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

J

JkelleyCDS

#11
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
You're right Randy. That is my schedule. When it comes to the audit plan that is what my satndard operating procedure is for. I guess I should have the terms reversed. Make the SOPs the item to be audited and reference the standard not the other way around like I am doing. Thanks for your input.
 
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Randy

Super Moderator
#12
Re: Which is correct: Audit elements of standard or QMS Processes???

Ya really wanna know the truth? (How do you like my English:lol:)

It really, really doesn't matter how you do it or what you call it as long as it effectively covers the requirements, your system and allows you to demonstrate that you and you methods are effective and improvement is taking place when necessary. You can audit forward, backward, inside out, from top to bottom or bottom to top and it matters not one iota as long as the process of auditing is effective.
 
#13
Re: Which is correct: Audit elements of standard or QMS Processes???

Ya really wanna know the truth? (How do you like my English:lol:)

It really, really doesn't matter how you do it or what you call it as long as it effectively covers the requirements, your system and allows you to demonstrate that you and you methods are effective and improvement is taking place when necessary. You can audit forward, backward, inside out, from top to bottom or bottom to top and it matters not one iota as long as the process of auditing is effective.
Randy, I beg to differ............because how you choose to audit, defines what is effective!:mg: I think you're thinking like a CB auditor and not like an internal auditor! Choosing an audit strategy is the domain of a very well experienced auditor - not for most internal auditors who only do this once or more times a year.

What's missing from this discussion, like so many threads here is 'scope' and 'criteria'. The CB auditor who raised this issue has blinders on, although Randy isn't in this category, since he rightly pointed out the 'status' and 'importance' aspects.

If you use well defined scope and criteria statements, it should be clear what was planned to be audited. Allowing an auditor to 'wander around' and check off those 'elements' or whatever - like it appears on some attachments, no wonder the CB auditor had a concern, even if it wasn't well expressed!:yes:

An audit manager's job is to do just that - manage the audits, and give direction to the auditors. They should be focused on certain aspects of the process they're set to audit, being given clear scope (I love that scope and focus relate to each other) and criteria.

Each time we have this discussion, people seem to be word blind around certain requirements, apparently avoiding using them when it suits them.:mg: The requirements are there and, if read in their entirety, actually help understand the whole deal!!:notme:
 

Randy

Super Moderator
#14
Re: Which is correct: Audit elements of standard or QMS Processes???

Randy, I beg to differ............because how you choose to audit, defines what is effective!:mg:
That's why audits have to be "planned" and where many aren't........I wasn't inferring a shotgun and pray approach at all:nope:
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#15
Re: Which is correct: Audit elements of standard or QMS Processes???

Goodness.....it seems that since I left the 9K world behind a bit over 6 years ago, that world has gone downhill.....

To me, basic issue is this.....can you hang your hat on the CAR? If not, then recind or reword it, or STAND BY for a formal complaint for an unjustified CAR, sent to the registrar Executive Management and also copied to ALL the ABs for the registrar.....and maybe even copied to IAF.....oh, maybe that is because I am at this level now and know how the system works just a bit better.....
 

love02eat

Involved In Discussions
#16
Re: Which is correct: Audit elements of standard or QMS Processes???

Do you have a template or a picture to show how you created your audit report I am also having this issue and needing to make sure in compliance with iso 13485.. thanks
 

Helmut Jilling

Auditor / Consultant
#17
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?
The intent all along, since 2000, was that the system should be based on your processes..... However, ISO has done an incredibly poor job of making that clear. Finally, finally, with the 2015 version, the expectation is they will make "process approach" a requirements, a shall....Lordy, only took 15 years....Geez. Of course, they still won't explain WHAT that means, nor HOW to implement it, so we will have plenty to discuss and debate for some time to come.


Base your audits on your processes. The important processes should receive more auditing, because of their status. The problem processes should get more auditing because they have problems.


The system should work for you, but, slant it toward your processes, not just the clauses. There are a couple free templates and tools on my website, if you care to take a look at them ...www.Jilling.com.


Good luck to you...
 
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