Training for ISO 13485 Implementation: A Vital Step
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Implementing a Quality Management System (QMS) for your medical device manufacturing company using ISO 13485:2016 can be a challenging task. Along with understanding what needs to be done to meet the standard’s requirements, you’ll need to ensure your employees are well-trained. Training is often a hidden yet crucial task during QMS implementation.
ISO 13485 Training Requirements
Under ISO 13485:2016, all personnel dealing with quality processes and specialized tasks need the necessary skills and competency. Competency can be gained through education, training, skills development, and experience. The standard requires the following:
Document Skills and Training Needs: Identify the skills, training, and experience needed for each person. Document how training needs will be met.
Maintain Training Records: Keep records of all training programs, such as certificates of attendance and tests of knowledge.
Assess Training Effectiveness: Evaluate training effectiveness through exams or tracking non-conformances caused by errors.
Awareness of Impact on Quality: Ensure individuals understand the relevance and importance of their work and its impact on product quality.
Periodic Training: Provide regular training to maintain high skill levels.
Taking a risk-based approach to training is advisable. The higher the risk associated with the work, the greater the need for training. Training and effectiveness checks should be proportionate to the risk involved.
Additionally, ISO 13485 emphasizes the need to provide training to end users of medical devices to ensure safe usage.
Critical ISO 13485 Training Courses
Some of the most critical training courses for ISO 13485 include the internal audit training course and the lead auditor training course.
ISO 13485 Internal Auditor Training
This training is typically a two- or three-day course based on the ISO 13485 Lead Auditor Training. It does not include an exam and does not lead to individual certification for auditing external companies. However, participants receive a certificate of completion.
ISO 13485 Lead Auditor Course
This is a four- to five-day training course, including an exam at the end to verify the attendee’s knowledge and competence. The course focuses on understanding the ISO 13485 QMS standard and using ISO 19011 guidelines for auditing management systems. It often includes role-playing different auditing scenarios.
The course must be delivered by an accredited provider, and only an accredited course allows participants to attain certification as an ISO 13485 Lead Auditor. This certification enables individuals to audit a company’s QMS against the ISO 13485 standard. Implementers of ISO 13485 also use this course to learn more about the standard and the criteria used by certification bodies.
Training Providers for ISO 13485
Many certification bodies provide ISO 13485 training, especially the Lead Auditor Training. Some common providers include BSI (British Standards Institution), TUV Rheinland, and SGS International. It is essential to choose a globally recognized accredited training provider.
Making ISO 13485 Training Work for You
Training is a vital component of ISO 13485 implementation. Ensure you document training needs, maintain records, and assess effectiveness. By investing in critical training courses like internal auditor and lead auditor training, you can ensure your team is well-prepared to maintain a robust QMS.
