AUBURN, Ind., March 29th, 2018—Stamets Tool & Engineering, Inc. has completed a total revamp of the Quality Management System in accordance with ISO13485:2016 and is now fully ISO13485:2016 Certified by NQA. NQA is a leading global independently accredited certification body, providing assessments (audits) of organizations to various Management System Standards since 1988. ISO 13485 is the quality management system standard for medical device manufacturers and their sub-tier suppliers and subcontractors. Based on the ISO 9001 standard, ISO 13485 includes additional requirements for medical device manufacturers to demonstrate their intent to comply with applicable regulatory and statutory requirements. ISO 13485 is recognized as an aid in supporting compliance with the Medical Device Directive.
