COURSE FORMAT & DELIVERY DETAILS You're making a strategic investment in your career, and we've engineered every element of Mastering ISO 13485: A Complete Guide to Medical Device Quality Management Systems to maximise your return on that investment. From the moment you enroll, you gain access to a fully structured, industry-respected learning journey designed for professionals who demand clarity, control, and credibility. Fully Self-Paced with Immediate Online Access
This course is 100% self-paced, built for professionals balancing demanding careers, tight deadlines, and global time zones. Once enrolled, you’ll gain direct access to the course platform, allowing you to begin learning the moment it’s convenient for you-no waiting for scheduled start dates, no onboarding delays, and no artificial enrollment windows. On-Demand Learning, No Fixed Commitments
There are no fixed schedules, mandatory live sessions, or deadlines. You decide how and when you progress. Whether you complete the course in five focused days or spread it across six weeks, the structure adapts entirely to your availability. This is learning designed for real-world professionals who need precision without pressure. Designed for Fast, Measurable Results
Most learners complete the core modules and achieve functional mastery of ISO 13485 fundamentals in just 15 to 20 hours of total engagement. You will begin applying essential concepts-like QMS documentation, risk-based thinking, and audit preparation-within the first 48 hours of starting. By the end, you won't just understand the standard, you'll be able to implement it with confidence. Lifetime Access, Future Updates Included Forever
Once enrolled, you receive permanent, lifetime access to all course materials. That includes every update, revision, and enhancement made in the future-free of charge. As ISO 13485 guidance evolves and regulatory expectations shift, your materials will be proactively refreshed to ensure your knowledge stays current, accurate, and audit-ready for life. 24/7 Global Access, Mobile-Friendly Platform
Access your learning from any device, anywhere in the world. Our responsive platform works seamlessly on desktops, tablets, and smartphones, allowing you to study during travel, lunch breaks, or downtime between meetings. No downloads. No compatibility issues. Just click and learn-whenever, wherever. Direct Instructor Support & Expert Guidance
You're not learning in isolation. Throughout the course, you’ll have access to structured guidance from ISO 13485 practitioners who have led QMS implementations across Class I, II, and III medical device organizations. Our support system includes curated feedback pathways, scenario-based Q&A tools, and guidance on applying concepts in role-specific contexts, whether you're in regulatory affairs, quality engineering, or operations management. Receive a Globally Recognised Certificate of Completion
Upon successful completion, you'll earn a formal Certificate of Completion issued by The Art of Service, an internationally recognised provider of professional training with a 20-year track record in quality, compliance, and systems excellence. This certificate is trusted by employers, auditors, and industry leaders across 67 countries. It validates your ability to interpret, apply, and operationalise ISO 13485 principles in real-world settings. It strengthens your resume, supports audit defence, and signals professional integrity and competence. Transparent, One-Time Pricing-Zero Hidden Fees
No subscriptions. No recurring charges. No upsells. The price you see is the only price you pay. All materials, support, updates, and your certificate are included. There are no additional costs at any point. This is a complete, all-inclusive package with total pricing clarity. Accepted Payment Methods
We accept all major payment forms, including Visa, Mastercard, and PayPal. Payment processing is secure, encrypted, and compliant with global standards, so you can enroll with full confidence in your transaction safety. 100% Satisfied or Refunded Guarantee
We eliminate all risk with a clear, no-questions-asked refund policy. If you complete the first two modules and do not believe the course will deliver value, simply contact support for a full refund. Your confidence is protected from day one. This is not just a course-it's a performance guarantee. What to Expect After Enrollment
After you enroll, you’ll receive a confirmation email acknowledging your registration. Your access details to the learning platform will be sent separately once your course materials are fully prepared and verified. This ensures that every learner receives accurate, thoroughly tested content. Please allow standard processing time for delivery, during which your commitment is secured and your materials curated for optimal learning readiness. Will This Work for Me? Absolutely-Here’s Why.
You may be wondering: Does this work if I’m not a quality manager? If I’m new to medical devices? If my company doesn’t have a full QMS? Yes-and here’s proof. This program is designed for professionals at every level: engineers transitioning into quality roles, regulatory specialists expanding their expertise, startups building their first compliance system, and seasoned auditors refreshing their knowledge. The content is structured to scale with your experience. - For Quality Engineers: Learn how to translate ISO 13485 clauses into design controls, CAPA procedures, and validation protocols that pass regulatory scrutiny.
- For Regulatory Affairs Professionals: Master the intersections between ISO 13485 and FDA 21 CFR Part 820, EU MDR, and Health Canada requirements-building audit-ready documentation in weeks, not years.
- For Startups & SMEs: Build a compliant, scalable QMS from the ground up using practical templates, risk-based prioritization, and implementation checklists you can apply immediately.
- For Senior Managers: Gain executive-level insight into QMS oversight, supplier management, and continual improvement frameworks that align with business strategy.
Social Proof: What Professionals Are Saying
After completing this course, I led my company’s ISO 13485 certification audit-our first ever. The documentation framework and clause-by-clause breakdown gave me the confidence to present to regulators. We passed with zero major nonconformities.
- Linh N., Quality Systems Manager, Vietnam I was responsible for setting up a QMS for a Class III device startup. I had no prior experience. This course gave me the structure, tools, and clarity to build a system that passed a Notified Body audit in under 10 months.
- David R., Founder & CEO, MedTech Innovations Inc. I used to dread audits. Now I prepare in under a week. The internal audit checklist alone has saved me 20 hours per cycle. This isn’t theory-it’s what works in the real world.
- Amina K., Senior Quality Auditor, Germany This Works Even If…
You have no prior experience with quality systems, your company lacks formal documentation, you work remotely, or your role is part-time. This course starts with foundational principles and builds to expert-level fluency through step-by-step guidance, practical examples, and role-specific applications. It works because it’s built for real people in real medical device environments-not perfect textbook scenarios. Your Risk Is Completely Reversed
You pay only once. You get lifetime access. You receive a globally respected certificate. You can request a refund if you’re not satisfied. You earn practical, immediately applicable knowledge. And if the course doesn’t deliver transformational results, you get your investment back. There is literally no downside to starting today. Enroll now with complete peace of mind. Your success is not just possible-it’s protected.
