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 ProcessISO 13485:2016 (4.2.4)No
Records Control ProcessISO 13485:2016 (4.2.3)Yes
Software Tool Validation ProcessISO 13485:2016 (4.1.6 & 7.5.6 & 7.6)Yes
Management Review ProcessISO 13485:2016 (5.6.1)Yes
Training ProcedureISO 13485:2016 (6.2)No
Monitoring & Controlling Work Environment ProcedureISO 13485:2016 (6.4.1)No
Risk Management ProcessISO 13485:2016 (7.2)Yes
Design and Development ProcessISO 13485:2016 (7.3.1)Yes
Design Transfer ProcessISO 13485:2016 (7.3.8)No
Design Change Control ProcessISO 13485:2016 (7.3.9)Yes
Purchasing ProcessISO 13485:2016 (7.4.1)No
Control of Production and Service provision ProcessISO 13485:2016 (7.5.1)No
Servicing ProcedureISO 13485:2016 (7.5.4)No
Process Validation ProcessISO 13485:2016 (7.5.6)Yes
Validation of Sterilization and Sterile Barrier Systems ProcessISO 13485:2016 (7.5.7)Yes
Product Identification ProcessISO 13485:2016 (7.5.8)Yes
Identification and distinguishment of returned Devices ProcessISO 13485:2016 (7.5.8)Yes
Traceability ProcessISO 13485:2016 (7.5.9.1 & 7.5.9.2)Yes
Product Preservation ProcessISO 13485:2016 (7.5.11)Yes
Control of Monitoring and Measuring Equipment ProcessISO 13485:2016 (7.6)Yes
Calibration and Verification ProcessISO 13485:2016 (7.6)Yes
Feedback ProcessISO 13485:2016 (8.2.1)Yes
Complaint Handling ProcessISO 13485:2016 (8.2.2)Yes
Reporting to Regulatory Authorities ProcessISO 13485:2016 (8.2.3)Yes
Internal Audit ProcedureISO 13485:2016 (8.2.4)No
Control of Nonconforming Product ProcedureISO 13485:2016 (8.3.1)No
Issuing Advisory Notices ProcessISO 13485:2016 (8.3.3)Yes
Rework ProcedureISO 13485:2016 (8.3.4)No
Data Analysis ProcessISO 13485:2016 (8.4)No
CAPA ProcessISO 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 13485:2016 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 ProcedureMDR – Article 61 – Clinical evaluation
Post-market Surveillance ProcessArticle 10: General obligations of manufacturers
Post-market Clinical Follow-up ProcessAnnex XIV – Part B – Post-market Clinical Follow-up
Regulatory Affairs ProcedureAnnex IX – Conformity Assessment Based on a Quality Management System and on Assessment of Technical Documentation
Identification of Applicable Regulatory Requirements ProcedureAnnex IX – Conformity Assessment Based on a Quality Management System and on Assessment of Technical Documentation
Performance Evaluation ProcessAnnex XIII – Part A – Performance Evaluation and Performance Studies
Post-market Performance Follow-up ProcessChapter VI – Article 56 – Performance Evaluation and Clinical Evidence
Customer-made Devices ProcedureAnnex XIII – Procedure for Customer-Made Devices

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

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