The standard ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The main objective of standard ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
Perhaps more than any other type of manufactured product, the quality of medical devices has a direct impact on their effectiveness as well as the safety of patients, users and, where appropriate, other persons. For these reason, most national regulatory schemes require manufacturers and suppliers of medical devices to establish an internal quality management system that has been independently audited and verified. Medical devices manufactured or supplied by organizations without a verified quality management system are routinely denied legal entry into major markets, usually resulting in extended delays in gaining access and lost revenue opportunities.
What is ISO 13485?
Quality management systems for medical devices manufacturers – Requirements for regulatory purposes, addresses the development, implementation and maintenance of a quality management system intended for use by medical device manufacturers and suppliers. ISO 13485 is similar in scope and intent to ISO 9001, but it includes additional requirements specific to medical devices while excluding certain ISO 9001 provisions. Therefore, in most jurisdictions, ISO 9001 certification is not an acceptable substitute for certification to the requirements of ISO 13485.
How can we help you?
Eucert’s technical professionals have first-hand knowledge and in-depth expertise with all types of medical devices. In addition, we are a leading management certification body for quality management systems, including management systems applicable in the manufacture of medical devices. Each audit team consists of experts with the skills & expertise needed to accurately assess the, and is headed by a lead auditor who will oversee the audit and any required management change notices. It makes Eucert ideally suited to address the needs of medical device manufacturers seeking to achieve or maintain ISO 13485 certification.
Major Benefits:
- Improve efficiency and marketability – with formal certification of your quality management system that will help you to market your products and services and improve the efficiency of your organization.
- Get benefits from expert partnership – with our experienced audit team to identify both non-conformities as well as opportunities for improvement.
- Gain a single source solution – with auditing and testing services that address compliance requirements with international standards and regulations applicable in all major medical device markets.