Training effectiveness is one of the key requirements associated to Quality Management System according to ISO 13485. Having adequate methodologies for delivery of training and evaluate effectiveness of this training is a must for an organization that wants to claim compliance with ISO 13485 requirements. Within the quality system, there are a lot of processes where specific training and competencies of the personnel must be demonstrated, for example risk management and design control, or validation activities, just to mention some of them.
ISO 13485 Requirements related to Training and Training Effectiveness
The ISO 13485 defines the requirements Human Resources in the section 6.2. The chapter describes the whole requirements for management of human resources in terms of education, training, skills and experience. First of all, it is important to highlight that the standards require that only personnel performing work affecting product quality shall be competent in terms of training and experience.
Let’s see how it is possible to cover the specific requirements we have just be mentioned above:
If we focus on the specific requirements associated to the personnel, we have 5 specific topics that should be covered by the Quality Management System of the organization:
- determination of the needed competence for personnel performing work affecting the quality of the medical device(s);
- provide training to the personnel performing work affecting the quality of the medical device(s);
- Perform an evaluation of the effectiveness of the actions taken;
- ensure awareness of the personnel for the importance of they activities when these are affecting product quality.
- document specific records for education, training skills and experience.
We would like here to focus on the requirements associated to the evaluation of the effectiveness of the training. At the end of the section 6.2 of the ISO 13485, there is a “Note” which explains that the methodology used for evaluation of the effectiveness of the training shall be proportional “to the risk associated with the work for which the training or other action is being provided”. We are going to focus on a simple methodology that might be used for the implementation of a risk-based approach for training effectiveness evaluation.
Risk-Based Approach for Training Effectiveness Evaluation
There might be plenty of different methodologies that could be used for the evaluation training effectiveness. Here we present a basic methodology for the implementation of the risk-based approach for training management.
It is possible, for example, to define different levels of Learning Objectives depending from the job performed by the trainee. For example it, could be possible to have:
Once the learning objectives have been defined, it is then possible to select the type of training which can be associated to the specific learning objectives. For example:
The combination of these different tables can be summarised in a training matrix, where for every personnel and for a specific training associated to a that personnel, it is possible to define the level of learning objectives and the type of training performed, and thus different types of effectiveness check.
It is very important highlight that this methodology allows the implementation of a risk-based approach both for the training methodology and for the training effectiveness check.
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Conclusions
In conclusion, we have been providing specific examples of methodology that could be used for training effectiveness evaluation. This is of course just one of the different methodology that could be used. This is a standard method that could be easily implemented in an organisation by means of a training matrix.
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