Importance of Internal communication in ISO 13485

Internal communication in ISO 13485

Communication is considered to be one of the crucial factors in compliance with ISO 13485. Internal communication channels, as well as external is one of the most important roles in an organization. The internal communication channels have some strategic objectives. With the communication channels, the medical device company can do the following:

  • Increase the sharing of information between bodies
  • Help to detect problems and chances for improvement
  • Increase the processes in the organization and lead to their effectiveness
  • Promote and reveal to employees the importance of meeting requirements, customers’ and regulatory

Effectiveness of Communication channel

The effectiveness of the Communication channel is an important piece of a healthy medical device company. They create transparency and allow the efficient flow of data and information. The usefulness is measured by the following:

  • Awareness and understanding of employees with their relevant channels and knowledge of where to report and what information or data must submit
  • Verification that information reaches its destination at the right time

The reporting methods and relationships in a medical device company are defined by the communication channels and it will be planned in accordance with organizational structure and flow of processes. Each employee will know who reports to them or to whom they must report, what is requested to be transferred or to be received, and in what manner. Communication channels can be used for the enhancement of human resources – knowledge management processes (training and sharing of knowledge). The characteristics of effective channels are:

  • Bidirectional
  • Motivated
  • Active on all organizational levels
  • Clear and understandable

The ISO 13485:2016 standard implies that the responsibility of communication channels belongs to top management because it is a strategic decision. Effective communication channels will promote processes and encourage parties to share information and knowledge, but they do require a lot of resources.

Choosing the communication channels

Brochures, internal news mails or e-mails, training, periodic meetings, etc. are examples of communication channels. It is necessary, for each channel to define the frequencies of use and the type of data or information it will handle. But it can be planned using a different approach, review what the required information to be transferred is, and then plan the channels appropriately.

 A designated system could be implemented if it can be the process of handling customer complaints in the organization isn’t effective and parties are neglecting their duties that will encourage the process. Strategic communication channels that meet all the objectives are the following:

  • The business process management system encourages systematization and integration of management principles with the strategy of the company. It boosts its control and effectiveness by collecting data from defined organizational entities, analyzing it and releasing information needed to support decisions
  • Product life-cycle management is a system that wraps together under one application various areas and ranges that usually do not have direct contact between them and they might use different tools for communication. The system supports and encourages each to share its information
  • Enterprise resource planning system is the classic example of a communication channel that binds all of the medical device company’s activities and departments under one application and merges all processes to one level. The organizational entities communicate and share information through the system processes. The organizational bodies communicate and share information through the system processes.    

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2 replies to “Importance of Internal communication in ISO 13485”

  1. Stan says:

    Being clear in communication is essential.

  2. Kristen F. says:

    We all learned during the pandemic caused by the spread of COVID-19 that we need to think about the way of communication in such times. Many were working from homes, so the official channel for the communication should be defined. I’m always for the integrated solutions that offer more features in the one platform. Managing project, document files, chat…

    I read about such here:

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