Medical Device Mgmt Review Training

2. • Understand what Management Review is and
why it is important to the Quality System.
• What practices and procedures are in place at
Stryker.
• Understand what metrics are monitored and
reported during the Management Review.

3. Per 21 CFR Part 820, Subpart B and ISO
13485:2003 Senior and Executive level
management will review an organizations
quality system to ensure:
Adequacy and Effectiveness
Opportunities for Improvement
Need for Changes.
Continuing Suitability
Evidence of Compliance

4.  Results of internal and external audits
 Customer feedback
 Process performance and product conformity
 Status of preventive and corrective actions
 Follow-up actions of previous management
reviews.
 Changes that could affect the quality system.
 Recommendations for improvement.

5. Any decisions and actions related to:
 Improvement of the effectiveness of the
quality management system and its processes
 Improvement of product related to customer
requirements
 Resource needs.

6. Divisional Level Management Review
Procedure
90644228
Operations Level Management Review
Procedure
00-01-00

8.  Is the right data being reported to capture
trends?
 Are goals being met, and are the goals set
appropriate?
 Is the system in a state of control?
 Are there any issues and do they need to be
escalated?

9. Department Person Responsible
Complaints Allison Harris
NCR’s Ashley James
CAPA’s Ashley James
PIR’s/ Field Actions Josh Debruyn or Tara Lopez
Training Cambria Rollo
Internal Audits Ashley James
External Audits Josh Debruyn
Product Distribution Gerry Yarber
Production and Process NCR’s Ashley James
Scrap Totals Denise Vargo
Calibration Robert Keel
Preventative Maintenance Brian Bowen
Supplier Quality Roberto Reyes
Inspection Cycle Time Saurabh Saini
Environmental Monitoring Lucy Kong

10. Motivation…..after manufacturing transfer date…..