We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
QSR-Compliant Purchasing Controls A Five-Stage Plan
You know your requirements for your supplier management program.
But what does the FDA expect? Supplier selection… specification of purchased components or services… verification of items received?
A compliant purchasing control system must have five stages:
Evaluate Your Suppliers
Determine the Level of Control Needed
Establish and Maintain Record-Keeping Procedures
Collect Purchasing Data for All Suppliers
Establish and Follow Acceptance Criteria and Activities
It seems simple enough, but 35 percent to 40 percent of FDA warning letters issued since 2008 target devicemakers’ supplier management systems.
Follow the five-step plan in QSR-Compliant Purchasing Controls to avoid becoming part of that statistic. This FDAnewsBrief explains what the regulation requires and how to make sure your system passes muster. You’ll learn:
How to create a supplier hierarchy based on risk;
The benefits of maintaining an Approved Supplier List;
What information to keep in each supplier’s file;
How to monitor changes in supplier procedures, personnel or products; and
How to design acceptance procedures that ensure what you get from your supplier is what you need.
BONUS: You’ll get a rundown of recent changes in ISO 13485’s purchasing control standards along with a point-by-point comparison of QSR and ISO requirements. You’ll also receive a Supplier Evaluation and Control Checklist to help you cover all the bases.
Order Your Copy Today
PDF Edition
Available Format
PDF Edition — $177
Multi-user Access
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Our Guarantee
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.
