Getting ISO 13485 Certified in Vinton, Virginia (VA)

Quality and safety are irreducible minimums in the industry of medical devices. It is one of the reasons why ISO 13485 was created. Regulatory requirements are becoming increasingly stringent through each step of the life cycle of the product, including delivery and service. It is expected that organizations throughout the industry demonstrate how their quality management processes work.

You have to make sure that you comply with the best practices in all that you do. ISO 13485 is an internationally agreed standard that sets out the guidelines for a quality management system that is unique to the medical devices industry. There is so much that you need to know about ISO 13485 before applying the standard.

A medical device is basically a product that is used in the treatment, prevention, and diagnosis of several medical conditions such as diseases. Examples of medical devices include in vitro reagents, implants, machines, instruments, and many more. Suppliers of these products have to make sure that they comply with the ISO 13485 standards.

ISO 13485 is exclusively designed for organizations that design, produce, install and service medical devices and other related services. internal and external parties like the certification bodies can also use this standard to help them carry out their auditing processes.

Like most of the other ISO management system standards, ISO 13485 certification is not a requirement of this standard. However, your organization can reap so many benefits by implementing this standard without going through the certification procedure. However, 3^rd party certifications show the regulators that you have met all the standard requirements. ISO does not carry out the certification. For more guidance on this, you can contact IQC The ISO Pros.

ISO standards are normally reviewed after every five years. The process establishes whether there is a need for a revision in order to keep these standards relevant and current for the marketplace. ISO 13485:2016 is designed in such a way that it responds to the latest practices of the quality management system. It includes changes in the regulatory requirements and technology and market expectations. The newer version puts more emphasis on a risk-based decision-making process and risk management. It also looks at the changes that are related to increased regulatory requirements for the organizations that are in the supply chain.

ISO 13485 remains to be the main quality management system for medical devices. However, each member country has its own set regulations that it also abides by. For instance, the United States has been in the process of harmonizing the FDA (Food and Drug Administration) guidelines for medical devices with the ISO 13485 standard. An organization can tailor the QMS to its own practices especially in section 7. The current version of ISO 13485 was published in March 2016.