ISO 13485 is an international standard that outlines the requirements for a Quality Management System (QMS) for medical devices. The standard provides a framework for medical device manufacturers and other organizations in the supply chain to demonstrate their ability to provide safe and effective medical devices that meet regulatory requirements.
The ISO 13485 standard was developed by the International Organization for Standardization (ISO) and was first published in 1996. It is applicable to all types of organizations involved in the design, development, production, installation, and servicing of medical devices, regardless of size or type.
ISO 13485 sets out a framework for a Quality Management System that includes requirements for documentation, risk management, design and development, production, and process control. The standard also includes requirements for monitoring and measurement, validation, and verification, as well as requirements for control of non-conforming products and corrective and preventive actions.
By implementing a QMS in accordance with ISO 13485, medical device manufacturers and other organizations in the supply chain can demonstrate their commitment to quality and regulatory compliance. Additionally, certification to ISO 13485 can provide a competitive advantage, demonstrating to customers and regulators that the organization has implemented a robust QMS that meets international standards.
The benefits of implementing a Quality Management System (QMS) in accordance with ISO 13485 for medical devices include:
Overall, implementing a QMS in accordance with ISO 13485 can result in numerous benefits for medical device manufacturers and other organizations in the supply chain, including improved regulatory compliance, enhanced customer satisfaction, increased efficiency, improved risk management, competitive advantage, improved product quality, and increased market access.
UMS evaluates your documentation and company records
UMS reviews the compliance against the standard requirements.
Non-conformances identified during the audit require closures.
UMS issues the certification and certification mark.
Annual audit required to maintain certification validity.
ISO 13485 is an international standard for the quality management system (QMS) requirements for medical device manufacturers and related organizations.
ISO 13485 is used by medical device manufacturers, suppliers, and related service providers to ensure that their products and services meet customer and regulatory requirements.
The benefits of implementing ISO 13485 include improved customer satisfaction, increased efficiency and effectiveness, reduced costs, enhanced regulatory compliance, and improved risk management.
ISO 13485 is specific to the medical device industry, while ISO 9001 is a general standard for quality management systems. ISO 13485 includes additional requirements specific to medical devices, such as risk management, product design and development, and traceability.
To get certified to ISO 13485, you will need to contact a certification body that is accredited to perform ISO 13485 audits. The certification process typically involves a review of your QMS documentation and an on-site audit of your operations.
ISO 13485 certification is valid for three years, after which time it must be renewed through a recertification audit.
While both ISO 13485 and FDA regulations address quality management for medical devices, there are some key differences. FDA regulations are specific to the United States, while ISO 13485 is an international standard. Additionally, FDA regulations require premarket approval for certain medical devices, while ISO 13485 focuses on the quality management system used to produce those devices.
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