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ISO 13485:2016 Quality System for Medical Devices

Is your organization prepared for the ISO 13485:2016 revision?

Is your organization prepared for the new ISO 13485:2016 revision? A revision of the standard ISO 13485:2016 for Medical Devices has been published in February 2016 with a three year transition period. This means that the ISO 13485:2016 standard will be in force in February 2019.

Invalid certificates ISO 13485:2003 & 2012.

Important is that after February 2019 the certificates from the earlier versions of the ISO 13485 standard (2003 or 2012) are not valid anymore and the certificate must be issued on the basis of the ISO 13485:2016 version.

Consequences for Quality Management Systems.

The ISO 13485:2016 revision has consequences for organizations who have implemented the ISO 13485 (2003 or 2012) quality management system as they would have to comply to the ISO 13485:2016 revision. As such all applicable organizations still have 18 months to modify and update their quality management systems to comply with the ISO 13485:2016 version.

The modifications of the new ISO 13485:2016 standard cover aspects such as:

• The position of the organization with regard to development, production and distribution.
• The design, developments and risks. Attention is given to eventual risks concerning design, development within the organization itself and further the suppliers and their processes are taken into account.
• The internal knowledge of the organization itself with regard to the regulations for medical device products that must comply to the applicable legislation.
• Requirements to the control and application of software within the quality system. More attention is given to the software, its process and the safety aspects of the software.
• Vigilance systems within the quality management system to support the post market surveillance systems.
• The information that must be compiled in the technical files and the responsibility of the compiling of the files themselves.

Act now!

From February 2019 certificates for ISO 13485:2003 or 2012 are no longer valid and must be issued on the basis of ISO 13485:2016. If your organization is already ISO 13485:2003 or 2012 certified it will be easier to comply to the ISO 13485:2016 revision as the basis is already implemented. CE Medical will evaluate your existing quality management system with a Gap Analysis which will indicate where the gaps are present in the current system.

Transition support.

CE Medical will fully support your organization in the transition period to comply with the ISO 3485:2016 revision. Our experts shall ensure that the modifications are carried out most efficiently.

Our pre-evaluation procedures for the upgrading or implementation of your quality management system are custom made for your company, your products and its present systems. Our pre-evaluation will optimally prepare you for the audit by the Notified Body.

For further information contact our support.