The 2016 update to the ISO 13485 standard brought about some notable changes for companies to focus on. If your company has been underperforming, it might be time to lean into the requirements of the standards and capitalize on these changes. Not only will you ensure that the medical devices you’re manufacturing are of the highest quality but all processes & elements of your business will benefit.
We discuss some of these changes below:
1. Increased Customer Involvement
ISO 13485:2016 requires manufacturers to obtain feedback as a regular part of production and post-production activities and then incorporate that feedback into their quality management systems. The requirements for complaint procedures and the reporting of specific complaints to regulators have also been widened.
This can help you develop a direct line from feedback to product development, ensuring that it ties into efforts to consistently improve your product lines.
2. Increased Effective Training
The standard now requires your company to document your processes for ensuring your personnel’s competence and provide them with training and awareness. Through processes such as testing & certification and criteria such as scores, the competence of your employees should be monitored, measured and improved as often as necessary. This will yield results in the form of a more skilled workforce.
3. Risk Minimization
While it’s not possible to eliminate risk entirely, ISO 13485:2016 substantially prioritizes risk management. The standard requires companies to integrate a risk-minimization approach throughout their quality management systems instead of limiting it to product design and development.
By increasing the scope of its risk management procedures, your company can become more proactive in identifying potential problems and resolving them before they get out of hand.
4. Revised Supplier Management
Branching from the standard’s focus on risk management, the requirements in relation to the suppliers of a manufacturer have also been revised. Companies are now required to evaluate the degree of risk a supplier adds to their processes and take steps to minimize that risk.
If your company can develop an effective, practical procedure for the evaluation and risk assessment of your suppliers, it will improve compliance and transparency throughout your business processes.
As a leading ISO 13485 consulting company, Barile Consulting has been empowering companies from every industry with our ISO 13485 certification consultants. Our 15 years of experience also enable us to provide dependable ISO 13485 consulting service and AS 9100D consulting services.
Contact us today and let us help your business meet the globally recognized standards of quality.
