Audits Before Assesment

CarolX

Super Moderator
Super Moderator
#1
Perhaps this question has been asked before - so my appologies in advance....

I interviewed a registrar yesterday and he stated that we must audit all of the ISO elements before we can be certified. Where is this requirment stated, or is it implied in some way?

This is how my procedures are set-up right now. Management reviews quality system on a weekly and monthly basis. From these reviews, quartly audits will be scheduled. I beleive this satisfies the requirements for internal audits.

Comments anyone .... or an old thread I can read-up on?
 
Elsmar Forum Sponsor

barb butrym

Quite Involved in Discussions
#2
why on earth would you want a registrar's auditor in without a full round of audits being done?

Anyway..its a registrar specific clause that I believe 99.99999% of them adhere to. It would be a waste of time and expense to come in if a company had not audited their own system for compliance first...sure would lead me (with my auditiors hat on) to look for more signs of a lack of commitment to the project if a company even suggested that they don't need to do a complete round before the registrar comes in......

As a consultant, my companies do several rounds before the registration audit is scheduled.
 
A

Alf Gulford

#3
Only a comment. I've had two different registrars tell me the same thing and, even though it may be a 'registrar requirement' rather than ISO, it made sense to me. How else could I have gone into a pre-assessment with any assurance that our bases were covered?
 
J

Jim Biz

#4
Originally posted by CarolX:
Where is this requirment stated?
Nope - not "spelled out" in the standards - as well as the "implied requirement" of auditing every element/procedure/system doc. every year (on the basis of importance of course). And the implied requirement from our particular registrar that we ask the same internal audit questions based on specific standards statements for each sentence/a.b.c.d.... task-line in the standards - every year. (which IMHO is a bit overboard)BUT

I do agree with Barb - even though it isn't written "clearly stated" (out in the open) it is a good management/registrar practice under the current version.

Our external auditor did indicate recently though that the "methods of registration auditing" would be undergoing a change with the new FDIS write-up.

Regards
Jim
--------------------
Edited to correct html.

[This message has been edited by Marc Smith (edited 07 September 2000).]
 
R

Rick Goodson

#5
I am in agreement with everyone else that it is certainly good practice even though not required.

With regard to the 2000 version, and by reference the 1994 version, Cianfrani, Tsiakals and West make an interesting statement in their new book (ISO 9001:2000 Explained ISBN 0-87389-481-2).

"It is now clear" [2000 version] "that audits are to be carried out periodically. Thought this was implied before, it was not clearly stated. A on-time set of audits to comply with ISO 9001 in order to obtain registraion is not sufficient."
 
L

Laura M

#6
This is how my procedures are set-up right now. Management reviews quality system on a weekly and monthly basis. From these reviews, quartly audits will be scheduled. I beleive this satisfies the requirements for internal audits.

B]
What exactly does management review weekly and monthly? Effectiveness of quality system needs to be a part of management review. Wouldn't you use internal audits for that data?
 

CarolX

Super Moderator
Super Moderator
#8
Barb - If I have done my job completely, my procedures should describe exactly how we are doing things now. My "proof" would be, how are we doing it a year from now? That is when I feel an audit is much more effective.

Jim - I concur - periodically means just that. What ever is neccessary, along with the evidience of review to back it up.

Laura - weekly review of inspection results, customer returns, and customer contacts. Monthly review of scrap and rework.

Our field is much to competative to allow internal audits to be truly helpful to us.

Lots to think about .... thanks everyone for your input.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#9
A full found of internal audits (system compliance to ISO 9001) has been a 'standard' registrar requirement for a number of years. The value depends on the company -- sometimes it's not a 'real' issue because the focus on the systems and more during the implementation is often sufficient.

More telling is when a registrar hits you during the registration audit for something that they should have spotted during document review or the pre-assessment.

But - I do see these early internal audits as a learning function and I do agree they can be (and typically are) helpful. In some companies they are, in my opinion, quite necessary. I wouldn't do an implementation without a complete round of internal audits late in the project either by me or the company.

> "PERIODICALLY" is CLEAR?

I agree. I don't see this as a change at all from the 1994 version.

> This is how my procedures are set-up right now. Management reviews
> quality system on a weekly and monthly basis. From these reviews,
> quartly audits will be scheduled. I beleive this satisfies the
> requirements for internal audits.

Management review is required to review the results of internal audits but is not related to internal audits (can't substitute for).

> Barb - If I have done my job completely, my procedures should describe
> exactly how we are doing things now. My "proof" would be, how are we
> doing it a year from now? That is when I feel an audit is much more
> effective.

Audits are supposed to prove people are following your procedures and that your systems work. I'm not sure how you're linking procedure content with "..how we're doing it in a year...' Procedures do change and to some extent it is expected (continuous improvement?) that many will change over a year. So - whether or not you're doing something the same way next year as you are now is a non-issue.

I have not been through an implementation where everyone was following procedures as written. Internal audits are supposed to root these people out.