EXTENSIVE & DETAILED COURSE CURRICULUM
Module 1: Foundations of ISO 13485 and Medical Device Quality - Understanding the Purpose and Scope of ISO 13485
- Key Principles of Medical Device Safety and Performance
- Hierarchy of Regulatory and Standards Frameworks in Healthcare
- Differences Between ISO 9001 and ISO 13485
- Evolution of ISO 13485 and Its Global Impact
- Role of National Competent Authorities and Notified Bodies
- Linking ISO 13485 to FDA Quality System Regulation (21 CFR Part 820)
- Understanding the Medical Device Lifecycle
- Classification of Medical Devices by Risk (Class I, IIa, IIb, III)
- Overview of EU MDR and IVDR Requirements
- Terminology and Definitions Specific to ISO 13485
- Understanding “State of the Art” in Medical Device Development
- Role of Risk Management in Quality Systems
- Importance of Patient and User Safety in QMS Design
- Global Harmonisation Task Force (GHTF) Contributions
Module 2: Leadership, Commitment, and Organisational Readiness - Top Management Responsibilities Under ISO 13485
- Establishing a Quality Policy That Drives Compliance
- Aligning Organisational Objectives with QMS Goals
- Defining Roles, Responsibilities, and Authorities
- Ensuring Adequate Resources for Quality Processes
- Building a Culture of Quality and Continuous Improvement
- Leadership Involvement in Internal Audits and Management Reviews
- Creating Accountability Through Documented Procedures
- Managing Outsourced Processes and Vendor Oversight
- Setting Quality Objectives with Measurable KPIs
- Delegation of QMS Authority Without Abdicating Responsibility
- Ensuring Leadership Competence in Regulatory Expectations
- Handling Conflicts Between Business and Quality Priorities
- Maintaining Leadership Continuity During Transitions
- Documentation of Management Commitment Activities
Module 3: Quality Management System Planning and Scope Definition - Determining the Scope of Your QMS
- Documenting Justifications for Exclusions
- Defining Boundaries for Internal and External Processes
- Mapping Core Business Processes to ISO 13485 Clauses
- Identifying Applicable Regulatory Requirements by Jurisdiction
- Planning for Scalability and Future Product Lines
- Developing a QMS Implementation Roadmap
- Creating a Gap Analysis Tool for ISO 13485 Readiness
- Integrating Risk Management into QMS Planning
- Establishing Process Ownership Across Departments
- Setting Up a QMS Project Team with Cross-Functional Roles
- Defining Success Criteria for QMS Launch and Certification
- Resource Planning: Time, Budget, and Personnel
- Determining Criticality of Processes Based on Patient Risk
- Documentation of Planning Decisions and Assumptions
Module 4: Documentation, Record Control, and Document Hierarchy - Understanding the ISO 13485 Documentation Requirements
- Creating a Document Hierarchy: Policies, SOPs, Work Instructions
- Designing a Master Document List (MDL)
- Standardising Document Templates and Formatting
- Document Approval, Review, and Revision Processes
- Control of External Documents and Regulatory References
- Version Control and Change History Tracking
- Electronic Document Management System (EDMS) Best Practices
- Ensuring Document Accessibility Across Sites
- Preventing Unauthorised Document Use
- Retention Periods and Record Preservation Requirements
- Handling Obsolete Documents and Archives
- Securing Sensitive Quality Records
- Linking Records to Specific Processes and Audits
- Periodic Review and Obsolescence Planning for Documents
Module 5: Risk-Based Thinking and Risk Management Integration - Principles of Risk-Based Thinking in ISO 13485
- Applying Risk Management Throughout the QMS
- Linking ISO 13485 to ISO 14971: Application of Risk Management to Medical Devices
- Identifying Hazards and Harmful Situations
- Conducting Risk Assessments for Processes and Products
- Establishing Risk Acceptability Criteria
- Developing Risk Control Measures
- Verifying and Validating Risk Controls
- Integrating Risk into Design and Development
- Using FMEA, FMECA, and HACCP Techniques in QMS
- Risk Documentation: Traceability and Audit Readiness
- Periodic Risk Review and Reassessment
- Linking Risk to Corrective Actions and CAPA
- Reporting Residual Risk to Management
- Aligning Risk Strategy with Product Lifecycle Stages
Module 6: Design and Development of Medical Devices - Planning the Design and Development Process
- Establishing Design Inputs with Clear, Verifiable Requirements
- Creating Design Input Checklists and Validation Protocols
- Managing Design Output Specifications and Release Criteria
- Ensuring Traceability from Input to Output (Design Trace Matrix)
- Design Review Processes and Documentation
- Verification vs. Validation: Understanding the Difference
- Design Verification Testing and Protocols
- Design Validation Using Simulated or Actual Use Conditions
- Design Transfer to Manufacturing: Protocols and Handover
- Managing Design Changes and Change Control Procedures
- Post-Market Feedback Loop for Design Improvement
- Documentation of Design History File (DHF)
- Handling Legacy Device Design Documentation
- Design Controls for Software as a Medical Device (SaMD)
Module 7: Supplier and Purchasing Control - Establishing Supplier Selection Criteria
- Conducting Supplier Audits and Assessments
- Creating a Qualified Supplier List (QSL)
- Classifying Suppliers by Risk and Criticality
- Developing Supplier Agreements and Quality Clauses
- Managing Supplier Nonconformities and Corrective Actions
- Monitoring Supplier Performance with KPIs
- Handling Sub-tier Supplier Oversight
- Ensuring Supplier Compliance with ISO 13485
- Managing Single-Source and Sole-Source Suppliers
- Verification of Purchased Product and Incoming Inspection
- Managing Supplier Changes and Change Notifications
- Documentation of Purchasing Information and Orders
- Use of Supplier Scorecards and Auditing Checklists
- Remote and International Supplier Management Strategies
Module 8: Production and Process Controls - Establishing Controlled Production Environments
- Validating Production Processes (IQ, OQ, PQ)
- Defining Process Parameters and Control Limits
- Developing Work Instructions and Operator Training
- Implementing In-Process Inspection and Testing
- Calibration and Maintenance of Production Equipment
- Handling and Storage of Components and Finished Devices
- Packaging, Labeling, and Sterilisation Controls
- Traceability Requirements: UDI, Batch, and Serial Numbers
- Implementing Product Identification and Status Tracking
- Control of Monitoring and Measuring Equipment
- Handling Nonconforming Product During Production
- Change Control for Manufacturing Processes
- Cleanroom and Environmental Controls for Sensitive Devices
- Process Validation for Aseptic and Sterile Devices
Module 9: Monitoring, Measurement, and Analysis of QMS Performance - Identifying Key Performance Indicators for Quality Processes
- Tracking Quality Metrics: Yield, Rework, Defect Rates
- Monitoring Customer Complaints and Field Alerts
- Analysing CAPA and Nonconformance Trends
- Using Pareto Analysis and Control Charts
- Conducting Process Capability Studies (Cp, Cpk)
- Reporting Metrics to Management in Review Meetings
- Setting Targets and Improvement Goals
- Ensuring Data Integrity and Accuracy
- Linking Data to Risk and Patient Outcomes
- Using Dashboards for Executive QMS Oversight
- Establishing Alert and Escalation Triggers
- Monitoring Supplier and Vendor Performance
- Analysing Post-Market Surveillance Data
- Using Data for Management Review Inputs
Module 10: Internal Audits and Audit Preparation - Planning a Robust Internal Audit Program
- Selecting and Training Internal Auditors
- Developing Risk-Based Audit Schedules
- Creating Detailed Audit Checklists by ISO 13485 Clause
- Conducting Opening and Closing Meetings
- Gathering Objective Evidence During Audits
- Writing Clear, Factual, and Non-Emotional NC Reports
- Classifying Nonconformities: Major vs. Minor
- Ensuring Auditor Independence and Objectivity
- Auditing Document and Record Controls
- Conducting Process Audits Across Functions
- Tracking Audit Findings and Closure Verification
- Preparing for External Audits (Notified Body, FDA)
- Running Mock Audits and Management Tabletops
- Documentation of Audit Program Effectiveness
