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Supplier Management for the Medical Device Industry

Format Virtual

This course helps medical device manufacturers govern supplier relationships. You’ll learn to apply the best practices for supplier selection, certification and monitoring and involve your organization on the front end of this vital relationship.

Better select, evaluate and manage your suppliers to ensure the quality of the product or service delivered. Apply the best processes for supplier selection, certification and monitoring in order to involve your organization on the front end of this vital relationship. Examine the importance of global supply chain management and get a clear understanding of the benefits of establishing long-term, mutually beneficial partnerships.

Course Data

  • CEU Hours: 1.4
  • Length: 14 Hours
  • ASQ RU: 1.4
  • Audience: New to Quality, Practitioner
  • Provider: WebEx Training
Course Overview

Learning Objectives:

  • Demonstrate how to prepare a supplier quality plan based on applicable standards and regulations
  • Examine and discuss the nature of a global supply chain
  • Evaluate a potential supplier’s business and operational capability
  • Develop a plan for evaluating and ranking potential suppliers
  • Use final controls over suppliers based on the level of risk to the product
  • Develop level definitions of a multi-level supplier certification process
  • Establish a process for measuring and monitoring supplier performance
  • Develop a process for communicating supplier performance and improvement

Who Should Attend:

Anyone in the medical device industry working with and responsible for vendor and supplier relationships and supplier quality. These include project managers, personnel associated with purchasing, suppliers, manufacturers, quality planners, schedulers, internal auditors, and ISO13485 implementation teams.
  1. Introduction to Supplier Management
    1. Key definitions and sources
    2. Applicable standards, laws and requirements
    3. Attributes of a desirable supplier
  2. 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)
  3. 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
  4. 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
  5. 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
  6. 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
  7. Feedback and Communication
    1. Communication
    2. Benchmarking
    3. Recognition and awards
System Requirements
Here is what you need to participate in an ASQ web-based, self-paced, or instructor-led virtual WebEx course.

Registration Email

After course registration, you will receive an email with access instructions. If you do not, please check your email junk, spam, or clutter folders. If the email is not there, please contact ASQ. For virtual WebEx courses, you will receive another email 24 hours prior to the start of class containing additional access information.

Technical Requirements

  • Computer – PC or Macintosh
  • High-speed internet connection
  • Adobe Flash Player 10.3 or later
  • Windows: Internet Explorer 8 or later, Google Chrome (latest version), Firefox (latest version)
  • Mac: Safari 7 or later, Google Chrome (latest version), Firefox (latest version)
  • For instructor-led virtual WebEx courses, a speakerphone or telephone headset in a designated room or space with no distractions (preferred)

NOTE: Refer to product description for any additional system requirements.

WebEx – Virtual Course: Advance Preparation and Student Information

Join a Test Session

We strongly suggest that you join a WebEx test session in advance of your scheduled virtual training, using your preferred web browser. This can help prevent problems launching content the day your training begins.

If you do not have administrative privileges on the SAME computer you will be using the day of your training (i.e., your workstation within your organization) you may need the assistance of your local IT/IS help desk staff for the platform to engage correctly.

To join a test session (meeting), click here and enter your name and email address to join. If successful, you will see a screen that says "Congratulations! Your system is now set up properly ..."

Deactivate Pop-up Blockers

You should deactivate any pop-up blockers, spam filters, and company firewalls that could prevent the WebEx client platform or web-based course from working properly. Third-party toolbars such as Bing, Yahoo, and Google should also be disabled due to their own pop-up blocking capabilities.

Cancellation Policy
ASQ reserves the right to cancel or re-schedule courses and to change instructors. Please be advised that in the event of a course cancellation, ASQ is not responsible for airfare penalties or other travel related expenses you may incur.
  • If you need to cancel, we will refund your paid registration fee as noted below.
    • Requests for cancellations/transfers received at least 5 business days before the start of the course receive a full refund/transfer.
    • Requests received within 5 business days of the course starting incur a $150 processing fee.
    • After the course starts, there are no refunds or transfers.
    • Registrants who fail to attend without advance notice are liable for the entire course fee.
    • If you cannot find a substitute, we can transfer your course fees to another ASQ course of your choice.
  • You must successfully complete the entire course or program before IACET CEUs and a Certificate of Completion can be awarded.

Enrollment Details

Format: Classroom
Format: Virtual

An Internet-based, instructor led course utilizing web and teleconferencing technologies to allow students to interact without traveling.  Virtual courses offer interaction with instructor and students via phone and Internet capabilities. Students have access to interaction both with the instructor and other students in an Internet-based learning environment (white board, Q&A tools, application sharing, and breakout rooms).  Virtual courses are classroom-like experiences offered using the latest Internet tools.

No Offerings Scheduled English List: $899 Member: $799



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