医用制品的包装原材料.根据良好加工规范(GMP)应用ISO 9001-2015的特殊要求

[中文适用范围]： 本国际标准规定了质量管理体系的要求，适用于需要证明其能够持续提供满足顾客和适用法律法规要求的产品和服务的组织，以及旨在通过体系的有效应用（包括改进体系的过程和确保符合顾客及适用法律法规要求的过程）来提高顾客满意度的组织。除ISO 9001外，本文件还规定了适用于药品主要包装材料的优良制造规范（GMP）要求，适用于需要证明其能够持续提供满足顾客要求（包括监管要求和国际标准）的药品主要包装材料的组织。本文件是用于药品主要包装材料的设计、制造和供应的应用标准。 [外文原描述]： 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.