Tentatively approaching a Certification Body - Any tips?

A

apinop

#1
So we are in the process of setting up our QMS (and your advice on a previous post of mine has been incredibly helpful to get us unstuck).

In principle we do not require certification by an accredited body, but we may go for it nonetheless. For one thing, the industry regulator can then use the certificate as proof of compliance as regards the QMS, and for another, many in our industry are ISO-9001 certified so that may give us a slight advantage.

However, we will only do it if the costs and any possible overhead can be kept at reasonable levels.

I was going to pick up the phone and start ringing the accredited bodies in this country, but it occurred to me to perhaps ask here before for any tips on how it might be best to approach this, considering that we may or may not go ahead with the accredited certification at this time (the main factor being cost vs. potential benefit).

The advice by Sidney Vianna in an old post [1] appears very relevant, and I'm also reading through some of the other threads, such as [2] and [3].

I have a feeling that the majority of CB customers will come to them as established companies, rather than right off the bat as in our case, so I expect not every CB may be experienced or comfortable with this scenario. Have any of you been in a similar situation, either as a customer or an auditor?

[1] https://elsmar.com/Forums/showpost.php?p=533135&postcount=3
[2] https://elsmar.com/Forums/showthread.php?t=46069
[3] https://elsmar.com/Forums/showthread.php?t=18976
 
Elsmar Forum Sponsor

normzone

Trusted Information Resource
#2
I've nothing to offer in direct response to your question, but it's helpful to work with a CB that is willing to let you interview the auditor prior to signing on with them.

Not all CBs can/will do this, but I prefer (to use a metaphor) to meet for coffee before committing to a blind date ;-)
 
R

randomname

#3
I line Normzone's idea. Remember that the CB is a supplier to your organization, and should be assessed and monitored as such.
 

Golfman25

Trusted Information Resource
#4
There is definitely an advantage if you know your auditor before hand. We where able to work with a group of like minded auditors over the years. We followed them from CB to CB. I have spent countless hours with the auditors over the years. Talked to the CB for maybe an hour total.
 
A

apinop

#5
I guess there is a consensus that it's the individual auditor that counts (mostly), and that it is with them, rather than their CB, that a relationship will be built.

Any particular traits to look out for in a good auditor (as opposed to a CB¹)? And conversely, any sure signs of a psychopath?


¹ I found this PDF helpful in that regard: elsmar.com/pdf_files/Registrar_C.pdf
 

normzone

Trusted Information Resource
#6
Re auditors, it's very helpful if you can find one with some experience in your field or something similar. If you drill oil wells and the auditor comes from food service or vice versa, it will be a challenge.

As for psychopaths, just the usual advice for interviewing somebody. We all have our interview personae we use - I try to get the person to relax and let down their guard and let you see what they are genuinely like. If they are unwilling to step out of character after a while, they are generally going to be tightly wound, which may translate into difficult to deal with in the long run. Your mileage may vary.
 

Randy

Super Moderator
#7
Take Sidney's advice, and if you interview me I may tell ya what you don't want to hear. Also the auditor you get 1st may not be the one you end up with in the long run, things change as do auditors
 
A

apinop

#8
If you drill oil wells and the auditor comes from food service or vice versa, it will be a challenge.
Yes indeed. This is in fact a major concern for one of my partners, as he can't see how an auditor can determine whether we are "doing it right" in a very technical field that employs less than a thousand people worldwide. I am not so bothered as, except for the very fine details, I believe that a capable consultant should be perfectly able to follow through and ask the right questions.

With that said, I'll consider asking our industry regulator (who will audit us) for the name of their own auditors. That way at least there will be some common ground between all of us.
 

normzone

Trusted Information Resource
#10
Take Sidney's advice, and if you interview me I may tell ya what you don't want to hear. Also the auditor you get 1st may not be the one you end up with in the long run, things change as do auditors
Well put, and in general if your QA guy does not periodically tell you something you don't like hearing then you're not getting your money's worth.


" If you drill oil wells and the auditor comes from food service or vice versa, it will be a challenge."

Yeah, I may have better phrased that as " MAY be a challenge". A good auditor will be able to set aside their own experiences in other fields while applying those lessons to your field.

