Supplier Management for the Medical Device Industry

1. Introduction to Supplier Management 
   1. Key definitions and sources
   2. Applicable standards, laws and requirements
   3. Attributes of a desirable supplier

   II. Planning

   1. Preparing a supplier quality plan (best practices, plan elements, team skills, types of suppliers, types of purchased products, supplier quality agreements, control plan)

   III. Global Supply Chain Risk

   1.  Alignment of business and regulatory compliance risk
   2. Risk of non-conforming products and services received, liability risk, conflict of interest
   3. Labeling challenges
   4. Business partnerships
   5. Make vs. Buy decisions
   6. Applicable international requirements

   IV. Supplier Evaluation, Selection, and Acceptance 

   1.  QMS maturity, socio-economic culture, partner relationships
   2. Performance and technological indicators
   3. Supplier criticality and business risk
   4. Implications of partnership
   5. Supplier selection criteria and decision rationale
   6. Documentation of potential suppliers

   V. Finalization of Controls 

   1. Residual risk
   2. Controls for monitoring suppliers
   3. Acceptance and verification activities
   4. Responsibilities and deliverables
   5. Reviewing and finalizing the agreement

   VI. Delivery, Measurement, and Monitoring  

   1. Levels of supplier certification process
   2. Tiered approach for supplier certification
   3. Certification compliance
   4. Performance measurement metrics
   5. Supplier rating and scorecard
   6. Supplier performance and revalidation activities
   7. Audit procedures, equivalency plan, decertification

   VII. Feedback and Communication  

   1. Communication
   2. Benchmarking
   3. Recognition and awards
   
   

 

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