Internal Auditing to ISO 9001 - How to schedule/plan and perform an ISO audit

#1
Feeling really confused here...I have been reading many posts and replies and I still don't get it. I come from QS-9000, auditing by elements, using a checklist and auditing the procedures, work instructions, etc. Now, I am implementing ISO 9001:2000 and I haven't a clue as to how to schedule/plan and perform an ISO audit. I have my registrar's checklist as a guide.

My audit plan is still setup to QS-9000 elements because I don't know/understand an effective way to change it to ISO. What if I have to transition to TS for some unknown reason (it is a remote possibility)....what path should I take for planning and auditing?

I am so lost. I want to do it "right" and being that I don't have any other influences (other than QS), what is the best effective way to plan and audit?
I'd like to cover all areas of ISO in 12 months time.

Know any good training programs or books or can someone shed some light here?

:confused: :frust:
 

Jeff Frost

Inactive Registered Visitor
#2
I may be in error but I believe that QS 9000 was based on ISO 9001:1994 (20 elements). The ISO 9001:2000 is based on process flow method where each clause is linked directly through a reference or through an implied link to each other.

The standard really is made up of 4 main or master process comprised of management processes, realization processes, specific (special) realization process and documentation requirements (not a real process but still must be audited).

Each of these 4 processes can be broken down into sub-processes that can be audited requiring just 11 internal audits (usually more). An example of one of these sub-processes is the audit Clause 5.5.3 and 7.2.3 which relates to the organizations communication process.

Here is a list of the main and sub-processes of the standard:


Management Process
• QMS Implementation & Maintenance Process
• Management Review Process
• Communication Process
• Internal Auditing Process
• CAPA Process

Realization Processes
• Design & Development Process
• Requirements - Determination & Review Process
• Purchasing Process
• Facilities & Equipment Management Process

Specific Realization Process (old ISO 9001:1994 special processes)
• Dye Penetrant Process
• NDT Process
• Material Testing Process
• Other ????

Documentation Requirements (requirements)
• Documentation requirements
• Quality Manual requirements

The hardest part for auditors and managers of the audit process is to move away from the old method of auditing procedure. Audits now are comprised of verifying the organizations operational procedures to requirements of the standard and then auditing the process to see if it conforms to the standard and the operational procedure requirements.

ISO/TS 16949 and AS9100 would add a few more processes to be audited but the same method can be used.

Hope this helps
 
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#3
Lee said:
Feeling really confused here...I have been reading many posts and replies and I still don't get it. I come from QS-9000, auditing by elements, using a checklist and auditing the procedures, work instructions, etc. Now, I am implementing ISO 9001:2000 and I haven't a clue as to how to schedule/plan and perform an ISO audit. I have my registrar's checklist as a guide.

My audit plan is still setup to QS-9000 elements because I don't know/understand an effective way to change it to ISO. What if I have to transition to TS for some unknown reason (it is a remote possibility)....what path should I take for planning and auditing?

I am so lost. I want to do it "right" and being that I don't have any other influences (other than QS), what is the best effective way to plan and audit?
I'd like to cover all areas of ISO in 12 months time.

Know any good training programs or books or can someone shed some light here?

:confused: :frust:
Please don't take me wrong but I'm pretty blunt and an old Grunt and cop so when I say things they are taken in a wrong way.

Based upon your statement above why are you even doing this? On the evidence of you own admission you have no business being involved in any audit process because you do not possess the "compentency" required.

You last question causes me to want to say "DUH!!!"

How about taking an auditing course from a "recognized" training provider? Internal, Lead Auditor, whatever. These things aren't new and the providers aren't kept on some secret list in a vault. The right hand side of this very website provides you answers to the training, books and other blah, blah, blah you asked about.

Think about what you are asking about. Do you perform your work by clause? Does your organization create its product by clause? Do you please you customers by clause? I'm pretty sure your answer to these questions is "no", so why in the H3ll do you or would you want to audit by clause?

Pardner you've come to the right place to seek assistance. As a 1st step seek out the "auditing" related threads. Also spend time in the ISO 9001:2000 threads. You will need to invest some "real" time in this. Don't piece-meal the task ahead of you. Instead of dangling your toes in the water, hold your breath and jump in head first, it's the only way that you will find your way.

