Internal Audit of our ISO 9001 Quality Systems prior to the Registration Audit

M

maranellohouse

#1
Hi all. I hope I've got this in the correct section, apologies if I haven't.

Bit of background first.
Our company have seconded me into the role of Quality Manager tasked with writing our Quality Management system, a role I've been doing for the past year now. Although I have been working for the Company 30 years, it was in an Operational role and I had absolutely no previous experience of ISO 9001 or how to implement a QMS.
However I have by pretty much by using up all of my brain sells, managed to write our Quality manual and our procedures manual.

The Quality manual is about to be signed off by the management, 3rd draft, pleased with that since it was from scratch.

Which brings me to my point.
My next challenge is to carry out an audit of our new quality systems to see we carry out everything we say we do.
I'm hoping someone can point me in the direction of a template, checklist or form to help me build an audit plan.

My boss is very keen to have our company certified by June this year, but I'm very keen to actually get the systems bedded in place because I truly believe it will improve our business greatly.
I've been one of those people who have commented on how we do things wrong and now I have the chance to actually do something about it, so I really don't want to fluff the audit setup now that I've got this far..
So any help you guys can give me on the subject would be very greatly appreciated. I have recently become a lead Auditor in ISO but I'm still learning each day.

Thanks in advance, Stuart
 
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harry

Super Moderator
#2
Re: ISO 9001 Quality audit.

......................... Which brings me to my point. My next challenge is to carry out an audit of our new quality systems to see we carry out everything we say we do.
I'm hoping someone can point me in the direction of a template, checklist or form to help me build an audit plan. .............................
Welcome to the Cove.

You can use a gap analysis checklist to see if you've covered all grounds. Since there were not much changes in ISO 9001: 2008, the ISO 9001:2000 version is still good. You can find a few of them in our post attachments list.

Alternatively, you can ask for a copy from your potential CB. Many will provide you with one.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
Welcome to the Cove!

It's true that registrars will expect to see a complete round of audits done prior to certification visit.

We have a Post Attachments function - see the green button in the header. I did a search using key words "audit plan" and came up with this list.

A search using key words "audit checklist" produced this list.

You get the idea... those attachments are within threads discussing the topics. I am sure you will get a great deal of insight from them.

I hope this helps!
 

qusys

Trusted Information Resource
#4
Hi all. I hope I've got this in the correct section, apologies if I haven't.

Bit of background first.
Our company have seconded me into the role of Quality Manager tasked with writing our Quality Management system, a role I've been doing for the past year now. Although I have been working for the Company 30 years, it was in an Operational role and I had absolutely no previous experience of ISO 9001 or how to implement a QMS.
However I have by pretty much by using up all of my brain sells, managed to write our Quality manual and our procedures manual.

The Quality manual is about to be signed off by the management, 3rd draft, pleased with that since it was from scratch.

Which brings me to my point.
My next challenge is to carry out an audit of our new quality systems to see we carry out everything we say we do.
I'm hoping someone can point me in the direction of a template, checklist or form to help me build an audit plan.

My boss is very keen to have our company certified by June this year, but I'm very keen to actually get the systems bedded in place because I truly believe it will improve our business greatly.
I've been one of those people who have commented on how we do things wrong and now I have the chance to actually do something about it, so I really don't want to fluff the audit setup now that I've got this far..
So any help you guys can give me on the subject would be very greatly appreciated. I have recently become a lead Auditor in ISO but I'm still learning each day.

Thanks in advance, Stuart
Hi Stuart,
welcome on the forum.
My advice is to be helped by a quality consultant if you want to reach the goal in a very challenging time.
Your top mgmt shall also sponsor this giving attention and resources,
I would like to suggest to treat this as project with project mgmt approach , otherwise there is the risk to forgot something and not staying in time. The cooperation of all is key as well process approach pursuing for QMS processes.:bigwave:
 
M

maranellohouse

#5
:bigwave: Hi guys.

Thank you for taking the time to respond and for the links. I'm finding them most useful in basing my audits setup.

Its great to find a place were I can feel comfortable when finding my feet. So thank you for that.

My 2 bosses and myself for now appear to be the ones who get the concept of moving the business on using ISO but not everyone concerned has bought into it yet. Its going to be a challenge moving them out of the silos they have built and been in for quite a few years now, but for us to move in the right direction its very much needed and although at the start I to felt threatened by it, I now welcome the challenge.

I can see how much it will benefit what we do, and if I'm honest I feel privilaged at being asked to put the setup in place. One thing I don't want to do is let the boss down after him putting the confidence in me to do it, so I have to get it right.
No pressure then. :mg:
 
S

snmurray

#6
It's true that registrars will expect to see a complete round of audits done prior to certification visit.
Is that true of the subsequent surveillance audits as well? In other words, we crammed in several System audits(multiple facilities) early in 2011 prior to our certification audit in March. Are we required to then do the same for the next surveillance audit? Or can when then go to an annual audit Schedule?

I have created an audit schedule for 2012 which is 25% complete, however, I received a non-conformance during my recent surveillance audit. The registrar claims that the audit schedule is not necessarily done by the calendar year but rather on a cycle - from Surveillance audit to Surveillance audit.

That does not sound like a requirement of the standard...
 

Jim Wynne

Staff member
Admin
#7
Is that true of the subsequent surveillance audits as well? In other words, we crammed in several System audits(multiple facilities) early in 2011 prior to our certification audit in March. Are we required to then do the same for the next surveillance audit? Or can when then go to an annual audit Schedule?

I have created an audit schedule for 2012 which is 25% complete, however, I received a non-conformance during my recent surveillance audit. The registrar claims that the audit schedule is not necessarily done by the calendar year but rather on a cycle - from Surveillance audit to Surveillance audit.

That does not sound like a requirement of the standard...
The registrar is wrong unless there's something to the contrary in your contract with the registrar.
 
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