SBS - The Best Value in QMS software

Is consultant prohibited in ISO9001 audit?

#1
Hi,

Anyone knows if consultant attending audit is prohibited by any accreditation or certification body rules?

I know that for IATF16949 it states clearly this prohibition.

How about ISO9001 audit?
 
Elsmar Forum Sponsor

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#2
Hi,

Anyone knows if consultant attending audit is prohibited by any accreditation or certification body rules?

I know that for IATF16949 it states clearly this prohibition.

How about ISO9001 audit?
It is basically the same for ISO9001:2015. They are there, only as observers, not for answers to the questions from the Assessor.
 
Last edited:

Sidney Vianna

Post Responsibly
Staff member
Admin
#3
It is basically the same for ISO9001:2015. They are there only as observers, not for answers to the questions from the Assessor.
Not really. I don't have the current IATF Rules book, but in a previous version of the document, the IATF EXPLICITLY PROHIBITED consultants from being at the plant, during the time of the CB audit.

In the ISO 9001 world, some CB's had such policy, but that was challenged as a possible restriction of trade and, I believe, no longer can be enforced.

So, in most cases, I believe that common sense says that the consultant obviously can be present during the audit, but must not interfere with the auditors job of assessing if the system is implemented and effective. Certainly the consultant can advise their clients during the audit, but must not answer questions on behalf of the auditee. When I worked as CB auditor, I interfaced with many consultants during the audits. The professional ones know their role and the limitations of their involvement during an audit.

PS. The IATF still requires CB's to have this legally enforceable clause in the contracts with the registrants:

https://www.iatfglobaloversight.org...mpact-for-Client-Condisderation-01Feb2017.pdf

consultants.JPG
 
Last edited:
#4
It is basically the same for ISO9001:2015. They are there only as observers, not for answers to the questions from the Assessor.
Depends on the role. The label "consultant" is misleading, since it's going to depend on what role they perform, not how they get paid. I am the internal auditor/audit process owner. I should be there at the audit. My contractual relationship is of zero consequence.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
Depends on the role. The label "consultant" is misleading, since it's going to depend on what role they perform, not how they get paid. I am the internal auditor/audit process owner. I should be there at the audit. My contractual relationship is of zero consequence.
Exactly. Also, nobody can prohibit an organization to outsource any role to someone who is a consultant, be it as a quality manager, a management representative, a supply chain director, a CEO, or whatever....
 

Ninja

Looking for Reality
Staff member
Super Moderator
#6
The term "contractor" comes to mind... ;) ...if your consultant will tolerate it.
 
#7
The term "contractor" comes to mind... ;) ...if your consultant will tolerate it.
Why label a person? I've been a consultant for 25 years. How I get paid doesn't affect my work. I've been the Quality Director for a tier 1 supplier and nothing was even mentioned at the upgrade audit. Any auditor who is concerned about labels, needs to wear one: "Close Minded"
 

Randy

Super Moderator
#8
Why label a person? I've been a consultant for 25 years. How I get paid doesn't affect my work. I've been the Quality Director for a tier 1 supplier and nothing was even mentioned at the upgrade audit. Any auditor who is concerned about labels, needs to wear one: "Close Minded"
Yep, right on. I've got clients (3rd party certification) whose regulatory compliance for environmental and safety are completely outsourced...No problem
 
#9
It also occurs to me that the ISO "Audit Practices Group" promulgate this vilification of the use of consultants when they publish guidance entitled "How To Deal With Consultants"... :eek:
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#10
But, Andy, the paper provides "guidance" on this aspect of the 3rd party auditing world. I think, if you read and analyze it without bias, you don't perceive it as vilification of consultants.

deal with consultants.JPG
 
Thread starter Similar threads Forum Replies Date
K Supplier Qualification for Engineering Consultant? Supplier Quality Assurance and other Supplier Issues 3
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

Similar threads

Top Bottom