Questions about an Internal Audit Checklist for our QMS

#21
If you've been assigned as the internal ISO auditor, you really need to go and get trained. This job is too important in most companies to be left to chance, keeping ISO accreditation is essential to retaining some customers, and winning deals and tenders.
But they aren't "ISO accredited" (the correct term is "certified" BTW) so it's not such a big deal. As the OP says, they have NO MONEY for training. Until that issue is resolved, or competency comes another way (maybe by reading a really, really good book, blog article etc and then practicing what's been read)
 
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lk2012

#22
Actually not. What the standard says is someone is competent, aware and, if necessary, trained. Training is only ONE path to competency.
Sorry Andy, I may have to disagree here.:argue:
Training is one of the key things any external auditor would home in on first thing. Awareness comes from it and the competency is something the OP has obviously been burdened with in the first place.
Training doesn't take much (it's only 3-4 days sometimes less) and it really goes a long way.
 

John Broomfield

Staff member
Super Moderator
#23
Sorry Andy, I may have to disagree here.:argue:
Training is one of the key things any external auditor would home in on first thing. Awareness comes from it and the competency is something the OP has obviously been burdened with in the first place.
Training doesn't take much (it's only 3-4 days sometimes less) and it really goes a long way.
lk2012,

Competent internal auditors may come from other processes such as recruiting, subcontracting and outsourcing.

John
 

Jim Wynne

Staff member
Admin
#24
Agree with Hutch.
Also, the standard requires a person trained specifically to do the QMS and the audits. :2cents:
Actually not. What the standard says is someone is competent, aware and, if necessary, trained. Training is only ONE path to competency.
Sorry Andy, I may have to disagree here.:argue:
Training is one of the key things any external auditor would home in on first thing. Awareness comes from it and the competency is something the OP has obviously been burdened with in the first place.
Training doesn't take much (it's only 3-4 days sometimes less) and it really goes a long way.
There is no requirement for auditor training in the standard (ISO 9001:2008). 8.2.2, which establishes the requirements for internal auditing, says nothing about auditor competence, and 6.2.2 (Competence, Awareness and Training) says nothing specific about auditors, but says:
The organization shall
a) determine the necessary competence for personnel performing work affecting conformity to product requirements,
b) where applicable, provide training or take other actions to achieve the necessary competence...
That "where applicable" in (b) is important. It may be decided, for example, that a person with ASQ auditor certification (which can be had without formal training) and x years of experience in internal audits may be deemed competent until on-the-job evidence contradicts that determination. No training necessary.

The organization may develop its own criteria for competence and the determination of whether or not competence has been achieved.
 

Golfman25

Trusted Information Resource
#25
Well if you're not going for certification, then I would simplify it. Take your procedures (documented and undocumented) and make checklists from them. Look at the who, what, how, where, etc.

Then on a regular basis, maybe quarterly to start, have people from other departments run thru the checklists with the "audited" department. Eventually, it should be quick and painless. If issues arise, then you can bring them forward for corrective action. Good luck.
 

insect warfare

QA=Question Authority
Trusted Information Resource
#26
Jim (in his post) has summed up the requirements for internal auditor competency very nicely.

To the OP, if you are truly seeking a checklist for your QMS, there are two tools that you could utilize. One would be to use a gap analysis checklist, which basically contains the verbiage from ISO 9001 in question form and allows you to answer where your organization is strictly from a conformance standpoint. Many companies already do this to some degree, and they are pretty easy to find online (some are located here in the Post Attachments List).

The other road less traveled is to construct a "turtle diagram" of each identified process in your organization. Many variations of this tool exist and can be directly downloaded online, but would need tailoring to your organization's specific parameters (again, some are located here in the Post Attachments List). A "turtle diagram" allows you to identify all the components (inputs, outputs, equipment/materials, resources, performance measures, etc.) that ultimately comprise a process. Not everyone is a fan of the "turtle diagram", but one noted benefit of its application is that it lends itself more as a "topic" list (and not a YES/NO "checklist" per se) that will help an auditor examine a process more thoroughly, plus follow the audit trails needed to effectively evaluate its interaction with other management system processes.

You don't have to use either of the tools I described above. However, it could be argued that a turtle diagram is the closest thing to an internal audit checklist that doesn't behave like a stereotypical "checklist".

Just my 2 cents...

Brian :rolleyes:
 
Last edited:

Mikishots

Trusted Information Resource
#27
The organization does not want to spend money on this this is why gave the project to an intern(me).
All I would want to say about this is that the project is doomed from the start if this is the attitude of upper management.

My reasons:

1. Well, there's only one that really matters at this point: Management Commitment. It's a requirement (see Subclause 5.1), and you ain't got it.

I sincerely wish you the best of luck. You will want to try and get them to understand that implementation of a functional and meaningful QMS is a big task and REQUIRES top management support and money. If you can't, I'm sorry to say that your task will not be successful.
 

cscalise

Starting to get Involved
#28
Is there a Quality Manager at this facility? Are you currently working on the company's QMS? Per regulations auditors "need to ensure objectivity and impartiality of the audit process and shall not audit their own work."

You definitely need audit training. You should point out to your supervisor that you training is stipulated in section 6.2.2 Competence, training and awareness.

Does this company have current certification or are they just trying to become compliant?
 
#29
Per regulations auditors "need to ensure objectivity and impartiality of the audit process and shall not audit their own work."

Does this company have current certification or are they just trying to become compliant?
Which "regulations" are you referring to? As previously mentioned, this org. isn't certified.
 

Helmut Jilling

Auditor / Consultant
#30
Jim (in his post) has summed up the requirements for internal auditor competency very nicely.

To the OP, if you are truly seeking a checklist for your QMS, there are two tools that you could utilize. One would be to use a gap analysis checklist, which basically contains the verbiage from ISO 9001 in question form and allows you to answer where your organization is strictly from a conformance standpoint. Many companies already do this to some degree, and they are pretty easy to find online (some are located here in the Post Attachments List).

The other road less traveled is to construct a "turtle diagram" of each identified process in your organization. Many variations of this tool exist and can be directly downloaded online, but would need tailoring to your organization's specific parameters (again, some are located here in the Post Attachments List). A "turtle diagram" allows you to identify all the components (inputs, outputs, equipment/materials, resources, performance measures, etc.) that ultimately comprise a process. Not everyone is a fan of the "turtle diagram", but one noted benefit of its application is that it lends itself more as a "topic" list (and not a YES/NO "checklist" per se) that will help an auditor examine a process more thoroughly, plus follow the audit trails needed to effectively evaluate its interaction with other management system processes.

You don't have to use either of the tools I described above. However, it could be argued that a turtle diagram is the closest thing to an internal audit checklist that doesn't behave like a stereotypical "checklist".
I like this idea of a turtle, but to be clear, just making a turtle is NOT doing an internal audit. It is only the first step. Auditing the items on the turtle, are they implemented, are they effective, are people doing them, is the other part of the turtle.

A proper internal process approach audit should include an audit of the inputs and outputs, performance metrics, sequence of the processes and linkages to related processes.

I wrote a very good white paper on internal process approach audits to help people understand what should be included (since ISO, IAF and ANAB did such a weak job of describing it). It is available FREE on my website - (www.jilling.com - click on the tools tab - Internal process approach audit - WHITE PAPER).

It is free and will provide a lot of useful information.
 
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