Claudia Mesica

ISO Management Systems Consultant

Isodirect • Freelance

Apr 2026 - Present • 6 mos

ISO Management Systems Consultant specializing in the development of management system documentation, manuals, procedures, policies, and compliance frameworks for organizations and professional clients. Worked with UESE ITALIA S.p.A. on the development of an ISO 9001:2015 Quality Management System, including a tailored Quality Management Manual, process documentation, quality objectives, document control structure, responsibilities, and procedures aligned with the organization's consulting and service operations. Developed structured information requirements and checklists to streamline the collection of client data for ISO documentation projects. Supported the development of reusable documentation frameworks for ISO 9001, ISO 14001, ISO 13485, ISO 27001, and ISO 45001, with additional expertise in ISO 50001 management system documentation. Areas of expertise include ISO management system documentation, QMS, ISMS, policies and procedures, compliance documentation, internal audit support, process mapping, risk-based thinking, documented information, continual improvement, and management system implementation support.

Food Safety & Regulatory Compliance Specialist

JAF Consulting • Freelance

Feb 2026 - Present • 8 mos

As a Food Safety & Regulatory Compliance Specialist, I provide regulatory and compliance support to food, beverage, cosmetic, pharmaceutical, and medical device businesses entering or operating in the Canadian, US, and European markets. I assist businesses with regulatory requirements, product compliance, documentation, registration, labeling, and food safety systems. My expertise includes CFIA food licensing, Safe Food for Canadians Regulations (SFCR), HACCP plans, Preventive Control Plans (PCP), food labeling and regulatory documentation. I also support FDA registration, US Agent services, FSVP compliance, OTC establishment and product listing, NPN-related regulatory requirements, and product label compliance for the US and Canadian markets. For medical device businesses, I provide regulatory support relating to EU MDR, CE marking, technical documentation, quality management systems, and ISO 13485 requirements. I review product and business information, identify regulatory requirements, organize compliance documentation, and provide practical guidance based on the applicable market and product category. My approach focuses on accuracy, clear documentation, regulatory readiness, and practical solutions that help businesses prepare their products for market entry and maintain compliance with applicable requirements.

ISO Documentation & QMS Consultant

Independent Compliance Documentation Practice • Freelance

Jun 2025 - Present • 1 yr 4 mos

Develop and review certification-ready documentation for businesses seeking ISO compliance and audit preparation. Focus areas include ISO 9001, ISO 13485, ISO 27001, ISO 14001, and ISO 37001 documentation, including quality manuals, SOPs, procedures, policies, records, risk-based documentation, and internal audit support materials. Help clients create structured, practical, and professional QMS documentation aligned with certification expectations while maintaining usability for real business operations.