Surprise audits by registrars

Howard Atkins

Forum Administrator
This is a post on my plastics and quality forum.

Can any one help?

Is it true that our registrar can show up at anytime to conduct an unannounced audit or is this just a scare tactic our Mgmt Rep is using?
Elsmar Forum Sponsor




Fully vaccinated are you?
IMHO the registrar can show up any time. That doesn't mean you have to let them in.

Every registrar I have worked with on any level has made it clear that they do not show up unannounced. I will admit there is a difference between CAN and WILL.

BUT - check the registrar's requirements. I have seen where a registrar has requirements which are different from just plain vanilla ISO900x requirements (personally I would stay away from such registrars.

I would say the Management Rep is blowing smoke. Or is just plain stupid... Pretty stupid 'scare' tactic.


When recently were recommended for certification and the agreement said they CAN do suprise audits. However we were told that they never do unless they have some very strong suspecisons that something underhanded is going on. Our auditor had been a lead auditor for 10+ years and had never done a suprize audit.


Fully vaccinated are you?
This is a good example of Read your Registrar's Requirements before you sign them on. As mchclark pointed out in their registrar's requirements there was an agreement that they can do that - I've seen the same thing in several registrar contracts - but I've never heard of a registrar actually stopping by without warning to audit.

I suspect they wouldn't stop by without warning to audit unless, as mchclark stated, there was strong suspician of fraud or similar.

Don Winton

ISO 10011 states that the client should be notified when an audit will be conducted. I will admit, however, that there is a distinction in the term client. And, ISO 10011 is a guidance document. As Marc stated, be sure to check the contract before signing. Surprise audits are indeed rare, and would not be conducted unless the registrar suspected something. I suspect that if, during an interview or site visit, the registrar observed something that would make them suspect things were not on the up-and-up, then they may be inclined to send in an assessor unannounced.

As far as the original post is concerned, I suspect that the Management Rep is using this to try to intimidate persons within the orginization. I agree with Marc...a pretty stupid scare tactic.

Best Regards,

Leslie Garon

It may be a stupid scare tactic, but it sure is effective during implementation. I have seen too many times when Associates treat ISO or QS as just another flavor of the year and look at it apatheticly<sp>.

Yes, I know :( this is a management problem, but all too frequently it is left to the implementation team to get the Associates to build ISO/QS into their daily routine.

Even though the auditor will not show up as a surprise in most cases, when left with no alternative, it provides backbone.


Fully vaccinated are you?

I've always told clients that registrars do not make surprise visits unless they suspect fraud. I disagree with your use of the threat as a hammer.

Yes - it can be hard to 'cheer lead' the folks to really accept ISO/QS. I do use the hammer of the "They will be back every 6 months." And, when I do employee awareness I make it clear that ISO is not only applicable to their company. I tell them to look through want ads in their local paper where they will see more and more jobs listed with something to the effect of "ISO9000 experience preferred". This works real well. I tell them no matter where they go next (every company has turn over) ISO may really make a difference in getting the job and that often there is even a pay differential. They tend to start listening about this time.

Leslie Garon


Please don't mis-intrupret<sp> my post. It is a last resort that has been used mostly in respect to internal auditing in a few client companies.


Fully vaccinated are you?
Yeah - my big hammer has been to threaten to quit as consultant. I've done it several times to the plant manager or other local top dog. You do risk actually loosing a client, but you save your professionalism, if you will. Example: I was hired by a quality manager. After 2 months of no progress I made an appointment with the plant manager and explained the reality. I told him there was no reason for me to come back again and that they were (in so many words) sitting on their asses. We briefly discussed the situation and at the next management meeting (a weekly weeting) he made it clear that the project plan I had laid out was not a joke and that each person's future with the company was at stake. One person said "I can't do it" and the discussion that followed was not nice and included a threat of being fired. He said what I tell people when a project first starts (I got the idea from him, in fact):

"You can tell me you need resources. You can tell me you need time. If you need resources and/or time you must only detail what you need in writing and I will address each issue with you and I will make sure you have what you need. But - if I ever hear 'I can't do it' out of anyone that person will be fired."

I don't use the 'fired' part, but I do practically yell that they have to detail what they need and they will get it.

I left a project with a plant of a very, very big international (which shall remain nameless here) about 2 years ago because they didn't want to move on with the project (upper management). I explained I have a reputation to maintain and that I had no intention of taking their money and then getting blamed for their failure.

