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Quality objectives or KPI in QMS Manual?

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Guest user Created:   Dec 17, 2018 Last commented:   Dec 17, 2018

Quality objectives or KPI in QMS Manual?

Hi. Just wanna know if the declared procedures in our QMS Manual should always have a Quality Objectives? Or is it just okay to have a KPI for whole department? Thanks a lot.
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Verlene Law Dec 17, 2018

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/
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Dec 17, 2018

Dec 17, 2018

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