ISO 13485: 2016 Medical Devices Quality Management System

What is ISO 13485 ?

    TS EN ISO 13485 Medical Devices Quality Management System Standard is the most reliable way for medical device manufacturers and suppliers to present their products to the market in a quality and fast way. It is also a guiding standard used by Competent Authorities and Notified Bodies in the inspections of medical device manufacturers.

    The updated version of ISO 13485 was published in February 2016. The ISO 13485 Standard has defined the requirements that indicate whether the products of medical device organizations meet the required criteria. The standard ensures that the design, development, manufacture, installation and delivery of medical devices are always carried out with safety in mind. In addition, it supports medical device manufacturers to ensure efficiency and protection in all business processes while establishing a Quality Management System.

    The new ISO 13485: 2016 is applicable to the entire supply chain and covers the entire product life cycle of medical devices.

    There is a 3-year transition period between February 2016 and February 2019. During this period, the old and new versions of the standard will be in effect together. After February 2019, ISO 13485: 2003 and the corresponding European Standard EN ISO 13485: 2012 certificates will not be valid.

WHAT ARE THE MAIN DIFFERENCES IN TS EN ISO 13485: 2016 VERSION?

Some key changes for the final standard are as follows:

• Harmonization of regulatory requirements
• Incorporating Risk Management into Quality Management Systems
• More clarity and clarity in validity, validation and design issues
• Strengthening supplier control processes
• Increasing the focus on the feedback mechanism
• Quality management standard, software for manufacturing and medical devices

Basic Changes With New Revision;

Article 4 Quality management system

Article 4.1 General Requirements

Article 4.2 Documentation requirements

Article 5 Management responsibility

Article 6 Resource management

Article 6.2 Human resource

Article 6.3 Infrastructure

Article 6.4 Work environment

Article 7 Product Realization

Article 7.1 Planning of Product Realization

Article 7.2 Customer Related Processes

Article 7.3 Design and Development

Article 7.4 Procurement

Article 7.5 Providing Products and Services

Article 8 Measurement, Analysis and Improvement

Article 8.2 Monitoring and Measurement

Article 8.3 Control of Unsuitable Product

Article 8.4 Data analysis

Article 8.5 Development

WHO IS IT SUITABLE FOR?

    ISO 13485, a standard that defines the specific requirements of quality systems for organizations operating in the field of trade and manufacture of medical devices, can be applied by all organizations that include the project, production, installation and procurement stages of medical devices or their services.

As a result;

• It will be possible for the products to show health, safety - security features and to meet the minimum requirements with EN ISO 13485 certification and CE Marking studies.
• It is a common language with the European Union and other countries in the production, sales and service of medical devices.
• It is closely related to the CE marking of medical devices.
• It is a very important guide in sterilization and hygiene.
• It has special conditions for sterile medical devices.
• It is a guide in determining the risk groups of medical devices.

    ISO 13485 Quality Management System Standard for Medical Devices can be applied to all institutions and organizations that work in the production of all products within the scope of medical devices and in the field of service activities.