Glossary Term
Bill of Materials (BOM)
Definition
A Bill of Materials (BOM) is a comprehensive list of raw materials, components, sub-assemblies, and quantities required to manufacture a product. In the MedTech industry, the BOM serves as a blueprint for assembling medical devices, ensuring compliance with design specifications, regulatory requirements, and quality standards.
Relevance to the MedTech Industry
The BOM is essential for efficient manufacturing and supply chain management. It provides a detailed inventory of all components needed to produce a medical device, ensuring consistency, traceability, and regulatory compliance. The BOM also supports cost estimation, production planning, and risk management.
Additional Information & Related Terms
Design Control Ensures the BOM aligns with design inputs and regulatory requirements.
Traceability Facilitates tracking of components and materials listed in the BOM.
ISO 13485 Governs the quality management processes that include BOM documentation.
Corrective and Preventive Actions (CAPA) Relies on the BOM for component-level investigations and actions.