ISO 13485 Course

Lesson 1 • Roles and Responsibilities Under the Standard

Defines organizational roles required by ISO 13485, including top management and quality representatives. Learners assign accountability within their own teams.

Lesson 2 • Overview of Medical Device Quality Standards

Introduces the global landscape of medical device regulation and quality expectations. Connects industry context to the specific purpose of ISO 13485.

Lesson 3 • Structure and Scope of ISO 13485

Examines the standard's clause structure, scope, and applicability across the supply chain. Learners map the standard's boundaries to their own organizational context.

Lesson 1 • Infrastructure and Work Environment Requirements

Addresses facility, equipment, and environmental controls needed to support product quality. Learners evaluate their work environment against standard requirements.

Lesson 2 • QMS Scope Definition and Exclusions

Guides learners through formally defining and documenting the QMS scope. Learners justify any exclusions and ensure the scope reflects actual operations.

Lesson 3 • Document Control and Record Management

Details the controls required for creating, approving, distributing, and retiring documents. Learners implement a document control system aligned with the standard.

Lesson 4 • Process Approach in ISO 13485

Applies the process approach to identify, sequence, and control QMS processes. Learners create process maps that reflect interactions and inputs and outputs.

Lesson 1 • Resource Planning and Allocation

Covers how management identifies and provides resources needed to maintain and improve the QMS. Learners assess resource gaps and build a resource plan.

Lesson 2 • Setting and Managing Quality Objectives

Establishes measurable quality objectives linked to the quality policy and regulatory requirements. Learners create objective plans with owners, timelines, and metrics.

Lesson 3 • Management Review Process

Defines the inputs, outputs, and frequency of management review meetings required by the standard. Learners design a review agenda and record-keeping system.

Lesson 1 • Risk Management Principles for Medical Devices

Introduces risk management concepts specific to medical devices, including hazard identification and risk acceptability. Learners connect risk principles to QMS requirements.

Lesson 2 • Risk Control and Residual Risk Evaluation

Teaches selection and implementation of risk controls and evaluation of residual risk. Learners apply a risk control hierarchy to device-specific scenarios.

Lesson 3 • Risk Management in Design and Production

Applies risk management outputs to design controls and production processes. Learners trace risk decisions through design history and process validation.

Lesson 1 • Design Inputs and Outputs

Defines requirements for capturing design inputs and translating them into verifiable outputs. Learners write compliant design input and output documents.

Lesson 2 • Product Realization Planning

Covers the creation of quality plans for product realization, including objectives, processes, and resources. Learners develop a product-specific quality plan.

Lesson 3 • Design Transfer and Change Control

Manages the transition from design to production and controls subsequent design changes. Learners execute a design transfer checklist and change request process.

Lesson 4 • Design and Development Planning

Establishes the design and development plan, including stages, reviews, and responsibilities. Learners create a design plan for a representative device.

Lesson 1 • Purchasing Information and Controls

Covers the content requirements for purchasing documents and how they communicate quality expectations. Learners draft compliant purchase orders and specifications.

Lesson 2 • Supplier Qualification and Evaluation

Defines criteria and methods for qualifying and re-evaluating suppliers of critical materials. Learners build a supplier qualification procedure and approved supplier list.

Lesson 3 • Supplier Performance Monitoring

Tracks supplier quality metrics and manages corrective actions for supplier-related issues. Learners create a supplier scorecard and escalation process.

Lesson 1 • Data Analysis and Continual Improvement

Uses quality data to identify trends and drive continual improvement of the QMS. Learners build a quality metrics dashboard and improvement action plan.

Lesson 2 • Corrective and Preventive Action Systems

Implements CAPA processes that identify root causes and prevent recurrence of quality issues. Learners complete a CAPA from initiation through effectiveness verification.

Lesson 3 • Customer Feedback and Complaint Handling

Establishes a compliant system for collecting, evaluating, and responding to customer feedback. Learners design a complaint handling procedure linked to regulatory reporting.

Lesson 4 • Nonconforming Product Control

Controls identification, segregation, and disposition of nonconforming products. Learners write a nonconforming product procedure and practice disposition decisions.

Lesson 1 • Conducting the Audit and Gathering Evidence

Applies audit techniques including interviews, observation, and document review. Learners practice opening meetings, evidence collection, and closing meetings.

Lesson 2 • Audit Preparation and Checklist Development

Prepares auditors to develop clause-based checklists and gather objective evidence. Learners build audit checklists for key ISO 13485 clauses.

Lesson 3 • Audit Reporting and Finding Classification

Produces clear audit reports with classified findings and actionable recommendations. Learners write nonconformity statements and opportunity-for-improvement notes.

Lesson 4 • Internal Audit Program Planning

Establishes an annual audit program based on process risk and previous audit results. Learners create an audit schedule and program management procedure.