Below are the standards that we reference to fulfill our customers regulatory compliance needs:

  • ISO 9001-2008 Quality Management System (QMS) (Continuous Improvement)
  • ISO 11137-2006 Sterilization of health care products (Gamma Irradiation, Bioburden)
  • ISO 14644-1 Airborne Particle Monitoring (Cleanroom Environmental Monitoring, Classification is ISO 8)
  • ISO 17025-2005 General requirements for the competence of testing and calibration laboratories (Sensor and Laboratory Equipment Calibration)
  • ISO 13485-2003 Medical Devices – QMS (Based on 9001:2008 framework)