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Best Practices for Lean Supplier Management in Compliance with FDA and ISO 13485 Requirements

Compliance Key INC  - FDA Compliance Training Overview Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meets all required regulations, especially for critical suppliers. Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that you have sufficient control over your suppliers to assure auditors and regulatory agencies that your product is safe and meets all your requirements? Your supplier management program can be in compliance, but is it cost effective? If not, your unquantifiable overhead costs may be out of control. Is your supplier management program collaborative with your suppliers? If your company is too demanding of your suppliers, you risk alienating them or even worse losing them - try explaining that to your supply ch...