This bulletin concerns the arrangements for the introduction of IAF MD9 for Medical Device Quality Management Systems. IAF MD9 sets out the general requirements for bodies operating audit and certification of organisations' Quality Management Systems in accordance with ISO 13485 and has an application date of 15 July 2012. Certification Bodies (CBs) that are accredited for this certification activity shall review the requirements contained in MD9 and ensure that they are implemented by the application date. UKAS will assess the implementation and application of MD9 at surveillance and reassessment visits to CBs. Visits that take place prior to July 2012 will focus on the plans the CB has in place to implement any changes necessary.
The content of MD9 incudes guidance on time on site allocation for Medical Devices assessment, CBs are to implement this guidance by the next contract review for each certified customer. Therefore existing signed contracts between the CB and its customers covering the 3 year cycle do not need to be revisited until the contract is due for renewal, for example at the next reassessment.
For information, IAF has also published an associated document IAF MD 8 for the Application of ISO/IEC 17011 in Medical Devices Quality Management Systems for Accreditation Bodies. The objective of this Mandatory Document is to enable Accreditation Bodies to harmonise their application of ISO/IEC 17011 for the accreditation of bodies providing audit and certification to ISO 13485. Adoption of this document by UKAS may result in the way in which ISO 13485 schedules are scoped being subject to change. UKAS will be implementing the requirements set out in this document and where any changes are required to the assessment of CBs as a consequence of MD8, CBs will be notified by their Assessment Manager.
MD 9 is available to download from the publications section of the IAF website - http://www.iaf.nu/
If you have any questions regarding this Bulletin please contact: Kevin Belson: Technical Manager email@example.com
Kate Rolfvondenbaumen: Technical Focus Person, Medical Devices firstname.lastname@example.org