ISO 15378:2017规定了当组织: a） 需要证明其能够始终如一地提供满足客户和适用法律法规要求的产品和服务，以及 b） 旨在通过有效应用系统，包括改进系统的过程，以及确保符合客户和适用的法律法规要求，提高客户满意度。 本国际标准的所有要求均为通用要求，适用于任何组织，无论其类型或规模，或其提供的产品和服务。 注1:在本国际标准中，术语“产品”或“服务”仅适用于为客户设计或要求的产品和服务。 注2:法定和监管要求可以表示为法律要求。 除ISO 9001外，本文件还规定了质量管理体系中适用于初级包装材料的良好生产规范（GMP）要求，其中组织需要证明其提供医药产品初级包装材料的能力，该材料始终满足客户要求，包括监管要求和国际标准。 在ISO 15378:2017中，术语“如果适用”被多次使用。当一项要求被这个短语限定时，它被认为是“适当的”，除非该组织能以其他方式证明理由。 ISO 15378:2017是医药产品初级包装材料设计、制造和供应的应用标准。

ISO 15378:2017 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. NOTE 1 In this International Standard, the terms "product" or "service" only apply to products and services intended for, or required by, a customer. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards. In ISO 15378:2017 the term "if appropriate" is used several times. When a requirement is qualified by this phrase, it is deemed to be "appropriate" unless the organization can document a justification otherwise. ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.