NEN-EN-ISO 15378
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
active, Most Current
| Organization: | NEN |
| Publication Date: | 1 November 2017 |
| Status: | active |
| Page Count: | 100 |
| ICS Code (Quality management and quality assurance): | 03.120.10 |
| ICS Code (Packaging materials and accessories): | 55.040 |
| ICS Code (Medicaments): | 11.120.10 |
| ICS Code (Medical equipment in general): | 11.040.01 |
| ICS Code (Management systems): | 03.100.70 |
scope:
NEN-EN-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.
Document History
NEN-EN-ISO 15378
November 1, 2017
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
NEN-EN-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...
November 1, 2015
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
NEN-EN-ISO 15378 specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable...
November 1, 2011
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
This International Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and...
August 1, 2007
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal...