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First, this company had not been conducting any internal audits, which is a huge red flag for any auditor.
#Iso 13485 latest version iso
This company had undergone an audit a few months prior to gaining its ISO 13485 certification, and the report uncovered two significant findings. This plan of attack will help lay a foundation and company culture built on quality standards across the entire business and throughout all future operations and regulatory processes.Ĭompanies that adopt a quality-first mindset when completing ISO 13485 practices will find it to be a significant value-add for their business as a whole, rather than a simple check-the-box activity.Īnother process that leads to many mistakes for manufacturers, and just so happens to also be commonly treated as a checkbox activity, is internal auditing.įor example, a company recently reached out to us that was about to lose its ISO 13485 certification. When manufacturers begin implementing ISO 13485, they should take a holistic approach that emphasizes quality from the onset. Many contract manufacturers obtain their certification solely to gain a competitive advantage that will help secure more business, rather than earning a certification for their practiced beliefs in the framework for improving quality assurance. Unfortunately, this checkbox mindset has become commonplace amongst device manufacturers when implementing ISO 13485 processes to achieve compliance. It is common in today's society to treat repeat activities like a to-do list finish a job task, check the box and move on to the next task. However, there are six that stand out as the most common: While this harmonized standard is generally helpful, ISO itself is not a governing regulatory body, unlike traditional government agencies such as the FDA the organization does not publish audit findings or reports of violations to the general public, making it nearly impossible for device manufacturers to learn from other's mistakes.ĭuring my more than 20 years of experience in the medical device industry, I've seen plenty of mistakes made when companies are implementing processes from ISO 13485. The latest version of this standard, ISO 13485:2016, has now been adopted by regulatory agencies on a global scale to build a comprehensive standard that medical device companies can follow. To build systems focused on this end, the International Organization for Standardization (ISO) outlined standard 13485 to provide guidelines for medical device quality management systems. alone, and each one is required to ensure the production of safe and effective medical devices. According to a study from MedPAC, there are more than 5,000 medical device companies in the U.S.