Expert ISO & Regulatory Consulting

Wintersmith Advisory helps organizations implement and maintain ISO systems for compliance and performance.

Elevating Systems. Enhancing Performance.

Wintersmith Advisory delivers practical, precision-driven support to strengthen your management systems, meet regulatory requirements, and improve how your organization runs.

Abstract geometric artwork featuring intersecting circles, triangles, and lines in orange and beige on a dark background, symbolizing structured systems and precision
Abstract geometric artwork featuring intersecting circles, triangles, and lines in orange and beige on a dark background, symbolizing structured systems and precision

Frameworks and Standards

  • ISO 9001 – Quality Management Systems

  • AS9100 – Aerospace Quality Management

  • ISO 14001 – Environmental Management

  • ISO 45001 – Occupational Health & Safety

  • ISO/IEC 27001 – Information Security Management

  • ISO/IEC 27701 – Privacy Information Management

  • ISO 31000 – Risk Management Guidelines

  • ISO 14064-1 – Greenhouse Gas Emissions Accounting

  • GRI Standards – Sustainability Reporting

  • ISO 26000 – Social Responsibility Guidance

  • SA8000 – Social Accountability

  • ISO 37001 – Anti-Bribery Management

  • ISO 13485 – Quality management for medical devices

  • ISO 14971 – Risk management for medical device manufacturers

  • ISO/IEC 17025 – Competence of testing and calibration laboratories

  • ISO/IEC 20000-1 – IT service management systems

  • ISO 21001 – Educational organization management systems

  • ISO 22000 – Food safety management systems

  • ISO 22301 – Business continuity management systems

  • ISO 26000 – Social responsibility guidance

  • ISO 30401 – Knowledge management systems

  • ISO 31000 – Risk management guidelines

  • ISO 35001 – Biorisk management for laboratories and related organizations

  • ISO 37001 – Anti-bribery management systems

  • ISO/IEC 42001 – Artificial intelligence management systems

  • ISO 50001 – Energy management systems

  • ISO 56001 – Innovation management systems

  • ACMP Standard for Change Management – Organizational change management framework

  • EU MDR (2017/745) – European Medical Device Regulation

  • GRI Standards 1–3 – Sustainability reporting principles and general disclosures

  • IWA 48:2024 – ESG-related competencies for boards and governing bodies

  • 21 CFR Part 111 – Dietary supplement manufacturing practices (U.S. FDA)

  • 21 CFR Parts 210/211 – Pharmaceutical manufacturing practices (U.S. FDA)

  • 21 CFR Part 820 – Quality system regulation for medical devices (U.S. FDA)

  • GDPR – General Data Protection Regulation (EU data privacy)

  • CMMI – Capability Maturity Model Integration (process improvement)

  • CMMC – Cybersecurity Maturity Model Certification (U.S. DoD contractors)

Recommendations

  • “We passed our first ISO 14001 audit with minimal findings—thanks to Alex’s guidance, patience, and deep understanding of our operations.”

    GENESYS Systems Integrator - View Recommendation from GENESYS

  • “Alex helped us build our ISO 9001 system from the ground up—three successful audits later, his expertise still shows in everything we do.”

    KMAX Inspection - View Recommendation from KMAX

  • “Thanks to Alex’s hands-on guidance, we passed our ISO 9001 audit with confidence and built a foundation for continuous improvement.”

    Maclean Health - View Recommendation from Maclean Health

  • “Alex guided us to ISO 9001 certification with zero findings—his tailored, strategic approach made the entire process efficient, empowering, and stress-free.”

    CINDER - View Recommendation from CINDER

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