There are many of us here in the Cove that are providers (or work for providers) of the type of training you need. I'd like to tell you that my employer is the best, but we are represented here by many other folks who unquestionably work for great organizations that can help you get out of your rut.

BTW...Welcome to the Cove and don't be afraid or overwhelmed. We're just people looking for answers too and at times we provide them.
 
Q

qualitygoddess - 2010

#4
Since you probabably know how to read the standard and its requirements, perhaps you might benefit from a public course that covers just process auditing. I have seen these offered by several of the bigger, accredited training firms. It's usually a 2 day course that simply shows you how to do process auditing to the 9001 standard. If you do a search, I'm sure you will find several options.

You can always go to a 5 day lead auditor course, too. Depends on how you want to spend your money. These lead auditor classes combine process auditing with a review of the standard.

--QG
 

Cari Spears

Super Moderator
Staff member
Super Moderator
#5
Lee said:
...I have been reading many posts and replies...
Have a look at the thread titled: Looking for example of a good audit report. The last post was February 2005 - so you'll have to go to about the third page in this forum.
 
#6
Duh???

Go right ahead...Pour it on folks. I can take it. I am a QS-9000 ceritified lead auditor. But what good is that now? I went thru the 5 day course. That was then and I worked somewhere, where training was encouraged, provided easily and approved in 2 seconds time.

It's sooo easy for ya'll to say go get training from a outside training source. That may be easy in most companies....Training (here and now) is not so easily approved and not encouraged at all. I have begged for training for me and all the other 19 internal auditors. I have been waiting for an answer for a a little over a week now.....still waiting. So, I have been surfing the cove looking and reading to see how it is supposed to be done.

Everyone here thinks that ISO is easier because it is less paperwork - so why do I need training? - gee it's less paperwork. How do I answer that one?

I don't need more "duh" responses. I know it's a bigtime DUH GEORGE. That's why I am reaching out for other types of trainnig/help.

What type of auditing does ISO 9001 require or what type of audit approach should be done? My registrar already asked for a map of the processes....I don't have any. I didn't know that I was supposed to create them until UL asked. ARGGHHHHH!!!!!!

I'll just go back and crawl into my 1/4 cubicle (I don't have an office like most people at my level) and keep searching and reading. :(

Ohhhhh phart. I'm sorry for being pissed. It's not your fault. :truce:
 
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Cari Spears

Super Moderator
Staff member
Super Moderator
#7
I, for one, did not take a "process auditing" training coarse. I took a 3 day class on QS9000 auditing back in 1993 (ish - I don't remember exactly) given by AIAG. I created my stuff - which is posted in the thread I directed you to above - by looking at what everyone else does and picking out what I liked and didn't like. I looked at everyone's attachments here and I looked at as many registrar forms as I could get my hands on.

No formal training - I kept reading and searching.
 
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Joe Cruse

Mopar or No Car
#8
Lee,

There are examples of process diagrams on the site, so do a search on those. We based our map on one we found here. Actually, a flow chart map is NOT required, but you DO have to show the processes in your scope and how they interact. A flow chart is a nice, easy to follow way of doing that.

There is also a lot of good stuff on audit formats here. Heck, just look a couple of threads down at my thread on our audit format. Cari and Caster do a good job of showing how to make sure your QMS meets the Standard requirments and then making sure your actual practices meet your QMS. If you're a trained QS auditor, the part about making sure your QMS meets Standard requirements is old hat to you. Use the process approach to look at each area in your QMS, both to make sure practices meet your own QMS requirements and to look for opportunities for improvement in each area. Follow the inputs and outputs of each area.

Good luck.
 
#9
Joe Cruse said:
Use the process approach to look at each area in your QMS, both to make sure practices meet your own QMS requirements and to look for opportunities for improvement in each area. Follow the inputs and outputs of each area.
Yes...I am perusing the cove and downloading lots of stuff. Also searched internet for freebies too. The process approach is something I have never been exposed to until recently. I am searching for introductory materials on that topic - anything I can find for free. I really do not understand the "process approach" and I am trying to read and learn on my own.

Thanks!
 

Aaron Lupo

Inactive Registered Visitor
#10
Lee said:
I really do not understand the "process approach" and I am trying to read and learn on my own.

Thanks!
Lee-

The best way I can explain the process approach is- You have your processes that your perform to make your product you need to follow them from dock to stock from the time an order comes into the building till the time it makes it to the customer.
 

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