NEN-EN-ISO 15378
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
inactive
| Organization: | NEN |
| Publication Date: | 1 November 2015 |
| Status: | inactive |
| Page Count: | 81 |
| 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 where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
Document History
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...
NEN-EN-ISO 15378
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...