Module 11: Management Review and Continual Improvement - Planning and Conducting Effective Management Reviews
- Gathering Inputs: Audit Results, Customer Feedback, Metrics
- Reviewing Quality Objectives and Achievement Status
- Analysing Resource Adequacy and Competency Gaps
- Assessing QMS Performance and Regulatory Changes
- Reporting on Risk Management Activities
- Identifying Opportunities for Systemic Improvement
- Documenting Management Decisions and Action Items
- Tracking Follow-Up from Prior Reviews
- Ensuring Senior Leadership Engagement
- Linking Management Review to Strategic Planning
- Frequency of Reviews: Minimum Annual Requirement
- Handling Remote or Virtual Management Reviews
- Using Templates for Consistent Review Documentation
- Integrating Continual Improvement into Daily Operations
Module 12: Corrective and Preventive Action (CAPA) System - Establishing a Structured CAPA Process
- Identifying Triggers for CAPA: Complaints, Audits, Nonconformities
- Root Cause Analysis Techniques: 5 Whys, Fishbone, Fault Tree
- Distinguishing Between Correction, Corrective Action, and Preventive Action
- Setting Timelines and Escalation Procedures for CAPAs
- Verifying Implementation of Corrective Actions
- Ensuring Effectiveness Checks and Follow-Up
- Linking CAPA to Risk Management and FMEA Updates
- Preventing Recurrence Through Systemic Fixes
- Documenting CAPA Files for Audit Readiness
- Managing High-Risk CAPAs with Executive Escalation
- Using CAPA as a Proactive Improvement Tool
- Integrating CAPA with Change Control
- Minimising CAPA Backlog with Workflow Management
- Reporting CAPA Metrics in Management Reviews
Module 13: Customer Feedback, Complaints, and Post-Market Surveillance - Designing a Customer Feedback Collection System
- Handling Complaints in Accordance with MDR and FDA
- Distinguishing Reportable vs. Non-Reportable Events
- Establishing Complaint Investigation Procedures
- Linking Complaints to CAPA and Risk Assessments
- Reporting Adverse Events to Regulatory Authorities
- Conducting Trend Analysis on Complaint Data
- Using Complaint Insights for Design and Process Improvements
- Ensuring Complaint Investigation Timeliness
- Documentation of Complaint Files and Final Reports
- Training Customer Service Teams on Complaint Procedures
- Integrating Service Reports and Field Safety Notices
- Conducting Periodic Review of Post-Market Data
- Linking Field Corrective Actions to CAPA
- Using PMS for Management Review Inputs
Module 14: Change Control and Configuration Management - Establishing a Formal Change Control Process
- Types of Changes: Design, Process, Supplier, Software
- Conducting Impact Assessments on Proposed Changes
- Securing Cross-Functional Approvals
- Verifying Implementation and Effectiveness
- Updating Documentation and Records
- Communicating Changes Across the Organisation
- Using Change Control Logs and Tracking Systems
- Managing Emergency Changes with Documentation
- Linking Change Control to Risk Management
- Ensuring No Backward Compatibility Issues
- Configuration Management for Complex Devices
- Handling Legacy Device Change Documentation
- Reporting Significant Changes to Regulatory Bodies
- Periodic Review of Open and Closed Changes
Module 15: Preparation for Certification and Regulatory Audits - Understanding the ISO Certification Audit Process
- Selecting a Recognised Notified Body
- Conducting a Pre-Certification Readiness Review
- Gathering Audit Evidence and Documentation
- Preparing Site for Physical Audit (Records, Facilities, Staff)
- Conducting Internal Cross-Functional Audits
- Training Staff on Audit Interaction and Communication
- Handling Auditor Requests for Information
- Responding to Nonconformity Reports Effectively
- Developing a Corrective Action Plan for Major NCs
- Understanding Surveillance and Recertification Audits
- Preparing for FDA Inspections and Mock 483 Exercises
- Aligning Internal Processes with ISO 13485:2016 Clauses
- Documenting Audit Readiness Status
- Creating an Audit Survival Kit for Teams
Module 16: Advanced Implementation Strategies and Real-World Projects - Implementing ISO 13485 in a Startup Environment
- Scaling a QMS for Growth and New Markets
- Integrating Multiple Standards (ISO 13485, ISO 14971, IEC 62304)
- Managing QMS Across Multiple Sites and Jurisdictions
- Using Automation Tools for Document and Record Control
- Implementing eQMS Solutions with Cloud Platforms
- Leveraging AI for Risk and CAPA Trend Detection
- Managing Remote Teams and Virtual QMS Oversight
- Leading Cultural Change During QMS Rollout
- Conducting a Full QMS Gap Remediation Project
- Building a QMS for Software-Based Medical Devices
- Integrating Lean and Six Sigma with Quality Systems
- Creating a Sustainability Plan for Long-Term Compliance
- Running a Real-World QMS Simulation Project
- Presenting a QMS Implementation Case Study
Module 17: Certification, Career Advancement, and Next Steps - Final Verification Before Certification Audit
- Submitting Application to Notified Body
- Understanding the Certification Decision Process
- Maintaining Certification Through Surveillance
- Preparing for Recertification Every Three Years
- Updating Your Professional Profile with Certification
- Leveraging ISO 13485 Expertise in Job Applications
- Using the Certificate of Completion for Promotions
- Negotiating Higher Compensation Based on New Skills
- Joining Professional Quality and Regulatory Networks
- Continuing Education Pathways in Medical Device Compliance
- Pursuing Advanced Certifications (e.g., Lead Auditor)
- Mentoring Others in ISO 13485 Implementation
- Sharing Case Studies and Best Practices Publicly
- Accessing Alumni Resources and Future Learning Opportunities
Module 1: Foundations of ISO 13485 and Medical Device Quality - Understanding the Purpose and Scope of ISO 13485
- Key Principles of Medical Device Safety and Performance
- Hierarchy of Regulatory and Standards Frameworks in Healthcare
- Differences Between ISO 9001 and ISO 13485
- Evolution of ISO 13485 and Its Global Impact
- Role of National Competent Authorities and Notified Bodies
- Linking ISO 13485 to FDA Quality System Regulation (21 CFR Part 820)
- Understanding the Medical Device Lifecycle
- Classification of Medical Devices by Risk (Class I, IIa, IIb, III)
- Overview of EU MDR and IVDR Requirements
- Terminology and Definitions Specific to ISO 13485
- Understanding “State of the Art” in Medical Device Development
- Role of Risk Management in Quality Systems
- Importance of Patient and User Safety in QMS Design
- Global Harmonisation Task Force (GHTF) Contributions
Module 2: Leadership, Commitment, and Organisational Readiness - Top Management Responsibilities Under ISO 13485
- Establishing a Quality Policy That Drives Compliance
- Aligning Organisational Objectives with QMS Goals
- Defining Roles, Responsibilities, and Authorities
- Ensuring Adequate Resources for Quality Processes
- Building a Culture of Quality and Continuous Improvement
- Leadership Involvement in Internal Audits and Management Reviews
- Creating Accountability Through Documented Procedures
- Managing Outsourced Processes and Vendor Oversight
- Setting Quality Objectives with Measurable KPIs
- Delegation of QMS Authority Without Abdicating Responsibility
- Ensuring Leadership Competence in Regulatory Expectations
- Handling Conflicts Between Business and Quality Priorities
- Maintaining Leadership Continuity During Transitions
- Documentation of Management Commitment Activities
Module 3: Quality Management System Planning and Scope Definition - Determining the Scope of Your QMS
- Documenting Justifications for Exclusions
- Defining Boundaries for Internal and External Processes
- Mapping Core Business Processes to ISO 13485 Clauses
- Identifying Applicable Regulatory Requirements by Jurisdiction
- Planning for Scalability and Future Product Lines
- Developing a QMS Implementation Roadmap
- Creating a Gap Analysis Tool for ISO 13485 Readiness
- Integrating Risk Management into QMS Planning
- Establishing Process Ownership Across Departments
- Setting Up a QMS Project Team with Cross-Functional Roles
- Defining Success Criteria for QMS Launch and Certification
- Resource Planning: Time, Budget, and Personnel
- Determining Criticality of Processes Based on Patient Risk
