ISO 13485 5.5.2 - Can a consultant be our Management Representative

#1
A small device manufacturing company which is ISO13485 certified is seeking a consultant to maintain and continuously improve their QMS. Can this consultant also be their management representative and attend their ISO audits?
 
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#3
Thanks to Sidney for your response! I have a follow-up question. The ISO13485 5.5.2 states that the management representative is " a member of management who, irrespective of other responsivities, has responsibility and authority that includes: ......". Does this mean the consultant has to be a member of management? What is the evidence to show the compliance in this case?
 

JoshuaFroud

Involved In Discussions
#4
Management Representative must be "management" in that they must have the authority and responsbility to make changes to the Quality Management System.

I have acted as Management Rep, while having the job title of Quality Specialist.

As long as you can demonstrate that person has the relevant authorities to furfil the requirements of the role as defined in the standard they are "management".
 

Sidney Vianna

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#5
This issue has been discussed numerous times in the past for ISO 9001. The major challenge for a "consultant" or a low level employee acting as management representative is to have REAL AUTHORITY over senior people of the organization. The reporting aspect is doable, but real authority is hard to attain.
 

racglobal

Involved In Discussions
#6
Hello
Now you are outsourcing an important QMS process to an external party. Make sure this person is properly qualified just as you would qualify any other supplier.
 
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