Q about "control of production and service provision (7.5.1)"

B

BishDamo

Section 7.5.1 of ISO 13485/ISO 9001 states (I'm paraphrasing a bit): "the organisation shall plan and carry out production/service provision under controlled conditions (such as availability of specifications, work instructions, suitable eqpt, measurement standards, etc)". The "carry out" bit I have no problem with, but am a bit confused as to why you would also go about "planning" your activities under controlled conditions such as those listed in the standard. The types of controls listed will often be the output of planning, not a prerequisite for planning.

Maybe this requirement is just intended to be a reiteration of the planning activities described in 7.1, but it looks quite different? Would appreciate if anybody could clarify this for me.
 
Marc

Marc

Fully vaccinated are you?
Leader
Your planning is not being referenced as to be carried out under controlled conditions. Controlled conditions are referring to production/service provision. None the less, you should have a defined planning sequence.
 
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