ISO 9001 Internal Audit Checklist

[ChrissieO]

Re: ISO 9001 - Looking for an Internal Audit Checklist

You are definately heading the right way. Keep on the process path and you will find it more beneficial to your business. You must still relate any NCs back to the standard and this should keep your factory director happy

Chrissie

 

[insect warfare]

Re: ISO 9001 - Looking for an Internal Audit Checklist

Members

I am not sure if similar threads were posted before.I could not find any related to this.I am looking for the internal Audit checklist for ISO that may be used for conducting internal audit. Can anyone share the templates which have used in carrying out the internal audit.

Thank you all in advance for the help

I agree with my fellow Covers about working to a "pre-defined" or "pre-programmed" checklist. Opportunities for improvement always tend to fall by the wayside when you work to a snapshot in time.

See this post for my checklist example....the beauty of it is that it is blank - therefore it is not biased, nor is it limited to specific parameters. Some will argue that using a blank sheet of paper works just as good, but a template can be beneficial if designed with the user in mind. I'm sure you can find a use for this one.

Brian

 

[drgnrider]

Re: ISO 9001 - Looking for an Internal Audit Checklist

Thanks, Chrissie. The FD liked my Management Review I did yesterday, so hopefully he won't be looking over my shoulder. Now it's time to subtly change the audits to "process" and stealthy do away with the checklists.

Decided that when I first looked over all the documents.

 

[dickgent]

Re: ISO 9001 - Looking for an Internal Audit Checklist

OK... Now that you have all of the opinions as to why you should create your own. I have one that I created for ISO and I use it for my internal auditors. I have attached it here. Good Luck !! Re-posted Sanitized document.

 

[ChrissieO]

Re: ISO 9001 - Looking for an Internal Audit Checklist

OK... Now that you have all of the opinions as to why you should create your own. I have one that I created for ISO and I use it for my internal auditors. I have attached it here. Good Luck !! Re-posted Sanitized document.

I think the consensus of opinion was NOT to create one at all but to follow your processes.

I don't understand what use you find for your check list as it is basically a trip through the standard which is what we should be getting away from. We should be looking at the processes as the focal point and not the standard.

Your QMS is not about the standard and ticking boxes against the standard, it is about running your business effectively and by doing that your QMS should naturally fit with the requirements of the standard.

Chrissie

 

[dickgent]

Re: ISO 9001 - Looking for an Internal Audit Checklist

Thanks Chrissy.... and of course you are correct about our QMS and naturally fitting with the standard. AND at the end of the day when my internal auditors are looking for a means to decide whether a procedure, document, clause, record or interviewed response matches requirements, I want them to be able to show their work with evidence that they have discovered. How else would you have them report the evidence they used to make their determination of Suitable and Effective?

 

[drgnrider]

IMHO - As a newbie to ISO auditing, (but not auditing in general), I see only three reasons for checklists:
_ 1) to build the QMS - 'Have we covered this?'
_ 2) a starting point/guide for new auditors (training) until they get in the habit of what they are supposed to be looking for, not for the experienced auditor - a 'start here with this, follow the trail'
_ 3) "Have I audited ... (Management Review, calibration, shipping, etc)?"

Reason 2 is where I am currently at. I tried to explain the "show-me" to my IA's, but apparently it went in-one-ear-and-out-the-other! (Too new, not enough training, not sure what is expected of them, don't remember their training, too much work, ????
So I'm adjusting the checklists to get them to:
_ a) audit the people/process - not ask the department manager all the questions while sitting at his/her desk. I'm specifying what to: "ask the manager", "ask the floor employee", and "ask the floor employee (must), (manager is optional)"
_ b) "follow the trail" / "Show-me" instead of JUST 'yes-no, have me meet the clause'.

Ultimately, I will ween them off the checklists entirely [end up with reason 3]!

 

[Bogie]

Our "checklist" has these items as required to be checked:
1) Questions and observations pertaining to the document(s) / process being audited (to be determined during the pre-audit meeting). There are usually additional questions that arise during the actual audit itself.
2) Confirmation that training of the employees to the specified doc / process is current
3) Observations on safety habits and environment
4) Questions / observations on previous corrective action resolutions (were CA completeted, were they effective etc).
5) Questions / observations on what are the inputs to the process, what are the outputs of the process, and do they support the company goals.
6) Questioning if the auditee has any additional information or concerns that is appropriate to be brought up during the audit (once employees get used to audits for improvement, not blame, they bring up some really good points).

 

[ht2el]

Re: ISO 9001 - Internal Audit Questions, best correlation

Ajit, May I ask you a question...
What is your opinion on grouping the
the Questions used for the Internal Audit, ISO clauses and ISO elements, for example
I grouped together Items 4.1, 4.2.1,4.2.2, 4.2.3, 4.2.4
? Quality System and Document Control? Applicable Regulations and approval.


The Question: is it better to keep them in line or in correlation with the
Quality Manual or is it better to keep at random as long as they complement the
QMS element being done in the Internal Audit. In the case of an Internal Audit for Inspection,
that would be the inspection tools being calibrated and recorded, record keeping , the different logs etc?
so Audit all that is involved with Inspection. ?
Thanks
ht2el

 

[ht2el]

Re: ISO 13485 Internal Audit questions How would you correlate them,





Here is a generic Internal Audit questions we found needed to be answered,...
How would you correlate for, or group the elements for an Internal Audit.?
This is my correlation of them and we can always
combine them as needed.


(1) Audit Q Clause 4.4.1 thru. 4.2.4
(2) Audit Q Clause 5.0 thru. 5.4.2
(3) Audit Q Clause 5.5 thru. 5.6.3
(4) Audit Q Clause 6.0 thru. 6.4
(5) Audit Q Clause 7.0 thru. 7.3.1
(6) Audit Q Clause 7.3.2 thru. 7.3.7
(7) Audit Q Clause 7.4 thru. 7.6
(8) Audit Q Clause 8.0 thru. 8.5.3


THANK YOU