Steps to become ISO 13485 certified

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

Examples of ISO 13485 elements include

  • Document & Record Control
  • Assigning a Management Representative
  • Establishing Communication Processes
  • Controlling Infrastructure & Maintenance 
  • Contamination Control
  • Criteria to Select & Approve New Suppliers
  • Criteria to Evaluate the Performance of Existing Suppliers
  • Purchasing & Receiving 
  • Product Cleanliness
  • Sterile Medical Devices & Sterile Barrier Systems
  • Controlling Implantable Medical Devices 
  • Reporting to Regulatory Authorities
  • Preventive Action
  • Maintaining Medical Device Files
  • Maintaining a Quality Policy & Objectives
  • Internal Audits & Management Reviews
  • Determining Product & Customer Requirements
  • Reviewing Product & Customer Requirements
  • Controlling Design and Development
  • Maintaining Design & Development Files
  • Production, Inspection, and Calibration
  • Installation & Servicing Activities
  • Validation of Special Processes
  • Customer Feedback & Complaint Handling
  • Control of Nonconforming Product
  • Corrective Action