Let the Registrar audit the Internal Audit process

tony s

Information Seeker
Trusted Information Resource
#1
Due to issues regarding auditors’ independence and practicality, I’m thinking of writing in a Q or E or SH Manual something like this: “To ensure objectivity, our Certifying Body performs the audit of the company’s Internal Audit activity…”

Can you share your thoughts about this? Thanks in advance.
 
Elsmar Forum Sponsor

Randy

Super Moderator
#2
Due to issues regarding auditors’ independence and practicality, I’m thinking of writing in a Q or E or SH Manual something like this: “To ensure objectivity, our Certifying Body performs the audit of the company’s Internal Audit activity…”

Can you share your thoughts about this? Thanks in advance.

I'll write you a Major NC for not performing IA's if you do.

You have to audit how you meet all the requirements of whatever standard, if you fail to do so be prepared for bad, bad news. You could scream, cry, pee and moan all you want but the accreditation bodies would agree.
 
M

M Greenaway

#3
I guess Randy mis-understood the question.

I agree with the poster that we should not have to audit our own internal audit process, that is surely the job of the certification body.

However we do currently audit our own internal audit process.
 
C

curryassassin

#4
You could say that the certified body has audited a sample of the whole of your QMS, not just the internal audit process. A large, multi-national pharma that I know, used to use the fact that a certified body or a division/corporate audit had recently performed an inspection, so any scheduled internal audits that had not been performed, such as the internal audit process, were said to be covered by the certified body/division/corporate audit.

OR. Get your management or a trained auditor from another department to audit the audit process, as long as they are independent.
 
T

Ted Schmitt

#5
I guess Randy mis-understood the question.

I agree with the poster that we should not have to audit our own internal audit process, that is surely the job of the certification body.

However we do currently audit our own internal audit process.
IMHO, I think Randy did understand the question and I agree with him. Here we have 3 LA, me being one of them, I am responsible for the IA program and when it comes time for auditing 8.2.2, one of the other two LA audits me... it´s simple !
 
M

M Greenaway

#6
Well it doesnt warrant a major NC as i see nowhere that it states that we must audit our internal audit process.
 

Stijloor

Staff member
Super Moderator
#7
Well it doesnt warrant a major NC as i see nowhere that it states that we must audit our internal audit process.

From ISO 9001:2000

8.2.2 Internal audit
The organization shall conduct internal audits at planned intervals to determine whether the quality management system
a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and
b) is effectively implemented and maintained.
An audit program 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. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.


The audit PROCESS is an integral part of the quality management system and must be audited like any other process within the QMS.
In some of my Client's companies, a trained member of top management, audits the audit process to ensure that the process is compliant, effective and continually improving. No big deal.

Hope this helps.

Stijloor.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#8
Randy and Stijloor are correct.

The organization is held responsible to understand on its own and respond to findings regarding how well the internal audit process is supporting the management systems.

The internal audit function cannot audit itself, which makes it easy to conclude the registrar can fulfill the requirement. And the registrar may very well (I hope they will) audit the internal audit process, but that's definitely not enough to fulfill the requirement.

Moreover, the registrar should not be depended upon to tell us how well our programs are working. Registration is supposed to be a verifying function, while internal audits can be more analytical in their design.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#9
The internal audit process must be audited during internal system audits.

this is why it's best to have more than one auditor if you don't hire an outsider to do your internal audits.

We're just wrapping up our 2nd full internal audit. And, yes, the internal audit process was audited.
I, as process owner, was the auditee and two of my audit team were the auditors. They are not the process owners and are in different departments for their regular jobs so there was no conflict of interest even though they are auditors. Because they audited the PROCESS.

I agree that I would write a major NC if I was a registrar and found no records of the internal audit process being audited.

I know our CE marking notified body would pull our cert if we tried to put that over on him.
 
