ISO 13485 is an international standard that specifies requirements for a comprehensive quality management system (QMS) for the design and manufacture of medical devices. The standard aims to ensure the product safety and effectiveness of medical devices. ISO 13485 applies to organisations involved in various phases of the life cycle of medical devices, including design, development, production, storage and distribution. sales.
Structure:
ISO 13485 is divided into several chapters that cover different aspects of the QMS:
- Chapter 4: Quality management system
- Chapter 5: Management responsibility
- Chapter 6: Management of resources
- Chapter 7: Product realisation
- Chapter 8: Measurement, analysis and improvement
Main requirements:
- Documented procedures to ensure process reliability
- Proof of compliance with legal requirements
- Risk management
- Continuous improvement of the QMS
Regulatory significance:
ISO 13485 is used to demonstrate conformity with the European Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR).
Certification:
Certification is carried out by notified bodies or accredited certification bodies.
Difference to ISO 9001:
While ISO 9001 is aimed at the continuous improvement of the entire organisation, ISO 13485 focuses specifically on the safety and efficacy of medical devices.
Reference to ERP software:
ISO 13485 has a significant link to ERP (Enterprise Resource Planning) software in the medical technology industry. Here are the most important connections:
Quality management and compliance:
ERP systems support compliance with ISO 13485 by providing quality management functions such as the management of test protocols, certificates, deviations and audits. This helps companies to fulfil the requirements of the standard and ensure product safety.
Documentation and traceability:
ERP software enables end-to-end documentation of all business processes, which is essential for fulfilment of the ISO 13485 specifications. This includes the traceability of serial numbers and batches as well as the management of Unique Device Identifications (UDI).
Validation:
An ERP system must be validation-capable in order to fulfil the requirements of ISO 13485. This means that all software and IT systems involved in the development and production processes must be validated. The Validation ensures that the systems function correctly and cannot be changed without authorisation.
Integration and process control:
ERP systems integrate various business processes such as production planningmaterial procurement, quality control and compliance management. This integration helps to control processes along the entire value chain and fulfil the requirements of ISO 13485.
Regulatory requirements:
ERP software for medical technology is designed to fulfil strict regulatory requirements, including ISO 13485 and other regulations such as the EU Medical Device Regulation (MDR) and FDA regulations. This also includes standard-compliant release management and the digital storage of all relevant documents.
Software validation in medical technology
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