Hello All,

During a recent certification audit we were dinged for not having approved job descriptions under revision control. We do have job descriptions for all positions that are approved by the HR department but, there is no revision on the actual document or an approval signature.

I am having trouble connecting the finding to an acual requirement or clause from the standard (13485:2003).

4.2.3 (Control of Documents) states that documents required by the QMS shall be controlled.
5.5.1 (Responsibility and authority) states that top management shall ensure that responsibilities and authorities are defined, documented, and communicated.
6.2.2 (Competence, awareness and training) states that the organization shall determine the necessary competence for personnel performing work affecting product quality; provide training; evaluate the effectiveness; assure personnel are aware of the importance of their activities; and maintain appropriate records.

None of these clauses specifically states that job descriptions are part of the QMS or that job descriptions need to be a controlled document.

Can anyone shed some light on this one?

Thanks in advance.

Can anyone shed some light on this one? Do the job descriptions contain qualification requirements? Do such documents summarize basic requirements which be used to determine competence? If so, such documents become part of your QMS, and thus would need to be "controlled".

Hello All,

During a recent certification audit we were dinged for not having approved job descriptions under revision control. We do have job descriptions for all positions that are approved by the HR department but, there is no revision on the actual document or an approval signature.

I am having trouble connecting the finding to an acual requirement or clause from the standard (13485:2003).

4.2.3 (Control of Documents) states that documents required by the QMS shall be controlled.
5.5.1 (Responsibility and authority) states that top management shall ensure that responsibilities and authorities are defined, documented, and communicated.
6.2.2 (Competence, awareness and training) states that the organization shall determine the necessary competence for personnel performing work affecting product quality; provide training; evaluate the effectiveness; assure personnel are aware of the importance of their activities; and maintain appropriate records.

None of these clauses specifically states that job descriptions are part of the QMS or that job descriptions need to be a controlled document.

Can anyone shed some light on this one?

Thanks in advance.

Do the job descriptions contain qualification requirements? Do such documents summarize basic requirements which be used to determine competence? If so, such documents become part of your QMS, and thus would need to be "controlled".


I agree with the response above with the following additions. What documents do you have which satisfy the requirements you listed from the standard. Job descriptions normally fit the bill perfectly, but if HR wants "their" documents excluded, what documentation exists which will satisfy the requirement? We had a similar situation where HR wanted to be "exempt" from any requirements. We had to create job summaries which satisfied the requirements, but did not require control of the job descriptions (HR documents). It was a big waste of time that should not have been needed, but it did get the job done. :bonk: Hopefully, you can illustrate the situation to others and can persuade them that controlling the job descriptions is the best way to handle the situation. In our case, the HR gang is too powerful and has the ear of the "Boss". :( Best of luck!

There is no written word (or paragraph) in the standard specifying exactly about “job description”… or even the requirements to document & control it… :nope:

…but here’s the hint :cool: …if you go to clause 6.2.2 stating the requirements for competence, awareness and training… the standard requires (one of the following) that the organization shall;

a) determine the necessary competence for personnel performing work affecting product quality… now, how the organization is going to determine the competence of their personnel if they don’t have document (e.g. job descriptions with the required minimum qualifications) specifying what competence level is required for personnel performing certain task? this is also being used during recruitment process...

d) ensure that its personnel are aware of the relevance and importance of their activities and how their contribute to the achievement of the quality objectives… now, how the organization is going to ensure this kind of awareness if they don’t have a process similar to the orientation where the human resource department supposedly orienting new employees, telling them not only their benefits and company’s rules & regulation but as well as how they are going to be valuable to the company? what documents they are going to use? and how they are going to be evaluated by their superior in absence of this document as basis?

I have also experienced the same dilemma with my previous company HR Dept… they simply wanted to be invisible… :rolleyes: and I let them… but during the audit, I raised so many NCR’s to them for having no evidence of complying clause 6.2.2…

It's clear that job descriptions, per se, are not required by ISO 13485. If your organization has them as part of your own QMS, and/or they define people's responsibilities/authorities and they are referred to in your QMS documentation in some fashion, then yes, they have to be controlled.

However, your post suggests the auditor is looking for more than that; revision numbers and signatures on the job descriptions - even if they are part of your QMS - are not required as part of a control system. You only need to show that these documents are under control/approved, which (quite frankly) doesn't mean having signatures or a rev. number/letter.

Your auditor is reporting the wrong thing and putting their 'spin' on what they believe document control requires - unless your own doc. control procedure says you'll have sigs and numbers on your docs.............