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Medical Device Supplier and Subcontractor Quality Management Training

You can outsource manufacturing, but you can't outsource your compliance obligations. Poorly designed and executed supplier quality management systems can cost your company millions. With dozens or hundreds of suppliers to manage, you need a proven risk-based process that meets FDA and ISO 13485:2016 requirements, plus new mandates found in the EU Medical Device Regulation (MDR 2017/745). On paper, the requirements seem straightforward, but applying them can get tricky. You’ll walk away from this class with a clear understanding of the various regulatory requirements and how to establish an effective and efficient system using a risk-based approach.

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Brief Overview of This Medical Device Supplier Quality Management Class

SkillsLab Class ?

Class Content


Class Duration

5 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion


Continuing Education Units (CEUs)


* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 3 consecutive days. 

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Supplier and Subcontractor Quality Management Training Classes

SkillsLab $3295

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
SQF VIRTUAL DELIVERY (Eastern Time) 30 Sep 2024 04 Oct 2024 1:00PM - 5:00PM Eastern US Time Virtual - Spanish Delivery REGISTER


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Register 3 people, 4th attends free!


*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Intensive Supplier QMS Class

Supplier quality management issues continue to be a top observation in US FDA inspections and the source of numerous warning letters and 483s. In addition to compliance concerns, organizations face day-to-day supplier quality issues that pose significant risks, including production disruptions and high-profile recalls. This course will provide your organization with the knowledge and tools to manage a comprehensive, risk-based, cross-functional supplier quality management system. You will learn the requirements for establishing an effective and efficient system, starting with the development of product specifications and working through the maintenance of an approved supplier list. 

Course Overview
SkillsLab Class

Introduction to Supplier Quality Management

  • Current trends / issues in supplier quality
  • Key terms
  • Supplier-related concerns of stakeholders

Regulatory Requirements and International Standards

  • Supplier management requirements from:
    1. US FDA
    2. Medical Device Single Audit Program (MDSAP)
    3. European Union Medical Device Regulation (EU MDR)
    4. Global Harmonization Task Force (GHTF) Guidance
    5. ISO 9001:2015
    6. ISO 13485:2016

Supplier Quality Management System Overview – ISO 13485:2016

  • The process approach and risk-based thinking
  • Supplier quality management in the overall quality management system
  • Purchased product requirements
  • Evaluation, selection, and approval of suppliers
  • Verification of purchased product, re-evaluation of suppliers
  • Outputs / feedback that can be used to improve the supplier QMS

Product and Supplier Requirements Determination

  • Quality system planning activities for outsourced QMS processes
  • The relationship of the design process to SQM
  • Purchased products and suppliers that must be managed in the supplier QMS
  • QMS processes used to define purchased product and supplier requirements

Supplier Evaluation, Selection, and Approval

  • Purchasing process: supplier evaluation and selection requirements
  • Risk-based thinking in supplier evaluation, selection, and approval
  • The purchasing process: supplier evaluation, selection, and approval
  • Documentation needs for the Approved Supplier List (ASL)

Supplier Monitoring and Re-evaluation Process

  • Supplier QMS audits
  • Supplier feedback sources
  • Supplier scorecards
  • Supplier performance review
  • Supplier issues and disqualification
  • Supplier re-evaluation process
  • Related QMS processes:
    1. NC / CAPA
    2. Management review
    3. Design control / risk management

Verification of Purchased Product

  • Verification of purchased product, including on-site verification
  • Risk-based approach to choosing verification methods
  • Requirements for assessing supplier changes / supplier change notification
  • Risk-based statistical methods for verification of purchased product

Outsourced Processes

  • Requirements for outsourced processes: ISO 13485:2016, US FDA, MDSAP, EU MDR
  • Quality agreements: common contents and best practices

Business Considerations and Opportunities

  • Impact of supplier QMS on operational risks
  • Issues with overall supply chain management – global influences, concerns, etc.
  • Supplier trends and the distributed supply chain
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to

Identify regulatory requirements and international standards for supplier quality management, including ISO 13485:2016, US FDA, Medical Device Single Audit Program (MDSAP), and the EU Medical Device Regulation. 

Describe the life cycle of supplier quality management. 

Establish a risk-based process for evaluating, selecting, and re-evaluating suppliers. 

Translate product development and manufacturing needs into purchased product and supplier requirements. 

Identify and appropriately manage outsourced processes through the supplier quality management system. 

Develop and maintain an approved supplier list. 

Develop an effective supplier quality monitoring and measurement process. 

Communicate supplier quality management system status to the management team. 

Plan and implement an effective process for verifying purchased product.

Manage supplier nonconformances and escalation of issues through the supplier quality management and related quality management system processes.

Identify common issues in global supplier quality management.

Identify current and emerging topics in supplier quality and global supply chain management.

Who Should Attend

Who Should Attend

Designed for personnel involved in sourcing, securing, and maintaining suppliers that ensure excellent product quality and organizational reputation, including supplier quality and procurement / supply chain managers; product development engineering managers; management representatives; product, project, and program managers; RA/QA managers / engineers; auditors; and other cross-functional team members.

  • Supplier Quality Managers
  • Procurement / Supply Chain Managers
  • Product Development Engineering Managers
  • Product, Project, and Program Managers
  • RA/QA Managers / Engineers

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