ISO 13485:2016 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 and applicable regulatory requirements.
Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated.
Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.
What are the main changes?
- Incorporation of risk-based approaches beyond product realization. Risk is considered in the context of the safety and performance of the medical device and in meeting regulatory requirements
- Increased linkage with regulatory requirements, particularly for regulatory documentation
- Application to organizations throughout the lifecycle and supply chain for medical devices
- Harmonization of the requirements for software validation for different software applications (QMS software, process control software, software for monitoring and measurement) in different clauses of the standard
- Emphasis on appropriate infrastructure, particularly for production of sterile medical devices, and addition of requirements for validation of sterile barrier properties
- Additional requirements in design and development on consideration of usability, use of standards, verification and validation planning, design transfer and design records
- Emphasis on complaint handling and reporting to regulatory authorities in accordance with regulatory requirements, and consideration of post-market surveillance
- Planning and documenting corrective action and preventive action, and implementing corrective action without undue delay
- European Medical Devices Directive (MDD) 93/42/EEC
- European in Vitro Medical Devices Diagnostic Directive (IVDD) 98/79/EC
- Canadian Medical Devices Regulations SOR/98-282
- Medical Device Single Audit Programme (MDSAP)
- Requirements of other regulatory bodies in countries around the world