- Documentation of Planning Decisions and Assumptions
Module 4: Documentation, Record Control, and Document Hierarchy - Understanding the ISO 13485 Documentation Requirements
- Creating a Document Hierarchy: Policies, SOPs, Work Instructions
- Designing a Master Document List (MDL)
- Standardising Document Templates and Formatting
- Document Approval, Review, and Revision Processes
- Control of External Documents and Regulatory References
- Version Control and Change History Tracking
- Electronic Document Management System (EDMS) Best Practices
- Ensuring Document Accessibility Across Sites
- Preventing Unauthorised Document Use
- Retention Periods and Record Preservation Requirements
- Handling Obsolete Documents and Archives
- Securing Sensitive Quality Records
- Linking Records to Specific Processes and Audits
- Periodic Review and Obsolescence Planning for Documents
Module 5: Risk-Based Thinking and Risk Management Integration - Principles of Risk-Based Thinking in ISO 13485
- Applying Risk Management Throughout the QMS
- Linking ISO 13485 to ISO 14971: Application of Risk Management to Medical Devices
- Identifying Hazards and Harmful Situations
- Conducting Risk Assessments for Processes and Products
- Establishing Risk Acceptability Criteria
- Developing Risk Control Measures
- Verifying and Validating Risk Controls
- Integrating Risk into Design and Development
- Using FMEA, FMECA, and HACCP Techniques in QMS
- Risk Documentation: Traceability and Audit Readiness
- Periodic Risk Review and Reassessment
- Linking Risk to Corrective Actions and CAPA
- Reporting Residual Risk to Management
- Aligning Risk Strategy with Product Lifecycle Stages
Module 6: Design and Development of Medical Devices - Planning the Design and Development Process
- Establishing Design Inputs with Clear, Verifiable Requirements
- Creating Design Input Checklists and Validation Protocols
- Managing Design Output Specifications and Release Criteria
- Ensuring Traceability from Input to Output (Design Trace Matrix)
- Design Review Processes and Documentation
- Verification vs. Validation: Understanding the Difference
- Design Verification Testing and Protocols
- Design Validation Using Simulated or Actual Use Conditions
- Design Transfer to Manufacturing: Protocols and Handover
- Managing Design Changes and Change Control Procedures
- Post-Market Feedback Loop for Design Improvement
- Documentation of Design History File (DHF)
- Handling Legacy Device Design Documentation
- Design Controls for Software as a Medical Device (SaMD)
Module 7: Supplier and Purchasing Control - Establishing Supplier Selection Criteria
- Conducting Supplier Audits and Assessments
- Creating a Qualified Supplier List (QSL)
- Classifying Suppliers by Risk and Criticality
- Developing Supplier Agreements and Quality Clauses
- Managing Supplier Nonconformities and Corrective Actions
- Monitoring Supplier Performance with KPIs
- Handling Sub-tier Supplier Oversight
- Ensuring Supplier Compliance with ISO 13485
- Managing Single-Source and Sole-Source Suppliers
- Verification of Purchased Product and Incoming Inspection
- Managing Supplier Changes and Change Notifications
- Documentation of Purchasing Information and Orders
- Use of Supplier Scorecards and Auditing Checklists
- Remote and International Supplier Management Strategies
Module 8: Production and Process Controls - Establishing Controlled Production Environments
- Validating Production Processes (IQ, OQ, PQ)
- Defining Process Parameters and Control Limits
- Developing Work Instructions and Operator Training
- Implementing In-Process Inspection and Testing
- Calibration and Maintenance of Production Equipment
- Handling and Storage of Components and Finished Devices
- Packaging, Labeling, and Sterilisation Controls
- Traceability Requirements: UDI, Batch, and Serial Numbers
- Implementing Product Identification and Status Tracking
- Control of Monitoring and Measuring Equipment
- Handling Nonconforming Product During Production
- Change Control for Manufacturing Processes
- Cleanroom and Environmental Controls for Sensitive Devices
- Process Validation for Aseptic and Sterile Devices
Module 9: Monitoring, Measurement, and Analysis of QMS Performance - Identifying Key Performance Indicators for Quality Processes
- Tracking Quality Metrics: Yield, Rework, Defect Rates
- Monitoring Customer Complaints and Field Alerts
- Analysing CAPA and Nonconformance Trends
- Using Pareto Analysis and Control Charts
- Conducting Process Capability Studies (Cp, Cpk)
- Reporting Metrics to Management in Review Meetings
- Setting Targets and Improvement Goals
- Ensuring Data Integrity and Accuracy
- Linking Data to Risk and Patient Outcomes
- Using Dashboards for Executive QMS Oversight
- Establishing Alert and Escalation Triggers
- Monitoring Supplier and Vendor Performance
- Analysing Post-Market Surveillance Data
- Using Data for Management Review Inputs
Module 10: Internal Audits and Audit Preparation - Planning a Robust Internal Audit Program
- Selecting and Training Internal Auditors
- Developing Risk-Based Audit Schedules
- Creating Detailed Audit Checklists by ISO 13485 Clause
- Conducting Opening and Closing Meetings
- Gathering Objective Evidence During Audits
- Writing Clear, Factual, and Non-Emotional NC Reports
- Classifying Nonconformities: Major vs. Minor
- Ensuring Auditor Independence and Objectivity
- Auditing Document and Record Controls
- Conducting Process Audits Across Functions
- Tracking Audit Findings and Closure Verification
- Preparing for External Audits (Notified Body, FDA)
- Running Mock Audits and Management Tabletops
- Documentation of Audit Program Effectiveness
Module 11: Management Review and Continual Improvement - Planning and Conducting Effective Management Reviews
- Gathering Inputs: Audit Results, Customer Feedback, Metrics
- Reviewing Quality Objectives and Achievement Status
- Analysing Resource Adequacy and Competency Gaps
- Assessing QMS Performance and Regulatory Changes
- Reporting on Risk Management Activities
- Identifying Opportunities for Systemic Improvement
- Documenting Management Decisions and Action Items
- Tracking Follow-Up from Prior Reviews
- Ensuring Senior Leadership Engagement
- Linking Management Review to Strategic Planning
- Frequency of Reviews: Minimum Annual Requirement
- Handling Remote or Virtual Management Reviews
- Using Templates for Consistent Review Documentation
- Integrating Continual Improvement into Daily Operations
Module 12: Corrective and Preventive Action (CAPA) System - Establishing a Structured CAPA Process
- Identifying Triggers for CAPA: Complaints, Audits, Nonconformities
- Root Cause Analysis Techniques: 5 Whys, Fishbone, Fault Tree
- Distinguishing Between Correction, Corrective Action, and Preventive Action
- Setting Timelines and Escalation Procedures for CAPAs
- Verifying Implementation of Corrective Actions
- Ensuring Effectiveness Checks and Follow-Up
- Linking CAPA to Risk Management and FMEA Updates
- Preventing Recurrence Through Systemic Fixes
- Documenting CAPA Files for Audit Readiness
- Managing High-Risk CAPAs with Executive Escalation
- Using CAPA as a Proactive Improvement Tool
- Integrating CAPA with Change Control
- Minimising CAPA Backlog with Workflow Management
- Reporting CAPA Metrics in Management Reviews
Module 13: Customer Feedback, Complaints, and Post-Market Surveillance - Designing a Customer Feedback Collection System
- Handling Complaints in Accordance with MDR and FDA
- Distinguishing Reportable vs. Non-Reportable Events
- Establishing Complaint Investigation Procedures
- Linking Complaints to CAPA and Risk Assessments
- Reporting Adverse Events to Regulatory Authorities
- Conducting Trend Analysis on Complaint Data
- Using Complaint Insights for Design and Process Improvements
- Ensuring Complaint Investigation Timeliness
- Documentation of Complaint Files and Final Reports
- Training Customer Service Teams on Complaint Procedures
- Integrating Service Reports and Field Safety Notices
- Conducting Periodic Review of Post-Market Data
- Linking Field Corrective Actions to CAPA
- Using PMS for Management Review Inputs
Module 14: Change Control and Configuration Management - Establishing a Formal Change Control Process
- Types of Changes: Design, Process, Supplier, Software
