SBS - The best value in QMS software

Management Representative is NOT a member of Management

Elsmar Forum Sponsor
J

Jason PCSwitches

Jason, the M/R must be shown in the organogram, and this person must be formally appointed by the board/top management. The auditor found it written somewhere/or that the management rep was part of management.But the inconsistency must be that he/she was not formally appointed as such, for QMS purposes that is. The M/R will not sit at board meetings,but will sit at review meetings.

This is getting ludicrous. The intent of the standard is to ensure a competent member of the organization is placed in charge of the QMS associated with the corresponding standard. Sure, you can have Tom the Janitor be the MR, and he might be able to do the job. But is that the best way to go about this? And what would that say about the organization that made such a move in respect to how seriously they take their QMS??

Your statement about the organizational chart is mistaken. While I personally think every organization should have one, it's not a requirement and as long as the organization can demonstrate compliance I have no justification for an NC because "I" think there is a better way. The organization needs to ensure (under 5.5.1) that "responsibilities and authorities are defined and communicated".

As per 4.2.1; note 3; this can be in any form or type of medium.

The OP doesn't state how the auditor justified the NC, unless I missed it, but I agree, and I hope, it was based on some objective evidence and not just a preference.

The OP also stated that they chose to ignore that part of the standard, which is probably why they got a write-up.
 
J

Jason PCSwitches

Jason, the M/R must be shown in the organogram, and this person must be formally appointed by the board/top management. The auditor found it written somewhere/or that the management rep was part of management.But the inconsistency must be that he/she was not formally appointed as such, for QMS purposes that is. The M/R will not sit at board meetings,but will sit at review meetings.

This also brings another point to the surface: A good auditor must not be biased. Personal bias is generally derived from personal experience. An auditor must remain open minded and understand, not to be clique, that there are different strokes for different folks. At the end of the day the important thing is to ensure the intent and the integrity of the associated standard is being upheld and providing value to the organization; which has a positive ripple affect to the corresponding industry, sometimes.

After-all, isn't that one of the main reasons this whole game got started, improvement and quality???
 
Hello Jim, will get back to you on the 1st q. the 2nd, whose giving the input if the M/R is not part of the review meeting.
I don't believe that the MR needs to have total responsibility for the review of the QMS. Often it's the case that the review is totally run by the MR and everyone else merely 'shows up'. This helps them avoid being 'committed' to the QMS as a tool for improvement! If I had my druthers, the MR wouldn't say very much, at all!
 

Big Jim

Super Moderator
You can create as many 'Standard according to Jim' varieties as you wish, but I'm staying with the official version.
But you didn't.

You are reading much too narrow. Each of the three you cited has much more in it. You are the one creating your own standard.
 

Big Jim

Super Moderator
You would write up the situation I described, where the CEO has explicitly stated that Sally is a member of management, and all of the responsibilities of the MR had been satisfied? On what grounds?
I cannot say for certain that I would write this up. I said I probably would. What grounds? Probably 4.1 c. QMS controls must be effective. On its face this situation is ludicrous.
 

Jim Wynne

Staff member
Admin
I cannot say for certain that I would write this up. I said I probably would. What grounds? Probably 4.1 c. QMS controls must be effective. On its face this situation is ludicrous.
I think it's ludicrous too, but for a different reason, which is that our friends on the TC176 committee have never provided an unequivocal way to determine identify ascertain who's "a member of the organization's management."
 
Thread starter Similar threads Forum Replies Date
T Management Representative - Member of Management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
Q Quality Management Representative - Does the QMR HAVE to be a member of management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
M Management Representative - Shall appoint a member of the suppliers own management Other ISO and International Standards and European Regulations 6
J Management Representative and PRRC (Person Responsible for Regulatory Compliance) ISO 13485:2016 - Medical Device Quality Management Systems 10
L ISO 13485 5.5.2 - Can a consultant be our Management Representative ISO 13485:2016 - Medical Device Quality Management Systems 5
R Who is the Management Representative in my company? ISO 13485:2016 - Medical Device Quality Management Systems 6
S API Spec Q1 - How to define Management Representative competency for QMS Oil and Gas Industry Standards and Regulations 12
S Is management representative a temporary post or a job title Management Review Meetings and related Processes 16
S Management representative transition checklist IEC 27001 - Information Security Management Systems (ISMS) 7
J AS9100D Management Representative AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
P How to identify the Management Representative ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
M Audit of Management Representative Activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
S Quality Management Representative confusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
L Who should be appointed as the Management Representative? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
T Changes in ISO9001:2015 to the requirements for a management representative ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
C AS9100 Management Representative - Can it be an outsider? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
M Is a Management Representative still needed for ISO 13485:2015? ISO 13485:2016 - Medical Device Quality Management Systems 7
K Difference between being a Management Representative and being a Lead Quality ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Management Representative is an Accountant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
T ISO 9001:2008 Management Representative and other Management Staff ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 31
x-files Matrix for: Established, implemented, maintained (5.5.2 Management Representative) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
E Do I need to notify the FDA of Management Representative changes? Other US Medical Device Regulations 3
K Management Representative Responsibilities for Multiple Standards Misc. Quality Assurance and Business Systems Related Topics 11
R Distinction between Management Representative vs. Quality Manager Responsibilities IATF 16949 - Automotive Quality Systems Standard 5
eternal_atlas Audit of Management Representative Functions (ISO 9001 & OHSAS 18001) Occupational Health & Safety Management Standards 9
A Management Representative and Information Security Officer for ISO27001 IEC 27001 - Information Security Management Systems (ISMS) 3
M Is Management Representative a loose cannon or am I unnecessarily concerned? Quality Manager and Management Related Issues 6
G Management Representative as Lead Auditor within a Company Internal Auditing 6
K Selection Criteria for choosing a Management Representative for QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
S Management Representative Requirements and Responsibilities Clarification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Can one Management Representative operate between two sister firms ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 55
P Level of Management Representative in Organization Chart Quality Management System (QMS) Manuals 5
P Level of Management Representative in an Organization Chart Misc. Quality Assurance and Business Systems Related Topics 4
M New QMR (Quality Management Representative) in need of advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
V Is a Quality Representative (Management Representative) Designee Required? Management Review Meetings and related Processes 22
K More than One Management Representative? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Who does the Management Representative Report To? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
S Work as a QMR (Quality Management Representative) Quality Management System (QMS) Manuals 5
B Small Companies and the ISO 9001 Management Representative ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 31
B Management Representative Responsibilities Misc. Quality Assurance and Business Systems Related Topics 17
E AS9100 - Is the Management Representative a Top Manager? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
N Management Representative - Specific Training Required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 46
A MR (Management Representative) also doing Internal Audits? Internal Auditing 27
C Can an MR (Management Representative) be a Document Controller as well? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
J Management Representative Requirements - ISO 9001 - 5.5.2 Clarification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Z Involvement of Management representative (ISO 3834) in Quality Department Misc. Quality Assurance and Business Systems Related Topics 7
L Management Representative - 2 Person Device Company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
A What is criteria to be Management Representative (MR)? Is there any standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
W MR (Management Representative) Requirements and Responsibilites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Management Representative - Example procedure needed Document Control Systems, Procedures, Forms and Templates 20

Similar threads

Top Bottom