Quality Assurance

Beacon produces specialized packaging within a continually evolving quality system that is compliant to both the FDA Quality System Regulation and ISO 13485:2016. Beacon is a sustaining member of the American Society for Quality (ASQ), a founding member of the Sterilization Packaging Manufacturers Council (SPMC), and is an active participant in the SPMC technical committee and ASTM Committee F2 on Flexible Barrier Packaging as well as AAMI TC198/W607, the Packaging Working Group.


  • ISO 13485:2016 Certified

  • Quality System meets requirements of FDA Quality System Regulation, 21CFR820

  • Validation is done in accordance with ISO 11607-2

  • Test Methods used to evaluate materials and sterile barrier systems are validated in-house

  • Accepted Recognized Statistical techniques are used for establishing, controlling, and verifying acceptability of process and product characteristics

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