- Conducting Impact Assessments on Proposed Changes
- Securing Cross-Functional Approvals
- Verifying Implementation and Effectiveness
- Updating Documentation and Records
- Communicating Changes Across the Organisation
- Using Change Control Logs and Tracking Systems
- Managing Emergency Changes with Documentation
- Linking Change Control to Risk Management
- Ensuring No Backward Compatibility Issues
- Configuration Management for Complex Devices
- Handling Legacy Device Change Documentation
- Reporting Significant Changes to Regulatory Bodies
- Periodic Review of Open and Closed Changes
Module 15: Preparation for Certification and Regulatory Audits - Understanding the ISO Certification Audit Process
- Selecting a Recognised Notified Body
- Conducting a Pre-Certification Readiness Review
- Gathering Audit Evidence and Documentation
- Preparing Site for Physical Audit (Records, Facilities, Staff)
- Conducting Internal Cross-Functional Audits
- Training Staff on Audit Interaction and Communication
- Handling Auditor Requests for Information
- Responding to Nonconformity Reports Effectively
- Developing a Corrective Action Plan for Major NCs
- Understanding Surveillance and Recertification Audits
- Preparing for FDA Inspections and Mock 483 Exercises
- Aligning Internal Processes with ISO 13485:2016 Clauses
- Documenting Audit Readiness Status
- Creating an Audit Survival Kit for Teams
Module 16: Advanced Implementation Strategies and Real-World Projects - Implementing ISO 13485 in a Startup Environment
- Scaling a QMS for Growth and New Markets
- Integrating Multiple Standards (ISO 13485, ISO 14971, IEC 62304)
- Managing QMS Across Multiple Sites and Jurisdictions
- Using Automation Tools for Document and Record Control
- Implementing eQMS Solutions with Cloud Platforms
- Leveraging AI for Risk and CAPA Trend Detection
- Managing Remote Teams and Virtual QMS Oversight
- Leading Cultural Change During QMS Rollout
- Conducting a Full QMS Gap Remediation Project
- Building a QMS for Software-Based Medical Devices
- Integrating Lean and Six Sigma with Quality Systems
- Creating a Sustainability Plan for Long-Term Compliance
- Running a Real-World QMS Simulation Project
- Presenting a QMS Implementation Case Study
Module 17: Certification, Career Advancement, and Next Steps - Final Verification Before Certification Audit
- Submitting Application to Notified Body
- Understanding the Certification Decision Process
- Maintaining Certification Through Surveillance
- Preparing for Recertification Every Three Years
- Updating Your Professional Profile with Certification
- Leveraging ISO 13485 Expertise in Job Applications
- Using the Certificate of Completion for Promotions
- Negotiating Higher Compensation Based on New Skills
- Joining Professional Quality and Regulatory Networks
- Continuing Education Pathways in Medical Device Compliance
- Pursuing Advanced Certifications (e.g., Lead Auditor)
- Mentoring Others in ISO 13485 Implementation
- Sharing Case Studies and Best Practices Publicly
- Accessing Alumni Resources and Future Learning Opportunities
- Top Management Responsibilities Under ISO 13485
- Establishing a Quality Policy That Drives Compliance
- Aligning Organisational Objectives with QMS Goals
- Defining Roles, Responsibilities, and Authorities
- Ensuring Adequate Resources for Quality Processes
- Building a Culture of Quality and Continuous Improvement
- Leadership Involvement in Internal Audits and Management Reviews
- Creating Accountability Through Documented Procedures
- Managing Outsourced Processes and Vendor Oversight
- Setting Quality Objectives with Measurable KPIs
- Delegation of QMS Authority Without Abdicating Responsibility
- Ensuring Leadership Competence in Regulatory Expectations
- Handling Conflicts Between Business and Quality Priorities
- Maintaining Leadership Continuity During Transitions
- Documentation of Management Commitment Activities
Module 3: Quality Management System Planning and Scope Definition - Determining the Scope of Your QMS
- Documenting Justifications for Exclusions
- Defining Boundaries for Internal and External Processes
- Mapping Core Business Processes to ISO 13485 Clauses
- Identifying Applicable Regulatory Requirements by Jurisdiction
- Planning for Scalability and Future Product Lines
- Developing a QMS Implementation Roadmap
- Creating a Gap Analysis Tool for ISO 13485 Readiness
- Integrating Risk Management into QMS Planning
- Establishing Process Ownership Across Departments
- Setting Up a QMS Project Team with Cross-Functional Roles
- Defining Success Criteria for QMS Launch and Certification
- Resource Planning: Time, Budget, and Personnel
- Determining Criticality of Processes Based on Patient Risk
- Documentation of Planning Decisions and Assumptions
Module 4: Documentation, Record Control, and Document Hierarchy - Understanding the ISO 13485 Documentation Requirements
- Creating a Document Hierarchy: Policies, SOPs, Work Instructions
- Designing a Master Document List (MDL)
- Standardising Document Templates and Formatting
- Document Approval, Review, and Revision Processes
- Control of External Documents and Regulatory References
- Version Control and Change History Tracking
- Electronic Document Management System (EDMS) Best Practices
- Ensuring Document Accessibility Across Sites
- Preventing Unauthorised Document Use
- Retention Periods and Record Preservation Requirements
- Handling Obsolete Documents and Archives
- Securing Sensitive Quality Records
- Linking Records to Specific Processes and Audits
- Periodic Review and Obsolescence Planning for Documents
Module 5: Risk-Based Thinking and Risk Management Integration - Principles of Risk-Based Thinking in ISO 13485
- Applying Risk Management Throughout the QMS
- Linking ISO 13485 to ISO 14971: Application of Risk Management to Medical Devices
- Identifying Hazards and Harmful Situations
- Conducting Risk Assessments for Processes and Products
- Establishing Risk Acceptability Criteria
- Developing Risk Control Measures
- Verifying and Validating Risk Controls
- Integrating Risk into Design and Development
- Using FMEA, FMECA, and HACCP Techniques in QMS
- Risk Documentation: Traceability and Audit Readiness
- Periodic Risk Review and Reassessment
- Linking Risk to Corrective Actions and CAPA
- Reporting Residual Risk to Management
- Aligning Risk Strategy with Product Lifecycle Stages
Module 6: Design and Development of Medical Devices - Planning the Design and Development Process
- Establishing Design Inputs with Clear, Verifiable Requirements
- Creating Design Input Checklists and Validation Protocols
- Managing Design Output Specifications and Release Criteria
- Ensuring Traceability from Input to Output (Design Trace Matrix)
- Design Review Processes and Documentation
- Verification vs. Validation: Understanding the Difference
- Design Verification Testing and Protocols
- Design Validation Using Simulated or Actual Use Conditions
- Design Transfer to Manufacturing: Protocols and Handover
- Managing Design Changes and Change Control Procedures
- Post-Market Feedback Loop for Design Improvement
- Documentation of Design History File (DHF)
- Handling Legacy Device Design Documentation
- Design Controls for Software as a Medical Device (SaMD)
Module 7: Supplier and Purchasing Control - Establishing Supplier Selection Criteria
- Conducting Supplier Audits and Assessments
- Creating a Qualified Supplier List (QSL)
- Classifying Suppliers by Risk and Criticality
- Developing Supplier Agreements and Quality Clauses
- Managing Supplier Nonconformities and Corrective Actions
- Monitoring Supplier Performance with KPIs
- Handling Sub-tier Supplier Oversight
- Ensuring Supplier Compliance with ISO 13485
- Managing Single-Source and Sole-Source Suppliers
- Verification of Purchased Product and Incoming Inspection
- Managing Supplier Changes and Change Notifications
- Documentation of Purchasing Information and Orders
- Use of Supplier Scorecards and Auditing Checklists
- Remote and International Supplier Management Strategies
Module 8: Production and Process Controls - Establishing Controlled Production Environments
- Validating Production Processes (IQ, OQ, PQ)
- Defining Process Parameters and Control Limits
- Developing Work Instructions and Operator Training
- Implementing In-Process Inspection and Testing
