Internal Audits required before Registration Audit - Distributors

S

shri11

#1
#1
Hi, I am trying to get some info regarding ISO certification for Distributors. We have done internal audits of the following areas: Would this be considered a complete cycle of internal audits, prior to calling in for a registration audit?

Document Control
Purchasing
Receiving and Warehouse
Control of Non-conforming product
Corrective Actions
Preventive Actions

Thanks,
Shri
 
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Q

qusys

Trusted Information Resource
#2
#2
Re: Internal Audits before certification

shri11 said:
Hi, I am trying to get some info regarding ISO certification for Distributors. We have done internal audits of the following areas: Would this be considered a complete cycle of internal audits, prior to calling in for a registration audit?

Document Control
Purchasing
Receiving and Warehouse
Control of Non-conforming product
Corrective Actions
Preventive Actions

Thanks,
Shri
Click to expand...
Are you saying that these have been identified as your necessary processes for QMS?

Besides, I did not see if the results of these internal audit have been input in the management review.
Pls, give us more details:bigwave:
 
S

shri11

#3
#3
Re: Internal Audits before certification

Thanks for responding. There is some gray area because this is a distributor, they buy and reship products, and do some bit of modifications. So part of this post is also a question. The results of the audits have been input into the management review. Any help will be appreciated. Thanks
 
somashekar

somashekar

Leader
Admin
#4
#4
Re: Internal Audits before certification

I do not see you mention about audit of human resource and infrastructure / maintenance / work environment ... ?
 
Q

qusys

Trusted Information Resource
#5
#5
Re: Internal Audits before certification

shri11 said:
Thanks for responding. There is some gray area because this is a distributor, they buy and reship products, and do some bit of modifications. So part of this post is also a question. The results of the audits have been input into the management review. Any help will be appreciated. Thanks
Click to expand...
It could be useful to have more details.
Did you do a gap assessment?
Did you identify the QMS processes?


Then you mention that they do some modification. In what sense? Is there any change control process in place? Do they do some rework or repair?
:bigwave:
 
S

shri11

#6
#6
Re: Internal Audits before certification

Yes, a gap assessment was done, and procedures for each department have been established, the NCR system was put in place in early 2011, and before getting ready for the certification we are doing a complete cycle of internal audits. At this point a question arose as to this was enough!
So I thought I would ask other experienced folks.

They do some rework and repair, and those processes have been audited also.

With regards to audits of HR and maintenance/environment, questions were raised as to how are these related to QMS for a distribution environment? So no internal audits were done for these departments.
Thanks for your help
 
somashekar

somashekar

Leader
Admin
#7
#7
Re: Internal Audits before certification

With regards to audits of HR and maintenance/environment, questions were raised as to how are these related to QMS for a distribution environment? So no internal audits were done for these departments.
Click to expand...
Who raised the questions ... ?
The fact that no internal audits were done for these departments means that these departments exist and hence there is a need of these departments in your operations. These fall under the clause 6 of the ISO9001, which are to be integral in your QMS.
I suggest you have a relook at your process and interactions and find out what is missing in that and later what were not within your audit plan. Take a chance to audit them as well and update the process interactions as happening within the company..
 
Last edited:
S

shri11

#8
#8
There is a consultant we are using, and he did. Also, HR department exists, there is no maintenance department! Thanks for your suggestion.
 
A

AndyN

Moved On
#9
#9
It's not really a case of auditing departments, whatever they are called. If you have processes/activities etc - which take care of the human side as it relates to competency, training and awareness, or you consider the building condition etc which affects the quality of the products distributed - as part of your QMS, then those processes should have been audited, before the Certification Audit. If these aren't part of your QMS, then they should! Maybe that's the real issue here, that such processes aren't considered part of the QMS, even though they should. Don;t forget, you can't exclude anything outside of section 7.0 of ISO 9001.
 
J

JaneB

#10
#10
Re: Internal Audits before certification

shri11 said:
With regards to audits of HR and maintenance/environment, questions were raised as to how are these related to QMS for a distribution environment? So no internal audits were done for these
Click to expand...
As has already been said, do not audit departments - audit processes. The whole Standard is based upon a process-centric approach. To ignore that and audit departments is a flawed approach.

If a 'consultant' is raising the questions you mention, I'd start worrying (a lot!) about the competency, knowledge and experience of so-called 'consultant'. And I am a consultant.

Go read the section on competency (6.2) again. Anyone doing work that affects quality of service/product needs to be competent. Who defines the competencies for the various roles? Who recruits? Who trains and inducts people so that they know what they're supposed to be doing and how? Who does performance assessment to see if they are?

Your so-called 'consultant' doesn't see why it matters that people are competent for their jobs just because you're in a distribution environment? Spare me.

Even if one of the lucky few who have never had any of the following happen to him/to his knowledge, doesn't he have any ability to read the Standard properly?
  • something sent to the wrong place, because someone got it wrong
  • something arrive damaged because it wasn't packed/handled properly in the first place, or it had been delivered to the warehouse like that and no one inspected it or no one noticed
  • the wrong goods delivered because someone hadn't been taught something like how to look up product codes/use the online system/enter orders correctly or couldn't read etc
  • etc
  • etc
You think those kinds of things don't 'affect quality' in a distribution environment???
 
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