Quality objectives or KPI in QMS Manual?

Answer:

The QMS Manual should have quality objectives established at the beginning as it much easier to track the effectiveness than KPI for a single department and it also provides a broader goal that the company is working toward for its Quality Management System. The objectives can be specified within or out of the Manual as ISO 13485 does not specify where the objectives need to be documented.


For more information, please refer to :

-How to manage the Quality Manual according to ISO 13485:2016 requirements: https://advisera.com/13485academy/knowledgebase/how-to-manage-the-quality-manual-according-to-iso-13485-requirements/

-Setting good quality objectives for ISO 13485: https://advisera.com/13485academy/knowledgebase/setting-good-quality-objectives-for-iso-13485/