Director vs. Manager - Roles in RA in a Medical Device Company

[dr1vn]

So I've been looking through some Quality Manuals to get familiar with my new role in RA in a Medical device company. I've been tasked with cleaning up a ISO 13485 QM that has several job responsibilities/descriptions listed in the manual.

What is the difference between Manager and Director?

What are your thoughts on listing positions? i.e. In an Org chart would you list just the top two levels (CEO, directors) or would you go further down to sales people and project managers? I'd be interested in hearing arguments for an against this.

[biboy2012]

In Reply to Parent Post by dr1vn

So I've been looking through some Quality Manuals to get familiar with my new role in RA in a Medical device company. I've been tasked with cleaning up a ISO 13485 QM that has several job responsibilities/descriptions listed in the manual.

What is the difference between Manager and Director?

What are your thoughts on listing positions? i.e. In an Org chart would you list just the top two levels (CEO, directors) or would you go further down to sales people and project managers? I'd be interested in hearing arguments for an against this.

I think Director and Manager are just job titles. The functions vary from organization to organization. Surely, they both manages and gives direction.

[dkusleika]

Here's my opinion on the matter:
Manager: Anyone with at least one subordinate
Officer: Anyone who has been named an officer by the Board of Directors in their meeting minutes
Director: Anyone who has been appointed to the Board of Directors by the shareholders in their meeting minutes

I realize that not every company uses those definitions, but that's what I use.

[insect warfare]

In Reply to Parent Post by dr1vn

So I've been looking through some Quality Manuals to get familiar with my new role in RA in a Medical device company. I've been tasked with cleaning up a ISO 13485 QM that has several job responsibilities/descriptions listed in the manual.

What is the difference between Manager and Director?

Biboy2012 is right when saying:

In Reply to Parent Post by biboy2012

I think Director and Manager are just job titles. The functions vary from organization to organization. Surely, they both manages and gives direction.

however the other job titles for your organization may already be defined elsewhere, such as job description documents, or you can find this out from your Human Resources department.

In Reply to Parent Post by dr1vn

What are your thoughts on listing positions? i.e. In an Org chart would you list just the top two levels (CEO, directors) or would you go further down to sales people and project managers? I'd be interested in hearing arguments for an against this.

I believe the main objective of an org chart should be to show interactions and identify key responsibilities / authorites within your organizational structure. I would think that your sales people and project managers are "key" to the structure, since without them there would be no sales, no projects, etc.

Let's also not forget - ISO 13485 mandates that responsibilities and authorities be documented - they just don't tell you how. That is up to each organization to decide. An org chart is not the only way to document this - job description documents, statements of work, etc. are utilized often. Even with these, then maybe listing only the top two or three tiers in an org chart would be sufficient for a small to medium-sized organization.

I presume there are usually multiple items working in tandem to help address the requirements of 5.5.1, and there is no universal method that works for every company.

Brian

[dr1vn]

In Reply to Parent Post by insect warfare

I believe the main objective of an org chart should be to show interactions and identify key responsibilities / authorites within your organizational structure. I would think that your sales people and project managers are "key" to the structure, since without them there would be no sales, no projects, etc.
:

That's an interesting point. I was initially thinking that just the top two or three levels would be sufficient/essential. But when you think of the words essential, then the lower levels are just as important.

Definitely some food for thought!

[insect warfare]

In Reply to Parent Post by dr1vn

That's an interesting point. I was initially thinking that just the top two or three levels would be sufficient/essential. But when you think of the words essential, then the lower levels are just as important.

Definitely some food for thought!

I also think about who the audience is regarding an organization chart (whether a customer, an auditor, etc.). Thinking along those lines, it is usually a given assumption that those lower level people are in place and sustaining the system. But if you asked me to create an organization chart, I would jump in all the way and do my absolute best to categorize everyone who directly or indirectly affected product or service quality (it's just my style). From that point I would decide whether or not it would be beneficial to document the fact that we have other personnel as well (like janitorial and sanitation teams), though in an industry like medical devices they can be just as important in terms of process conformity. I would like to think that R & A for these job functions are defined elsewhere.

Keep in mind, I work in a manufacturing environment and not in medical devices. But I think my opinions on this topic could be translated across the board...