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

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Presentation on theme: "1 IAF WG on ISO 13485 QMS for Medical Devices Azusa Nakagawa-Inoue (JAB) 16 June 2010 PAC TC meeting."— Presentation transcript:

1 1 IAF WG on ISO QMS for Medical Devices Azusa Nakagawa-Inoue (JAB) 16 June 2010 PAC TC meeting

2 2 IAF WG on ISO 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  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

3 3 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 in Medical Device Conformity Assessment System (MDCAS)  IAF Mandatory Document for the Application of ISO/IEC in Medical Device Conformity Assessment System (MDCAS)

4 4 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 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 Technical areas Competence of personnel involved in the certification activities  Auditors  Personnel carrying application review  Personnel making certification decision  Personnel managing program Audit duration Communication with regulatory organizations

5 5 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.

6 6 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.


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