ISO 9001:2000 Internal Audit Procedure - On the right track?

[michelle8075]

Why is this so hard for me? I am currently QS-9000 TE moving towards 9K2K, I can't seem to get the concept of process model vs. elements for internal auditing down. I am setting up the internal auditing procedure down, and I just want to ensure I am doing this correctly. Also, I have to figure out a internal auditor training program for my in-house auditors to teach them to go from QS-9000 TE to 9K2K

Ok, here is my major question:
1) Do I have to have an internal audit plan that shows I audited each of the elements and documented procedures, or Can I show an internal audit plan that shows my major processes i.e (with the elements that they go to documented next to it) laong with each of the documented procedures.

I think I just don't want to let go of what I already know from QS-9000 TE to audit each element. I just don't want to have a noncomliance because I am not auditing the entire system.

What I am planning on doing is showing Major Processes (with elements next to each process) and each of my documented procedures in my audit plan.

Am I on the right track, or am I just majorly confused?

 

[rtstewart1]

Audit Matrix

A couple of years ago, I copied the audit matrix used by my registrar to do pretty much what you are describing. I am attaching a copy of the one I created for you to review. As it happens, in October during a surveillance audit the registrar informed us that we were to identify our processes and the applicable sections of 9K2K on basically the same form. I was able to cut and paste the internal audit matrix I had developed into the one provided by the auditor (fortunately, their form was still the same!!!).

During my 9K2K registration and two subsequent surveillance audits, they were basically happy with the way I had incorporated the elements into my audit program. Additionally, I had been performing department/process audits for several years prior to the implementation of 9K2K to cover the elements of 9001-1994.

I hope this helps!!!

 

[amjadrana]

Internal audit procedure

Yes, you have to audit all clauses of the standard. How you do it, is up to you. A checklist to cover all clauses is a good way to demonstrate compliance. The checklist could be either process or element related. But make sure it covers all aspects.

 

[michelle8075]

rtsteward, excellent example! I am feeling better now that I was on the right track. Your attachment helps me to clarify what I was thinking all along.

I apprecite it! I dont' have much help here where I work to help me with implementation on 9K2K

 

[rtstewart1]

You're Welcome!

I was happy to help. I've been able to get quite a bit of help from this site, so it is always nice to be able to help someone else. I recently changed jobs and the company I now work for is working towards ISO 13485:2003 certification, so my experience in ISO 9K2K has been a big help here.

If you're interested, I've got a "status and importance" worksheet that I use to help me develop my audit schedule. I'd be happy to pass it along if you're interested. I know it made one of my surveillance auditors very happy to see that we were using the tool.

 

[michelle8075]

If you can attach the "status and importance" worksheet that you have that would be great!

I too have seen so much useful information here on the cove. People are always so great about helping each other out here. Even though I haven't posted a lot, I have learned so much just by reading the other posts.

Thanks again for sharing information with me, like I said earlier, I have nobody here and I am doing this all by myself, no consultant, no nothing. I am trying to put together teams now, but most people on the teams don't have a very strong quality background / QMS background. I find myself doing more teaching that getting things done. But, Together we can succeed! Good luck with your transition also!

 

[Patricia Ravanello]

...Operating System Input Check List


Quote...
1) Do I have to have an internal audit plan that shows I audited each of the elements and documented procedures, or Can I show an internal audit plan that shows my major processes i.e (with the elements that they go to documented next to it) laong with each of the documented procedures. "

RT Stewart's responses have pointed you in the right direction...I too have used a similar matrix to verify that each element and sub-element of the standard is captured in the operating system. Some clauses cover a lot of ground, and it's often hard to tell, just from the heading what should be covered (the clause might deal with one area primarily, but impacts on others also...as you see in the attached example)

I've attached a page from my System Input Check List that demonstrates how I verify that all aspects of the standard are covered and where (this example is for ISO/TS 16949). I've also used this matrix to identify mandatory records and mandatory monitoring activities.

 

[michelle8075]

Wow Patricia, that is also a great example too! I think that this would be a useful tool for my company also. Right now, I am the only Certified Lead Auditor. The other internal auditors here are trained, but they are so confused about this new standard, and this makes it really easy for them.

 

[rtstewart1]

Status and Importance Worksheet

Here's the worksheet that I was talking about. It was created by a consultant friend of mine and is also available on his website as a free download (https://www.schnauber.com/index.html). There are some other downloads there that you might be interested in.

Good luck.

 

[cheimmie23]

hello,

Good day....

Have problems with regards to documenting and making checklist for internal audit.. Would you mine if you can be of help to me sending me a copy of your internal audit procedure.. coz it's difficult for me to assess the system since i don't have knowledge on the ts standard...

looking forward for your soonest response.. thank you so much..

regards,
lea