INSTITUTE FOR STANDARD AND QUALITY DEVELOPMENT STUDIES
13/01/2024
ISO 13485 certification was developed by the International Organization for Standardization (ISO) specifically for the healthcare sector. This certification focuses on establishing a Quality Management System for organizations involved in the manufacturing, trading, or distribution of medical devices.
Currently, the medical device sector includes around 15,000 types of products. Each product carries different risk levels, with no limitation on manufacturing materials or intended use. Therefore, effective management of medical devices requires clear classification of risk levels based on an established medical device catalog.
Regular updates are necessary to ensure feasibility and convenience for enterprises while strengthening state management of medical devices. Manufacturing enterprises also need to meet ISO 13485 requirements to enhance their capabilities while still complying with legal requirements.
Domestically manufactured medical devices mainly focus on single-use products, hospital furniture, sterilization equipment, IVD medical devices, dialysis fluids, ultrasound gel, physiotherapy machines, electro-acupuncture machines, blood pressure monitors, hearing aids, high-tech devices, and medical gases.
Manufacturing facilities that apply and maintain a management system in accordance with ISO 13485 standards can maintain stable product quality. Over time, system improvement will gradually enhance product quality and competitiveness against imported products.
In addition, implementing ISO 13485 provides a means to perform tasks correctly from the beginning, thereby minimizing losses and waste. It also relieves management workload, allowing business leaders more time to focus on strategic business development and macro-level planning.
The ISO 13485 standard applies to all organizations regardless of type, location, or size. This may include facilities, companies, factories, distributors, etc., engaged in the production and trading of medical devices or comprehensive medical services (e.g., manufacturing medical gloves, sterilization equipment, syringes, infusion sets, feeding tubes, etc.).
ISO 13485 is voluntary and focuses on the safety management of medical products. When an organization develops and complies with ISO 13485 standards, it establishes a safety management system that creates a working environment minimizing risks related to medical devices and products, ensuring safety, meeting customer needs, and complying with legal requirements.
Organizations can establish an independent ISO 13485 Quality Management System or integrate it with other management systems such as ISO 9001, ISO 22301, etc.
ISO 13485 certification assessment is an inspection and verification activity to ensure that the requirements of the medical device Quality Management System have been fully met. Depending on each enterprise’s objectives, ISO 13485 assessments may be conducted accordingly.
Certification assessment according to ISO 13485:2016 is a condition for enterprises manufacturing or trading medical devices that wish to circulate their products in both domestic and international markets.
How long is an ISO 13485 certificate valid?
An ISO 13485 certificate is valid for 3 years.
During this 3-year period, the organization must undergo periodic surveillance audits at intervals not exceeding 12 months to ensure continued compliance with certification requirements.
When the certificate expires after 3 years, the enterprise must undergo recertification to maintain its production and business activities. The recertification assessment will be similar to the initial certification audit.
The above information summarizes ISO 13485 Certification – Safety Management for Medical Devices.
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Publication date: January 13, 2024
