ISO 13485 is issued by the International Standards Organization (ISO) in the Quality Management System standard 2003 for Medical Device Manufacturers. This standard, which constitutes the Quality Management System in the medical devices sector, has been prepared with the aim of applying EN 550 standards and ISO 46000 Quality Management System standard, which includes the EN 9001 series sterilization process prepared for medical device manufacturers before.

ISO 13485 The Quality Management System for Medical Device Manufacturers prepares the conditions required by companies producing or supplying medical devices to demonstrate their ability to meet customer needs and the requirements of legal regulations. The main purpose of this system is to facilitate the conditions of medical device legislation which are harmonized with quality management systems.

The scope of the ISO 13485 standard is as follows:

1. Scope

2. Cited standards and / or documents

3. Terms and recipes

4. Quality management system

5. Management responsibility

6. Resource management

7. Product realization

8. Measurement, analysis and improvement

In order to implement the TS EN ISO 13485 Medical Devices - Quality Management System standards and ensure the continuity of the application, TURCERT certification bodyIn addition to certification studies, it also provides consultancy and training services. The training subjects of the TURCERT certification body regarding the TS EN ISO 13485 Medical Devices - Quality Management System are as follows:

  • TS EN ISO 13485 Medical Devices - Quality Management System Training
  • TS EN ISO 13485 Medical Devices - Documentation Training

From these trainings, TS EN ISO 13485 Medical Devices - Documentation TrainingQuality Policy, Quality Objectives, Quality Manual, which are required to be prepared during the establishment of this system, the processes foreseen by the standard and the preparation methods of the support documents to ensure the implementation and supervision of these processes are given.

The main topics of ISO 13485 Medical Devices - Documentation Training given by the TURCERT certification body are:

  • Document structure of quality management systems
  • Preparation for documentation
  • Process approach and where to start
  • Documentation for levels and methods of preparation according to their level
  • Rules for writing procedures
  • Methods of preparation of processes, application instructions, charts, forms and similar supporting documents
  • Case studies

It is imperative to continue these trainings to achieve the expected benefit of ISO 13485 Medical Devices - Documentation Training, which is a two-day training. Persons participating in this training should have already received ISO 13485 Medical Devices - Quality Management System Training. At the end of the training, the certificate of achievement is given to the successful participants and the participant certificate is given to the others.

The instructors of the TURCERT certification body are also experienced and specialized in this area and many examples are shown during these trainings. This is also possible if the company requires training to be provided in their work environment.

If more information is required on ISO 13485 Medical Devices - Documentation Training or if you wish to provide this training, the experienced staff of the TURCERT certification body will be there for you.