Planning and documenting corrective action and preventive action, and implementing corrective action without undue delay and also considering adverse effect.
Add design and development transfer and design and development file as two new sub-clauses.
ISO 13485 VS ISO 9001 VERIFICATION
Additional requirements in design and development on consideration of usability, use of standards, verification and validation planning, design records and design changes considering the risk of changes.
Strengthening of supplier control processes and the changes made by them.
Adds requirement that infrastructure prevents product mix-up and ensure orderly handling of product.
Specific requirements for documentation and validation of processes for sterile medical devices considering control of contamination with microorganism or particulate matter.
Increased focus regarding feedback mechanisms to utilize feedback in risk management processes.
ISO 13485 VS ISO 9001 SOFTWARE
Emphasising the requirements for software validation for different software in different clauses of the standard considering the risk approach.
New requirement related to protection of confidential health information.
Application to organisations throughout the lifecycle and supply chain for medical devices.
Alignment of global regulatory requirements and meet customer and applicable regulatory requirements for safety and performance.
Risk is considered in the context of the safety and performance of the medical device and in meeting regulatory requirements
Incorporation of risk-based approaches beyond product realisation.
Some of the most critical changes in the 2016 version include: It also incorporates the Technical Corrigendum ISO 13485:2003/Cor.1:2009. This third edition cancels and replaces the second edition (ISO 13485:2003) and ISO/TR 14969:2004, which have been technically revised. ISO 13485:2016 identifies the requirements for a quality management system (QMS) in which an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet both customer and regulatory requirements. The latest edition of ISO 13485, the internationally recognised quality management systems standard for medical device industry, with over 27,000 certificates globally, has been published on March 1, 2016.