Insights & Articles | Wintersmith Advisory

Practical Guidance. Thoughtful Perspectives.

Welcome to the Wintersmith Advisory blog—your source for in-depth insights on ISO systems, ESG integration, risk management, regulatory strategy, and operational improvement.

Our articles are written for business leaders, compliance professionals, and change agents looking for clarity, strategy, and real-world implementation tips. Whether you're preparing for an audit, planning your ESG disclosures, or working to streamline operations, this blog delivers actionable ideas you can trust.

What You’ll Find Here:

  • Plain-language explanations of standards like ISO 9001, AS9100, 14001, 45001, and 27001

  • Frameworks and tools for building and maintaining management systems

  • ESG and sustainability reporting guidance (GRI, SDGs, CSRD, and more)

  • Risk-based thinking and process improvement strategies

  • Consultant commentary on trends and best practices

Stay Informed. Stay Compliant. Stay Competitive.

We publish regularly—follow along or subscribe for updates.

Alex Wintersmith Lackey Alex Wintersmith Lackey

What to Expect from a Medical Device Quality System Consultant

Compliance in the medical device field needs a strong Quality Management System (QMS) that meets global standards such as ISO 13485, FDA QSR, and EU MDR. This blog explains how a medical device quality consultant enhances value by conducting gap assessments, implementing QMS, and preparing for audits. It also offers guidance on choosing the right consultant and creating a flexible, compliant system for both new and established manufacturers.

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Alex Wintersmith Lackey Alex Wintersmith Lackey

How to Get ISO Certified

Feeling lost in the maze of ISO standards? Here's your no-fluff guide to getting ISO certified—faster, smarter, and with fewer headaches.

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