There are generally equivalencies between the most complex and simplex operations - customers have fantasies, and your organization turns those into deliverables that you can charge money for. Everything in between is meeting customer requirements and being able to prove that you do so, and doing what is appropriate to sustain the relationship. :agree:
 
Thread starter Similar threads Forum Replies Date
Marc Ford's newest SUV is B-I-G - Tentatively called "Everest" World News 0
Sidney Vianna OASIS database - deadline for setting up an administrator is fast approaching AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Stijloor REACH Regulatory Deadlines Approaching - Prepare Your Company RoHS, REACH, ELV, IMDS and Restricted Substances 5
I Turtle maps and Flowcharts - How is everyone approaching Turtle maps and flowcharts? Process Maps, Process Mapping and Turtle Diagrams 16
E Nissan Audit Approaching Customer and Company Specific Requirements 0
A Documents of External Origin - Approaching & Satisfying this Requirement? Document Control Systems, Procedures, Forms and Templates 17
Q KPI rules for ISO 9001 first certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Gravimetric blender for resin in automotive industry - periodical calibration via external lab with certification Reliability Analysis - Predictions, Testing and Standards 0
S ISO 13485 certification training Training - Internal, External, Online and Distance Learning 1
K Sales of MDD devices with expired CE that are pending MDR certification EU Medical Device Regulations 4
W Incoming Certification Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
B Multisite Certification Requirements for ISO 27001 IEC 27001 - Information Security Management Systems (ISMS) 8
PowerJunkie Cancelling AS9100 Certification - How and Who to notify? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
H Regarding UL Certification CE Marking (Conformité Européene) / CB Scheme 6
Q ISO 13485 certificate needed if I go for MDSAP certification? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Eligibility for certification to IATF16949 IATF 16949 - Automotive Quality Systems Standard 8
M ASQ certification study material Professional Certifications and Degrees 1
A New to QMS and regulatory... advice on training/certification? ISO 13485:2016 - Medical Device Quality Management Systems 1
D Is IATF certification required when customer doesn't require it? IATF 16949 - Automotive Quality Systems Standard 19
A Loss of certification because of outdated information in the Clinical Evaluation Report CE Marking (Conformité Européene) / CB Scheme 8
Sidney Vianna IAQG News Down with OPMT - Long live CERTIFICATION OVERSIGHT AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
H Relation of VDE mark with CE certification CE Marking (Conformité Européene) / CB Scheme 11
T Adding to certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
T Is NRTL certification mandatory in the US ? Registrars and Notified Bodies 2
H EAC-MED Certification CE Marking (Conformité Européene) / CB Scheme 0
Aliken Recommendation for the ISO 13485 certification company ISO 13485:2016 - Medical Device Quality Management Systems 7
A List of documents to prepare for Re-certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
F Attendance possibility for a certification audit ISO 13485:2016 - Medical Device Quality Management Systems 7
V ADDING NEW MEDICAL DEVICE / Product, WHEATHER THIS AFFECTS EXISTING ISO 13485 CERTIFICATION? ISO 13485:2016 - Medical Device Quality Management Systems 4
K SGS Certification - Advice on their Performance Service Industry Specific Topics 9
V ISO 9001 or ISO 17065 required for an organization issuing 5 star rating certification of digital experience? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
P How to keep a ISO 9001:2015 certification when a company is sold ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Scope of ISO 13485 certification as legal manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
J CMO in Canada do they need MDSAP/13485 certification? ISO 13485:2016 - Medical Device Quality Management Systems 1
R ISO 13485 certification scope ISO 13485:2016 - Medical Device Quality Management Systems 5
A AS9100D new certification cost?? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
N ISCC Plus - The international Sustainability Carbon Certification Sustainability, Green Initiatives and Ecology 2
S Which certification to get? Professional Certifications and Degrees 3
J Implementation, establishment and certification of IATF 16949. IATF 16949 - Automotive Quality Systems Standard 6
D Regulatory Affairs Certification (RAC) Devices Exam - Autumn 2022 study Professional Certifications and Degrees 3
A MDR Article 16 Certification of Distributors by a Notified Body? EU Medical Device Regulations 8
T NDT/NDE Level 2 Technicians Certification Oil and Gas Industry Standards and Regulations 20
M PSE Certification Japan Medical Device Regulations 5
C IATF16949 certification eligibility IATF 16949 - Automotive Quality Systems Standard 6
D IATF 16949 Certification and Letter of Conformance expiry (Help!!!) IATF 16949 - Automotive Quality Systems Standard 8
H API monogram 4F - Certification process Oil and Gas Industry Standards and Regulations 2
J Recommendations for certification bodies ISO 13485:2016 - Medical Device Quality Management Systems 4
S Certification of equipment after move General Measurement Device and Calibration Topics 14
J Help to understand and response to API AAR during the re-certification audit Oil and Gas Industry Standards and Regulations 17
G Medical Device Auditor (CMDA) certification exam by ASQ - looking for input Career and Occupation Discussions 3

Similar threads

Top Bottom