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How to perform ISO 13485 training

Implementing a Quality Management System (QMS) for your medical device manufacturing company using the requirements of the ISO 13485:2016 standard can be difficult. Along with figuring out what needs to be done within your organization to meet the requirements of the standard, and implementing these processes, you will also need to ensure that you have the training in place so that your employees understand what they need to do and why. Training for ISO 13485 can be one of the biggest hidden tasks that is forgotten during QMS implementation.

Below is information on what the ISO 13485 standard requires for your training, as well as information on some of the most critical ISO 13485 training courses you need to consider in your organization: the internal audit training course and the lead auditor training course.

ISO 13485 training requirements

Under ISO 13485:2016, all personnel dealing with quality processes and specialized tasks need to have the necessary skills and competency to execute their roles. Competency can be gained through education, training, skills development, and experience. The standard requires the following:

  • You must document how you will identify the skills, training, and experience needed for each person. Next, training needs are to be identified, such as how to solder or learn the skill of inspection. The frequency of training and how awareness is to be created should also be documented.
  • The records of all training programs, such as certificates of attendance, attendance sheets, or even tests of knowledge, are to be maintained. Typically, these records are managed as employee files along with certificates. The competency of the trainer is also documented, through the documented choice of training organization, or in-house “train the trainer” testing.
  • Training effectiveness must be assessed, such as testing the knowledge via exams, or tracking the non-conformances caused by errors after testing is performed.
  • Each individual involved in a critical process needs to be fully aware of the relevance and importance of his/her work and its impact on product quality and quality objectives.
  • For some skills, it is advisable to have periodic training to maintain the high level of skill required in the organization.

You will want to take a risk-based approach to training as a best practice. The higher the risk associated with the work, the higher the need for training. Both training and effectiveness checks should be proportionate to the risk involved in the person’s work and impact on quality. The standard encourages manufacturers to look at training as a risk mitigation tool to minimize human errors, deviations, and non-conformances. Often, when the root cause of a non-conformance is determined, it turns out to be inadequate training.

Additionally, ISO 13485 emphasizes that it may be necessary to provide training to the end users of the medical devices manufactured by the organization. Such training may be required to educate the user to use the device safely.

For a helpful presentation for training your employees on ISO 13485, see this free ISO 13485:2016 training presentation: Why ISO 13485? – Awareness presentation.

ISO 13485 Internal Auditor Training

Some of the most critical ISO 13485 training courses that you need to include are those for the employees who will be performing the internal audits for your QMS. These individuals will need to understand not only the requirements of the ISO 13485 standard and you own internal processes, but also the involved process of performing a management system process audit.

The ISO 13485 Internal Auditor Training is commonly a two- or three-day training course that is based on the ISO 13485 Lead Auditor Training described below. The course does not include an exam and does not lead to an individual certification to audit external companies; however, a certificate of completion is presented.

ISO 13485 Lead Auditor Course

The ISO 13485 Lead Auditor Training is a four- to five-day training course and includes an exam at the end to verify the knowledge and competence of the attendee. The course will focus on understanding the ISO 13485 Quality Management System standard and using the ISO 19011 guidelines for auditing management systems to assess company processes against these requirements. Role play of different auditing situations will often form part of this training.

The course can only be delivered by a company that itself has been accredited to present ISO 13485 Lead Auditor Training, and it is only with an accredited course that a participant can attain certification as an ISO 13485 Lead Auditor. After this, it is possible to be hired by a certification body (companies that can grant ISO 13485 certificates to companies) to audit a company’s Quality Management System against the ISO 13485 standard. This course is also used by implementers of ISO 13485 in order to learn more about the standard and to find out the criteria that will be used by the certification bodies.

See the main similarities and differences between these two trainings in the table below:

ISO 13485 training requirements & available courses

Where can you go for ISO 13485 auditor training?

Many of the companies that provide ISO 13485 training, especially the ISO 13485 Lead Auditor Training, are the certification bodies themselves. Some of the more common companies are BSI (British Standards Institution), TUV Rheinland, and SGS International.

There are many other providers, but if you are going to obtain a Lead Auditor Certification, it is good to look for a training provider that holds an accreditation that is recognized globally rather than locally.

For more information on ISO 13485:2016 training online, see our free webinars at: ISO 13485 Webinars.

Advisera Kristina Zvonar Brkic
Kristina Zvonar Brkic
Kristina Zvonar Brkic is an experienced consultant, auditor, assessor, and trainer for ISO 13485 and the EU MDR. She runs a thriving ISO 13485 consulting practice and helps companies and consultants to build their businesses. In her career, she also worked as an ISO 9001 and ISO 22716 consultant and lead auditor, and as an auditor and assessor for the MDD.

The portfolio of medical devices for which she has approval is plastic products with measuring function, various creams and gels, different systems for wound care, disinfectants, different catheters, panels for operating rooms and clean rooms, accessories and kits for performing surgical procedures of non-woven materials, medical gases, and various dental materials.
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