Are you ready?
ISO 13485:2016 transitions must be completed by March 1, 2019
The length of time it will take your organization to upgrade to the ISO 13485:2016 standard is highly dependent upon your progress in completing critical preparatory activities. Here is some background information that will help you gauge how close you are to meeting the revised standard.
What your organization must know prior to an ISO 13485:2016 upgrade
- ISO 13485:2016 is now a risk based assessment where every process must have a risk component, even outsourced processes.
- For medical devices that are intended to be connected to, or have an interface with, other medical devices, the updated verification process ensures proper interconnection and interoperability.
- Product design and development inputs include, among other things: outputs of risk management and post-production review; functional, performance, usability and safety requirements, according to the intended use.
- The “role” undertaken by our organization has been documented as required by ISO 13485:2016.
Example Steps your organization must take prior to an ISO 13485:2016 upgrade:
- Complete a comprehensive review of your Quality Management System (QMS) to include requirements for risk management approach.
- Review the documents you maintain to demonstrate conformity with regulatory requirements as will now be included by reference to “applicable regulatory requirements”.
- Perform a detailed review of the changes to the prior version.
- Declare and define any permissible exclusions based on the regulatory requirements for medical devices.
- Implement a risk management approach in management review.
- Document processes of establishing competence, providing needed training and ensuring awareness of personnel.
While these steps are a good starting point, there is much more to be done. If your organization needs assistance, we can help. Our experts have been selected on the basis of their extensive industry knowledge, and they understand both your processes and your business environment.
The depth of experience we provide will enable you to efficiently and cost-effectively upgrade to the ISO 13485:2016 standard, putting your organization in solid position to meet the coming deadline.