> Our field is much to competative to allow internal audits
> to be truly helpful to us.

I would like to hear your reasoning for this statement.
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#10
Originally posted by Randy:
Around here periodically means within the last millinium.
Yipes!! How true, how true...............

But there is always time for corrective action.



[This message has been edited by Kevin Mader (edited 07 September 2000).]
 
Thread starter Similar threads Forum Replies Date
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
K Internal Audits - Necessary before Stage 1 Audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 42
S Internal Audits required before Registration Audit - Distributors ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Y Internal Audits of All Facilities World Wide Before the Certification Audit Internal Auditing 9
A Management Review and Internal Audits Before Registration Audit Management Review Meetings and related Processes 2
I Audits before QS -9000 Certification QS-9000 - American Automotive Manufacturers Standard 1
S Internal Audits Before Registration? Internal Auditing 2
R IATF 16949 - Outsourcing of internal audits Internal Auditing 10
M Major vs. Minor for Internal Audits? Internal Auditing 10
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
D Layered Process Audits - FCA 9.2.2 - Exemption Clause? IATF 16949 - Automotive Quality Systems Standard 5
S Obligation to accept customer audits? IATF 16949 - Automotive Quality Systems Standard 23
M Supplier Audits - Stop Wasting Everyone's Time! General Auditing Discussions 15
C Internal Audits in a tiny Dx Company Internal Auditing 33
H ISO 13485 - Separate Microbiology Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
A Question on ISO 14001:2015 - Are annual audits required? ISO 14001:2015 Specific Discussions 11
H Remote product audits in Coivd-19 - IATF 16949 9.2.2.4 IATF 16949 - Automotive Quality Systems Standard 3
N Sampling Plan for Internal Audits - ISO 2859 or 3951 - Or Neither? Internal Auditing 6
Ed Panek Corona Virus impact on Supplier Audits and Received Parts ISO 13485:2016 - Medical Device Quality Management Systems 4
JoCam Increase to bi-annual ISO 13485 audits ISO 13485:2016 - Medical Device Quality Management Systems 2
P Supplier Audits in the wake of COVID-19 ISO 14971 - Medical Device Risk Management 3
O Informational Scaling back internal audits due to corona virus while avoiding a NC Internal Auditing 7
R Is it required to have an SOP for external audits? Medical Device and FDA Regulations and Standards News 7
G Internal Audits and Employee engagement Internal Auditing 16
D Root Cause for Missed Audits Misc. Quality Assurance and Business Systems Related Topics 1
M Notified Body audits -Class Ia medical device product EU Medical Device Regulations 4
S Internal audit discrepancy - We missed a few audits that were scheduled Internal Auditing 12
C Design and implementation of process audits as defined within IATF 16949 IATF 16949 - Automotive Quality Systems Standard 2
F ISO 17025 8.8 Internal Audits in a segmented company ISO 17025 related Discussions 5
J Requirements for Layered Process Audits including Maintenance, Shipping, Receiving IATF 16949 - Automotive Quality Systems Standard 4
qualprod Internal Audits - Categories of non conformances Internal Auditing 12
G Non Conformance During ISO 9001 Audit - Not All Internal Audits Completed General Auditing Discussions 19
K A way to monitor our Internal Audits as a KPI AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
blackholequasar Internal Auditing Inspiration - Getting volunteers to perform internal audits. Internal Auditing 22
Sidney Vianna Interesting Discussion ISO 9001 audits from the perspective of registrants' customers - an interesting paper Registrars and Notified Bodies 0
M Honda Audits - Does anyone have any experience with the QAV audit? General Auditing Discussions 3
A External Auditor issue with Internal Audits Internal Auditing 7
W Internal Auditing carried out by a 3rd party - Review of previous audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
H IATF 16949 9.2.2.3 - Manufacturing process audits IATF 16949 - Automotive Quality Systems Standard 9
Y Performing product audits in a manufacturing facility Manufacturing and Related Processes 11
Genofear Customer wants to audit our supplier audits - seems inappropriate General Auditing Discussions 11
E Informational Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work) Internal Auditing 149
A Supplier Process Audits - Creation of Reports General Auditing Discussions 3
Gman2 Quality Record Retention (Internal Audits, CA's) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
T Informational What is the purpose of Internal Audits? Internal Auditing 27
F API Spec Q1 9th Edition Surveillance Audit - Questions about internal audits. Oil and Gas Industry Standards and Regulations 23
U Dock Audits - Isn't waiting to do an audit when the product is "supposed" to ship a little late? Manufacturing and Related Processes 12
Pmarszal ISO 19011:2018 - Risk Based Approach for planning, conducting and reporting of internal audits Internal Auditing 8
R ISO 13485:2016 Registration - NC on full cycle of internal audits ISO 13485:2016 - Medical Device Quality Management Systems 7
J Internal Audit clarification - How to perform the audits IATF 16949 - Automotive Quality Systems Standard 6

Similar threads

Top Bottom