- Calibration and Maintenance of Production Equipment
- Handling and Storage of Components and Finished Devices
- Packaging, Labeling, and Sterilisation Controls
- Traceability Requirements: UDI, Batch, and Serial Numbers
- Implementing Product Identification and Status Tracking
- Control of Monitoring and Measuring Equipment
- Handling Nonconforming Product During Production
- Change Control for Manufacturing Processes
- Cleanroom and Environmental Controls for Sensitive Devices
- Process Validation for Aseptic and Sterile Devices
Module 9: Monitoring, Measurement, and Analysis of QMS Performance - Identifying Key Performance Indicators for Quality Processes
- Tracking Quality Metrics: Yield, Rework, Defect Rates
- Monitoring Customer Complaints and Field Alerts
- Analysing CAPA and Nonconformance Trends
- Using Pareto Analysis and Control Charts
- Conducting Process Capability Studies (Cp, Cpk)
- Reporting Metrics to Management in Review Meetings
- Setting Targets and Improvement Goals
- Ensuring Data Integrity and Accuracy
- Linking Data to Risk and Patient Outcomes
- Using Dashboards for Executive QMS Oversight
- Establishing Alert and Escalation Triggers
- Monitoring Supplier and Vendor Performance
- Analysing Post-Market Surveillance Data
- Using Data for Management Review Inputs
Module 10: Internal Audits and Audit Preparation - Planning a Robust Internal Audit Program
- Selecting and Training Internal Auditors
- Developing Risk-Based Audit Schedules
- Creating Detailed Audit Checklists by ISO 13485 Clause
- Conducting Opening and Closing Meetings
- Gathering Objective Evidence During Audits
- Writing Clear, Factual, and Non-Emotional NC Reports
- Classifying Nonconformities: Major vs. Minor
- Ensuring Auditor Independence and Objectivity
- Auditing Document and Record Controls
- Conducting Process Audits Across Functions
- Tracking Audit Findings and Closure Verification
- Preparing for External Audits (Notified Body, FDA)
- Running Mock Audits and Management Tabletops
- Documentation of Audit Program Effectiveness
Module 11: Management Review and Continual Improvement - Planning and Conducting Effective Management Reviews
- Gathering Inputs: Audit Results, Customer Feedback, Metrics
- Reviewing Quality Objectives and Achievement Status
- Analysing Resource Adequacy and Competency Gaps
- Assessing QMS Performance and Regulatory Changes
- Reporting on Risk Management Activities
- Identifying Opportunities for Systemic Improvement
- Documenting Management Decisions and Action Items
- Tracking Follow-Up from Prior Reviews
- Ensuring Senior Leadership Engagement
- Linking Management Review to Strategic Planning
- Frequency of Reviews: Minimum Annual Requirement
- Handling Remote or Virtual Management Reviews
- Using Templates for Consistent Review Documentation
- Integrating Continual Improvement into Daily Operations
Module 12: Corrective and Preventive Action (CAPA) System - Establishing a Structured CAPA Process
- Identifying Triggers for CAPA: Complaints, Audits, Nonconformities
- Root Cause Analysis Techniques: 5 Whys, Fishbone, Fault Tree
- Distinguishing Between Correction, Corrective Action, and Preventive Action
- Setting Timelines and Escalation Procedures for CAPAs
- Verifying Implementation of Corrective Actions
- Ensuring Effectiveness Checks and Follow-Up
- Linking CAPA to Risk Management and FMEA Updates
- Preventing Recurrence Through Systemic Fixes
- Documenting CAPA Files for Audit Readiness
- Managing High-Risk CAPAs with Executive Escalation
- Using CAPA as a Proactive Improvement Tool
- Integrating CAPA with Change Control
- Minimising CAPA Backlog with Workflow Management
- Reporting CAPA Metrics in Management Reviews
Module 13: Customer Feedback, Complaints, and Post-Market Surveillance - Designing a Customer Feedback Collection System
- Handling Complaints in Accordance with MDR and FDA
- Distinguishing Reportable vs. Non-Reportable Events
- Establishing Complaint Investigation Procedures
- Linking Complaints to CAPA and Risk Assessments
- Reporting Adverse Events to Regulatory Authorities
- Conducting Trend Analysis on Complaint Data
- Using Complaint Insights for Design and Process Improvements
- Ensuring Complaint Investigation Timeliness
- Documentation of Complaint Files and Final Reports
- Training Customer Service Teams on Complaint Procedures
- Integrating Service Reports and Field Safety Notices
- Conducting Periodic Review of Post-Market Data
- Linking Field Corrective Actions to CAPA
- Using PMS for Management Review Inputs
Module 14: Change Control and Configuration Management - Establishing a Formal Change Control Process
- Types of Changes: Design, Process, Supplier, Software
- Conducting Impact Assessments on Proposed Changes
- Securing Cross-Functional Approvals
- Verifying Implementation and Effectiveness
- Updating Documentation and Records
- Communicating Changes Across the Organisation
- Using Change Control Logs and Tracking Systems
- Managing Emergency Changes with Documentation
- Linking Change Control to Risk Management
- Ensuring No Backward Compatibility Issues
- Configuration Management for Complex Devices
- Handling Legacy Device Change Documentation
- Reporting Significant Changes to Regulatory Bodies
- Periodic Review of Open and Closed Changes
Module 15: Preparation for Certification and Regulatory Audits - Understanding the ISO Certification Audit Process
- Selecting a Recognised Notified Body
- Conducting a Pre-Certification Readiness Review
- Gathering Audit Evidence and Documentation
- Preparing Site for Physical Audit (Records, Facilities, Staff)
- Conducting Internal Cross-Functional Audits
- Training Staff on Audit Interaction and Communication
- Handling Auditor Requests for Information
- Responding to Nonconformity Reports Effectively
- Developing a Corrective Action Plan for Major NCs
- Understanding Surveillance and Recertification Audits
- Preparing for FDA Inspections and Mock 483 Exercises
- Aligning Internal Processes with ISO 13485:2016 Clauses
- Documenting Audit Readiness Status
- Creating an Audit Survival Kit for Teams
Module 16: Advanced Implementation Strategies and Real-World Projects - Implementing ISO 13485 in a Startup Environment
- Scaling a QMS for Growth and New Markets
- Integrating Multiple Standards (ISO 13485, ISO 14971, IEC 62304)
- Managing QMS Across Multiple Sites and Jurisdictions
- Using Automation Tools for Document and Record Control
- Implementing eQMS Solutions with Cloud Platforms
- Leveraging AI for Risk and CAPA Trend Detection
- Managing Remote Teams and Virtual QMS Oversight
- Leading Cultural Change During QMS Rollout
- Conducting a Full QMS Gap Remediation Project
- Building a QMS for Software-Based Medical Devices
- Integrating Lean and Six Sigma with Quality Systems
- Creating a Sustainability Plan for Long-Term Compliance
- Running a Real-World QMS Simulation Project
- Presenting a QMS Implementation Case Study
Module 17: Certification, Career Advancement, and Next Steps - Final Verification Before Certification Audit
- Submitting Application to Notified Body
- Understanding the Certification Decision Process
- Maintaining Certification Through Surveillance
- Preparing for Recertification Every Three Years
- Updating Your Professional Profile with Certification
- Leveraging ISO 13485 Expertise in Job Applications
- Using the Certificate of Completion for Promotions
- Negotiating Higher Compensation Based on New Skills
- Joining Professional Quality and Regulatory Networks
- Continuing Education Pathways in Medical Device Compliance
- Pursuing Advanced Certifications (e.g., Lead Auditor)
- Mentoring Others in ISO 13485 Implementation
- Sharing Case Studies and Best Practices Publicly
- Accessing Alumni Resources and Future Learning Opportunities
- Understanding the ISO 13485 Documentation Requirements
- Creating a Document Hierarchy: Policies, SOPs, Work Instructions
- Designing a Master Document List (MDL)
- Standardising Document Templates and Formatting
- Document Approval, Review, and Revision Processes
- Control of External Documents and Regulatory References
- Version Control and Change History Tracking
- Electronic Document Management System (EDMS) Best Practices
- Ensuring Document Accessibility Across Sites
- Preventing Unauthorised Document Use
