ISO 13485:2016 specifies the requirements for a quality management system for organizations involved in one or more stages of the life cycle of a medical device. It provides the basis for ensuring the consistent design, development, production, installation, and delivery of products that are safe for their intended purpose.
ISO 13485:2016 can be used by internal and external parties, including certification bodies, to test an organization’s ability to meet both customer and regulatory requirements. However, certification is not a requirement of ISO 13485, and organizations can reap the benefits of the standard without being certified.
The benefits of ISO 13485
The framework for effectively managing your business.
In common with other management systems’ standards, it is based on the ‘Plan-Do-Check-Act’ model that seeks to improve continually the effectiveness of the organization through proficient planning, implementation, supervision, review and maintenance.
