ISO 15378 - Primary packaging materials for medicinal products
Particular requirements for the application of ISO 9001, with reference to good manufacturing practice (GMP)
ISO 15378 specifies requirements for a quality management system when an organization: (a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and (b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
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