BS EN ISO 15378:2015 specifies requirements 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 applicable to primary packaging materials.

In this International Standard, 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.


Cross References:
ISO 9001:2008
ISO 9000:2005
ISO 14698-1
ISO 14698-2
ISO 9001
ISO 9004
ISO 10007
ISO 10012
ISO 11135
ISO 11137-1
ISO 11137-2
ISO/TS 11139
ISO 13485
ISO 14001:2004
ISO 14644-1
ISO 14644-2
ISO 14644-3
ISO 14644-4
ISO 14644-5
ISO 14644-7
ISO 14644-8
ISO 14937:2009
ISO 14971
ISO 19011
ISO 31000
IEC 31010
ISO/IEC 90003
ISO/IEC Guide 2
ISO Guide 73
ISO/IEC Guide 99:2007
IEC 60601-1
IEC 60812
IEC 61025
IEC 61882
ICH Q9
ICH Q10
ASTM E 2500


All current amendments available at time of purchase are included with the purchase of this document.