Support Cases Quality & Compliance

At Wintersmith Advisory, we specialize in guiding organizations through the complexities of quality management systems, ensuring compliance with international standards such as ISO 9001, ISO 13485, and AS9100. Our support cases illustrate our commitment to excellence in quality and compliance.

ISO 9001 - Quality Management Systems

We help organizations implement, maintain, and audit ISO 9001-compliant quality systems that drive consistency, improve processes, and meet certification goals. Whether you're building from the ground up or refining an existing QMS, we deliver practical, risk-based solutions tailored to your operations.

  • Wintersmith Advisory provides structured ISO 9001 implementation services—from gap analysis and documentation to training and internal audits. We guide organizations through the full process of building a compliant, practical Quality Management System (QMS) that supports certification, improves performance, and aligns with real operational goals.

    Click to view: ISO 9001 Implementation

  • Wintersmith Advisory supports ongoing ISO 9001 compliance through internal audits, documentation updates, corrective action management, and staff training. Our maintenance services ensure your Quality Management System (QMS) remains effective, audit-ready, and continuously improving over time.

    Click to view: ISO 9001 Maintenance

  • Wintersmith Advisory conducts independent ISO 9001 internal audits to evaluate compliance, identify nonconformities, and support continual improvement. Our audits are structured, objective, and aligned with ISO 19011—ensuring your QMS is ready for certification, surveillance, or internal review.

    Click to view: ISO 9001 Audit

ISO 13485- Quality Management Systems for Medical Devices

We support medical device companies in implementing, maintaining, and auditing ISO 13485-compliant quality systems that meet regulatory requirements and ensure product safety. From design controls and risk management to production and post-market processes, we deliver practical QMS solutions aligned with ISO 13485 and global market expectations.

  • Wintersmith Advisory helps medical device manufacturers, suppliers, and service providers implement ISO 13485-compliant Quality Management Systems tailored to the lifecycle of medical products. We guide your team through system design, risk management integration, documentation development, and regulatory alignment—ensuring your QMS meets both standard requirements and applicable market regulations like EU MDR or FDA QSR.

    Click to view: ISO 13485 Implementation

  • We support ongoing ISO 13485 compliance through internal audits, document control, CAPA management, and change implementation. Our maintenance services help you manage product and process updates, ensure traceability and validation, and keep your QMS aligned with evolving regulatory and customer requirements—reducing risk while supporting quality and safety.

    Click to view: ISO 13485 Maintenance

  • Our internal audits evaluate the effectiveness of your ISO 13485 Quality Management System with a focus on risk control, product realization, and regulatory compliance. Conducted per ISO 19011 and aligned with regulatory expectations, these audits identify gaps, nonconformities, and improvement opportunities—preparing your team for surveillance, recertification, or regulatory inspection.

    Click to view: ISO 13485 Audit

ISO 14971 - Risk Management Systems for Medical Devices

We guide medical device manufacturers in implementing, maintaining, and auditing ISO 14971-compliant risk management systems that support safety, regulatory compliance, and product lifecycle control. From hazard analysis to benefit-risk evaluation and post-market updates, we help you build risk processes that are structured, traceable, and audit-ready.

  • Wintersmith Advisory guides medical device organizations in implementing ISO 14971-compliant risk management systems that integrate seamlessly into product development and quality processes. We help you define risk management procedures, perform hazard analysis and risk evaluations, and document benefit-risk justifications—supporting compliance with ISO 13485, EU MDR, and FDA expectations.

    Click to view: ISO 14971 Implementation

  • We support the ongoing maintenance of your ISO 14971 risk management system by facilitating risk file updates, post-market surveillance integration, and periodic risk reviews. As products, processes, and regulatory requirements evolve, we help you maintain a current and defensible risk management framework that supports both safety and regulatory alignment.

    Click to view: ISO 14971 Maintenance

  • Our internal audits assess the completeness, traceability, and effectiveness of your ISO 14971 risk management activities. We review procedures, risk analyses, risk acceptability decisions, and controls to ensure your system complies with regulatory expectations and aligns with ISO 13485 and applicable market requirements—helping you prepare for audits and inspections with confidence.

