I have a check list for internal audits that was developed by our previous Quality Manager, but it "relates" too closely to our procedures "verbadum". I need to "steal" from someone out there. Does anyone have a check list that parallels the standard that I can have ? It would be very appreciated.
George T.

I do, and as soon as my e-mail is working again I'll send it.

WORD OF WARNING. What you describe is also know as "gap analysis", a useful tool when determining gaps in the system during the stages of QMS development and implementation, and also useful for desk-top/system/adequacy audits where you are only looking at compliance to the standard. For internal (compliance) audits however you also need to determine compliance to your procedures, which from a 'meaningful' point of view is more appropriate than compliance to the standard.
Clear???

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My company used checklists before I started. Based on the reviews of the IAR's, I found a bit of redundancy that seemed wasteful. I have found that printing the primary procedure and any direct link procedures, I can more easily coordinate the trails I tend to find, which can lead to other Sections temporarily. Since I know that my Quality System Manual meets the QS standard, and my Procedures meet my Quality System Manual, I want to focus on the Procedural level but with the procedures right there as a continual reference as I stated. I am always mindful of the standard requirements as I proceed however, just in case I do find an opportunity.
I also like to take 3 complete vertical audits annually. With this I will track a job through each and every step from Quote to Acceptance by the customer. I find that this will expose weaknesses I usually will not find in a direct Section audit. My "checklist" for this comes specifically from our system and its rare that I can deviate from the track I am on.
Back to the checklist, I tend to have a general idea of what I want to look at and not get too specific via a list. It works well for me and for our system.

Steve,
I have been looking high and low for an example of what you call a "vertical" audit. Any chance I can have a sample?
Thanks, Dawn

Hi Steve,

Vertical Audit...Is that a process audit you're talking about? If so, I'm with you: After all, the major problems always seem to pop up in the "grey area" between different departments or machines..

As for the checklists....: I have no preset ones. I start off with the standard ( ISO 9002 ), going via the manual and the procedures to the previous audit, customer complaints and rejects to put together a unique checklist for every audit.

/Claes

I've spent a fair bit of time knocking checklists. I think they are unprofessional and quite unnecessary for internal process audit where all you should be doing is establishing compliance to document.
But Steven's checklist for vertical audit seems to be the exception to my rule and I think I'll follow his example in future. To keep on track and cover everything in this type of investigation is very difficult. In fact, in my esperience, you get pulled off line and never get back, so it's just another sample audit, when, in Steven's words, it should be a 'complete' vertical audit. As Claes says, it's the interfaces that cause most of the problems and typical documentation tends to ignore the interfaces, so we need a means to check them thoroughly.
I never heard the term 'vertical' audit before or any name for the activity. I would also like to hear more from you, Steven, on the subject.
rgds, John C

I attended a QS9000 Lead Auditor class put on by "Excel Partnership". The class instructor was a British gent named John Killman who was the origin of the term "Vertical Audit". I adopted the term as it was the first reference for what I am now reading as a "process audit" stated by others. Regardless of the name, I truly love this audit method because it is easy to maintain focus and its really hard to dance and hide from it because it is so specific to the objective and mandates evidence at every step.

For what it's worth, I've made reference here before to 'audit trails' which differ from the individual clause audit in that my auditors start from the shipping dock where they pick a product ready to go and follow the trail backwards through the various departments. To help them understand what they're looking for, I give them a copy of a flowchart with process elements and ISO references (I lifted it from the Memory Jogger 9000) and turn it upside down.

A similar approach to yours, but with a different starting point.

I like that idea of running the audit backwards from the end. I'll try it that way as well. Im always open to another approach http://www.16949.com/ubb/smile.gif

Regarding the issue of vertical audits, I found a link at Internalauditor.com to the National Computing Centre where there is a free download of "Internal Quality Audit Handbook." It gives the following definitions:

"Vertical audits look, in depth, at a particular function or department. This type of audit would monitor the use of all relevant procedures as they are used to support the function or activity. Internal audits are usually vertical audits."

"Horizontal audits follow a process from start to end. This type of audit would look at procedures as they support the process itself and is likely to span many different functions or departments. Audits or assessments leading to certification are likely to be horizontal."

