Can someone help me with examples of Quality objectives that related to ISO13485 e.g. of the examples:
From Quality policy drill down to Quality objectives and drill down to KPI.
Hello Yodon,
The Quality policy is part of ISO13485, the Quality objectives comes from the quality policy and to measure them you need to define KPI's,
I asked for examples if you know some.
Thank you.
Here's where we may disagree. You just need to define how they will be measured. There's nothing in the standard that mentions KPIs. You are certainly free to use them but there may be KPIs you choose to measure that aren't part of the quality objectives. My point was that it may be muddying the waters to automatically bring in KPIs to help define your objectives.
Some examples I've seen include:
number of complaints -v- number of parts shipped
on-time delivery %
supplier parts rejected
comparison of internal audit findings -v- external audit findings