ISO 13485: 2016

ISO 13485: 2016

ISO 13485:2016 specifies requirements for a quality management system of an organization that needs to demonstrate its ability to provide medical devices and related services and 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. ISO 13485:2016 can also be used by suppliers or external parties that provide products, such as quality management system-related services to such organizations. It is thus the basis for companies that are in the field of medical technology.

The list below represents the main processes and procedures required by the ISO 13485:2016. The second column lists all of the affected chapters of ISO 13485:2016 for additional information. The third column shows if the new medical device regulation could have some additional impact on these processes and procedures or not.

ISO 13485: 2016
ISO 13485:2016 Required Documented Procedures and Processes: Reference in ISO 13485:2016: Will be affected by MDR:
Document Control Process ISO 13485:2016 (4.2.4) No
Records Control Process ISO 13485:2016 (4.2.3) Yes
Software Tool Validation Process ISO 13485:2016 (4.1.6 & 7.5.6 & 7.6) Yes
Management Review Process ISO 13485:2016 (5.6.1) Yes
Training Procedure ISO 13485:2016 (6.2) No
Monitoring & Controling Work Environment Procedure ISO 13485:2016 (6.4.1) No
Risk Management Process ISO 13485:2016 (7.2) Yes
Design and Development Process ISO 13485:2016 (7.3.1) Yes
Design Transfer Process ISO 13485:2016 (7.3.8) No
Design Change Control Process ISO 13485:2016 (7.3.9) Yes
Purchasing Process ISO 13485:2016 (7.4.1) No
Control of Production and Service provision Process ISO 13485:2016 (7.5.1) No
Servicing Procedure ISO 13485:2016 (7.5.4) No
Process Validation Process ISO 13485:2016 (7.5.6) Yes
Validation of Sterilization and Sterile Barrier Systems Process ISO 13485:2016 (7.5.7) Yes
Product Identification Process ISO 13485:2016 (7.5.8) Yes
Identification and distinguishment of returned Devices Process ISO 13485:2016 (7.5.8) Yes
Traceability Process ISO 13485:2016 (7.5.9.1 & 7.5.9.2) Yes
Product Preservation Process ISO 13485:2016 (7.5.11) Yes
Control of Monitoring and Measuring Equipment Process ISO 13485:2016 (7.6) Yes
Calibration and Verification Process ISO 13485:2016 (7.6) Yes
Feedback Process ISO 13485:2016 (8.2.1) Yes
Complaint Handling Process ISO 13485:2016 (8.2.2) Yes
Reporting to Regulatory Authorities Process ISO 13485:2016 (8.2.3) Yes
Internal Audit Procedure ISO 13485:2016 (8.2.4) No
Control of Nonconforming Product Procedure ISO 13485:2016 (8.3.1) No
Issuing Advisory Notices Process ISO 13485:2016 (8.3.3) Yes
Rework Procedure ISO 13485:2016 (8.3.4) No
Data Analysis Process ISO 13485:2016 (8.4) No
CAPA Process ISO 13485:2016 (8.5.2 & 8.5.3) Yes

(Note: This graphic is purely for information only and should not be considered as a recommendation. It shows a possible ideal process landscape, which does not necessarily have to match with your process landscape.)

MDR 2017/745:

Most processes and procedures should already be in place if you have already fully implemented a quality management system in accordance with ISO 3485:2016 and with the new upcoming medical device regulation (MDR) only a few processes and procedures are new. A proposal of potential new processes and procedures can be gathered from the list below.

MDR Required Procedures and Processes: Reference in MDR:
Clinical Evaluation Procedure MDR – Article 61 – Clinical evaluation
Post-market Surveillance Process Article 10: General obligations of manufacturers
Post-market Clinical Follow-up Process Annex XIV – Part B – Post-market Clinical Follow-up
Regulatory Affairs Procedure Annex IX – Conformity Assessment Based on a Quality Management System and on Assessment of Technical Documentation
Identification of Applicable Regulatory Requirements Procedure Annex IX – Conformity Assessment Based on a Quality Management System and on Assessment of Technical Documentation
Performance Evaluation Process Annex XIII – Part A – Performance Evaluation and Performance Studies
Post-market Performance Follow-up Process Chapter VI – Article 56 – Performance Evaluation and Clinical Evidence
Customer-made Devices Procedure Annex XIII – Procedure for Customer-Made Devices

(Note: This graphic is purely for information only and should not be considered as a recommendation.)