ISO 13485:2016 Section 6.2 - Documenting the process for establishing competence

J

james

Hello,

I am trying to satisfy ISO 13485:2016 section 6.2 Human Resources and I got stuck on how to go about documenting the process for establishing competence, do I have to create an SOP or does our Training SOP cover this?

Thanks,
James
 

racglobal

Involved In Discussions
Hello
The staff training SOP covers the process for establishing competence or the method by which you would evaluate training effectiveness. One staff training SOP should cover it.
 

AndyN

Moved On
Hello,

I am trying to satisfy ISO 13485:2016 section 6.2 Human Resources and I got stuck on how to go about documenting the process for establishing competence, do I have to create an SOP or does our Training SOP cover this?

Thanks,
James
Who is responsible in your organization for training people? Maybe instead of you doing this, they might be able to help.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Is this in regards to competence for hiring people to do work or competence in training them?
 

JoshuaFroud

Involved In Discussions
At my organisation, we document this, by using two training matrices. One covers competency assessed processes and is updated quarterly with the shifting competency of the team. Each of the relevant staff members have a row against the tasks (columns), the staff are rated, "Skill not required", "Skill required", "Under Training", "Competent", "Trainer". This allows at a glance to see who is able to do each of the relevant competency assessed skills.

The other training matrix is "read and understand" of each of the Quality Procedures, each staff member has a list of assigned Quality Procedures relevant to their role, as and when they are updated they are notified by our document management system that an updated has been made, they read and acknowledge the procedure and the matrix is updated.

The handling of both of these matrices is covered by our training procedure. This was accepted as suitably addressing the requirement when we transitioned to 2016.

To answer your question directly, no, you do not require a separate procedure on competency it can be captured in whichever procedure you wish as long as it is captured somewhere and can be demonstrated to be fit for purpose, if and when required.
 

John Broomfield

Leader
Super Moderator
Recruiting and training for competence suggests this is a process owned by HR if you have such a function. If not it could be owned by the person who does most of your recruiting.

Work with that person and you may find it starts with supervisors specifying the required competence in terms of abilities, skills and knowledge.

Note that training alone does not necessarily deliver the competences required..
 
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