The new 13485 standard requires we prove compentence in our training for employees and also at what level they are trained at. What is a simple way to do this.

The new 13485 standard requires we prove compentence in our training for employees and also at what level they are trained at. What is a simple way to do this.

There are many ways to do this. In our company, we define the training and skills needed for each department in a list form with blocks for signoffs for each item. At the end of a new hire's 90 day evaluation period, the supervisor determines if all training was effective and if they are competent to do the work. If they are, they sign off on the training checklist, otherwise, they request an extension of the probationary period.

Whenever an employee transfers to a new department, their supervisor starts another training checklist specific to that department. The safety and most of the Quality items will carry over, and they may only need the on-the-job items.

We take training effectiveness a bit further by reviewing during Management Review, and by including a section on our appraisal forms for recommended training and re-training. This is done by the supervisors during employee evaluations.

I am attaching one example of our training checklist for you to look at. Good luck!

The new 13485 standard requires we prove compentence in our training for employees and also at what level they are trained at.

No it doesn't, at least not quite. ;)


The standard says this:

6.2.1 Personnel.....shall be competent on the basis of appropriate education, training, skills and experience.

6.2.2.b The organisation shall provide training....to satisfy these needs.

6.2.2.e The organisation shall maintain appropriate records of education, training, skills and experience.


So it may be that your staff arrive fully competent and never require training. Uncommon, but not impossible.


To answer your second question:

Work out the processes / activities that occur.*
Record this data
Work out the competencies required to perform those activities
Record this data
Work out how to determine whether an individual is competent to perform those activities
Provide appropriate training or other action to close any gaps
Confirm competency following training
Record this data
Reconfirm competency at appropriate intervals, and when anything significant changes.
Record this data

Many organisations use a combination of job descriptions, CVs, process descriptions and/or competency matrices to achieve this.


*note that being able to supervise/train other people is an activity in itself.

Does it not state in the new standard about levels of compentence

As people found in a recent seminar I attended. 6.2.2 is my favorite "tack on" for almost any human related breakdown to the process. I believe that the questions is going toward 6.2.2 c from ISO 13485:2003

6.2.2 Competence, awareness and training
The organization shall

c) evaluate the effectiveness of the actions taken,

Which when taken with a, b, & d means that you would have use some form for competence, training, and skills.

I think the approach of katydid would work, since this is one element that I am working on. If a person comes totally competent, how did you evaluate this against your criteria?

I like Katydid's form because it's a direct approach that can be used for startup training, and it is adaptable for specific departmental training needs.

A checklist can include blocks to check for verifying knowledge of theory and demonstration of competence. Both of these can be simply run through with competent incoming people to ensure their skills in truth are aligned with the organization's needs. Simple tasks won't require much such evidence, just what's required by law. However, if a person is running a highly complex machine that makes sensitive or costly parts I would surely want evidence the skills are as described in whatever other evidence (documents and references) the new hire provided.

I don't agree that employees can come in fully trained because every organization has, in the least, some startup needs that must be trained to. Federal requirements including Right to Know, and the QMS are two examples.

I feel exasperated with companies that expect their people to come in and function without more than a how-do-you-do with the systems they will be working in. Building a feeling of confidence (among wage employees) and establishing effective communications (among interdepartmental salaried staff) is hard to do without a decent indoctrination.

I don't agree that employees can come in fully trained because every organization has, in the least, some startup needs that must be trained to. Federal requirements including Right to Know, and the QMS are two examples.

I feel exasperated with companies that expect their people to come in and function without more than a how-do-you-do with the systems they will be working in. Building a feeling of confidence (among wage employees) and establishing effective communications (among interdepartmental salaried staff) is hard to do without a decent indoctrination.

Well of course the standard does include a specific note that national or regional regulations might well play a part.

However the standard applies to competence in those activities affecting product quality. Knowing where the fire escape is located is certainly important, but not a requirement of ISO13485 per se . :mg: :D


Also it is not absolutely true that companies always need to train their new staff, national regulations aside.

Two-man start-up companies generally couldn't operate if the two founding employees didn't have a decent grasp of what was required to get the product made. This doesn't remove the requirement to confirm their competence, but it may well remove the need for initial training.

If and when their company expands, everything you said above would certainly apply. :)

We use a method similar to what Katydid outlined. We were dinged in a recent audit for not having a gap analysis of training effectiveness for promoted employees.

In the case of formal/classroom type training, we have a short quiz at the end of the session. The quiz is included in the employee’s training record. This seems to satisfy the auditors,.