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QA/RA Consulting, Auditing & Training

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

In-Depth

Class Duration

5 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEUs)

2.5

* 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

SkillsLab $3295

Course Code	Location	Class Begins	Class Ends	Daily Schedule	Course Delivery	Class Agenda	Registration
SQF	VIRTUAL DELIVERY (Eastern time - PM)	19 May 2025	23 May 2025	1:00PM - 5:00PM Eastern US Time	Virtual		REGISTER
SQF	VIRTUAL DELIVERY (Eastern time - PM)	29 Sep 2025	03 Oct 2025	1:00PM - 5:00PM Eastern US Time	Virtual		REGISTER

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

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

International Standards and Regulatory Requirements

Supplier management requirements from:
- ISO 13485:2016
- US FDA
- Medical Device Single Audit Program (MDSAP)
- European Union Medical Device Regulation (EU MDR)
- Global Harmonization Task Force (GHTF) Guidance

Supplier Quality Management System Overview – ISO 13485:2016

The process approach and risk-based thinking
Overview of ISO 13485:2016 supplier QMS requirements
- Purchasing process
- Purchased information
- Verification of purchased product
Outputs / feedback that can be used to improve the supplier QMS

Product and Supplier Requirements Determination

Quality system planning activities for outsourced QMS processes
Design process and supplier quality management
Traceability requirements
QMS processes used to define purchased product, supplier requirements, and change notification
Exercise! Determine Requirements

Data Collection, Appraisal Analysis, and Trend Analysis

Risk-based thinking in supplier evaluation, selection, and approval
Supplier evaluation and selection requirements
Supplier evaluation methods
Exercise! Create Tool
Supplier selection and approval
Approved supplier list (ASL)
Exercise! Evaluate Suppliers

Supplier Monitoring and Reevaluation Process

Process overview
Supplier performance review
Supplier scorecards
Exercise! Supplier Monitoring Plan
Related QMS processes
- NC/CAPA
- Management review
Supplier issues and disqualification
Exercise! Supplier Nonconformance Responses
Supplier feedback sources

Verification of Purchased Product

Identifying and choosing verification methods
Assessing supplier changes / supplier change notification
Sampling plans and statistical methods
Exercise! Verification Plan

Outsourced Processes

Outsourced process basics
Requirements for outsourced processes: ISO 13485:2016, US FDA, MDSAP, EU MDR
Quality agreements
Exercise! Quality Agreement

Successul PMS Audit Outcomes

Operational risks
Supply chain management

What You Will Learn

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

SkillsLab

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.

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

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.