#ISO 13485:2012 ISO#
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.
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.Ĭertifications are issued by third party certifying bodies.
ISO 13485:2003 remains the applicable standard for all other international markets, including the U.S.ĮN ISO 13485:2012 is a certification intended for organizations that provide medical devices. The standards' requirements remain unchanged and the updated revision is only applicable to manufacturers placing devices on the market in Europe. The package process is easy to understand with our video tutorials and remote consultancy, you will be able to secure savings above 80 than having an on-site consultant. 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. With our ISO 13485:2012 kit you will be able to implement the standard on your own steam. The standard includes portions of ISO9001 but excludes some clauses that are not appropriate for the regulatory requirements. 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".
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