ISO9001:2015 6.3 - Planning of Changes - OFI from auditor

skb76

Involved In Discussions
#1
All,

Good day!

I received OFI from auditor

~ (The Change Control Procedure could be est to outline control with regards to sudden changes with regards to internal/external aspect, such people, amendment in customer requirements, legal/regulatory requirements, technology, environment and QMS (see 4.4) .
Thus, enable changes carried out in planned and systematic manner (6.3)

SO, how i want to 'close' this OFI, how to prove to auditor the 'plan of changes'?
(#we are very small office)

*Such as
~doing a plan table/chart (7.4 ~ Communication) ? :unsure:

p/s advise

thanks in advance! :)
 
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somashekar

Staff member
Super Moderator
#2
All,

Good day!

I received OFI from auditor

~ (The Change Control Procedure could be est to outline control with regards to sudden changes with regards to internal/external aspect, such people, amendment in customer requirements, legal/regulatory requirements, technology, environment and QMS (see 4.4) .
Thus, enable changes carried out in planned and systematic manner (6.3)

SO, how i want to 'close' this OFI, how to prove to auditor the 'plan of changes'?
(#we are very small office)

*Such as
~doing a plan table/chart (7.4 ~ Communication) ? :unsure:

p/s advise

thanks in advance! :)
OFI aka Opportunity For Improvement is for your QMS benefit, if you seen something in that.
You are not required to respond / close an OFI
 

skb76

Involved In Discussions
#3
Somashekar,

I knew BUT the auditor SOMEHOW needs 'us' to WORKING ON something even its OFI, (based on my experience/knowledge previous audit with them)
 

somashekar

Staff member
Super Moderator
#4
Somashekar,

I knew BUT the auditor SOMEHOW needs 'us' to WORKING ON something even its OFI, (based on my experience/knowledge previous audit with them)
I agree. But the working on is on your QMS changes that will consider points said in the OFI.
The next audit cycle may look into the area and would see the improvements you have made
 

Mikey324

Quite Involved in Discussions
#7
Sometimes auditors point out OFI's that we see as beneficial. Eye opening stuff from someone who doesn't see our process every day. We work on implementing them in a way that will add value to our QMS.
Sometimes they point out OFI's that add zero value to our QMS. If there is no value add, we don't work on them at all.
 

Mikey324

Quite Involved in Discussions
#9
Strange that some registrars fail to sell the value of their well-crafted nonconformity statements instead of issuing OFIs.
Isn't that what its all about though? Of course, we need to meet the intent of the standard, but it should be a partnership that adds value to your organization. Or am i just dreaming :deadhorse::deadhorse:
 

John Broomfield

Staff member
Super Moderator
#10
A system that relies on its auditor to prompt improvement is probably not working as specified by the system standard. So, behind every OFI may be a system weakness that would benefit from a well-crafted nonconformity statement instead.

So, before we issue an OFI we should determine what part of the system is letting the organization down.
 
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