Key mistakes to avoid in your Training Process [ISO 13485]
26 APRIL 2022
Trinzo discusses how to avoid non-conformances in your training process with Easy Medical Device
The training process can create a lot of non-conformances during audits. Trinzo’s Training CoE Lead, Katie Cooney and Regulatory CoE Lead, Rod Beuzeval, discuss with Monir El Azzouzi at Easy Medical Device what makes a compliant training process and the key mistakes to avoid.
Time again, the same mistakes come up when auditing training procedures within your Quality Management System. ’’You have to be confident you have the evidence to prove the competences for your role’’ explained Rod. Lack of competency evidence is one of the key mistakes seen during a procedure audit and plugging the gap can be a challenging task.
‘’I’ve seen a lot of cases where the auditor has asked to see documentation to prove training in specific areas’’ explained Monir.
It is favoured for companies to employ external providers to create training tailored to their knowledge gaps and external training certification is just one of the ways you can provide the evidence required by ISO 13485. But, it’s not just the certification you need to be concerned about – effectiveness monitoring and content validity is just as important.
Effectiveness monitoring is a process you need to have in place to demonstrate the learning objectives of the training have been met. Can your team now perform the tasks expected, to the standard required?
Competency and content validity is another key area the auditor is interested in. Will the Notified Body recognise my training? There are many ways this can be addressed and be sure to have copies ready for your audit:
Trainer experience. Do you have a copy of the trainer CV?
Certification. Have you received a certificate for the training? Did you pass an examination? Is your training file complete, with no gaps?
Content. Do you have a copy of the training material? Is the training a relevant level for your role?
Your CV and Job Specification. Do you have copies of your CV, degree certification and job specification readily available? Does your job description clearly define the levels of competency required?
Watch the full podcast now at: Training Process - What are the mistakes to avoid? [ISO 13485] (easymedicaldevice.com)
About Trinzo and Meddev Solutions
Trinzo is a medical device and pharmaceutical consultancy firm that excels at compliance, regulatory and project management issues. Founded in 2015, Trinzo creates bespoke solutions for clients globally on a project basis and finds the route of structural issues. In 2021, Trinzo announced the acquisition of Meddev Solutions – a training firm for the medical device industry. Meddev Solutions offer bespoke training packages tailored to your internal knowledge gaps and use industry-leading methodologies to understand your teams preferred learning style to ensure the content and delivery method is impactful.
About Easy Medical Device
Easy Medical Device is a consulting firm that helps Medical Device manufacturers all over the world to place compliant Medical Devices on the market. Their mission is to support Medical Device manufacturers with their objectives of design, development, manufacturing, maintenance, distribution, representation in diverse region and monitoring devices on the market.