- Retention Periods and Record Preservation Requirements
- Handling Obsolete Documents and Archives
- Securing Sensitive Quality Records
- Linking Records to Specific Processes and Audits
- Periodic Review and Obsolescence Planning for Documents
Module 5: Risk-Based Thinking and Risk Management Integration - Principles of Risk-Based Thinking in ISO 13485
- Applying Risk Management Throughout the QMS
- Linking ISO 13485 to ISO 14971: Application of Risk Management to Medical Devices
- Identifying Hazards and Harmful Situations
- Conducting Risk Assessments for Processes and Products
- Establishing Risk Acceptability Criteria
- Developing Risk Control Measures
- Verifying and Validating Risk Controls
- Integrating Risk into Design and Development
- Using FMEA, FMECA, and HACCP Techniques in QMS
- Risk Documentation: Traceability and Audit Readiness
- Periodic Risk Review and Reassessment
- Linking Risk to Corrective Actions and CAPA
- Reporting Residual Risk to Management
- Aligning Risk Strategy with Product Lifecycle Stages
Module 6: Design and Development of Medical Devices - Planning the Design and Development Process
- Establishing Design Inputs with Clear, Verifiable Requirements
- Creating Design Input Checklists and Validation Protocols
- Managing Design Output Specifications and Release Criteria
- Ensuring Traceability from Input to Output (Design Trace Matrix)
- Design Review Processes and Documentation
- Verification vs. Validation: Understanding the Difference
- Design Verification Testing and Protocols
- Design Validation Using Simulated or Actual Use Conditions
- Design Transfer to Manufacturing: Protocols and Handover
- Managing Design Changes and Change Control Procedures
- Post-Market Feedback Loop for Design Improvement
- Documentation of Design History File (DHF)
- Handling Legacy Device Design Documentation
- Design Controls for Software as a Medical Device (SaMD)
Module 7: Supplier and Purchasing Control - Establishing Supplier Selection Criteria
- Conducting Supplier Audits and Assessments
- Creating a Qualified Supplier List (QSL)
- Classifying Suppliers by Risk and Criticality
- Developing Supplier Agreements and Quality Clauses
- Managing Supplier Nonconformities and Corrective Actions
- Monitoring Supplier Performance with KPIs
- Handling Sub-tier Supplier Oversight
- Ensuring Supplier Compliance with ISO 13485
- Managing Single-Source and Sole-Source Suppliers
- Verification of Purchased Product and Incoming Inspection
- Managing Supplier Changes and Change Notifications
- Documentation of Purchasing Information and Orders
- Use of Supplier Scorecards and Auditing Checklists
- Remote and International Supplier Management Strategies
Module 8: Production and Process Controls - Establishing Controlled Production Environments
- Validating Production Processes (IQ, OQ, PQ)
- Defining Process Parameters and Control Limits
- Developing Work Instructions and Operator Training
- Implementing In-Process Inspection and Testing
- Calibration and Maintenance of Production Equipment
- Handling and Storage of Components and Finished Devices
- Packaging, Labeling, and Sterilisation Controls
- Traceability Requirements: UDI, Batch, and Serial Numbers
- Implementing Product Identification and Status Tracking
- Control of Monitoring and Measuring Equipment
- Handling Nonconforming Product During Production
- Change Control for Manufacturing Processes
- Cleanroom and Environmental Controls for Sensitive Devices
- Process Validation for Aseptic and Sterile Devices
Module 9: Monitoring, Measurement, and Analysis of QMS Performance - Identifying Key Performance Indicators for Quality Processes
- Tracking Quality Metrics: Yield, Rework, Defect Rates
- Monitoring Customer Complaints and Field Alerts
- Analysing CAPA and Nonconformance Trends
- Using Pareto Analysis and Control Charts
- Conducting Process Capability Studies (Cp, Cpk)
- Reporting Metrics to Management in Review Meetings
- Setting Targets and Improvement Goals
- Ensuring Data Integrity and Accuracy
- Linking Data to Risk and Patient Outcomes
- Using Dashboards for Executive QMS Oversight
- Establishing Alert and Escalation Triggers
- Monitoring Supplier and Vendor Performance
- Analysing Post-Market Surveillance Data
- Using Data for Management Review Inputs
Module 10: Internal Audits and Audit Preparation - Planning a Robust Internal Audit Program
- Selecting and Training Internal Auditors
- Developing Risk-Based Audit Schedules
- Creating Detailed Audit Checklists by ISO 13485 Clause
- Conducting Opening and Closing Meetings
- Gathering Objective Evidence During Audits
- Writing Clear, Factual, and Non-Emotional NC Reports
- Classifying Nonconformities: Major vs. Minor
- Ensuring Auditor Independence and Objectivity
- Auditing Document and Record Controls
- Conducting Process Audits Across Functions
- Tracking Audit Findings and Closure Verification
- Preparing for External Audits (Notified Body, FDA)
- Running Mock Audits and Management Tabletops
- Documentation of Audit Program Effectiveness
Module 11: Management Review and Continual Improvement - Planning and Conducting Effective Management Reviews
- Gathering Inputs: Audit Results, Customer Feedback, Metrics
- Reviewing Quality Objectives and Achievement Status
- Analysing Resource Adequacy and Competency Gaps
- Assessing QMS Performance and Regulatory Changes
- Reporting on Risk Management Activities
- Identifying Opportunities for Systemic Improvement
- Documenting Management Decisions and Action Items
- Tracking Follow-Up from Prior Reviews
- Ensuring Senior Leadership Engagement
- Linking Management Review to Strategic Planning
- Frequency of Reviews: Minimum Annual Requirement
- Handling Remote or Virtual Management Reviews
- Using Templates for Consistent Review Documentation
- Integrating Continual Improvement into Daily Operations
Module 12: Corrective and Preventive Action (CAPA) System - Establishing a Structured CAPA Process
- Identifying Triggers for CAPA: Complaints, Audits, Nonconformities
- Root Cause Analysis Techniques: 5 Whys, Fishbone, Fault Tree
- Distinguishing Between Correction, Corrective Action, and Preventive Action
- Setting Timelines and Escalation Procedures for CAPAs
- Verifying Implementation of Corrective Actions
- Ensuring Effectiveness Checks and Follow-Up
- Linking CAPA to Risk Management and FMEA Updates
- Preventing Recurrence Through Systemic Fixes
- Documenting CAPA Files for Audit Readiness
- Managing High-Risk CAPAs with Executive Escalation
- Using CAPA as a Proactive Improvement Tool
- Integrating CAPA with Change Control
- Minimising CAPA Backlog with Workflow Management
- Reporting CAPA Metrics in Management Reviews
Module 13: Customer Feedback, Complaints, and Post-Market Surveillance - Designing a Customer Feedback Collection System
- Handling Complaints in Accordance with MDR and FDA
- Distinguishing Reportable vs. Non-Reportable Events
- Establishing Complaint Investigation Procedures
- Linking Complaints to CAPA and Risk Assessments
- Reporting Adverse Events to Regulatory Authorities
- Conducting Trend Analysis on Complaint Data
- Using Complaint Insights for Design and Process Improvements
- Ensuring Complaint Investigation Timeliness
- Documentation of Complaint Files and Final Reports
- Training Customer Service Teams on Complaint Procedures
- Integrating Service Reports and Field Safety Notices
- Conducting Periodic Review of Post-Market Data
- Linking Field Corrective Actions to CAPA
- Using PMS for Management Review Inputs
Module 14: Change Control and Configuration Management - Establishing a Formal Change Control Process
- Types of Changes: Design, Process, Supplier, Software
- Conducting Impact Assessments on Proposed Changes
- Securing Cross-Functional Approvals
- Verifying Implementation and Effectiveness
- Updating Documentation and Records
- Communicating Changes Across the Organisation
- Using Change Control Logs and Tracking Systems
- Managing Emergency Changes with Documentation
- Linking Change Control to Risk Management
- Ensuring No Backward Compatibility Issues
- Configuration Management for Complex Devices
- Handling Legacy Device Change Documentation
- Reporting Significant Changes to Regulatory Bodies
- Periodic Review of Open and Closed Changes
