Introducing the New Revision of ISO 13485 Standard: Medical Devices – Quality Management System – Requirements for Regulatory Purposes.
The new edition of the ISO 13485 standard was published on March 1 2016, concluding almost five years of intense discussion and development by experts around the world to improve and update the standard with new European requirements and other international regulatory changes, implemented since its previous revision in 2003.
ISO 13485 defines the requirements for a quality management system designed to demonstrate an organization’s ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Organizations complying with this standard, such as medical devices manufacturers, as well as suppliers and external parties that provide products or services to manufacturers, will be able to demonstrate compliance with regulatory requirements, manage risk, ensure best practice for quality and safety, improve processes and provide confidence to patients and users.
The new ISO 13485:2016 focuses on how companies should manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of the quality management system.
Some of the key changes between the 2003 and 2016 version include:
- 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 life cycle 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
Organizations have until March 1, 2019 to transition from ISO 13485:2003 to ISO 13485:2016. SGS will soon provide materials, services and courses to help make the transition in the best possible conditions.
SGS is currently making arrangements with the appropriate accreditation authorities to confirm the plan to start the certification service for ISO 13485:2016 and will soon communicate accordingly.
Click here for more information on ISO 13485:2016.
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