More than One Management Representative?

K

Ktrna

#1
A little background info:
I have recently "taken over" ISO documentation/ regulations for our company. The person who was responsible for this before me has now become quality control supervisor and I am considered quality assurance supervisor.
The owner has divided the duties. The quality supervisor is responsible for ensuring production follows procedure while I am responsible for ensuring processes, SOP's, and forms follow regulation in addition to maintaining all regulatory documentation. The quality supervisor was the management rep before but was not quite up to dealing with or interpreting regulations. We have an audit in January and I am unsure of who should handle it. The quality supervisor is having a difficult time "letting go" and the owner has difficulties with decisions regarding staff. Both of us relay to the staff any changes in processes, procedures etc. (we are an extremely small company of 12 employees so information sharing is not as formal as in a larger company)
Is it regulation to have to only 1 management rep? Should the quality supervisor and myself handle the audit together? Can we both be considered management reps?
Thanks in advance for the help...this forum has already taught me so much!!
 
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#2
A little background info:
I have recently "taken over" ISO documentation/ regulations for our company. The person who was responsible for this before me has now become quality control supervisor and I am considered quality assurance supervisor.
The owner has divided the duties. The quality supervisor is responsible for ensuring production follows procedure while I am responsible for ensuring processes, SOP's, and forms follow regulation in addition to maintaining all regulatory documentation. The quality supervisor was the management rep before but was not quite up to dealing with or interpreting regulations. We have an audit in January and I am unsure of who should handle it. The quality supervisor is having a difficult time "letting go" and the owner has difficulties with decisions regarding staff. Both of us relay to the staff any changes in processes, procedures etc. (we are an extremely small company of 12 employees so information sharing is not as formal as in a larger company)
Is it regulation to have to only 1 management rep? Should the quality supervisor and myself handle the audit together? Can we both be considered management reps?
Thanks in advance for the help...this forum has already taught me so much!!
The standard says " Top management shall appoint a member of management ... "
So it is expected that any one be the MR and most certainly can have an other to support and popularly called the deputy MR.
Keeping your internal confusions aside, why are you talking about handling the audit by MR. MR will facilitate the audit, and the auditee will be the process owner in any audit, internal or certification audit. Apart from being the MR (or deputy MR) you will also have other core responsibilities for which you will handle the audit of those processes.
Per ISO 13485, the MR (or the MR and deputy) must be doing the following:
a) ensuring that processes needed for the quality management system are established, implemented and maintained,
b) reporting to top management on the performance of the quality management system and any need for improvement (see 8.5), and
c) ensuring the promotion of awareness of regulatory and customer requirements throughout the organization

Any one of you can liaison with external agencies like your certification body etc., about your QMS certification process and its maintenance.
Please come back if you still have somethings unclear ....
Good luck.
 
K

Ktrna

#3
So to clarify, the auditor will be speaking with the person responsible for each of the processes. I guess my confusion is last year's audit, the auditor only spoke with the current quality control supervisor and the owner. I was under the impression during the audit one person is responsible for audit questions except when the auditor "tours" the facility. Perhaps only one person was spoken to last year due to the fact we all wear many hats at this company and this employee worked in all "departments".
So what I understand now, is the person responsible for approving all purchases will be audited for purchasing, the one responsible for production will be audited for all production processes and procedures, etc. And as I am responsible for the documentation of the QMS I will be audited on those documentations. (If these happen to fall under the scope of our audit.)
Am I on the right track?
 

sagai

Quite Involved in Discussions
#4
Normally there is a QM responsible and the process area related responsible, but you shall clarify why you delegate someone with different hats, no problem, you can arrange it before with the auditor.
For any appointment, when there is such wording in the standard, do not forget, to have a proof (doc, email, something), regarding that appointment.
br.
Sz.
 
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