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

ISO 13485 IMDRF choose not to adapt yet Annex SL 2012 for its format, and maintained revision ISO 9001 2008 / ISO 13485 2003 versions format, 8 sections. And transition to the 2016 version needs be by the first assessment in year 2019.

    Introduction in ISO 13485 2016...for regulatory purpose interestingly, we believe that brings the most significant change. The Introduction (0.1 - 0.5) establishes the responsibility for OEM on whether they invoke QMSMDD ISO 13485 to suppliers, whether Tiers 1, 2, 3...No longer one particular world region or a thirds-party imposes applicability of QMSMDD ISO 13485 to the entire supply-chain. It is the responsibility of the OEM (such as Stryker, St. Jude, Medtronics, Siemens, Philips, GEMS, Griffols...naming a few) to demonstrate that their products are safe and effective to statutory based regulatory entities, whether the FDA, an NB, MDA or likewise. Without naming nations, yet, still in some countries around the world there is a believe that QMSMDD ISO 13485 is a substitute to any and all applicable laws and regulations. Indeed, ISO 13485 is hollow if there are no regulations to adhere.   

    QMSMDD ISO 13485 applies to OEM exporting to the European Union, as the U.S.A. requires QSR. Not all suppliers based tiers are forced to the QMSMDD mandate (within the medical devices supply-chain), thus are not necesarily obligated to QMSMDD ISO 13485, as it is decision of the OEM and the choices may include ISO 9001.

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; both ISO 9001 and ISO 13485 are exclusive for the purpose of granting and issuing certification. This means that transition may occur as part of the reassessment, 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, in addition to the Introduction (sections 0.1 through 0.5):

  • 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 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;
  • Planning and documentation of corrective action and preventive (based risks) actions, and associate implementation without undue delay; and if applicable;
  • Consider including CYBERSECURITY measures, if your device is on-line, and for which we can also help.



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