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A Bulletproof, Cost-Efficient Supplier Management Program
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A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA cannot regulate component suppliers, it is imperative that your company’s purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices.
Most medical device manufacturers have acceptable systems in place to assure component quality. But what about supplier quality? Your company must have a procedure in place that describes the methods you use to evaluate potential suppliers, and set forth requirements that your suppliers must meet to be considered “approved.” You must also have a system in place to routinely assess your suppliers, and set forth the applicable criteria they must meet to remain “approved.” You may never have to pay a visit to your supplier if you have a great supplier control program in place.
QSR and ISO 13485 requirements for supplier selection and assessment
How to qualify new suppliers in a cost efficient manner
How to assess current suppliers in a cost efficient manner
How to perform supplier-related corrective action
Minimum documentation requirements for supplier qualification, assessment, and related corective action
Who Should Attend
Quality Assurance Departments
Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management.
(Contact us : 844-267-7299 | 954-947-5671
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