Thread starter Similar threads Forum Replies Date
ScottK Let's Catch Up... what's happened to you since last June Coffee Break and Water Cooler Discussions 24
E Contacting FDA via phone to let them know a Submission is Imminent Other US Medical Device Regulations 6
W Let's play... Classify My Medical Device!!! EU Medical Device Regulations 15
S Is it alright to let the supplier do all measurements and inspection? Quality Manager and Management Related Issues 10
J How many Major Nonconformances could let the Audit be Terminated? General Auditing Discussions 9
T Let's share ideas about an inspection problem.... Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
Z Let us Discuss ISO 9001's Tomorrow ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
N TL 9000 Starter - Please let me know if anyone has worked on TL 9000 Software Quality Assurance 1
L It is fair and legal to let a customer to make an assessment audit based on other cus IATF 16949 - Automotive Quality Systems Standard 2
Hershal Congrats! Let's talk about top posters in the threads General Measurement Device and Calibration Topics 17
R Quality Management System not active for 6 months. Registration let it Lapse or Fail? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
R The Improvement in Sigma Level (from Let's fix six sigma) Six Sigma 4
T Let's fix Six Sigma! Six Sigma 197
S How do you let customers know you are certified on your literature? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q How to write my CV if I was let go? Career and Occupation Discussions 11
A Quality Policy - Please let me know your opinions and comments ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Claes Gefvenberg Let's do age! How 'Old' will you be in 2007? A poll - Version 3 Coffee Break and Water Cooler Discussions 91
K What do you expect from a new position? Let?s compare benefits Career and Occupation Discussions 18
Hershal Football! (OK, we will even let soccer come in) - Fall 2006 Coffee Break and Water Cooler Discussions 162
H Benchmarks for Plastic Injection Molding - Let's Share! Benchmarking 18
Hershal MEMORIAL DAY 2007 - Let it be heard Coffee Break and Water Cooler Discussions 18
W Useful PC software utilities let's share some info? After Work and Weekend Discussion Topics 20
Jim Wynne A Modest Proposal: Let's Get Rid of "Quality." Philosophy, Gurus, Innovation and Evolution 15
Douglas E. Purdy 7.5.2 e) Revalidation - Let me run this by you for verification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Steve Prevette Let's nominate a Cove'r for ASQ Board! ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 13
Q And now, let's add software development - Medical Devices - Applying ISO9001:2000 ISO 13485:2016 - Medical Device Quality Management Systems 12
E The Chit Chat and 'Let's Meet' Thread - Meeting Other Elsmar Cove Participants Coffee Break and Water Cooler Discussions 186
E Let's do age! How 'Old' are you? A poll - Version 2 Coffee Break and Water Cooler Discussions 223
Marc Let The Lawsuits Begin! Lawsuit could set crucial Y2K precedent World News 3
M AS9100D Registrar pre-audit requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
G 0 non conformities in registrar audits over 4 years Management Review Meetings and related Processes 12
M Do AS9100 Registrar Auditors have nonconformity quotas? General Auditing Discussions 18
J Conflict of Interest Registrar/Notified Body/Testing House Quality Manager and Management Related Issues 4
R Change Notification - Registrar vs Notified body ISO 13485:2016 - Medical Device Quality Management Systems 1
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
E Choosing an ISO 9001 registrar with auditors familiar with our industry Registrars and Notified Bodies 10
L Audit boundaries - Is a Registrar permitted to audit a company's QMS by visiting their suppliers? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 26
Jen Kirley Is your registrar (CB) accredited? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 9
K Seeking ISO 13485 Registrar Recommendations Registrars and Notified Bodies 15
P Notify Registrar of Escalation letter IATF 16949 - Automotive Quality Systems Standard 1
M New AS9100 Registrar - Recommendations for Transfer Registrars and Notified Bodies 3
M Notifying Registrar of Significant QMS changes ISO 13485:2016 - Medical Device Quality Management Systems 2
A ISO 9001:2015 registrar Auditor requesting copies of procedure prior to audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
N Does anyone know a registrar that offers both ISO 9001 and ISO 17020? Registrars and Notified Bodies 6
S Certification Body, Registrar, Notified Body - What is the difference? Registrars and Notified Bodies 3
1 ISO Registrar with waste water treatment experience Registrars and Notified Bodies 1
D How can a company transfer their AS certificate from a suspended AS91XX registrar? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
P Delay in IATF 16949 Certification from Registrar Registrars and Notified Bodies 10
M Should Potential Customer Complaint Outcome Define Registrar NC Rating? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Q Is a Domain Registrar a Critical Supplier? ISO 13485:2016 - Medical Device Quality Management Systems 11

Similar threads

Top Bottom