ISO 13485: 2016

ISO 13485: 2003 Medical Devices Quality Management System Standard
The ISO 13485: 2003 standard is an international standard, which is based on the ISO 9001: 2000 standard.

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

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

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

This Standard covers the quality management system requirements for an organization that must provide medical devices and demonstrate the ability to consistently meet customer requirements and applicable regulatory requirements for services related to medical devices.

The main objective of this standard is to facilitate harmonized medical device legislation requirements for quality management systems.

The fact that medical device manufacturers operate in the European Union and North American markets depends on overcoming many legal barriers.

In many countries, particularly 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.

ISO 13485: 2003 is the latest version of the standard 13485.

It is based on ISO 9001: 2000 process approach model. ISO13485: 1996 and 13488: 1996 are older models that are not based on the process approach (ISO 13485: 1996: ISO 9001: 1994, ISO 13488: 1996: ISO 9002: 1994).

Quality System Services for Medical Device ManufacturersGeneral Check-Up Determination of Processes Determination of Critical Control Points Determining Project Manager and Team ISO 13485 Standard Training Internal Quality Supervision Training Document Review

Revision of pre-audit preparations 13485 Establishment of a Quality Management System Standard Training in the determination of the work team and the creation of strategies Quality Manual Creation of Support Procedures Implementation of the System Application Certification Certification for Certification