Registered Medical Device Manufacturer - Are documented job descriptions required?

Bunny

Quite Involved in Discussions
#1
I work for an ISO 9001 and ISO 13485 registered medical device manufacturer. Are documented job descriptions required? I was recently told by a third party auditor that they were not required. Please clarify if you can.
 
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Marcelo

Inactive Registered Visitor
#2
Re: Are documented job descriptions required?

The standards require that responsibility and authority, related to the processes of the company, be defined. Job descriptions generally are related to the functions, not the processes. So no, job descriptions are not required.

You CAN fulfill the requirement if you have the responsibilities and authorities detailed in each job description.
 

Marcelo

Inactive Registered Visitor
#4
Re: Registered Medical Device Manufacturer - Are documented job descriptions required

In a processes x responsibilities matrix, for example.
 

somashekar

Staff member
Super Moderator
#5
Re: Are documented job descriptions required?

How else would you define them without job descriptions?
If your Job description = Responsibility and authority of personnel ...
Then it needs to be defined, documented and communicated within the organization.
 
Last edited:

Ronen E

Problem Solver
Staff member
Moderator
#6
Re: Registered Medical Device Manufacturer - Are documented job descriptions required

I work for an ISO 9001 and ISO 13485 registered medical device manufacturer. Are documented job descriptions required? I was recently told by a third party auditor that they were not required. Please clarify if you can.
Hi,

Maybe "Job Descriptions" as such are not required, however, ISO 13485:2003 requires:

6.2 Human resources
6.2.1 General
Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.
6.2.2 Competence, awareness and training
The organization shall
a) determine the necessary competence for personnel performing work affecting product quality,
...
How does one determine competence on the basis of appropriate education, training, skills and experience?... What is considered "appropriate"? In my opinion, this can only be consistently achieved if the "appropriate education, training, skills and experience" or "necessary competence" are documented and controlled; call it any way you like, these would qualify as job descriptions (in my opinion). So in a way I think yes, job descriptions are required, albeit under different terminology.

Cheers,
Ronen.
 

Marcelo

Inactive Registered Visitor
#7
Re: Registered Medical Device Manufacturer - Are documented job descriptions required

How does one determine competence on the basis of appropriate education, training, skills and experience?... What is considered "appropriate"? In my opinion, this can only be consistently achieved if the "appropriate education, training, skills and experience" or "necessary competence" are documented and controlled; call it any way you like, these would qualify as job descriptions (in my opinion). So in a way I think yes, job descriptions are required, albeit under different terminology.
This is related to the planning stage of your quality system processes, per the standard - for example, when you perform a process analysis. This information is better fitted in a process description.

A job description is a result of the planning, not planning. The QMS standards (ISO 9001 and ISO 13485 + others) do not require that you document these results, but you may need to document it in some way (and then you can create a job description with the required information) to show evidence. The standards just let it open so users can define the best way to deal with the required documentation.
 
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