bc). The consortium is part of the Obama Administration and the U.S. Department of Labor’s Medical Device Harmonization Initiative. Two main objectives of this initiative are to create a set of medical device industry skill and knowledge standards and develop curriculum for a national network of community colleges that will elevate the skills and knowledge base of entry-level workers.
For more information: www.operonresource.com
July 16, 2024 
