ISO 14001 EMS Recertification Support for California Biopharmaceutical Manufacturer

Project Details:

KERAMIDA provided ISO 14001:2015 Environmental Management System (EMS) corrective action and recertification support for a biopharmaceutical manufacturing facility in Northern California. The engagement focused on resolving internal audit findings, strengthening the facility's EMS, and preparing for external recertification.

EMS Assessment & Corrective Action Support

KERAMIDA conducted a multi-day on-site assessment that included a facility tour, review of the existing EMS and electronic documentation, clarification of roles and responsibilities, and detailed evaluation of nonconformities, comments, observations, and opportunities for improvement identified during the internal audit.

Working with facility personnel, KERAMIDA:

  • Updated EMS documents and procedures

  • Developed recommended revisions to internal systems

  • Addressed open corrective and preventive actions

  • Established an implementation schedule

ISO 14001 Recertification Readiness

KERAMIDA performed a follow-up on-site gap analysis of the revised EMS program elements to evaluate the effectiveness of the changes and readiness for external recertification.

The facility subsequently passed its ISO 14001:2015 registrar audit.


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