Examples of Quality Objectives related to ISO 13485:2016

R

relad

#1
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.

Thank you.
Roni.
 
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yodon

Staff member
Super Moderator
#2
Quality objectives shouldn't relate to 13485; they need to relate to your quality policy.

And there's nothing that ties quality objectives to KPIs (although you may choose to, I suppose, as appropriate).
 
#3
Roni

Try Slideshare April Brights presentation How to Implement ISO 13485 Updates

This may help see the requirements of 13845 and relate back to Quality Objectives ( KPI's )

Hope of use

Steve
 
R

relad

#4
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.
 

yodon

Staff member
Super Moderator
#7
The Quality policy is part of ISO13485,
Yes, of course.

the Quality objectives comes from the quality policy
Still in agreement (although "consistent" with the quality policy is a bit more accurate).

and to measure them you need to define KPI's,
I asked for examples if you know some.
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
 
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