September 22, 2023
The international standard, ISO 13485:2016 Medical Devices – Quality Management Systems Requirements for regulatory purposes identifies the requirements for a quality management system that is used by an organization involved in one or more stages of the life-cycle of a medical device, including the design and development, production, storage and distribution, installation, servicing, final decommissioning and disposal of a medical device, design and development, or provision of associated activities.
While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance; therefore it is more prescriptive in nature and requires a more thoroughly documented Quality Management System.
ISO 13485 provides the manufacturer with a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements. It can also help to minimize surprises and failures which might adversely affect patient safety and damage a manufacturer’s reputation & marketability.
When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products, and ensuring effectiveness, control and maintenance of your QMS is critical to customers, stakeholders, patients and users, and regulatory agencies.