The newer revision of ISO 13485 is in year version 2016, as of February 25, 2016, in its 3rd revision.

ISO 13485 IMDRF choose not to adapt Annex SL 2012 for its format, and maintained revision ISO 9001 2008 versions format, 8 sections. Transition to the 2016 version needs be by the first assessment in year 2019.

If your organization's QMS includes ISO 13485 and ISO 9001 certification status, consideration may be given to the transition to ISO 9001:2015. Regardless, transition certifications onto ISO 13485:2016 may occur at any time throughout the certification - registration cycle. This means that may occur as part of the reassessment, as including planned surveillance assessments, or by having a special assessment done at the organization's preferred time.

BULLTEK LLC / LTD is planning training venues in various world regions on matters of adjustements that the 2016 version brings and integration with the 2015 revision of ISO 9001. The key changes between the 2003 and 2016 versions of ISO 13485 include:

  • Inclusion of risk-based approaches that include beyond product realization, as applicable. We suggest in compliance to regulations, may ISO 14971 provide a guide-tool to identification and control of risks within the context of safety and performance to patients and users regulatory requirements;
     
  • Continuance basis "...for regulatory purpose" for adequacy based documentation based appropriateness;
     
  • Consideration needs be given to throughout equipment-device...life cycle and supply chain;
     
  • Integration of the requirements for software validation and different versions based applicability (whether for process control, for monitoring and measurement and inclusive QMS applicability), as reference within the context of ISO 13485, yet as applicable supersede by regulations;
     
  • The organization' appropriateness in infrastructure, including production of sterile medical devices, which includes validation of sterile barriers in accordance to laws and regulations;
     
  • As applicable, planning for design, development with consideration applicability, (homologation), verification and validation planning, design transfer, design records and changes;
     
  • Complaint handling continues as a reporting to regulators in accordance to statutory regulations with post-market surveillance consideration; and
     
  • Planning and documentation of corrective action and preventive (based risks) actions, and associate implementation without undue delay.

 


 

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