Here at QCS we work with several core standards including ISO 13485. For those more familiar with other standards such as ISO 9001 Quality Management, ISO 14001 Environmental and ISO 45001 Health & Safety Management, the medical device standard can appear to be a bit of a mystery. So, what is ISO 13485 and who is it for?
ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) specifically for the medical device industry. Here are the key points:
- Quality Management System (QMS): Organisations must implement and maintain a QMS that meets the standard’s requirements, ensuring consistent quality in their processes and products.
- Management Responsibility: Top management must demonstrate commitment to the QMS, including establishing a quality policy, setting quality objectives, and conducting management reviews.
- Resource Management: Adequate resources, including trained personnel and infrastructure, must be provided to ensure the effective implementation and maintenance of the QMS. This section includes contamination control.
- Product Realisation: This covers the entire lifecycle of a medical device, from design and development to production, installation, and servicing. It ensures that products meet customer and regulatory requirements.
- Measurement, Analysis, and Improvement: Organizations must monitor and measure the performance of their QMS, analyse data, and implement improvements to enhance the effectiveness of their processes and products.
- ISO 13485 helps organizations ensure the safety and effectiveness of medical devices, building trust with regulators, stakeholders, and customers.
ISO 13485 is likely to be applied in organisations manufacturing a product subject to MHRA regulation and for use in a healthcare environment. Patient safety is central to the standard which is itself based on ISO9001 in that it promotes the process approach in management systems used in the manufacture of medical devices.
If there a specific aspect of ISO 13485 you are particularly interested in then do get in touch. We are sure to be able to offer guidance or at the very least our expert opinion on quality management in the medical device sector. QCS International is a leading provider of medical device quality management systems training including CQI IRCA registered ISO 13485 Lead Auditor training.