SBS - The best value in QMS software

Is consultant prohibited in ISO9001 audit?

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#61
We have used a consultant here for years in our ISO audits and not had one issue raised by any CB we have used. He has been in charge of our MS since its instigation until I took on my role last year he has always been named as part of the management structure.
Nothing wrong with that at all. Given our "gig economy" trend, I expect we will start finding more of that.
 
Elsmar Forum Sponsor

Candi1024

Quite Involved in Discussions
#62
Did Yukon always have their description like this, or did you do it Marc? :applause::ROFLMAO::ROFLMAO:

Yukon

Now that we know he is a real auditor, it has been reverted.
-----------------
Edited to remove my unwarranted edit.
 
Last edited by a moderator:

Randy

Super Moderator
#63
It would be interesting for Yukon to visit any one of a number of my clients whose management/leadership across numerous departments is made up of contracted "consultants" that are granted the title of manager etc, but are not in fact full time personnel, and to forbid them take part in an audit...One I know of is the Comptroller/Finance Manager and signs the checks for the corporation. Wonder how the CB would feel about not getting a check because that persons authority to do so wasn't recognized by the auditor....And of course there are those who's total regulatory management is done by a contracted consultant, every single bit of the EPA compliance obligation management done by someone who wouldn't be allowed to participate in an EMS audit! Oh yeah, they have a QMS and OHS and that contracted consultant is identified on the org charts as a member of senior management....That decision to not allow a consultant would go over like the proverbial feces in a punch bowl...especially with that very, very large Japanese electronics corporation's decision as to who can do what on their behalf here in the good old USofA.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#65
@Candi1024 That was an edit that was inappropriate and has been corrected. I take full responsibility for it. I did it prior to him being identified as a real auditor. There was a discussion between the moderators and I was one who thought he was a troll, both from his abrasiveness and the fact that, as I say below, He came in like a bat out of hell and immediately started churning things up. There are people on the internet these days that do register in a discussion forum with the intent to try to "stir things up".

In addition, remember that Elsmar has been online for over 23 years (less the 10 months offline issue). We have seen people come to the forum, register 2 or 3 accounts, and then start posting against each other. If I remember some years ago we identified a "Jim Wade" who did this. I don't know what his motives were.

However - I offer this public response:

It is true that @Sidney Vianna and @AndyN can be a bit opinionated and at times egotistical and combative, as some people over the years have said I can be - I have been and realize that reality. Andy and I have exchanged a few "disagreements from time to time. And I can understand Sidney - In large part I agree with him that over the years things in the certification business have deteriorated. @Randy and I have had some significant disagreements in his posting "style" and, at times, over his "attitude" in some posts. I will say I would never say Randy isn't extremely knowledgable - I believe he is not only knowledgeable, but I am sure he audits much like I did in my day. In small companies I gave a lot of leniency - I would not have made a big deal out of an internal auditor not being "totally and unambiguously" dissociated from "auditing his/her own work". See the embedded quote bellow.

On the other hand, "Yukon" was, in my opinion, not professional, was intentionally antagonistic, combative and, I believe, purposefully disruptive in general. He came in like a bat out of hell and immediately started churning things up. It degrades the forum and its reputation when pissing matches occur. My actions aren't always what everyone agrees with, but I challenge anyone to try to monitor and maintain an internet discussion forum, not to mention for as long as I have.

Personally, I wish the forum would totally "run its self", which to some degree it does, but... After over 23 years of much of this, I don't like to have to get involved in monitoring and mediating in threads like this one. I'm just getting too old for some of this stuff. And unfortunately a topic like "auditor independence" or, as another example, discussions on "risk", bore me because I first dealt with them in the 1980's and over many years between then and now. I used to be quite prolific in posting, but these days for me it's obvious I don't too often get involved, especially in what I consider "common - Asked and Answered in other discussion threads" discussions.

There are several people here I depend on for a "reality check" from time to time. @Randy is one. E.g.:
Nope, as a 3rd party I've seen it, validated the objectivity and impartiality of the process and all the gobblety goo that goes with it, said nice job, and moved on to more serious stuff
This is reality. Randy audits like I audited.

@Jen Kirley is another. @Big Jim is another. I watch their interactions to get cues to things going amiss here. In this case, the need for a reality check with regard to what Mr. "Yukon" was posting, was warranted, in my opinion. In part this also has to do with information being posted being important here. Many people who are new to their profession, or are not "experienced", need a way to be confident that what is being posted is, in fact, good information. I made a specific "user group" here to address that. People with the "Trusted" badge are people I have personally vetted for their professionalism and their posts being accurate. I do consider the moderators and the admins here to be in the "Trusted" group.

If we did not address what we believe to be inaccurate information, I believe it would be bad for Elsmar particularly with regard to "Trust" that the information is just that - That a person can Trust information here. The problem, so to speak, is how we do this. I think we all do our best here. I understand that from time to time there will be people who disagree with what we do. After all these years I know I cannot please everyone. That is reality.

