ISO 13485 Gap Analysis Identifies Investment Opportunties

411 Industries is a locally-owned Greeneville, Tennessee-based company providing testing and inspection, small bench work, assembly & fabricating, sorting, special projects, contract assembly services, packaging services, quality inspection, and rework services for other OEM and tier suppliers.

While already ISO 9001 certified, the company was interested in expanding to the medical device industry and requested that TMEP, part of the MEP National Network™, facilitate an ISO 13485 gap analysis incorporating both of their manufacturing locations. The gap analysis is important to identify discrepancies between the existing ISO 9001 quality management system and the requirements outlined in ISO 13485:2016.

A TMEP certified ISO 13485 Lead Auditor spent sixteen hours across both locations reviewing and documenting 411’s production processes. The consultant worked with 411 employees to review existing documentation, procedures, and policies, observed processes, and noted discrepancies between the existing QMS and ISO 13485 requirements. Recommendations were provided to close the gaps and a detailed action plan was developed for the 411 team to implement.