I have never had a problem getting the rank and file to go along with the project program with the exception of an individual here and there (I call them whiners or hecklers). In fact in my 'rantings' within some of the pages on my site I cite failure of management as the single greatest cause of implementation failures and that they often make the effort cost many, many times (I'm afraid to venture a per centage guess) more than it needs to. I watched one company jetting exects all over the country to meetings and they didn't get REDACTED done. In the mean time they balked at things like costs involved in getting the cal lab up to par. They had a 'reduce inspections and tests' theory from some years ago. With that theory was their belief that the cal lab was of minor importance... Their meetings cost more than the lab upgrade eventually did. They pissed and moaned every time you turned around.

Yup - how to get upper management motivated and focused is about on par with getting kids motivated and focused.They do what they damn well please for as long as they can.
Thread starter Similar threads Forum Replies Date
Q Medical Device Notified Body Surprise Audits Required in 2014 EU Medical Device Regulations 31
Marc Surprise! American ISPs to launch massive copyright spying scheme on July 12 After Work and Weekend Discussion Topics 5
J Surprise - And Hello - Just Checking In Coffee Break and Water Cooler Discussions 20
Marc No proof airport security makes flying safer - Surprise? Travel - Hotels, Motels, Planes and Trains 8
C Quality at Toyota - Story of the Week - Toyota Closes in on GM (A Surprise?) Coffee Break and Water Cooler Discussions 24
D What are the IATF rules regarding doing internal audits remotely? IATF 16949 - Automotive Quality Systems Standard 1
GStough Suppliers Starting to Charge A Fee for Customer Audits Supplier Quality Assurance and other Supplier Issues 14
A Internal Audits - skipped clauses? Internal Auditing 11
L Internal Audits during the MDR Transition Period EU Medical Device Regulations 5
L Internal audits for IATF IATF 16949 - Automotive Quality Systems Standard 7
E FDA & Internal Audits US Medical Device Regulations 3
D Integrated Management System (IMS) - Process Vs Clause Based Audits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
qualprod Statements into a procedure against audits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Sidney Vianna Informational ISO/NP TS 17012 - Guidelines for use of remote methods in conducting audits of management systems Other ISO and International Standards and European Regulations 0
G NC criteria during internal audits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Stefan Mundt Split Scope = Separate Audits ??? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
Ed Panek Audit Protocol? Simultaneous surveillance and recertification audits. ISO 13485:2016 - Medical Device Quality Management Systems 11
A Layered Process Audits for Medical Device Manufacturing? ISO 13485:2016 - Medical Device Quality Management Systems 3
Quality Specialist Quick question on the sequence of ISO 17025 external audits ISO 17025 related Discussions 14
B Consistently Late Internal Audits- Any Suggestions? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 116
John C. Abnet GM sqr- second party audits IATF 16949 - Automotive Quality Systems Standard 4
S Question: Best alternatives to audits for ensuring compliance Quality Tools, Improvement and Analysis 5
cgaro62 Using internal audits as part of document reviews Document Control Systems, Procedures, Forms and Templates 21
S Is it required to complete Internal Audits within one year? ISO 13485:2016 - Medical Device Quality Management Systems 29
C First Round of QMS Internal Audits - Ethical Dilemma Internal Auditing 10
T How to conduct combined internal audits (9001 and 13485) Internal Auditing 1
A ISO 9001 Internal Audits - No production right now due to furloughs Internal Auditing 5
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 5
lanley liao How to understand this words that the planning of internal audit shall take into consideration the results of previous audits? Oil and Gas Industry Standards and Regulations 10
J External third party audits Registrars and Notified Bodies 1
B How many nonconformances have you received on average during IATF audits? General Auditing Discussions 27
M ISO13485:2016, MDSAP and Internal Audits ISO 13485:2016 - Medical Device Quality Management Systems 9
G 0 non conformities in registrar audits over 4 years Management Review Meetings and related Processes 12
S Would this be a second site for the purposes of internal and third party audits? General Auditing Discussions 4
R Remote Audits for ISO 9001 (or any other standard) General Auditing Discussions 31
J ISMS - Internal Audits Internal Auditing 5
A TUV Audits - 21 CFR 820 General Auditing Discussions 6
L Documented Information in Internal Audits Process (9.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D CB and customer audits considered as internal audits? General Auditing Discussions 9
R IATF 16949 - Outsourcing of internal audits Internal Auditing 11
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 24
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 8
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 IATF 16949 - Automotive Quality Systems Standard 3
N Sampling Plan for Internal Audits - ISO 2859 or 3951 - Or Neither? Internal Auditing 6

Similar threads

Top Bottom