Quality Manager as part of Management - 13485

Candi1024

Quite Involved in Discussions
#1
Hello All!

Can someone help me describe to someone else that is new to ISO, why the quality manager needs to report to top management, and what types of problems could occur if they do not.

The hypothetical situation I am describing would have the Quality Manager reporting to the Plant Manager, rather than the Position directly above the plant manager, the Vice-President. Let's also assume this is a small company with one manufacturing location.
 
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lanley liao

Involved In Discussions
#2
Hi,Candi,
The answer to the question you asked is just the ISO series-related standards. including why the quality manager needs to report to top management. if they do not do, which will result in serious management and operational issues, or worst,the company broke up,you know.
 

yodon

Staff member
Super Moderator
#3
The quality manager should be independent of 'forces' that may try to influence decisions. For example, if the quality manager reported to R&D, there may be pressure to accept, let's say, sketchy test results. If reporting to operations, maybe pressure to release product that shouldn't be released. (In practice, of course, there are always those forces but I think that's the idea behind it.)
 

Tidge

Trusted Information Resource
#4
Commensurate with the response from @yodon above, the quality manager (or management representative) inherits/is assigned specific responsibilities from management with executive responsibility. The responsibilities are important enough (in context) that the standard cannot trust that someone else who reports to MWER has delegated them to a subordinate. Similarly it is necessary to accurately assess the performance of those activities, and take appropriate action.... things considered so vital to MWER that it isn't appropriate to delegate to someone who doesn't report directly to MWER.
 

Candi1024

Quite Involved in Discussions
#5
Let's say this hypothetical company, decided to change the plant managers title to COO. Then it's ok?

What kind of decision making do COOs typically make, that plant managers do not.
 

bme007

Starting to get Involved
#6
Let's say this hypothetical company, decided to change the plant managers title to COO. Then it's ok?

What kind of decision making do COOs typically make, that plant managers do not.
COO is a higher position than the plant managers. Many companies have org chart that Quality manager reports to COO because COO’s task is to oversee the day-to-day administrative and operational functions of a business. Yes. I agree that quality manager should be in the same level as other managers in the company and he/she should have the same voting power in an operational discussion.
 

Tidge

Trusted Information Resource
#7
Let's say this hypothetical company, decided to change the plant managers title to COO. Then it's ok?
In this 'hypothetical company', the newly minted COO has also inherited all of the good things that come with the new position. For example in the USA, as a member of MWER the new COO can now be held personally accountable for criminal liability and find themselves subject to fines and imprisonment. 'Hypothetically' considering such a promotion simply to avoid a more standard org chart makes me wonder just how 'hypothetical' the risks of criminal and civil liability might be (for this 'hypothetical' company).
 

Tagin

Trusted Information Resource
#9
Since this is posted in the 13485 forum...

5.5.1 Responsibility and authority
Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization. Top management shall document the interrelation of all personnel who manage, perform and verify work affecting quality and shall ensure the independence and authority necessary to perform these tasks
5.5.2 Management representative
Top management shall appoint a member of management who, irrespective of other responsibilities, has responsibility and authority that includes...
 
Last edited:

Mike S.

Happy to be Alive
Trusted Information Resource
#10
Unless I missed it, I didn't see a definitive answer as to whether under ISO13485 the "Quality Manager" could report to the "Plant Manager". I don't have a copy of that standard as I don't play in that arena, but I am curious.

In AS9100 world it would not be a problem.

FWIW, I've seen cases where the President (highest position in that company) was a sleazeball who ordered the shipment of known bad product, so titles don't mean a lot to me.
 
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