QMS for Life Sciences
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Management Representative - Management Status of the person responsible for the QMS?



Management Representative

What type of Management Status does the person responsible for QMS need to be? Currently I have no management status but I am the only one responsible for the whole quality system. No one above me has the knowledge or responsibilities that I do. The President of our company is considering making me the Quality Manager, but was wondering if there were any other possibilities. As it stands right now my manager is the Maintenence Manager and has no desire to be involved in the Quality side of our company.

Thanks in advance for your suggestions!


Al Dyer

As a Mngt. Rep. I am responsible to report the state of the implemented quality system to executive management, who have the responsibility to act upon my recommendations.

One area I am concerned about is the ongoing trend to make the Mngt. Rep. the Lead Internal Auditor. I see a conflict of interest.

To make it more cohesive, I have always worked for the President, Vice President (son) or the General Manager of the company and have always worked at least at the level of a depatment manger. (notice lower caps).

To a point, you need to keep youself at a distance, but accessible to all personnel in the organization.



Al Dyer
Mngt. Rep.
[email protected]

Dan Larsen


I've never run into a problem with the Management Rep being the effective lead auditor in an organization. In fact, who best to objectively lead an audit on the quality system than the person who wants to make the whole thing work.

The only issue has been with the systems tied to the Management Rep (most notably the audit system). In those cases, we shift responsibility to another manager (just for that particular audit). Not had a problem with this yet.


Willie –

I don’t believe that QS standard has a ‘cut & dry’ definition that states the QMR must have this title or status. However, it does state that it must be a member of management and this individual must have defined authority to ensure that a quality system is established, implemented and maintained.

Call it what you want….. Quality Manager, Quality Management Representative or Quality Guru. I don’t believe an auditor will argue with you about the title, but the will argue with you if executive management has not identified a representative that has the defined authority.

Secondly, I tend to agree with Al. I have a problem with the Management Rep also being the lead auditor. I have witnessed in the past where QMR’s did not give findings because they did not want to make their own system and work look bad. They are able to cover things up just in time for the next surveillance audit. Also, sometimes QMR’s can have tunnel vision during an audit. They know what to look for and where to find it. I don’t know whether this is the norm or exception to the rule. I do feel if other individuals act as the lead auditor, it provides a series of checks and balances to the whole audit system.

Alex Grguric

No one person will make the "whole thing" work, however one person must to be made responsibility for the quality system. The management representative needs to be at a level to ensure proper resources are availble and the project is given appropriate status within the organization.
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