Content
       • Personal Introduction
       • Quality Management:
          –key concepts
          –key elements
          –is QM required?
       • QM for Biomedical Engineering
       • Academic / Industrial Cooperation
       • Summary
                           Jürgen Schmitt, SES          2
                                         Personal Introduction
     • 2016      SES project with NIB, Montevideo
     • 2014      Retirement, SES Expert
     • 2005 – 2014Quality Auditor, GE HealthCare
     • 1996 – 2005Quality Manager, GE HealthCare
     • 1992 – 1996Design Manager Application Software, 
                 Marquette-Hellige
     • 1976 – 1991Design Engineer, Hellige
     • 1972 – 1975Design Engineer, Nixdorf Computer AG
     • 1972      Graduation as Dipl. Ing. (FH) for 
           Electronics and Control Engineering
                              Jürgen Schmitt, SES               3
                                 Quality Management, key concepts
     This is a story about four people named Everybody, 
     Somebody, Anybody and Nobody:
     There was an important job to be done and Everybody was 
     sure that Somebody would do it. 
     Anybody could have done it, but Nobody did it.
     Somebody got angry about that, because it was Everybody’s 
     job. 
     Everybody thought Anybody could do it, but Nobody realized 
     that Everybody wouldn’t do it. 
     It ended up that Everybody blamed Somebody when 
     Nobody did what Anybody could have done.
                                          Jürgen Schmitt, SES              4
                                     Quality Management, key concepts
      • Planning
          –“think first than act”
          –Goals
          –Time 
          – Resources
          –plans are to be updated
                                Jürgen Schmitt, SES                  5
                                       Quality Management, key concepts
       • Process approach             Input    Process    Output
       • “do it right the first time” (better “try to do it right…”)
                trial & error is OK as long as we learn from errors
       • no surprises, always having everything under control
                (examples: Emergency Plans, Deviations)
                                  Jürgen Schmitt, SES                    6