Human resources in ISO 13485

human resources skills

This part of the standard explains how employees whose actions impact product quality that has to be qualified to work on products based on their background, education, training, skills, and experience.

The main focus of improving the human resources sector is to provide the organization’s employees with the ability to perform their job and planned activities.

It’s very important the connection between qualified employees, the implementation of a QMS, and maintenance of its effectiveness. In the organization, employees are responsible for the realization of medical devices and meeting requirements, regulations, and customers.
For success, a medical device company has to combine human resources and knowledge, in other words, the training of employees is unavoidable. And it will undouble increase the effectiveness of the QMS.

Identifying the training needs

To get effective training and certification you must first identify what certain training requires. Its purpose is to support the employees performing better and more effective in their tasks. The aim is to introduce them with skills, knowledge, and professional and organizational approaches.  

Training is usually required when is needed:

  • To support organizational processes
  • Improvement of knowledge and skills
  • Introduction of innovations in the organization
  • In case of hiring and introducing new employees

It goes without saying that in each organizational structure, different workers do different tasks. And they are all doing it for the same shared goal, creating a medical device. Hence, it must be defined as the level of qualifications and skills that the employee needs to possess to perform their tasks. This is usually managed by the personnel responsible for human resources. Some elements and job characteristics must be defined and documented, as ISO 13485:2016 standard requires:

  • Education will be the preconditions for the hiring of personnel for specific roles
  • Regulatory requirements – if it requires a certain certification according to a law or a standard, it will be stated as a precondition for hiring an employee
  • Experience – defines the scope of experience and background as well as areas and scopes of activities
  • Certification – the manufacturer will define a certification plan or process needed to introduce a person to a specific role
  • Training – according to the job position manufacturer will provide it

The end goal is to make sure that only qualified employees can do certain tasks and human resources will make sure that all this will be documented.

Certification plan

Each employee that is involved in the realization of the medical device is obligated to go through a planned and documented process of the organization’s introduction and the relevant processes. The plan covers the following:

  • Introduction of the organization
  • Administrative issues
  • Introduction to personnel in the organization
  • Introduction to the zones and areas in the organization
  • Things like working hours, vacations, social conditions, etc.
  • Designated realization and quality processes

Training plan and it’s types

The organization is required to plan training or other activities to satisfy the necessary skills. the point is to fill in the gaps between the current skills and the desired skills. Someone with a background in a specific field should create effective training that will truly help and assist employees.


The organization can define training as online tutoring or self-learning. The purpose stays the same, just a method needs to be defined. Here are a few possible trainings:

  • Frontal training
  • E-learning courses
  • Purchasing literature for special training 
  • External courses
  • A visit to suppliers’ facilities
  • A suppliers training about his products

Training effectiveness evaluation

Every type of training has a specific goal. Of course, that goal has to be in order to support and/or promote the organization’s values.

Evaluation is absolutely necessary because it will identify if the training was effective or not. It has to be done periodically and should include physical examinations. And last but not least important, for training needs, each employee will be evaluated.

Employee Awareness and motivation

Training is one of the methods of implementing the policy and achieving the goals. Here is really important that the employees be aware of hierarchy and to understand the relevancy, relation, and effect of their actions and activities on achieving the quality objectives.

They must be aware that their activities and expected output promote the quality objectives of the organization. Such awareness will create the identification of employees with the quality objectives and initiate the motivation to meet them.

The employees must understand that they are bearing the operative responsibility of achieving the objectives. By demonstrating during the training, the organization can show them the relationship between the results of their actions and the quality objectives.

Expected Documentation and records

The issue of planning and managing human resources demands the establishment of certain documentation and the maintenance of records. The requirements for documentation is the following:

  • Training needs – definitions of qualifications and training needs according to function role
  • Certification plan – list of activities and training required to introduce the employee to a specific function or job
  • Training plan – there is no requirement to document the plan, but it will assist in following the implementation of training
  • Evaluation of employees – a plan that specifies the parameters for assessing and evaluating employees and proposes topics for discussion between the employee and his supervisor

The documentation is intended to be submitted to the documents control process on the organization as required in the ISO 13485:2016 standard, in subclause Control of Documentation. If the organization is planning and maintaining a set of forms for the training records these forms will be submitted to the control of documents.

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2 replies to “Human resources in ISO 13485”

  1. Vincent C. says:

    Interesting that you said that because in our company we are changing HR manager every year. Just can’t get it what’s wrong?

  2. Victor M. says:

    I have to emphasize that you never know, or you can’t predict what employees are going to do next. I am just trying to say that it’s super important to have strong HR!

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