Beyond Compliance: How the Best Device Makers Build on Quality Practices

Originally Published MDDI May 2004

Quality

Beyond Compliance: How the best device makers
Build on quality practices

Jennifer Parkhurst and Beth Shaw

Analysis of the results from the MD&DI/PRTM quality systems survey highlight a number of practices that help set top device makers apart from the crowd: 

• Focusing on proactive quality topics in management review meetings.
• Providing sufficient resources for quality activities.
• Meeting with partners regularly to address quality.
• Assigning the quality department lead responsibility for identifying and maintaining quality metrics.
• Using quality metrics to motivate improvement efforts.
• Using metrics to drive quality improvements with suppliers and partners.
• Ensuring that procedures are applied across the company.
• Giving the quality department responsibility for change control.
• Linking with other operational processes (such as human resources) as 
well as with partners' processes.
• Meeting with partners to address the effects of procedure changes.
• Considering the use of maintenance, training, and PDM systems to gain quality management advantages.

Copyright ©2004 Medical Device & Diagnostic Industry