Glossary Term
Inspection Plan
Definition
An inspection plan is a documented strategy outlining the processes, criteria, and methods used to examine and verify the quality and compliance of materials, components, or finished products in manufacturing. It specifies what to inspect, when to inspect, and how to inspect to ensure adherence to design specifications, regulatory requirements, and quality standards.
Relevance to the MedTech Industry
Inspection plans are critical for ensuring that medical devices meet stringent quality and safety standards throughout the production lifecycle. They help manufacturers identify and address defects early, maintain compliance with regulatory bodies like the FDA or ISO standards, and deliver reliable products that protect patient safety.
Additional Information & Related Terms
Examples of Applications
Incoming Material Inspection: Verifying the quality of raw materials or components from suppliers before use in manufacturing.
In-Process Inspection: Checking partially assembled devices for dimensional accuracy or functional performance during production.
Final Product Inspection: Ensuring finished devices meet all design and regulatory specifications before shipment.
Sterility Testing: Inspecting sterilized devices for packaging integrity and sterility assurance.