Commitment to Quality
The late Joseph Juran stated, “It is most important that top management be quality-minded. In the absence of sincere manifestation of interest at the top, little will happen below.” For those that aren’t familiar with Joseph Juran, he was an evangelist for not only quality, but the importance of setting up and maintaining a quality management system within a manufacturing company. Juran founded the Juran Institute in 1979, which is a institute for international training, certification, and is also a consulting company that provides training and services.
Optimizing Compliance
As a contract manufacturer specializing in cable assemblies and interconnects, Juran’s philosophy impacts how we think, operate and ultimately manufacture. As we support a variety of original equipment manufacturers within the medical device industry, the assemblies we manufacture may in some cases transmit and receive electrical signals for diagnosis of patient conditions, while others may provide therapeutic outcomes to augment recovery or pain management. Each of our customers have similar, but uniquely different quality requirements that are suited for the technologies and products that they offer. As you can imagine, developing a one-size-fits-all Quality Management System (QMS) may seem challenging considering the breadth of our customer base. But we enjoy a good challenge, so we set out to establish a system that allows for flexibility in customer needs while, in all aspects, maintaining compliance to FDA 21 CFR Part 820 guidelines and ISO-13485 requirements.
Walking the Walk
After months of QMS development, simulations and validations, we accomplished that challenge. In March of 2019, we successfully gained ISO 13485:2016 certification. We are a young company but often describe our Quality Management System as mature. We’ve taken the best practices of our previous experiences in medical device manufacturing and constructed procedures to employ a nimble yet effective QMS that is both logical and comprehensible by all the members of our organization.
To understand and embrace the principles defined within our procedures takes training, but also requires a commitment from leadership to consistently hold a sharp focus on quality. Quality best practices are primarily about execution. Delegation plainly doesn’t work. So, our motto is walk the walk…and leave a good documentation trail.
Would you like to learn more about ClearPath Medical’s Quality Management System?
Regardless of what role you play within the world of medical devices , the foundation of having a robust quality management system is just the beginning. All people within the company, regardless of position, seniority, or skill level, must live and breathe the philosophy of the system for it to truly become reality. Having a partner with a solid Quality Management System is one of the primary requisites to delivering medical assemblies that are life saving and life sustaining.
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