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.
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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
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