Who is the Management Representative in my company?

racglobal

Involved In Discussions
#1
Hi everyone,

My company is in a somewhat unique situation. The company has a senior management team consisting of people who do have experience in regulatory/quality or RA/QA. The only person who knows this piece is a employee outside of management, who manages RA/QA but is not sitting on the management team. By ISO 13485, the management representative is somebody representing senior management but none of the roles in senior management are in a position to be the "management representative" as defined in ISO 13485. In this case, can the non-management RA/QA employee be the management representative? In my past workplaces, the management representative is usually the Director of RA/QA or the Quality Director/Manager. But here at this company, there is nobody representing RA or QA on the management team. It's one of those grey areas that we run into too often at startup companies. I do not know any company where there is no RA/QA representation on the management team or an entire management team has nobody running RA/QA. I've seen a company where at least one person on the management team does the RA/QA work but has a different title (e.g. a title in product management for example) so that a VP of marketing or Sales is the management representative.

Who is the management representative in this situation? How can we make this more clear when it comes to audits? Is the sole RA/QA employee barred from leading audits because they are not a management representative?

I'd like to seek any advice on this.
 
Elsmar Forum Sponsor

Tagin

Trusted Information Resource
#2
There is no stated requirement that the mgmt representative must be a member of senior management. All that is required is that the mgmt rep is [edit: a member of management and] given the requisite authority and responsibility to carry out activities in 5.5.2 a-c. So, this is really a requirement on senior mgmt to delegate that authority and responsibility to, and support, the mgmt rep accordingly.

Organizationally, it may be awkward to have a non-mgmt non-senior mgmt person have the authority and responsibility but not have some accompanying title, but that is for the organization to address, not the standard.

Edited to clarify that 5.5.2 does state "Top management shall appoint a member of management..."
 
Last edited:

Golfman25

Trusted Information Resource
#3
If it was me, I'd push for someone in manufacturing, engineering, or the President him(her)self. Your QA guy can take care of the audits.
 

Tagin

Trusted Information Resource
#4
If it was me, I'd push for someone in manufacturing, engineering, or the President him(her)self. Your QA guy can take care of the audits.
Hmm, I suppose there is nothing in the standard that precludes the mgmt rep from delegating most of their authority and responsibility to other personnel, as long as the mgmt rep is actively involved and making sure 5.5.2 a-c are being done.
 

racglobal

Involved In Discussions
#5
Thanks all. What each of you said makes sense to me. A viable approach is just to name the CEO/President management representative who delegates this authority to the RA/QA person. I would probably make this clear in the Quality Manual. It's a little bit unusual but many situations faced in a small company are unique.
 

JoshuaFroud

Involved In Discussions
#6
To jump on this again, a short time ago I had the job title of Quality Specilist and did not form part of the senior managerment team. I was nominated to be the Management Rep (I was the only member of the Quality Team), to this ends I had a dotted line report to the CEO in addition to my normal line management.

I organised and chaired Management Reviews with the Top Management as well as being involved in many of the Quality/Regulatory issues Top Management encountered.

Essentially anyone can be your Management Rep as long as they are given the authority of a management rep as stated in the standard.
 

QChas

Involved - Posts
#7
To jump on this again, a short time ago I had the job title of Quality Specilist and did not form part of the senior managerment team. I was nominated to be the Management Rep (I was the only member of the Quality Team), to this ends I had a dotted line report to the CEO in addition to my normal line management.

I organised and chaired Management Reviews with the Top Management as well as being involved in many of the Quality/Regulatory issues Top Management encountered.

Essentially anyone can be your Management Rep as long as they are given the authority of a management rep as stated in the standard.
This is the same way things are at my company. I am the Quality Manager and Management Rep with a dotted line to the managing partners of our company. I run the Management Review, but during external audits they have Management Responsibility. No issues with this approach in over 14 years!
 
Thread starter Similar threads Forum Replies Date
G Management Representative as Lead Auditor within a Company Internal Auditing 6
L Management Representative - 2 Person Device Company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
V Company Director as Management Representative - TS 16949 Clause 5.5.2 IATF 16949 - Automotive Quality Systems Standard 7
A Can a CEO be the management representative AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
J Management Representative and PRRC (Person Responsible for Regulatory Compliance) ISO 13485:2016 - Medical Device Quality Management Systems 12
L ISO 13485 5.5.2 - Can a consultant be our Management Representative ISO 13485:2016 - Medical Device Quality Management Systems 5
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
T Management Representative - Member of Management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
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 6
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 Management Representative is NOT a member of Management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 246
K More than One Management Representative? ISO 13485:2016 - Medical Device Quality Management Systems 3
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
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
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

Similar threads

Top Bottom