Which is correct: Audit elements of standard or QMS Processes?

J

JkelleyCDS

#1
Here is my second question coming out of my pre-assessment this week and a comment the auditor made regarding my internal audit plan.

He stated that internal ISO 9001:2000 audits should be an audit of the QMS and how they relate to the standard and not an audit of the elements of the standard.

Currently, I have internal audits consisting of standard elements (sections) and how my company's QMS complies to the standard. I reference SOPs that relate to those standard elements in my audit checklists.

The auditor states this is incorrect. I should audit based on the interaction of QMS processes representing my company's business model (processes).

Doesn't the reference to my SOPs show that I am auditing the QMS process/ procedures?

Which is correct? Am I not understanding the requirements correctly?
 
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I

ISOBlue

#2
Re: Which is correct: Audit elements of standard or QMS Processes???

I have had similar issues when first creating our own QMS auditing system. When i first created our system, i had developed an audit schedule based only on our own internal procedures, without references to the standards. My auditors indicated that we needed to relate the standards to the processes to show that we were auditing to the actual standards and not just checking our own work internally.

To comply with the requirements, i created an auditing schedule that was split by company departments. Each department was audited to the procedures that applied to that segment of the business. The audit schedule ALSO includes references to the ISO standards though as they apply to that specific element of the business. In this way, i'm auditing our internal processes and showing how they are interrelated, and i'm also demonstrating how the entire ISO standard is included in our audit schedule because all parts of the standards are covered throughout the entire schedule.

Since then, i've been audited multiple times by ISO and FDA inspectors, and they have been satisfied that our internal audits are including all aspects of the standards and that we are checking our internal processes for compliance.

It seems to me that your problem is somewhat the reverse of mine, but you might have a similar solution. Why not create an audit schedule that includes sections of the standards, as it appears you may have already done, and then try to include references to the processes that you are looking at in each part of the audit schedule? I think that would show that you are looking at the processes as they apply to your specific business.
 
D

Duke Okes

#3
Re: Which is correct: Audit elements of standard or QMS Processes???

Basically it's a matter of semantics. Most of the elements of the standard are processes. However (and it is NOT a requirement) the preference is that you audit the flow of product/service through your organization, and while you're doing that audit of the components of the standard at each step of the process as you go through.
 

Marcelo

Inactive Registered Visitor
#4
Re: Which is correct: Audit elements of standard or QMS Processes???

Your auditor i correct. ISO 9001:2000 intruduced the "process-approach" to management systens, in which you should focus in the process and process outcomes to maintain a coherent system which delivers quality outputs. The standard´s elements are secodary and not "elements" at all. In fact, a lot of these "elements" are applied to every process in the organization (i remember a discussion somewhere where an experienced auditor and standard develope siad that he could trace almost every requirement (mnus one) of the standard to any single process).

What you need, in fact, is to understand the customer requirements and follow the trail down the process, or processes, flow and find "links". This is a dynamic audit, in contrast with a "standard´s elements" audit in which you simply asks questions regarding the elements.

For a better understanding, a suggest the book "ISO 9000: 2000 Auditing Using the Process Approach " (http://www.amazon.com/ISO-9000-Auditing-Process-Approach/dp/0750675977) by David Hoyle, the best (IMHO) writer on quality system standards. Also, take a look at this comparison from Hoyles company website (transittion support) - http://www.transition-support.com/Process-Auditing_Technique.htm
 
#5
Re: Which is correct: Audit elements of standard or QMS Processes???

IMHO, neither of you are entirely correct. Your audit program should be based on your own QMS, that much is true. The program (a number of individual audits) should be focused on auditing the processes defined by the QMS, which is apparently what your auditor is saying.

If you adopt the recommended 'process approach' you will cover many 'elements' or 'sections' of the ISO 9001 requirements, which pertain to the process. Maybe the auditor cannot 'see' how you're addressing these. It's true to say you shouldn't schedule by element or clause, however, neither do you have to show in your audit plan how you intend to address the requirements of ISO 9001, in your audits.

Please do a search for my 'football' diagram, which has been used by a number of people - and recommended by CB auditors to their clients - as a way to prepare/plan a process based audit and show how many related ISO requirements are met. It's in the attachments list too.
 

Randy

Super Moderator
#6
Re: Which is correct: Audit elements of standard or QMS Processes???

It doesn't matter how you cover your system or the direction you go with it as long as it's effective for you and your needs. Your auditor said "should"? Have him/her show you the "shall".

If you really take a close gander at ISO 9001:2000 every clause has an input, and activity, and an output.....everyone, and that makes them, as previously stated "processes". Now seeing that ISO 9001 (4.1-8.5.3) is the Template or "design" of your system of which relevent elements of your organization and activities have been matched, a properly designed audit program with proper audit planning you can concievably cover all "your stuff" and the requirements of the standard.

Now if your auditor doesn't "like" that, then tell 'em to go pass a peach seed, because his likes or dislikes are not what is necessary nor what is required, only the meeting of the requirements effectively should be coming into play here.
 
#7
Re: Which is correct: Audit elements of standard or QMS Processes???

I have used this document when doing internal audits of the processes to show what clauses of the standard that were covered during the audit. This has satisfied my CB's in the past.
 

Attachments

J

JkelleyCDS

#8
Re: Which is correct: Audit elements of standard or QMS Processes???

Thanks Roy. I have attached my internal audit plan. What am I doing wrong?

Any feedback would be appreciated.
 

Attachments

Randy

Super Moderator
#9
Re: Which is correct: Audit elements of standard or QMS Processes???

It's not a plan, it's a schedule.

Where's the tie-in with importance and results from previous audits? "9001:2000-An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits."


From ISO 19011:2002 "Guidelines for quality and/or environmental management system audits"

3.12
audit plan
description of the activities and arrangements for an audit (3.1)

3.1
audit
systematic, independent and documented process for obtaining audit evidence (3.3) and evaluating it objectively
to determine the extent to which the audit criteria (3.2) are fulfilled
 
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Doug Tropf

Quite Involved in Discussions
#10
Re: Which is correct: Audit elements of standard or QMS Processes???

Thanks Roy. I have attached my internal audit plan. What am I doing wrong?

Any feedback would be appreciated.
I have a somewhat similar internal audit schedule. I also developed a process interaction matrix which has been beneficial when explaining our internal audit approach to outside auditors. I agree with Randy, ask the auditor to show you the shall.
 
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