Quality Management and ISO 13485 Essentials Training by Tonex
Master the essentials of ISO 13485 and modern quality management to build safe, compliant medical devices and reliable processes across the product lifecycle. You will translate regulatory requirements into practical controls, scalable documentation, and measurable performance.
Cybersecurity is inseparable from device quality: threat-aware design, secure configuration management, and evidence-backed updates protect patients and data. This course shows how to integrate cybersecurity risk into QMS artifacts, audits, and CAPA. You’ll connect supplier oversight, software validation, and postmarket surveillance to resilient, audit-ready operations that withstand scrutiny from regulators, notified bodies, and demanding customers. Gain clarity, confidence, and repeatable excellence across teams worldwide.
Learning Objectives
- Establish an ISO 13485-aligned QMS with clear process ownership and measurable outcomes
- Implement robust document control and records management for full traceability
- Apply risk management and design controls that accelerate safe, compliant releases
- Operate effective CAPA, NCR handling, and management review for continual improvement
- Integrate supplier quality, software validation, and production controls across the lifecycle
- Map postmarket surveillance data to proactive corrective and preventive actions
- Strengthen product safety by embedding cybersecurity risk assessment and secure change control within the QMS
Audience
- Quality Managers and Engineers
- Regulatory Affairs Professionals
- Manufacturing and Operations Leaders
- R&D and Design Engineers
- Supplier and Procurement Managers
- Compliance and Audit Specialists
- Cybersecurity Professionals
Program Modules
Module 1 – ISO 13485 Foundations
- Scope, structure, key clauses
- QMS policy, objectives, governance
- Process approach and interactions
- Roles, responsibility, accountability
- Documentation hierarchy, control
- Metrics, audits, and KPIs
Module 2 – Document and Record Control
- Document lifecycle and ownership
- Revision control and change history
- Templates, forms, and metadata
- Electronic records and signatures
- Training, acknowledgment tracking
- Archiving, retention, retrieval
Module 3 – Risk and Design Controls
- Risk management per ISO 14971
- Design and development planning
- Design inputs, outputs, reviews
- Verification and validation strategy
- Design transfer to production
- Change control and revalidation
Module 4 – CAPA, NCRs, and Review
- NCR intake and triage workflow
- Root cause analysis methods
- Corrective versus preventive actions
- Effectiveness checks and closure
- Management review inputs, outputs
- Trending, escalation, prioritization
Module 5 – Supplier and Production Quality
- Supplier selection and qualification
- Quality agreements and scorecards
- Incoming inspection and sampling
- Process validation and monitoring
- Software and equipment validation
- Postmarket feedback to suppliers
Module 6 – Certification and Cybersecurity Integration
- Audit readiness and stage gates
- Notified body expectations overview
- Surveillance and recertification planning
- Cybersecurity risk within QMS
- Secure configuration and patch control
- Evidence packs and traceability
Advance your team’s mastery of ISO 13485 and build a resilient, audit-ready QMS that integrates quality, safety, and cybersecurity from design through postmarket. Enroll your group with Tonex to customize this program to your products, processes, and regulatory landscape—and accelerate compliant, high-quality releases.