IAF WG on ISO 13485 QMS for Medical Devices Azusa Nakagawa-Inoue (JAB) 16 June 2010 PAC TC meeting

IAF WG on ISO 13485 QMS for Medical Devices Has set up for the purpose of the development of Medical Device Conformity Assessment System (MDCAS) at IAF meeting in Sydney, Oct 2007. The target of the WG is to create a single ISO13485　accreditation and certification scheme which legal authorities can use within their regulatory frameworks. For this purpose, the WG has developed IAF documents for MDCAS

IAF Documents for Medical Device Conformity Assessment System The WG has developed the following documents; IAF MDCAS Manual giving a framework for understanding the IAF MDCAS scheme to stakeholders explaining the interaction with stakeholders, objectives and structure of the scheme Lists applicable documents and their relationships IAF Mandatory Document for the Application of ISO/IEC 17011 in Medical Device Conformity Assessment System (MDCAS) IAF Mandatory Document for the Application of ISO/IEC 17021 in Medical Device Conformity Assessment System (MDCAS)

IAF Document for Medical Device Conformity Assessment System Main contents in order to conform with GHTF requirements and develop the scheme trusted by interested organizations: IAF MD for the Application of ISO/IEC 17011 Accreditation scope Competence of personnel involved in the accreditation activities Assessment team (document review, office assessment, witness) Application review Making accreditation decisions Administrating program Communication with regulatory organizations IAF MD for the Application of ISO/IEC 17021 Technical areas Competence of personnel involved in the certification activities Auditors Personnel carrying application review Personnel making certification decision Personnel managing program Audit duration

Progress and next steps Completed 60 day comment period among IAF TC members Revised draft documents responding to comments Another 30 day comment period in IAF TC from 19 May to 21 Jun. The WG is planning to issue the IAF documents within this year, after 60 day comment and 30 day voting periods in IAF members.

IAF Medical Device Conformity Assessment System (MDCAS) The target of the WG is; to create a single ISO13485 accreditation and certification scheme which legal authorities can use within their regulatory frameworks. The WG would like to develop the scheme which is used widely by IAF and PAC members. Thus, your comments to draft documents are highly appreciated.