ISO 13485 Quality Management System Certification

ISO 13485 is an internationally recognized quality management system (QMS) standard designed for the medical device industry. It sets requirements for organizations to demonstrate their ability to consistently provide medical devices and related services that meet customer and applicable regulatory requirements, with particular emphasis on regulatory compliance, risk management, process control, documentation, supplier management and validation.

ISO 13485 certification is relevant to organizations involved in one or more stages of the medical device lifecycle, including legal manufacturers, in vitro diagnostic (IVD) manufacturers, Software as a Medical Device (SaMD) companies, contract manufacturers, component suppliers, sterilization providers, packaging providers, logistics providers and other suppliers supporting medical device manufacturers.

The appropriate certification scope depends on your organization's activities, products, sites and responsibilities within the medical device supply chain. Contact us to discuss whether your activities and products can be mapped to ISO 13485 requirements.

ISO 9001 is a general quality management system standard that can be applied across many industries. ISO 13485 is specifically designed for organizations involved with medical devices, and includes requirements particularly relevant to the regulated sector, such as regulatory compliance, risk management, traceability, cleanliness, process validation, medical device documentation, complaint handling and regulatory reporting.

ISO 13485 establishes requirements for a medical device quality management system, which the Medical Device Single Audit Program (MDSAP) uses as a basis, adding country-specific regulatory requirements so that recognized Auditing Organizations can conduct regulatory audits covering participating authorities. The MDSAP certificate is also considered an unaccredited ISO 13485 certificate.

We are both an accredited ISO 13485 certification body and a recognized MDSAP Auditing Organization, so we can discuss certification and regulatory audit requirements as part of a broader market-access strategy.

ISO 13485 certification is generally managed through a three-year certification cycle, subject to successful ongoing surveillance and continued conformity with certification requirements. Surveillance audits are conducted annually during the cycle, followed by recertification before the cycle ends to maintain continuous certification.

If you hold an existing accredited ISO 13485 certificate, you may be able to transfer it to us, subject to review and applicable accreditation and certification requirements. The transfer process typically includes reviewing your existing certificate, certification scope, previous audit reports, open nonconformities and certification status. Contact us to find out whether your ISO 13485 certification is eligible for transfer.

We provide ISO 13485 certification as part of a comprehensive portfolio of medical device quality, regulatory and market-access services. You can draw on our global network and medical device expertise, together with access to services including MDSAP audits, EU MDR and IVDR conformity assessment, UKCA services, medical device testing, medical device training, Software as a Medical Device services and supply chain assessment. This broad capability helps you address quality management and regulatory requirements across multiple markets.

Start by contacting us with basic information about your organization, including your medical device activities, locations, number of employees, existing quality management system and desired certification scope. We will review your requirements, determine the appropriate certification approach and provide a proposal for your ISO 13485 certification.