A medical device is a product such as an in vitro machine, instrument, implant or reagent designed to diagnose, prevent and treat diseases or other diseases.
As an international standard, ISO 13485 sets the requirements for the medical device industry. This standard is designed to be used by companies throughout the life cycle of medical devices, from production to postproduction, including dismantling and disposal. However, ISO 13485 can also be used by other parties, such as certification bodies, that can assist in the certification process. ISO 13485 serves as a tool for organizations to efficiently develop and maintain their processes. Companies that strive for continuous improvement benefit from this standard by providing safe and competent medical devices and gaining the trust of their customers.
As an ISO 13485 certified professional, you are determined to provide quality products and services to your company and / or customers. Learning the skills and knowledge necessary to execute an ISO 13485 framework shows that you are helping your company ensure continuous improvement and better work processes. It also demonstrates that you understand the importance of the safety and performance of medical devices and how the quality management system of a medical device can do exactly that, resulting in customer satisfaction. It can also provide new opportunities, for example, to work for large companies that offer high-quality products and services. These companies value their knowledge and experience in relation to this standard while maximizing their revenue potential.
As with other ISO management system standards, ISO 13485 certification is not a requirement of the standard, and companies can obtain many benefits from implementing the standard without undergoing the certification process. However, third-party certification can demonstrate to supervisors that you have met the requirements of the standard. ISO does not certify.
All ISO standards are reviewed every five years to determine if a revision is needed to keep them updated and relevant to the market. ISO 13485: 2016 is designed to respond to the latest practices of the quality management system, including changes in technology and regulatory requirements and expectations.
The new version focuses more on risk management and risk-based decision-making, as well as changes related to increasing regulatory requirements for supply chain organizations.
When you are ready to face the challenge of ISO 13485 certification, our experts provide a quality experience that meets your needs and becomes part of our global network.
ISO 13485:2016 Certification is available from your national ISO member or the 361 Certifications.