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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.
 

Tagin

Quite Involved in Discussions
#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..."
 
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Tagin

Quite Involved in Discussions
#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!
 
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