Our commitment to world-class quality ensures that our products and services meet or exceed the highest standards set by all U.S. and internationally recognized agencies. Spiros Medical is established as an industry-wide, award-winning supplier with high-quality standards through medical certifications and continued enforcement of inspection requirements.
Key Certifications Include: (Click each to learn more)
ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).
IATF 16949 is an International Automotive Task Force (IATF) standard that was originally created in 1999 with the goal of unifying the different assessment and certification systems used in the automotive supply industry. This quality management system for automotive works in conjunction with the ISO 9001:2015 standard.