ISO 13485:2016

ISO 13485:2016

The ISO 13485 standard was created on the basis of the ISO 9001 standard, an international standard that includes special requirements for medical devices.

In addition to meeting the legal requirements, medical device manufacturers who want to gain competitive advantage must prove that they comply with the requirements of the quality management system.

Medical device manufacturers feel the need to establish and certify a quality system in order to meet current legal requirements, to ensure customer satisfaction, to increase internal efficiency and to create legal assurance against lawsuits.

The EN 46001 / ISO 13485 Management System includes additional specific requirements for medical device manufacturers, including the ISO 9000 Quality Management request requirements.

This Standard covers quality management system requirements for an organization that must demonstrate its ability to provide medical devices and consistently meet customer needs and regulatory requirements applicable to medical device related services. The main purpose of this standard is to facilitate harmonized medical device legislation requirements for quality management systems.

The ability of medical device manufacturers to operate in the European Union and the North American market depends on overcoming many legal obstacles. In many countries, especially in Canada, some types of medical device manufacturers are required by law to establish a quality management system in accordance with the ISO 13485 standard.

It is the latest version of ISO 13485: 2016 standard 13485. It is based on ISO 9001: 2015 risk and process approach model.

Quality System services for Medical Device Manufacturers

  • General Check-Up (Analysis of the current situation)
  • Determination of processes
  • Determination of Critical Control Points
  • Determination of the Project Manager and Team
  • ISO 13485 Standard training
  • Internal quality audit training
  • Document review
  • Pre-audit preparations passing

13485 Establishing the Quality Management System

  • Getting Standard Training
  • Determining the Working Team and Strategies
  • Creating the Quality Handbook
  • Creating Support Procedures
  • Implementing the System
  • Application for
  • Certification • Certification Audit