Is a Management Representative still needed for ISO 13485:2015?

[MantleMickey]

Greetings,
I have seen in ISO 9001:2015 no Management Rep requirement.
Is this the same for ISO 13485:2015, no Mgt. Rep???
Thanks,

 

[Stijloor]

Re: Mgt. Rep still needed for ISO 13485:2015?

Greetings,
I have seen in ISO 9001:2015 no Management Rep requirement.
Is this the same for ISO 13485:2015, no Mgt. Rep???
Thanks,

That is true (for now) but look at ISO/DIS 9001

5.3 Organizational roles, responsibilities and authorities.

Top management shall assign the responsibility and authority for:
a) ensuring that the quality management system conforms to the requirements of this International Standard;
b) ensuring that the processes are delivering their intended outputs;
c) reporting on the performance of the quality management system, on opportunities for improvement and on the need for change or innovation, and especially for reporting to top management;
d) ensuring the promotion of customer focus throughout the organization;
e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

The original assigned responsibilities to the Management Representative are still there. No reference to a Mgt Rep here, but Top Management is still obligated to assign these activities... Guess to whom??

 

[Marcelo]

It?s still clearly there on 13485 because it?s based on the old ISO 9001.

 

[MantleMickey]

Thank you for your replies,
So I guess since we are certified to ISO 9001:2008 and ISO 13485:2003
my duties as management rep will not change, because as you state, 13485 still requires it. No big deal, I just have not seen any discussion about this in 13485, whereas, 9001 specifically deals with it.
Regards,

 

[AndyN]

Greetings,
I have seen in ISO 9001:2015 no Management Rep requirement.
Is this the same for ISO 13485:2015, no Mgt. Rep???
Thanks,

Not in ISO 9001:2015. Only the committee draft (CD) or DIS (draft international standard). It can still change.

 

[John Broomfield]

Not in ISO 9001:2015. Only the committee draft (CD) or DIS (draft international standard). It can still change.

Andy,

The "job title" Management Representative may have disappeared from DIS 9001 but its clause 5.3 still specifies the role of a System Manager in its full glory but without using any job title.

The role of System Manager will continue.

John

 

[AndyN]

Andy,

The "job title" Management Representative may have disappeared from DIS 9001 but its clause 5.3 still specifies the role of a System Manager in its full glory but without using any job title.

The role of System Manager will continue.

John

You missed my point John. There is no ISO 9001:2015. Plus, I'd take issue with your comments for clients coming new to the standards. If no-one ever heard of a "Management Rep" requirement, are you sure they'd assign just one person?

 

[John Broomfield]

Andy,

For roles 5.3 a, c and e, yes.

I admit roles 5.3 b and d can be shared among suitably authorized managers.

John