Are you ready for the transition to ISO-1385-2016?
How can RQS Help?
a. RQS can help you understand the changes to ISO-13485-2016 and how it will affect you.
b. Assist you with gap assessments and analysis to understand the impact & challenges facing you.
c. Work with you and your notified body or help select a notified body to obtain certification.
d. Help you schedule and plan updates for your QMS and make the transition.
e. Help you to complete the transition to ISO-13485-2016 sooner rather than later.
What are the changes with ISO-13485-2016?
a) Incorporating risk-based approaches beyond product realization. Risk is considered in the context of the safety and performance of the medical device and in meeting regulatory requirements
b) More linkage with regulatory requirements, particularly for regulatory documentation.
c) Application to organizations throughout the lifecycle and supply chain for medical devices.
d) Harmonizing software validation requirements for different software applications (QMS software, process control software, software for monitoring and measurement) in different clauses of the standard.
e) Planning and documenting corrective action and preventive action, and implementing corrective action without undue delay.
f) Emphasis on appropriate infrastructure, particularly for the production of sterile medical devices, and additional requirements for validating sterile barrier properties.
g) Additional requirements in design and development and consideration of usability, use of standards, verification and validation planning, design transfer and design records
h) Emphasis on complaint handling and reporting to regulatory authorities in accordance with regulatory requirements, and consideration of post-market surveillance.
What is the transition period?
a) There is a three year transition period until February 28th, 2019
b) Some Notified Bodies are cutting this by a year since some manufacturers appear to be reluctant to transition to the new standard.
Is the new Standard Available?
The new version of ISO 13485-2016 is available. You can buy from various sites or you can buy it here:
How do we prepare for the transition?
a. Perform a gap assessment/analysis of your QMS
b. Create a custom plan to address the gaps
c. Supplement your staff to update your procedures
d. Provide/Conduct training to your staff and top management
e. Conduct your internal audit to verify readiness
f. Provide a report to management to state/review readiness for upcoming certification audit
g. Avoid the wait and help arrange your certification with your certification body (industry could expect long wait times for audits)