DPS has published the SSH standard ISO 15378:2017/Amd 1:2024 “Primary packaging materials for medical devices - Specific requirements for the implementation of ISO 9001:2015, with reference to their good manufacturing practice” - Amendment 1

The standard specifies requirements for a quality management system, where an organization: a) shall have priority to consistently provide products and services that meet customer requirements, applicable legal and regulatory requirements and b) aims to enhance customer satisfaction through effective implementation of the system, including processes for improving the system and ensuring compliance with customer requirements, applicable legal and regulatory requirements. All requirements of this standard are general and are intended to be applicable to any organization, regardless of type, size or the products and services it provides.