Avantor® ISO Certifications

Meeting and exceeding customer expectations

Avantor has helped establish international standards for quality and purity in product manufacturing for more than 100 years. Quality is important to our company and is the foundation of the value we deliver to customers. This is why ISO certification is important to us.

International Organization for Standardization (ISO) certifications ensure that our QMS, manufacturing processes, services, and documentation procedures meet global quality standards.

ISO certifications, as well as certifications from other accrediting bodies, mean you can be sure that products, supplies, and services from Avantor meet stringent standards for quality and reliability.

ISO 9001:2015 certified Avantor manufacturing facilities

ISO 9001:2015 Certified Avantor Distribution Facilities

ISO 13485 certified Avantor facilities

Other ISO certifications

Several other Avantor facilities have specific certifications to meet global quality standards.

ISO/IEC 17025 (International Electrotechnical Commission) certified Avantor facilities

Manati, Puerto Rico, USA

FSSC 22000:2018 certified Avantor^® facilities

Phillipsburg, NJ, United States

AS9100D certified Avantor manufacturing facilities

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

What is ISO?

ISO, short for International Organization for Standardization, is a set of guidelines developed to establish a Quality Management System (QMS) for any business.

The International Organization for Standardization was founded in 1946 when a delegation of 65 members from 25 countries met in London to discuss international standardization in the post-World War II era. Because an acronym for the organization would vary among languages, the founders decided to use the acronym ISO, which is based on the Greek word “isos” or “equal.”

What is ISO 9001?

ISO 9001 is one of the international standards published by the International Organization for Standardization. ISO 9001 is a compilation of industry best practices that could be used as a management tool. More than 1 million organizations worldwide have completed the ISO 9001 certification process and are ISO 9001 certified.

ISO standards are updated periodically. The latest ISO standard is ISO 9001:2015, announced in 2015.

Other relevant standards and regulations

In addition to ISO certifications, many Avantor facilities operate in compliance with other relevant quality system standards and regulations, including:

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

The Value of ISO certification at Avantor®