Overview of the assessment program

An AO undergoes a Stage 1 – documentation review and Stage 2 – head office assessment. If the outcome is successful, the AO will be granted authorization to perform witnessed audits under the MDSAP. The AO is then required to perform three witnessed audits prior to a recognition decision being made. 

Once recognized, the AO enters a four-year assessment cycle involving annual surveillance head office assessments and one witnessed audit per year. Towards the end of the recognition period, a re-recognition assessment is performed, and the Technical Review and Recognition Committee (TRRC) makes a recommendation to the RAC as to whether the AO should be re-recognized for another four-year period. This review includes results from all assessment activities conducted over the life of the recognition period. The assessment program may be modified as needed, for example the addition of special assessments if required.  

The assessment program that MDSAP RA assessors follow is defined in key documents: MDSAP AS P0034: Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations and associated MDSAP Assessment Procedure Documentation. These describe how MDSAP RA assessor teams should plan for and conduct assessments and also the follow-up and monitoring activities.    

AOs are assessed for compliance with the requirements of ISO/IEC 17021-1 and the additional requirements of IMDRF MDSAP WG N3 and IMDRF MDSAP WG N4. RA assessors identify objective evidence of compliance with each of the requirements. If assessors identify nonconformities, they use a grading system to determine the timeline for any corrections or corrective actions and to support a predefined recognition and de-recognition process.