Tokyo, Japan - ISO/TC 210 (ISO 13485 2016), Quality management a nd corresponding general aspects for medical devices, hosted by the IMDRF and the Japan Federation of Medical Devices Associations (JFMDA) including representatives from the ISO and member companies representing the USA Food and Drug Administration (FDA).
At Tokyo an agreement by the GHTF / nowIMDRF concluded the promotion and circulation of ISO 13485 (Quality Management Systems - Medical devices - System requirements for Regulatory Purposes) as a tool to help in fulfilling regulatory and legal requirements.
Committee 210 drafts the International Standard ISO 13485 and revisions, now with the assistance from regulators. ISO 13485 is a stand-alone document for
the medical device sector maintain concurrence with the format of 2008 ISO 9001. As it did in ISO 13485 additional requirements are specific to this sector, among the decisions taken. ISO 13485 is a management tool assisting in
fulfillment of regulatory requirements and legal obligations whether 93/42/EEC MDD, USA QSR, Canada CMDCAS...
Canada has set the stage wherein current ISO 13485 is a requirement under the Canadian Medical Devices Conformity Assessment System (CMDCAS) a market closing accreditation protocol, as consideration to transition to MDSAP.
The view within TC 210 is that, while these concepts of customer focus and improvement may be appropriate for a business excellence model, they do not belong in a baseline standard for a quality system that will become a tool for regulation in many jurisdictions abiding to safety, litigation, and product concerns. In lieu the product safety and effectiveness focus remains as bearer of ISO 13485. While current ISO 9001 significantly reduces these procedure requirements, current ISO 13485 retains explicit procedures, its purpose is regulatory focus.