ISO 13485:2016 is the internationally recognised standard for a quality management system applied to the manufacture of medical devices (MD-QMS).
Organisations can be certified to this standard to showcase that their products have been subject to rigorous and detailed processes. The standard covers all aspects of a medical device's lifecycle, including design, development, production, storage, installation, use, servicing, and decommissioning.
Compliance with ISO 13485 is a crucial part of the medical device industry and demonstrated to regulatory bodies that a company has a fully effective QMS in place.
Like other ISO standards, certification may not be compulsory. However, certification to ISO 13485 demonstrates regulatory compliance and provides potential customers, clients, regulators, and other professionals within the supply chain with the level of assurance that they seek before deciding to authorise, purchase, or use your product.
One of the key components of ISO 13485 is the necessity to demonstrate that staff within the organisation are competent to perform the tasks that they are required to do. Having highly competent staff minimises risk to the organisation, the manufacturing process, and the end user. Personnel responsible for the application of ISO 13485 requirements have a particular relevance to the company as they will deliver processes, procedures and advice that will be relied upon to fulfil certification ambitions quickly and successfully.
As the standard places particular emphasis on risk management, having competent staff is one of the key actions to take to address any risks that are identified. Our courses provide guidance on understanding the requirements of the standard and ensuring your internal auditors are competent and deliver results that drive improvement - a key element of ISO 13485.