Certifications : We work to the highest standards

Nelipak is committed to Quality Management. All of our facilities are ISO 13485 certified for the design and manufacture of custom thermoformed plastic packaging and products to customer specifications

Key Features

  • EN ISO 13485 and EN ISO 9001 certified
  • Work according to EU and FDA GMP directives
  • Automated statistical process control (SPC) system
  • Bacteriological testing of class 7 and 8 cleanrooms

ISO certifications

Cranston ISO 13485:2003
ISO 9001:2008

EN ISO 13485:2012 & ISO 9001:2008 EN

EN ISO 13485:2012 & ISO 9001:2008 NL

EN ISO 13485:2012 & ISO 9001:2008 DE

EN ISO 13485:2012 & ISO 9001:2008 FR

ISTA Membership Certification

Galway EN ISO 13485:2012
EN ISO 9001:2008
Heredia CR ISO 13485:2003
Phoenix ISO 13485:2003

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