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ISO 13485 Certification

Medical devices - Quality management systems

ISO 13485 Certification in Malaysia

The ISO 13485:2016 quality management system (QMS) standard for medical devices was introduced in 1st March 2016, with the Accreditation enabling the transition of certified organizations from previous versions within three years. IAS is an established ISO 13485 certification body in Malaysia, we can assist you in your journey towards local and international compliance. ISO 13485 certification for medical devices is an internationally recognized quality standard which affirms the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices anywhere in the world.

ISO 13485 certification for Medical Equipments establishes subtle, yet characteristic changes demanding in-depth documentation on the work environment, risk assessment, design authority and regulatory specification. ISO 13485 certification is applicable to both manufacturers of medical devices and organizations that support medical device manufacturers. It supports the manufacturer’s responsibility for guaranteeing medical devices invariably meet customer requirements and applicable regulatory specifications.

ISO 13485:2016 Certification is conceived in a detail to respond to current quality management system practices, inclusive of alters in technology and regulatory requirements and expectations.

Why IAS?

We are here to provide a full-length auditing service to achieve your ISO 13485 certification in Malaysia. IAS is a globally recognized ISO certification body which provides ISO certification and Lead Auditor Training in various ISO standards. Our global presence helps to gain the clients the advantage of having international expertise as well as the real depth of local knowledge. We can help you and your organization understand each phase of the assessment and certification process to make sure you have in-depth knowledge in ISO 13485 process and regulations. We are also providing training courses which allow you to acquire a good knowledge of the complexities of complying with the standard, as well as the rules and regulations the standard helps to discourse.

Benefits of ISO 13485 Certification

The ISO 13485 certification in Malaysia helps to meet regulatory requirements and go beyond customer expectations. The certification helps to demonstrate that your organization manufactures and develops good quality and safer devices and your services meet the requirements. ISO 13485 Certification helps to reduce costs and monitor supply chain performances. Improved efficiency is another benefit of ISO 13485 certification. The certification helps to review and improve the process in your organization. Global access to the markets of your products and services of your organization can be improved with the ISO 13485 certification.