Primary packaging materials for medicinal products-Particular requirements for the application of Iso 9001:2015, with reference to good manufacturingpractice (GMP)

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IsO 15378:2017(E) Primary packaging materials for medicinal products —Particular requirements for the application of Iso 9001:2015, with reference to good manufacturingpractice (GMP)1 Scopelso 9001:2015,Quality management systems - Requirements1 ScopeThis International Standard specifies requirements for a quality management system when anorganization:a) needs to demonstrate its ability to consistently provide products and services that meetcustomer and applicable statutory and regulatory requirements, andb) aims to enhance customer satisfaction through the effective application of the system, includingprocesses for improvement of the system and the assurance of conformity to customer andapplicable statutory and regulatory requirements.All the requirements of this International Standard are generic and are intended to be applicable toany organization, regardless of its type or size, or the products and services it provides.NOTE 1 In this International Standard, the terms "product " or "service" only apply to products and servicesintended for, or required by, a customer.NOTE2 Statutory and regulatory requirements can be expressed as legal requirements.ln addition to lSo 9001, this d

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