Originally Published MDDI
May 2004
Quality
Beyond Compliance: How the best device makers
Build on quality practices
Jennifer Parkhurst and Beth Shaw
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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
