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ISO 15378:2017现行

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

出版：International Organization for Standardization

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基本信息

标准编号： ISO 15378:2017

发布时间：2017/9/14 0:00:00

标准类别：Standard

出版单位：International Organization for Standardization

标准页数：79

标准简介

Defines 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.

本标准替代的旧标准

ISO 15378:2015

ISO/DIS 15378 : 50.20 (2017)

ISO 15378 : 2015

等同采用的国际标准

DS EN ISO 15378 : 2017 - Identical

UNE-EN ISO 15378:2018 - Identical

ONORM EN ISO 15378 : 2018 - Identical

NF EN ISO 15378 : 2018 - Identical

SS-EN ISO 15378:2017 - Identical

I.S. EN ISO 15378:2015 - Identical

UNI EN ISO 15378 : 2011 - Identical