ISO 13485
Quality management systems
The ISO 13485 standard is an internationally recognized standard for quality management systems (QMS) specific to the medical device industry. It outlines the requirements for organizations to ensure that their medical devices meet both customer and regulatory demands for safety and efficacy throughout the entire lifecycle of a device, from design and development to production, installation, and servicing. This standard emphasizes patient safety and consistent quality, providing a framework for organizations to maintain high standards in their operations.
Management System Standards
Providing a model to follow when setting up and operating a management system, find out more about how MSS work and where they can be applied.
What you need to know about iso 13485
What is a medical device?
A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.
Who is ISO 13485 for?
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
Certification to ISO 13485
Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organizations can reap many benefits from implementing the standard without undergoing the certification process. However, third-party certification can demonstrate to regulators that you have met the requirements of the standard. ISO does not perform certification.
All ISO standards are reviewed every five years to establish if a revision is required in order to keep it current and relevant for the marketplace. ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations. The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.
Reducing the risks of medical devices:
international guidance just updated
Virtually no medical procedure is without risk, but there are many ways to minimize it. One such way is through applying sound risk management processes to medical devices. The International Standard to do just that has now been updated.
FDA plans to use ISO 13485 for medical devices regulation
The US Food and Drug Administration (FDA), the government department that regulates the medical devices sector, announced its intention to use ISO 13485 as the basis for its quality system legislation.
The medical devices industry is one of the most highly regulated sectors in the world. Significant quality systems and product requirements must be satisfied to ensure the medical devices produced are fit for their intended purpose
