MDSAP INSPECTION SERVICE DESCRIPTION
We can provide an MDSAP inspection at your facility to determine the level of compliance of your quality management system with the combined requirements. Medicom clients are increasingly using this service as part of their preparation for future inspections by regulatory agencies, using Medicom associates as external SMEs to improve audit objectivity and effectiveness.
This normally requires two (2) to four (4) days onsite depending on the scope of the inspection. A detailed exit meeting is provided on the afternoon of the final day, with our final report generally being provided within five (5) working days after completion of the inspection.
The inspection benefits the company in that it provides personnel with a real experience of how an MDSAP inspection will take place and our report containing inspection findings will help you improve the adequacy of the QS so that the identified problems do not arise during a real regulatory agency inspection.
Our report will detail all observations of nonconformity found during the inspection, with attribution to the clause(s) of the relevant regulations not complied with, including an evaluation of how individual observations would be viewed by regulatory authorities, and what would likely be the overall conclusion on compliance status.
Many valuable lessons will be learned in how to prepare for and manage the MDSAP inspection, ensuring your company reduces the potential for the issuance of damaging nonconformity notices that can seriously disrupt business and profitability.