ISO 13485:2016 Cl. 5.1 - Management commitment verbiage change

Mortalis

Involved In Discussions
#1
I would like to know why the ISO 13485:2016 standard changed the verbiage in 5.1 Management Commitment from Top management shall provide evidence of its commitment to the development and implementation...and maintaining its effectiveness to maintenance of its effectiveness.
Sounds like tom-A-to, tom-a-to to me but for some reason our internal auditing service recommends we update our Quality Manual accordingly.
 
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Ronen E

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Staff member
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#2
for some reason our internal auditing service recommends we update our Quality Manual accordingly.
Sounds to me like :ca:

As if top management’s commitments are just a matter of how it’s spelled out in the manual. As if aligning a random word with the standard changes anything. It’s the essence and the actions that matter.
 

Mortalis

Involved In Discussions
#3
Sounds to me like :ca:

As if top management’s commitments are just a matter of how it’s spelled out in the manual. As if aligning a random word with the standard changes anything. It’s the essence and the actions that matter.
It's just like when we would say, it's just common sense. Apparently, when less scrupulous business owners want to cut corners and cite the letter of the standard (or lack there of) to justify their shortcomings, the rest of us have to suffer the indignities of their lacking common sense.
It is a sad state when standard writers have to reword their intentions that most of us understood (using common sense) so that everything, and I underline everything is spelled out in not so uncertain terms.
 
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