Regulatory

Medical Device: ISO 13485 Training Requirements

In regulated environments, training is necessary to make the concept of quality a reality. It’s the reason why quality regulations and standards require a formal training control and management process. ISO 13485 training requirements are meant to help medical device manufacturers and suppliers achieve that goal. The standard was updated in 2016 to address technological advances and adapt to a changing regulatory landscape.

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21 CFR Part 820 – ISO 13485 Harmonisation

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White Paper: cGMP and ISO 13485 Integrated Quality Management System White Paper: Ten Signs Your CEO Still Has No Idea About ISO 9001 and Lean
Industry Brief: How Effective Training Management Can Help You Prevent Quality Issues
FAQ: 21 CFR Part 820 – ISO 13485 Harmonisation
Summary: ISO 9001 Compliance Requirements

What to Expect from ISO 13485:2016 Training

While there’s no change in ISO 13485’s training requirements themselves, there’s an added emphasis on the assessment of competency. The wording of ISO 13485:2016 training-related provisions encourages certification bodies to focus on assessing the effectiveness of ISO 13485 courses instead of simply verifying that the training occurred. The standard also encourages medical device companies and suppliers to consider the training process as a way to minimize human error and a preventative measure against poor quality. Inadequate training and human error are common causes of deviations and nonconformances.

Implications of ISO 13485:2016 Training

Training implies managing people and making sure they have the right skills. The goal of ISO 13485’s training provision is no different. Personnel must have the right education for their jobs and their training must be commensurate with their impact on the quality of the product. The quality system must include a training process that defines acceptable levels of competence. Here are some of the ways training coordinators and managers can evaluate training competence:

Conduct a written test following any training. This is the standard method for assessing competence.
Conduct a competency-based performance review. This includes evaluating an employee’s goals, accomplishments, and behavior over a certain period.
Conduct regular refresher training. It’s the best way to help employees remember the basics and at the same time keep up with changes.
Require ISO 13485 certification for jobs critical to quality. Certification boosts the confidence not only of the employee but also customers.
Inspection of employee’s work. There’s nothing better than seeing a person perform the actual work.
Conduct a follow-up inspection or two, if necessary, until the employee’s performance is up to par.

ISO 13485 Training and the Concept of QP

Under ISO 13485:2016, training on quality processes and establishing personnel competency are crucial. Medical device manufacturers must make sure that training is commensurate with the risks associated with an employee’s job and its corresponding impact on quality. The concept is in the vein of the role of a qualified person (QP) in the pharmaceutical industry as required by European Union (EU) regulations. A QP is responsible for appraising the safety of every batch of medicine manufactured. The EU Commission has proposed that the QP requirement also cover medical device companies.

Employee’s knowledge of applicable requirements found in ISO 13485, FDA regulations such as 21 CFR Part 820, and other relevant rules.
Appropriate skills for employees who have been reassigned to new positions.
Adequate skills for employees whose positions have changed.
Record of employee’s training and test results.
Record of employee’s résumé and job description.
Record of certifications and performance reviews.

How MasterControl Can Help You

Hundreds of companies worldwide use MasterControl to comply with ISO 13485 training and other quality requirements. MasterControl Quality Excellence (Qx) combines a cloud-based quality management system (QMS) with configurable products and platform functionality to automate and improve training control, document management, corrective action and preventive action (CAPA), and other quality processes throughout the lifecycle.

MasterControl Qx facilitates compliance, increases operational efficiency, fosters product quality, and accelerates time to market through automation. The solution includes MasterControl Training, which streamlines processes and improves training management by automating the assignment of tasks, distribution of training materials, testing, and verification. It’s designed to address the most stringent regulations and standards, including ISO 13485:2016 training requirements.

Trusted by Regulators and Regulated Companies

Whether your company is trying to establish a training management process from scratch or improving your existing process, take advantage of the latest technology when choosing a training platform. Hundreds of medical device and other life science companies, as well as regulators, trust MasterControl. Over a dozen federal and state agencies use MasterControl as their quality management system.

MasterControl product managers come from the life science industry and other regulated environments. Their expertise covers compliance with FDA, MHRA, EMA, and MHLW regulations, in addition to ISO 13485 training standards. For more information about MasterControl solutions, contact a MasterControl representative today.