ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
ISO 13485 includes 8 sections and is based off of the Plan-Do-Check-Act cycle. Out of the 8 sections, only 5 of them contain auditable requirements. The basic concept is to make a plan, resource the plan, execute the plan, evaluate the results, and take appropriate action based upon the evaluation. If this cycle is consistently followed, the natural results will be excellent quality products, extraordinary customer service, and a healthy Quality Management System.
How the PDCA cycle is represented in the standard:
- Sections 4, 5, and 6 - The "planning" sections
- Section 7 - The "doing" section
- Section 8 - The "checking" and "Acting" section