Sorry to confuse the issue, but it seems, at least if we accept this definition, that process audits are horizontal. Any thoughts?

Great site Marc.

John - Can you be more specific about how you found that handbook. I can be kind of WebDumb. When I went to that site, I couldn't find any path towards the handbook, and search engines took me to a Japanese university with a handbook link that only served up blank PDF pages.

I'd appreciate any specific guidance.

Thanks.

Wallybaloo:

Go to Internal-Auditor.com (http://www.internal-auditor.com) and select "links" in the free area and scroll down to "links archive." You'll find the Internal Quality Audit Handbook about a third of the way down the list.

I have a check list for internal audits that was developed by our previous Quality Manager, but it "relates" too closely to our procedures "verbadum". I need to "steal" from someone out there. Does anyone have a check list that parallels the standard that I can have ? It would be very appreciated.
George T.

George:

In order to preserve the copyright laws, I will point you in the direction of a Canadian company that has developed a checklist that has every single clause of the 9001:2000 standard in its gap analysis document. iso-specialists dot com.

I have found it helpful, and the price was right a few years ago.

Attached is the checklist I use.

Wallybaloo:

Go to Internal-Auditor.com and select "links" in the free area and scroll down to "links archive." You'll find the Internal Quality Audit Handbook about a third of the way down the list.
Hey db - Is this current?

Here I attached other check-list ISO TS 16949:2002 in English and...

Regards.

:bonk:

And I I said in other post.

The Pdf could be conver to Word with the legal program.

solidpdf.com

A trial version is for free and for a long time.

A warning about checklists for internal auditing for TS 16949. We just had our 1st surveillance audit last Thursday and Friday, 6/29 and 6/30. During that audit we discussed internal auditing quite extensively. According to our auditor, TS strictly prohibits checklists for internal auditing that our based on the standard. As he explained the logic, summarized below, it made sense to me.

Check lists tends to direct you over the same ground over and over again and inhibits you from truly exploring and uncovering the weaknesses in your system.

Based on my discussion with the auditor, I intend to implement the following generic checklist for our internal auditors (auditing a TS compliant QMS):

1) Ask the process owner to show you their measurments of effectiveness and efficiencies. For any measurments that are deficient, ask the process owner what is their action plan for improvement.

2) Choose a recent example of something that the process "produced" and follow it through the process. If something doesn't seem right, investigate further.

3) The key to this process is to be curious, and dig a little.

The outcome is that the internal auditor learns something new about the process she/he is auditing, and the process owner may discover an area for improvement.

I'd much rather a problem be uncoved in an internal audit then a surveillance audit. That way I have more control over the solution.

In my opinion the check-list is a tool for beginners, whether not would be enough hard.

And after that to follow the Audit focusing on processes ;)

Tabu Check List.

I want to be controversial ... :notme:

It is curious, many Auditors say do not used the check-lists but they used it or stil using in mind as a part, the AITF released it and know may be is more profitable to delete it to protect some interests :mad:

for me this is not a good idea, I understand that we must follow the process, therefore I think that a new tool combining the following of the process and check list must be arisen in order to proof that we audited in align with the TS. :read:

It woud be interesting your ideas regarding that....

A warning about checklists for internal auditing for TS 16949. We just had our 1st surveillance audit last Thursday and Friday, 6/29 and 6/30. During that audit we discussed internal auditing quite extensively. According to our auditor, TS strictly prohibits checklists for internal auditing that our based on the standard. As he explained the logic, summarized below, it made sense to me.

Check lists tends to direct you over the same ground over and over again and inhibits you from truly exploring and uncovering the weaknesses in your system.

Based on my discussion with the auditor, I intend to implement the following generic checklist for our internal auditors (auditing a TS compliant QMS):

1) Ask the process owner to show you their measurments of effectiveness and efficiencies. For any measurments that are deficient, ask the process owner what is their action plan for improvement.

2) Choose a recent example of something that the process "produced" and follow it through the process. If something doesn't seem right, investigate further.

3) The key to this process is to be curious, and dig a little.

The outcome is that the internal auditor learns something new about the process she/he is auditing, and the process owner may discover an area for improvement.

