ISO certifications

Meeting and exceeding customer expectations

For more than a century, Avantor has helped set the global standard for quality and purity in product manufacturing. Quality is an essential element of every process, program, product and solution from Avantor and is the foundation for the value we deliver to our customers every day. Our commitment to excellence and continuous improvement in quality is reflected in our ISO (International Organization for Standardization) certifications, which ensure our management systems, manufacturing processes, services, and documentation procedures meet all requirements for global standardization and quality assurance.

The following Avantor manufacturing facilities are ISO 9001:2015 certified:

Avantor distribution facilities also have ISO 9001:2015 certifications: 

The ISO 13485 standard represents the requirements for a comprehensive quality management system for the production, sales and supply of high-purity reagents and kits for in vitro diagnostics.

The following facilities are ISO 13485:2016 certified:

In conjunction with ISO certifications, several other institutions have catered certifications to meet global quality standards.

The ISO/IEC 17025 (International Electrotechnical Commission) is the internationally recognized reference for testing and calibration for laboratories wanting to demonstrate their capacity to deliver reliable results both nationally and around the world. The following location is ISO/IEC 17025:2017 certified:

  • Manati, Puerto Rico, USA

The FSSC 22000 (Food Safety System Certification) provides a framework for managing food safety responsibilities and ensures Avantor has a robust food safety management system that meets the requirements of our customers. The following location is FSSC 22000:2018 certified:

  • Phillipsburg, NJ, United States

The AS 9100 certification is an internationally recognized quality system standard tailored for the aerospace industry. It ensures the quality, safety and technology of all our products and services serving the Aviation, Space and Defense businesses. The following facilities are AS 9100D certified:

  • Carpinteria, CA, United States
  • Bakersfield, CA, United States

Other relevant standards & regulations

In addition to ISO certifications, many of Avantor’s facilities operate in compliance with other relevant Quality System standards and regulations including, but not limited to:

  • 21 CFR Part 210 & 211 cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Finished Pharmaceuticals as interpreted through ICH Q7 Good Manufacturing Practice (GMP) Guide for Active Pharmaceutical Ingredients
  • 21 CFR Part 820 Quality System Regulation
  • 21 CFR 110 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food
  • IPEC/PQG Joint Good Manufacturing Practices Guide
  • EFFI GMP for Cosmetic Ingredients

Avantor®, a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. Our portfolio is used in virtually every stage of the most important research, development and production activities in the industries we serve. Our global footprint enables us to serve more than 225,000 customer locations and gives us extensive access to research laboratories and scientists in more than 180 countries. We set science in motion to create a better world.