Data is proving to be a catalyst for continuous improvement in many sectors, this is no different for quality management systems (QMS). We recently took up the challenge to reimagine our older practices and internal data analysis procedure meticulously to align seamlessly with the new changes in the ISO 13485 standards. Curious to learn more about the changes we’ve made? Continue reading!
Creating a roadmap to success
Data analysis serves as our watchdog, it scans the information we generate by monitoring and measuring multiple parameters. From the insights derived from feedback, assessing conformity and product requirements, to tracking process, product characteristics and trends, and monitoring suppliers, audits, and service reports.
But why do we embark on this data-driven journey? Because it enables us to continuously improve the quality of our medical device development services and react more quickly to any changes. By establishing clear key performance indicators (KPIs) and goals, and measuring their fulfillment or improvement, we can create a ‘roadmap to success’. From corrective and preventive actions (CAPA) driven by customer feedback to the profound impact of advisory notices.
Determining key performance indicators
So how did we integrate this data-driven approach? We diligently monitor and measure feedback, gauging customers’ experiences through feedback and satisfaction measurements. In addition, we determine conformity to product requirements based on verification, testing, and inspection KPIs.
Recognizing the vital role played by our suppliers, we continuously monitor their performance as well through yearly audits and their quality evolution. Rigorous monitoring of internal audits, second-party audits (from suppliers or customers), and third-party audits (by certification organizations, notified bodies, or competent authorities) allows us to respond and take proactive actions.
Innovation and exceptional results are born from collaboration with various people and processes. To ensure the smooth functioning of our design process, our personnel is conducting yearly training, and gate reviews are conducted on medical projects continuously. Furthermore, we continuously invest in our team’s growth by monitoring the average quantity of training per full-time employee each year, while sharing knowledge through our internal master classes remains.
In essence, this data-driven approach fueled by ISO 13485 propels us toward a future where continuous improvement isn’t just a goal but a way of life for the projects of our customers.
