ISO 13485
What is ISO 13485?
- ISO 13485: 2003 is the internationally recognized standard for quality management systems in the medical device industry. It is a Quality System that applies to the design, development, production, installation, servicing and sales of Medical Devices.
- Though based on ISO 9001, 13485 removes 9001’s emphasis on continual improvement and customer satisfaction. In its place, the emphasis focuses on meeting regulatory and customer requirements, risk management and maintenance of effective processes.
Why should I carry this Standard ?
- This certification aligns an organization’s management system to the requirements of the FDA’s Quality System Regulation (QSR) requirements as well as many other regulatory requirements found throughout the world.
- Therefore, 13485 certification serves to create a management system that acts as a framework on which to build compliance to various regulatory and customer requirements.
Prerequisites
- 13485 requires the QMS to be thoroughly documented and conducted throughout a product’s lifecycle, from initial concept to delivery and post-delivery.
- However, the standard leaves the specifics to a related standard, ISO 14971: 2001, Application of Risk Management for Medical Devices.
- While 13485 states that a “manufacturer’s management team is charged with the management of device-related risks and the development of risk management plans,”14971 defines a list of steps to be taken by management in order to fulfill these risk-related requirements.
- It is not mandatory for a manufacturer to be 14971 certified in order to attain 13485
- Certification, but it is advisable to get both the certifications.
Who Needs ISO 13485?
All types of organizations in this industry irrespective of size or nature. If a company intends to manufacture medical devices shall need ISO 13485 Certification.
How long does it take to get this implemented?
In 4 - 6 Months depending on their size and complexity
Advantage ISO 13485
- Guarantees high quality and reliability of services and products.
- Reduces production loss rate.
- Reduces operational costs and risks.
- Increases effectiveness across the whole organization.
- Increases customers‘trust in you as a safe supplier or producer.
