Let me take a moment to get us on the same page regarding Quality and a Quality Management System.įor me, when I hear the word “quality”, two names come to mind: W. My view is that a QMS should be a set of processes that help me to run a better, more efficient business that focuses on true quality and what is best for the patients who will be recipients of my medical devices. If you see no issues with this approach and your opinion is that a QMS is simply a means to demonstrate regulatory compliance, then this guide may not be for you.
The conventional approach for establishing a quality management system is that of addressing compliance to regulations-sometimes resulting in direct regurgitation of requirements defined in ISO 13485:2016 and other quality system requirements and regulations. And frankly, most companies implement a QMS that is largely rule-based, restrictive, cumbersome, and largely ineffective. Many view a Quality Management System (QMS) as a necessary evil for a medical device company-something you must have in order to be compliant.Ī QMS is often times seen as the set of procedures that define the rules and restrictions that must be followed in the quest for designing, developing, and manufacturing medical devices.įew embrace the notion that a QMS is beneficial.
Note: If you would like to schedule a demo of Greenlight Guru's Quality Management Software, click here » Bottom line: This approach allows you to put emphasis on what is best for the patients who receive your life-saving technologies. Greenlight Guru is a purpose-built solution for the medical device industry that addresses compliance, allowing you to better focus on developing high quality products through streamlined processes. Our industry specific platform is architected to support the requirements of ISO 13485:2016 (and other regulatory requirements), where they are addressed automatically with no configuration required. Our team of medical device industry experts has designed and built an eQMS software platform specifically for the medical device industry. It’s because of these reasons and my own personal experiences with these QMS approaches that led me to start Greenlight Guru. Anytime a tool is configurable, what assurances do you have that it aligns with the applicable regulations and requirements-in this case, ISO 13485:2016? And how do you validate this? While on one hand this approach seems more advanced, this approach also comes with risks.
Some medical device companies have progressed from ad hoc to eQMS software tools that are highly customizable and configurable. Risks that QMS knowledge lies solely with the people managing the day to day. Risks of relying on tools that don’t scale. I mean no disrespect if this is your method. The best way to describe this approach to a QMS is ad hoc. How do you manage your Quality Management System? If you are like the majority of the medical device industry, chances are you have a QMS that is a combination of paper-based processes and general purpose tools, loosely held together by a group of people within your company-usually document control.
What is ISO 13485 Quality management system How Greenlight Guru Streamlines ISO 13485 Certification Allowing You to Focus on True Quality Validation of Processes for Production and Service ProvisionĬontrol of Monitoring and Measuring Equipment ISO 13485 Design and Development ProcessesĬontrol of Design and Development ChangesĬontrol of Production and Service Provision Responsibility, Authority & Communication