EN ISO 13485:2012 Definition

EN ISO 13485:2012 is a company level certification based on a European established revision to the standard developed and published by the International Organization for Standardization (ISO) titled "Medical Devices-Quality Management Systems-Requirements for Regulatory Purposes". The standard includes portions of ISO9001 but excludes some clauses that are not appropriate for the regulatory requirements. This revision of the ISO13485: 2003 standard, which only affects the foreword and annexes of the document, was created by the European Committee for Standardization (CEN) version in order to be compliant with CE-marking requirements. The standards' requirements remain unchanged and the updated revision is only applicable to manufacturers placing devices on the market in Europe. ISO 13485:2003 remains the applicable standard for all other international markets, including the U.S.

EN ISO 13485:2012 is a certification intended for organizations that provide medical devices. The standard puts an emphasis on regulatory requirements, custom requirements, risk management and maintaining effective processes such as safe design, manufacture and distribution of medical devices.

Certifications are issued by third party certifying bodies. For an organization to maintain EN ISO 13485:2012 certification, they will be subjected to annual or regularly scheduled audits where the organization's compliance with the standard is evaluated by the certifying body.

Related Certifications
ISO 13485
ISO 13485:2003