I'd much rather a problem be uncoved in an internal audit then a surveillance audit. That way I have more control over the solution.

This is what is required in my mind but this requires a lot more training and there are auditors still being taught to take the procedures and make a checklist from them.
The problem is that the standard in the note to 8.2.2.4 says "specific checklists should be used for each audit" Ok a note is only for guidance but I think here instead of "clarifying" it confuses!

A warning about checklists for internal auditing for TS 16949. We just had our 1st surveillance audit last Thursday and Friday, 6/29 and 6/30. During that audit we discussed internal auditing quite extensively. According to our auditor, TS strictly prohibits checklists for internal auditing that our based on the standard. As he explained the logic, summarized below, it made sense to me.

Check lists tends to direct you over the same ground over and over again and inhibits you from truly exploring and uncovering the weaknesses in your system.

Based on my discussion with the auditor, I intend to implement the following generic checklist for our internal auditors (auditing a TS compliant QMS):

1) Ask the process owner to show you their measurments of effectiveness and efficiencies. For any measurments that are deficient, ask the process owner what is their action plan for improvement.

2) Choose a recent example of something that the process "produced" and follow it through the process. If something doesn't seem right, investigate further.

3) The key to this process is to be curious, and dig a little.

The outcome is that the internal auditor learns something new about the process she/he is auditing, and the process owner may discover an area for improvement.

I'd much rather a problem be uncoved in an internal audit then a surveillance audit. That way I have more control over the solution.


The TS Rules 2nd edition states that internal audits also must be performed to a "Process Approach." That does not mean that checklists cannot be used as an aid, but it is intended to stop people from using a checklist based on the standard.

A checklist can be very useful for any auditor, particularly for inexperienced ones. But, the checklist can be designed to lead an auditor through a particular process, the criteria for effectiveness as defined, the metrics showing performance of the process, inputs and outputs, internal customers and suppliers, linkages to supporting processes. These are all a key part of the process approach and easily fit into a "checklist" or cheatsheet approach.

Couple that with the flowcharts or diagrams of the process, showing the sequence, and bingo, you're home free. Short and sweet.

Hi there, I have been looking for a good checklist that includes ISO13485:2003, QSR, and CMDCAS. I like the one you created and was wondering if you made any improvements? Also, how has it held up to external auditor's that usually do not like checklist?

Do you have an update to the list that is dated 2003? If so, please email to gsmith(at)dicombox.com

:applause:

Attached is the checklist I use.

ddunn

I have been looking for a good checklist that includes ISO13485:2003, QSR, and CMDCAS. I like the one you created and was wondering if you made any improvements? Also, how has it held up to external auditor's that usually do not like checklist?

Do you have an update to the list that is dated 2003? If so, please email to gsmith(at)dicombox.com

good post ..thank you

......
Where are you finish? Are you again in vacation from first of June. :magic:

As a fairly new auditor...I am looking for ISO 9001:2008 checklist to use as a starting point...does anyone have one? :thanx:

Thanks I found all the checklists that have been posted...:biglaugh:

As a fairly new auditor...I am looking for ISO 9001:2008 checklist to use as a starting point...does anyone have one? :thanx:

Cully - please be aware that an ISO 9001 based checklist is not the most applicable type of checklist for internal auditors.

The main and most effective focus for internal auditors is based on the audited organization's own QMS, not the standard. The checklist will be of limited use to you so many of us here would advise that you should develop your own - perhaps based on some format that have found here and you like.

Cully - please be aware that an ISO 9001 based checklist is not the most applicable type of checklist for internal auditors <snip> The purpose of the internal audit plays a part in this. Sometimes in an internal audit they may want to do a Compliance to the Standard type of audit.

What is used to audit in any audit is dependent upon the *type* and *intent* of the audit.

The purpose of the internal audit plays a part in this. Sometimes in an internal audit they may want to do a Compliance to the Standard type of audit.

What is used to audit in any audit is dependent upon the *type* and *intent* of the audit.

True, Marc, however for a 'new' auditor (pointed out by the poster) using the standard as a checklist is going to be fraught with pitfalls. I stand by my comment!