    Click to view: ISO 14971 Audit

ISO/IEC 17025 – Laboratory Quality Management Systems

We help testing and calibration laboratories implement, maintain, and audit ISO/IEC 17025-compliant systems that ensure technical competence, method validity, and reliable results. Whether you're seeking accreditation or managing ongoing compliance, we deliver practical support for quality control, documentation, traceability, and audit readiness.

  • Wintersmith Advisory designs and implements ISO/IEC 17025-compliant quality systems for testing, calibration, and analytical laboratories. We guide you through system scoping, documentation, method validation, traceability, and impartiality controls—ensuring your lab meets both technical and management requirements for accreditation. Our implementations are practical, technically aligned, and built to support reliable, defensible results.

    Click to view: ISO 17025 Implementation

  • We provide structured support to help accredited labs maintain ISO/IEC 17025 compliance through regular system reviews, internal audits, document control, proficiency testing oversight, and continual improvement planning. Whether you're preparing for surveillance audits or managing operational changes, we help you preserve technical competence and audit readiness across your lab operations.

    Click to view: ISO 17025 Maintenance

  • Our internal audits evaluate your lab’s conformance to ISO/IEC 17025 with a focus on technical validity, quality system effectiveness, and accreditation body expectations. We assess method validation, equipment calibration, personnel competence, and data traceability—providing objective findings and actionable guidance to prepare you for surveillance, reassessment, or initial accreditation audits.

    Click to view: ISO 17025 Audit

ISO 22000 – Food Safety Management Systems

We help food manufacturers, processors, and distributors implement, maintain, and audit ISO 22000-compliant food safety systems that manage hazards, ensure traceability, and support certification. From HACCP integration to documentation and audit readiness, we deliver FSMS solutions that protect consumers and strengthen operational reliability.

  • Wintersmith Advisory implements ISO 22000-compliant Food Safety Management Systems (FSMS) for food manufacturers, processors, and distributors. We guide you through hazard identification, prerequisite program development, documentation, and certification preparation—ensuring your system controls food safety risks and meets global compliance standards.

    Click to view: ISO 22000 Implementation

  • We help food businesses maintain ISO 22000 certification through system performance reviews, documentation updates, corrective action tracking, and hazard control improvements. Whether adapting to process changes, audit findings, or regulatory shifts, we keep your FSMS aligned, effective, and audit-ready.

    Click to view: ISO 22000 Maintenance

  • Our internal audits evaluate the effectiveness and compliance of your ISO 22000 FSMS, focusing on HACCP implementation, operational controls, traceability, and verification procedures. We provide objective findings and corrective action guidance to prepare your team for certification, surveillance, or supplier audits.

    Click to view: ISO 22000 Audit

AS9100 – Aerospace Quality Management Systems

We help aerospace manufacturers, suppliers, and service providers implement, maintain, and audit AS9100-compliant quality systems that meet stringent industry, regulatory, and customer requirements. From documentation and risk management to internal audits and certification prep, we deliver QMS solutions built for precision, traceability, and operational excellence.

  • Wintersmith Advisory partners with aerospace and defense manufacturers, distributors, and service providers to implement AS9100D-compliant Quality Management Systems from the ground up. We guide you through gap analysis, process mapping, documentation development, risk-based thinking, and audit preparation—ensuring your QMS supports product conformity, regulatory compliance, and continual improvement across the full aerospace supply chain.

    Click to view: AS9100 Implementation

  • We help certified organizations maintain and enhance their AS9100D systems through structured internal audits, risk reviews, process and document updates, and change management support. Whether responding to corrective actions, shifting customer requirements, or operational changes, we ensure your QMS remains aligned, effective, and ready for surveillance or recertification audits.

    Click to view: AS9100 Maintenance

  • Our independent internal audits assess the performance and compliance of your AS9100D Quality Management System using a process-based approach aligned with ISO 19011 and AS9101 auditing practices. We evaluate documentation, process controls, risk management, and corrective actions—providing objective findings and improvement guidance to prepare you for customer, registrar, or regulatory audits.

    Click to view: AS9100 Audit

Contact us.

info@wintersmithadvisory.com
(801)-558-3928