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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)	29 Apr 2024	03 May 2024	1:00PM - 5:00PM Eastern US Time	Virtual		REGISTER
SQF	VIRTUAL DELIVERY (Eastern Time)	30 Sep 2024	04 Oct 2024	1:00PM - 5:00PM Eastern US Time	Virtual - Spanish Delivery		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

Regulatory Requirements and International Standards

Supplier management requirements from:

US FDA
Medical Device Single Audit Program (MDSAP)
European Union Medical Device Regulation (EU MDR)
Global Harmonization Task Force (GHTF) Guidance
ISO 9001:2015
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:

NC / CAPA
Management review
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

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.

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

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.