EN ISO 13485:2016

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 offer 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 audits of medical device manufacturers.

The updated version of ISO 13485 was published in February 2016. The ISO 13485 Standard defines the requirements for medical device organizations to demonstrate whether their products meet the required criteria. The standard ensures that the design, development, production, installation and delivery of medical devices are carried out continuously with safety in mind. It also supports medical device manufacturers to ensure and maintain efficiency 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 force together. After February 2019, ISO 13485:2003 and the related European Standard EN ISO 13485:2012 certificates will no longer be valid.

What are the Main Differences in ISO 13485:2016 Version?

Some of the main changes for the final standard are as follows:

  • Harmonization of regulatory requirements
  • Inclusion of Risk Management in Quality Management Systems
  • Greater clarity on validity, verification and design issues
  • Strengthening supplier control processes
  • Increased focus on the feedback mechanism
  • Quality management standard, production and software for medical devices

Key Changes in the New Revision;

  • Article 4 Quality management system
  • Article 4.1 General Requirements
  • Article 4.2 Document requirements
  • Article 5 Responsibility of management
  • Article 6 Resource management
  • Article 6.2 Human resources
  • Article 6.3 Infrastructure
  • Article 6.4 Working environment
  • Article 7 Product Realization
  • Article 7.1 Planning Product Realization
  • Article 7.2 Customer Related Processes
  • Article 7.3 Design and Development
  • Article 7.4 Purchasing
  • Article 7.5 Provision of Products and Services
  • Article 8 Measurement, Analysis and Improvement
  • Article 8.2 Monitoring and Measurement
  • Article 8.3 Control of Non-Conforming Product
  • Article 8.4 Data analysis
  • Article 8.5 Development

Who is it suitable for?

ISO 13485, a standard that defines the specific requirements that quality systems must meet for organizations operating in the field of trade and manufacturing of medical devices, can be applied by all organizations that include the project, production, installation and supply phases of medical devices or related services.

As a result

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

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