--------------------------------------
Edit: Minor additions/clarifications.
 
Last edited:

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#67
@Ninja - You have always been "Trusted" here. People can depend on anything you post as being authoritative, professional and trusted. We are all opinionated - That works. It is expected. The forum history is full of conflicting opinions in discussions.

Your participation is very much appreciated. You are another person who is on my "watch for cues to appropriateness and well founded responses" "cues" radar.
 
Thread starter Similar threads Forum Replies Date
chris1price EtO Sterilisation Consultant Wanted Job Openings, Consulting and Employment Opportunities 0
normhowe Seeking a De Novo Consultant Paid Consulting, Training and Services 7
JoCam MDR Gap Analysis - Consultant fees EU Medical Device Regulations 10
K ISO 50001 Consultant wanted Paid Consulting, Training and Services 0
E Consultant with Office 365 experience Consultants and Consulting 2
D Automotive Hospitality Consultant Career and Occupation Discussions 11
L AS 9100 D consultant in Delhi, India AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
D ISO 9001 & AS9100 Certificate issued by a consultant for a Distributor Registrars and Notified Bodies 11
S MDR consultants - in search of recommendations for a consultant for MDR transition. Paid Consulting, Training and Services 7
A ISMS - Seeking VAPT Consultant Food Safety - ISO 22000, HACCP (21 CFR 120) 1
William55401 How Often Does FDA State Consultant Recommended in a Pharma WL? US Food and Drug Administration (FDA) 1
H Looking for Tips on finding an IATF consultant Consultants and Consulting 6
L ISO 13485 5.5.2 - Can a consultant be our Management Representative ISO 13485:2016 - Medical Device Quality Management Systems 5
D Clinical Evaluation Report - Consultant Recommendations Consultants and Consulting 9
M Internal audit consultant ISO 13485 (English speaker) Consultants and Consulting 3
P Consultant Auditing Qualifications Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
N Is ISO14001 consultant allowed to attend ISO14001 audit? ISO 14001:2015 Specific Discussions 17
S ISO 13485 Consultant Question - The company has 5 part time employees ISO 13485:2016 - Medical Device Quality Management Systems 1
C Specification Developer or Consultant? Definitions 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R Who here is Using a Consultant for ISO 9001 Transition? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Setting up an LLC as a Consultant Paid Consulting, Training and Services 27
K Sister Company Moving to AS - First time "consultant" - Help? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
S Can anyone share a Consultant Proposal for QMS Remediation? Consultants and Consulting 5
T IATF Certified Auditor/Consultant Wanted in the Evansville, Indiana Area Consultants and Consulting 0
M Can a Consultant be the main contact for a Medical Device Company? Other Medical Device and Orthopedic Related Topics 6
F Cost of hiring ISO 17025 Consultant to Build Laboratory From Scratch ISO 17025 related Discussions 6
J Is getting a UDI Consultant a good idea? Other Medical Device Regulations World-Wide 4
E Consultant Person who implemented ALSO the Registrar Auditor? Consultants and Consulting 17
H How to find a good ISO 9001 Implementation Consultant in Calgary, Canada? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
P How to deal with a Recruitment Consultant Career and Occupation Discussions 3
A Creative ways to access Expert Information when you can't afford a top $ Consultant Misc. Quality Assurance and Business Systems Related Topics 7
S Design and Development Document evidence for Engineering Consultant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P FDA QSR Inspection Consultant Recommendations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
L Mock Audit by External Consultant (ISO 13485) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
S GDPMD MALAYSIA Consultant and what they teach Other Medical Device Regulations World-Wide 14
Jen Kirley This international consultant thing sure is a ride! Career and Occupation Discussions 13
R Ethical Aspects while being Consultant and Certifier within same Organization. Consultants and Consulting 6
M Can an Auditor introduce a Consultant to help fix NCs after the audit? General Auditing Discussions 12
G Has anyone used shlomo Aviv-lean consultant? Lean in Manufacturing and Service Industries 1
E What are the major difficulties when working as a consultant in your industry? Consultants and Consulting 20
S Advice on becoming an ISO Management Systems Consultant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
C Medical Device Regulatory Consultant in Mexico Other Medical Device Regulations World-Wide 3
P Can an outside consultant audit all the AS9100 requirements including Internal Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
R ISO 17025 Accreditation - Need for consultant? ISO 17025 related Discussions 10
JoCam Reputable, UK based Consultant for the Health & Safety standard OHSAS 18001 Consultants and Consulting 14
I How to measure the performance of ISO 9001 Consultant? Consultants and Consulting 9
R Charge (Fair Prices) by a Consultant for a traditional 510k Review Other US Medical Device Regulations 2
P Medical Device Consultant Professional Liability Insurance (O & E) Career and Occupation Discussions 5
N Consultant Obligations, CFR 803 and Sterility Quality Manager and Management Related Issues 4
S FDA Consultant Needed for Class I Medical Device Development 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3

Similar threads

Top Bottom