Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485)
[Contenuto in lingua inglese]
As a company certified by BSI Group pursuant to the requirements of ISO 13485, and we would like to inform you of the following change to audit durations.
IAF MD9: Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485) has been updated. IAF MD9:2022 specifies the mandatory requirements for conformity assessment bodies auditing and certifying organizations’ Quality Management systems to ISO13485 including auditor competency, impartiality, and audit durations. As result of the updates, there may be changes to your audit duration:
1) If you hold a ISO 13485 certificate - IAF MD9:2022 uses Medical Devices Technical Areas to classify medical devices.
The change that may have an impact on your audit duration is as follows:
When more than one main technical area is required to be audited, the audit duration shall be increased to address any additional requirements related to the additional main technical area(s).
To be compliant with this update of the requirements in IAF MD9, BSI will increase the audit duration with 0.5 day for each additional main technical area. This will be applicable for each site mentioned on the ISO13485 certificate. The increase in audit time might also influence the billable reporting time.
The one exception to this is if the additional main technical area is “Sterilization Method for Medical Devices”. In this case there will be no time added as BSI already performs separate Microbiology audits where a client has sterilization in scope.
2) If you have a combined ISO 13485 and ISO 9001 audit -
When determining the required time for conducting an ISO13485 and ISO9001 audit together, a minimum of 25% will be added to the minimum number of audit days as per current audit time calculation.
BSI will implement IAF MD9 by its application date of 1st February 2023. For our clients this means that we will review audit durations in 2023 during audits or contract reviews, and update cycles for the next routine audits.
You as a client do not need to take any action in relation to the change in IAF MD9.
BSI Group provides its services worldwide and we remain committed to providing you with the best possible services.
Should you have any queries, please contact RSAQueries@bsigroup.com.
We appreciate your trust in us to manage the changes above and will endeavour to continue to provide you with any future assistance required regarding your certifications.
SVP Global Regulatory and Quality, Medical Devices