Seeking: ISO 9001:2000 Internal Audit Checklist for Newbie

A

Alexander Keith

Hello all QA Forum Members,
I am new to this forum and relatively new to the mysterious world of auditing to the 2000 version of the ISO 9001 standard.
What I am looking for is a simple and straigtforward tool, in the form of a checklist, that I could use to conduct an internal audit of all elements of a company's quality system to ISO 9001:2000 less the design element.
Hope I'm not offending anyone with the newbiness of this question.
Thank you!
Alexander Keith
 
I

IEGeek - 2006

First, welcome to the Cove. This is truly a wonderful tool full of great resources and great advice some of the foremost experts in Quality systems.

I would like a little more info before I start just downloading and attaching "checklists". What is the company size? Why are you new to the ISO world? Promoted? New Hire? What is your background with ISO?

I am personally not a huge fan of "checklists". I prefer the Process Audit approach and insted of being able to check a box yes or no, I would rather the auditor take some thought and put some effort into actually initiating a dialogue vs. pencil whipping a checklist to satisfy a registrar's requirement.

There are some great resources and threads on the Cove relating to this subject. Just do a search.

Just some thoughts.....
 
A

AllanJ

Alexander Keith said:
Hello all QA Forum Members,
I am new to this forum and relatively new to the mysterious world of auditing to the 2000 version of the ISO 9001 standard.
What I am looking for is a simple and straigtforward tool, in the form of a checklist, that I could use to conduct an internal audit of all elements of a company's quality system to ISO 9001:2000 less the design element.
Hope I'm not offending anyone with the newbiness of this question.
Thank you!
Alexander Keith

In each of the three editions of "Management Audits", on which the process approach was based, I have refused to provide checklists. I have always held the view it is more important for the auditor to be able to prepare his/her own checklist according to the objective of the audit, the nature of the processes involved (its technology etc) and the audit scope.

In the case of ISO 9001 or any other "standard" or code, you would need to prepare what I classify in that book as a "criteria" checklist. To do so, merely take the actual words of each clause and turn them into a question. Therefore, if the standard/ code says something like "The supplier/ organization/ wheoever shall do such and such", your question would be "Has the supplier/ organization/ whoever done such and such". The answer would thus be "yes" or "no". Supporting evidence obtained during the audit justifying your conclusion could be added in a margin/ commentary area or on the fly sheet of the checklist.

If you compile your own checklist, you will be forced to actually read the words of whatever standard against which you are auditing the process owner. And you are more likely to understand the actual words. This will help you be more effective when auditing. I never advise using others' checklists in preference to preparing one's own.

But, if you have not been trained as an auditor, I would recommend you do attend a good training course. And, though there are many courses around, good ones are in the minority.
 
A

Alexander Keith

Hmmm... I did a (quick) search and I can't find what I'm looking for... checklists. I hear what you all are saying (PA approach and develop your own) but, I'm in a rush for something basic and easy to work with. I should also clarify that the checklists I am seeking should be oriented towards verifying consistent implementation of requirements.... audit after audit after audit. Is there such a document out there that could help me?
Thank you!
Alexander Keith
 
R

Raptorwild

Checklists

Alexander Keith said:
Hmmm... I did a (quick) search and I can't find what I'm looking for... checklists. I hear what you all are saying (PA approach and develop your own) but, I'm in a rush for something basic and easy to work with. I should also clarify that the checklists I am seeking should be oriented towards verifying consistent implementation of requirements.... audit after audit after audit. Is there such a document out there that could help me?
Thank you!
Alexander Keith

Hello Alexander Keith,
I am attaching a sample of our Internal Audit Questionaire for ISO 9001:2000 and AS9100B for Quality Management System area. Hope this helps. Paula
 

Attachments

  • IAQ4.doc
    77.5 KB · Views: 2,597
W

WALLACE

With reference to Allan J Sayle's process approach to audits:
Have a look at this link to an audit guide list Audit.xls.
The audit guide list overviews the process approach originated by Allan J Sayle.
I made this guide list to assist some auditors who were getting to know the Management audit approach and, it was quite successful.
Hope it helps you, the process approach is generic enough to use within and out with the constraints of ISO or any other standard of compliance.
You may also wish to go to Auditing the Task (Process) Elements - Visual Map Attached for an overview of Allan J's approach.
Wallace.
 
I

IEGeek - 2006

You said you are in a rush for something basic and easy yet you want it to stand the test of time audit after audit after audit.

I think that actually goes against everything ISO stands for in practicum.

If all you want is a checklist to show your registrar or your boss that you are doing something, them I am sure there are plenty out there. You may not even have to get up from your desk. A checklist on a process can be done in about 8 minutes, maybe even at lunch or during a presentation.

If you want to implement and maintain a proactive effective quality system, take the high road. Do not study the test, get the knowledge, then take the test. :read:

Good luck.
 

Cari Spears

Super Moderator
Leader
Super Moderator
Alexander Keith said:
...I'm in a rush for something basic...
Take the standard and turn every shall into a question if all you are interested in is verifying conformance to the standard.
 
D

db

Cari Spears said:
Take the standard and turn every shall into a question if all you are interested in is verifying conformance to the standard.

While this is a good start, it will only determine if the "shalls" have been fulfilled. I recommend you go a lot further. I would also make a checklist based on your procedures (remember that procedures are the specified way to carry out a process) and other organizational criteria. As we audit, our audit criteria needs to be focused on our internal stuff a lot more than it does the standard.
 
R

RosieA

Alexander, I, too, am not a fan of checklists. They become stale over time and the auditee gets to the point where they can anticipate the questions.

I don't know what stage you're at with ISO. Checklists based on the standard are helpful in the beginning when you don't have a certified system, but if you have documented processes, I would base your audit questions on your procedures.

For example: Your Receiving Inspection procedure says that your computer system flags incoming parts as needing inspection, and the parts are then routed to QA for inspection. Pull 3 part numbers requiring inspection from the computer master file and have your question be: "Show me the inspection records for part numbers X, Y, and Z".

This approach keeps the audit fresh, as each successive auditor will find different things to pull out of the procedures.
 
Top Bottom