BS EN 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.


Cross References:
ISO 14698-2:2003 Ed 1
ISO 9000:2015
ISO 14698-1:2003 Ed 1
ISO 10014:2006 Ed 1
ISO 14937:2009 Ed 2
ISO 14644-5:2004
IEC 61025:2006
ISO 14644-7:2004 Ed 1
ISO 11135:2014 ED2
ISO 10012:2003 Ed 1
ISO 14971:2007
ISO 19011
IEC 61882:2016
IEC 60300-1:2014
ISO/IEC 90003:2014
ISO 10003:2007 Ed 1
ISO 9001:2015
ISO/TS 11139:2006 Ed 2
ISO 14644-2:2000 Ed 1
ISO 10018:2012 ED1
ISO/TR 10017:2003 Ed 2
ISO/IEC Guide 99:2007
ISO 10019:2005 Ed 1
ICH Q10
ISO 9001:2008
ISO 31010:2009
ISO/IEC Guide 2
ISO/IEC Guide 73
ISO 14644-1
ICH Q9
ISO 14644-4:2001 Ed 1
ISO 11137-1:2006 Ed 1
IEC 61160:2005
ISO 14644-8:2013 ED2
ISO 9004:2009 Ed 3
ISO 13485:2016
ISO/TR 10013:2001
ISO 31000:2009 Ed 1
ISO 10015:1999
ISO 10006
ISO 10002:2004 Ed 1
IEC 60601-1:2005
IEC 60812:2006
ISO 10004:2012 ED1
ISO 10001:2007 Ed 1
ISO 14001:2015
ISO 14644-3:2005 Ed 1
ISO 37500:2014 ED1
ISO 11137-2:2012 ED2
ISO 10008:2013 ED1
ISO 10005:1995
ISO 10007:2017


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