ISO 13485:2016 Utilizing Principles of Lean Documents and Lean Configuration

Overview:

Medical device and life science organizations are expected to maintain a Quality Management System (QMS) that stays in control through clear, controlled documentation and objective evidence in the form of records. Yet many teams find that their documentation environment grows in the wrong direction over time—overlapping SOPs, bloated work instructions, inconsistent formats, unclear ownership, and record systems that feel disconnected from real execution.

With QMSR effective as of February 2, 2026, the pressure shifts from “do we have documents” to “can we demonstrate consistent, defensible evidence of control.” Organizations may understand ISO 13485:2016 at a high level, but still operate documentation systems built on legacy structures that were never designed to scale under modern expectations for traceability, evidence reliability, and cross-functional alignment.

This webinar addresses that gap directly. It is built for teams who want a practical, current-state approach grounded in ISO 13485:2016 intent—without treating the standard as theory. The session begins with a focused look at how ISO 13485:2016 differs from ISO 13485:2003 in intent and emphasis, and why those differences show up immediately in documentation, records, and evidence during audits and inspections.

From there, the webinar moves into the method: Lean Documents and Lean Configuration. You’ll learn why traditional document hierarchies often create redundancy and “paper compliance,” and how to restructure documentation into modular, role-appropriate components that better connect procedures to records, roles, and real work. The approach is designed to reduce friction, improve maintainability, and make evidence easier to generate and retrieve—without expanding your document set.

Attendees will leave with practical guidance to reduce documentation sprawl, strengthen traceability, and modernize legacy document structures so the QMS functions cleanly under today’s expectations—without rewriting the entire system from scratch.

Areas Covered in the Session:

• A brief introduction to Lean Documents and Lean Configuration
• ISO 13485:2016 vs ISO 13485:2003: intent-level differences and why they still matter in real documentation systems
• How ISO 13485:2016 expectations show up in practice: documentation, records, traceability, and objective evidence
• Why traditional document hierarchies and document-centric compliance approaches often become difficult to sustain at scale
• How Lean Documents and Lean Configuration restructure documentation into modular, role-appropriate, evidence-driven components that scale

Why Should You Attend?

Many quality systems don’t fail because teams lack procedures—they fail because the documentation system becomes too heavy to run consistently. When SOPs overlap, work instructions multiply, and records are hard to generate or retrieve, “compliance” turns into constant clean-up. This webinar shows a practical way to reduce that friction while keeping your QMS controlled and defensible.

Organizations may understand ISO 13485:2016, yet still operate documentation structures built for an older way of working. You’ll learn how ISO 13485:2016 intent changes what “good” documentation and objective evidence look like in day-to-day execution—and why legacy document hierarchies often break down under modern expectations for traceability and proof of control.

Most importantly, you’ll walk away with an actionable method—Lean Documents and Lean Configuration—to restructure documentation into modular, role-appropriate, evidence-driven components that scale. The outcome is a documentation environment that’s easier to maintain, faster to defend in audits/inspections, and more aligned to how teams actually work—without rewriting the entire QMS from scratch.

Handouts:

Attendees will gain access to exclusive handouts, including presentation materials provided by the speaker and additional resources developed by Amorit Education to aid your teams in post-session implementation.

Who will benefit?

This webinar is built for professionals who own or support ISO 13485-aligned QMS documentation, record control, and evidence readiness—especially those responsible for fixing document sprawl and improving traceability without rewriting the entire QMS. Those include:

• VP of Quality / Head of Quality
• Director of Quality Assurance (QA)
• Quality Systems Manager / QMS Lead
• Quality Compliance Manager
• Document Control Manager / Documentation Manager
• Document Control Specialist / Documentation Specialist
• Quality Engineer (QMS / Compliance)
• Lead Internal Auditor / Internal Audit Manager
• Supplier Quality Manager / Supplier Quality Engineer (SQE)
• Regulatory Affairs Manager (Medical Devices)
• Inspection / Audit Readiness Lead
• CAPA Manager / Quality Improvement Lead
• Process Validation Manager / Validation Engineer
• Manufacturing Quality Manager / Manufacturing Quality Engineer