What is ISO 13485?
ISO 13485 is a Quality Management System (QMS) specifically designed for medical devices. It sets out specific requirements for the manufacture, installation and maintenance of medical devices.
If you’re unsure which class your medical device falls into, take a look at our post ‘How to classify medical devices’, where we’ll help you identify it quickly and easily.
Benefits of ISO 13485
ISO 13485 helps organisations to:
- Demonstrate compliance with customer requirements (legal and regulatory). These apply to medical devices and related services.
- Facilitate the CE marking of medical devices through a Notified Body. Certification is a requirement for obtaining the CE marking for medical devices. The CE marking is the process by which the manufacturer/importer indicates to users and competent authorities that the equipment placed on the market complies with the legislation.
- Be applied in any organisation involved with medical devices. All the requirements of the ISO 13485 standard are applicable to any organisation, regardless of its size or type.
- Integrate it with other certificates. ISO 13485 certification can be integrated with other certificates such as ISO 9001, ISO 14001 and ISO 45001.
Why choose our consultancy for ISO 13485
As consultants in quality management systems, we offer the following ISO consultancy services:
- ISO 13485 certification. Consultancy to achieve ISO 13485 certification for medical devices, healthcare products and related services.
- CE marking. We handle the CE marking process for your medical devices, healthcare products and related services.
- ISO outsourcing to save you costs by outsourcing the tasks of the ISO 13485 manager to Emas Consultores.
- Tailored quality training that meets your company’s needs, delivered in-house, online or via a hybrid approach. We offer courses eligible for funding through Fundae.
ISO 13485 requirements for medical devices
The standard specifies the requirements that manufacturers and distributors of medical devices must meet. Certification demonstrates a commitment to, and the ability to, design, manufacture and sell medical devices in compliance with customer requirements, regulations and standards.
Certification is a guarantee of reliability in the healthcare sector. It demonstrates that the products/services have implemented and applied all the technical requirements necessary to ensure the safety and quality required for them to be placed on the market.
It includes specific requirements for medical devices and excludes certain requirements of the ISO 9001 standard that are not appropriate as regulatory requirements.
The processes required by the standard, which are applicable to the medical device but are not carried out by the organisation, remain the organisation’s responsibility and are accounted for within the organisation’s quality management system.