ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
What are the benefits of being certified to ISO 13485?
Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.
- Increase access to more markets worldwide with certification
- Outline how to review and improve processes across your organization
- Increase efficiency, cut costs and monitor supply chain performance
- Demonstrate that you produce safer and more effective medical devices
- Meet regulatory requirements and customer expectations
ISO 13485 Accreditation
QACS is accredited by QASL Independent accreditation to audit and certify organisations to ISO 13485. This means that we have the authority, expertise and know-how to go into organisations and assess them against the requirements of ISO 13485.
The term ‘Accreditation’ can lead to confusion for organisations. To clarify, only certification bodies can be accredited for a standard. As an organisation, you are certified to a standard. As an accredited certification body, we certify our clients when they have successfully met the requirements of ISO 27001.
Accreditation is the process by which a certification body is recognised to offer certification services. In order to become accredited, QACS is required to implement ISO 17021 which is a set of requirements for certification bodies providing auditing and certification of management systems. QACS is audited annually by our accreditation bodies to ensure its services meet the exact requirements of the relevant accreditation standards.
The quality management standard for medical devices lasts for three years and is subject to mandatory audits to ensure that you are compliant. At the end of the three years, you will be required to complete a reassessment audit in order to receive the standard for an additional three years.
Contact our team today to receive a free no-obligation competitive quotation from our dedicated business development team. We will devise a comprehensive quote which will be in line with your requirements.