ISO 15378 is a subordinate standard program in ANAB’s fee schedule. Applicant CBs shall be accredited by ANAB or attain ANAB accreditation concurrently to certify organizations for ISO 9001 quality management systems.
Please refer to the information about the accreditation process at How to Become an ANAB-Accredited Certification Body.
You can view the ISO 15378 application in .pdf format to understand specific requirements but the application process must be completed online via ANAB’s EQM database; first-time EQM users must register to create an account.
Organizations with a certified ISO 15378 management system can be expected to conform with ISO 9001 and GMPs applicable to primary packaging materials for a quality management system. An organization with a certified ISO 15378 management system will consistently demonstrate its ability to conform with applicable customer requirements, regulatory requirements, and international standards.
Accreditation Requirements for Management Systems CBs
Available from ANSI (with member discount):
ISO 15378:2017, Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
Also see requirements for QMS accreditation
For more information, contact anab@anab.org.
