Improving quality while maintaining safety at the same time, is the best way for a medical device manufacturing company to achieve the required results, thus enabling them to raise their profile and grab new opportunities. Certification of a management system helps to achieve this and provides evidence to the customers and to the market, about client’s compliance towards the international standards. Hence, a successful audit and certification process is the outcome of a prompt third-party certification body such as DIQC B.V.
We at DIQC B.V provide Audit and Certification services of ISO 13485:2016 (Medical Devices QMS) – Third party Audit, Certification, Surveillance and Recertification services in conformance with ISO 13485:2016 standard.
WHY ISO 13485 CERTIFICATION?
ISO 13485:2016 is the internationally recognized standard for quality management systems in the medical devices industry and is a brand that ensures quality, trust and guarantees regulatory compliance in the medical devices sector. It helps to enhance the overall performance, eliminate uncertainty and manage risks. It can be used as a reference by the manufacturers for implementation of quality systems within specified procedures governing the design, production and marketing of medical devices. Choosing to certify your management system in accordance with this standard ISO 13485:2016, demonstrates the compliance with mandatory documents, and your commitment for updating and improvising to maintain quality, and in return gain confidence and trust from your customers, which is an overall competitive advantage.
We at DIQC B.V. support and provide services to our clients in the medical sector whose organization’s management system has a scope to get ISO 13485:2016 certified. Regardless of the size, the organizations involved in any of the activities related to medical devices manufacturing, starting from design to production to disposal, and various other activities such as logistics and distribution, testing and calibration, sterilization, production of raw materials, components, and sub-components, can be ISO 13485:2016 certified by our team.