Module 15: Preparation for Certification and Regulatory Audits - Understanding the ISO Certification Audit Process
- Selecting a Recognised Notified Body
- Conducting a Pre-Certification Readiness Review
- Gathering Audit Evidence and Documentation
- Preparing Site for Physical Audit (Records, Facilities, Staff)
- Conducting Internal Cross-Functional Audits
- Training Staff on Audit Interaction and Communication
- Handling Auditor Requests for Information
- Responding to Nonconformity Reports Effectively
- Developing a Corrective Action Plan for Major NCs
- Understanding Surveillance and Recertification Audits
- Preparing for FDA Inspections and Mock 483 Exercises
- Aligning Internal Processes with ISO 13485:2016 Clauses
- Documenting Audit Readiness Status
- Creating an Audit Survival Kit for Teams
Module 16: Advanced Implementation Strategies and Real-World Projects - Implementing ISO 13485 in a Startup Environment
- Scaling a QMS for Growth and New Markets
- Integrating Multiple Standards (ISO 13485, ISO 14971, IEC 62304)
- Managing QMS Across Multiple Sites and Jurisdictions
- Using Automation Tools for Document and Record Control
- Implementing eQMS Solutions with Cloud Platforms
- Leveraging AI for Risk and CAPA Trend Detection
- Managing Remote Teams and Virtual QMS Oversight
- Leading Cultural Change During QMS Rollout
- Conducting a Full QMS Gap Remediation Project
- Building a QMS for Software-Based Medical Devices
- Integrating Lean and Six Sigma with Quality Systems
- Creating a Sustainability Plan for Long-Term Compliance
- Running a Real-World QMS Simulation Project
- Presenting a QMS Implementation Case Study
Module 17: Certification, Career Advancement, and Next Steps - Final Verification Before Certification Audit
- Submitting Application to Notified Body
- Understanding the Certification Decision Process
- Maintaining Certification Through Surveillance
- Preparing for Recertification Every Three Years
- Updating Your Professional Profile with Certification
- Leveraging ISO 13485 Expertise in Job Applications
- Using the Certificate of Completion for Promotions
- Negotiating Higher Compensation Based on New Skills
- Joining Professional Quality and Regulatory Networks
- Continuing Education Pathways in Medical Device Compliance
- Pursuing Advanced Certifications (e.g., Lead Auditor)
- Mentoring Others in ISO 13485 Implementation
- Sharing Case Studies and Best Practices Publicly
- Accessing Alumni Resources and Future Learning Opportunities
- Planning the Design and Development Process
- Establishing Design Inputs with Clear, Verifiable Requirements
- Creating Design Input Checklists and Validation Protocols
- Managing Design Output Specifications and Release Criteria
- Ensuring Traceability from Input to Output (Design Trace Matrix)
- Design Review Processes and Documentation
- Verification vs. Validation: Understanding the Difference
- Design Verification Testing and Protocols
- Design Validation Using Simulated or Actual Use Conditions
- Design Transfer to Manufacturing: Protocols and Handover
- Managing Design Changes and Change Control Procedures
- Post-Market Feedback Loop for Design Improvement
- Documentation of Design History File (DHF)
- Handling Legacy Device Design Documentation
- Design Controls for Software as a Medical Device (SaMD)
Module 7: Supplier and Purchasing Control - Establishing Supplier Selection Criteria
- Conducting Supplier Audits and Assessments
- Creating a Qualified Supplier List (QSL)
- Classifying Suppliers by Risk and Criticality
- Developing Supplier Agreements and Quality Clauses
- Managing Supplier Nonconformities and Corrective Actions
- Monitoring Supplier Performance with KPIs
- Handling Sub-tier Supplier Oversight
- Ensuring Supplier Compliance with ISO 13485
- Managing Single-Source and Sole-Source Suppliers
- Verification of Purchased Product and Incoming Inspection
- Managing Supplier Changes and Change Notifications
- Documentation of Purchasing Information and Orders
- Use of Supplier Scorecards and Auditing Checklists
- Remote and International Supplier Management Strategies
Module 8: Production and Process Controls - Establishing Controlled Production Environments
- Validating Production Processes (IQ, OQ, PQ)
- Defining Process Parameters and Control Limits
- Developing Work Instructions and Operator Training
- Implementing In-Process Inspection and Testing
- Calibration and Maintenance of Production Equipment
- Handling and Storage of Components and Finished Devices
- Packaging, Labeling, and Sterilisation Controls
- Traceability Requirements: UDI, Batch, and Serial Numbers
- Implementing Product Identification and Status Tracking
- Control of Monitoring and Measuring Equipment
- Handling Nonconforming Product During Production
- Change Control for Manufacturing Processes
- Cleanroom and Environmental Controls for Sensitive Devices
- Process Validation for Aseptic and Sterile Devices
Module 9: Monitoring, Measurement, and Analysis of QMS Performance - Identifying Key Performance Indicators for Quality Processes
- Tracking Quality Metrics: Yield, Rework, Defect Rates
- Monitoring Customer Complaints and Field Alerts
- Analysing CAPA and Nonconformance Trends
- Using Pareto Analysis and Control Charts
- Conducting Process Capability Studies (Cp, Cpk)
- Reporting Metrics to Management in Review Meetings
- Setting Targets and Improvement Goals
- Ensuring Data Integrity and Accuracy
- Linking Data to Risk and Patient Outcomes
- Using Dashboards for Executive QMS Oversight
- Establishing Alert and Escalation Triggers
- Monitoring Supplier and Vendor Performance
- Analysing Post-Market Surveillance Data
- Using Data for Management Review Inputs
Module 10: Internal Audits and Audit Preparation - Planning a Robust Internal Audit Program
- Selecting and Training Internal Auditors
- Developing Risk-Based Audit Schedules
- Creating Detailed Audit Checklists by ISO 13485 Clause
- Conducting Opening and Closing Meetings
- Gathering Objective Evidence During Audits
- Writing Clear, Factual, and Non-Emotional NC Reports
- Classifying Nonconformities: Major vs. Minor
- Ensuring Auditor Independence and Objectivity
- Auditing Document and Record Controls
- Conducting Process Audits Across Functions
- Tracking Audit Findings and Closure Verification
- Preparing for External Audits (Notified Body, FDA)
- Running Mock Audits and Management Tabletops
- Documentation of Audit Program Effectiveness
Module 11: Management Review and Continual Improvement - Planning and Conducting Effective Management Reviews
- Gathering Inputs: Audit Results, Customer Feedback, Metrics
- Reviewing Quality Objectives and Achievement Status
- Analysing Resource Adequacy and Competency Gaps
- Assessing QMS Performance and Regulatory Changes
- Reporting on Risk Management Activities
- Identifying Opportunities for Systemic Improvement
- Documenting Management Decisions and Action Items
- Tracking Follow-Up from Prior Reviews
- Ensuring Senior Leadership Engagement
- Linking Management Review to Strategic Planning
- Frequency of Reviews: Minimum Annual Requirement
- Handling Remote or Virtual Management Reviews
- Using Templates for Consistent Review Documentation
- Integrating Continual Improvement into Daily Operations
Module 12: Corrective and Preventive Action (CAPA) System - Establishing a Structured CAPA Process
- Identifying Triggers for CAPA: Complaints, Audits, Nonconformities
- Root Cause Analysis Techniques: 5 Whys, Fishbone, Fault Tree
- Distinguishing Between Correction, Corrective Action, and Preventive Action
- Setting Timelines and Escalation Procedures for CAPAs
- Verifying Implementation of Corrective Actions
- Ensuring Effectiveness Checks and Follow-Up
- Linking CAPA to Risk Management and FMEA Updates
- Preventing Recurrence Through Systemic Fixes
- Documenting CAPA Files for Audit Readiness
- Managing High-Risk CAPAs with Executive Escalation
- Using CAPA as a Proactive Improvement Tool
- Integrating CAPA with Change Control
- Minimising CAPA Backlog with Workflow Management
- Reporting CAPA Metrics in Management Reviews
Module 13: Customer Feedback, Complaints, and Post-Market Surveillance - Designing a Customer Feedback Collection System
- Handling Complaints in Accordance with MDR and FDA
- Distinguishing Reportable vs. Non-Reportable Events
- Establishing Complaint Investigation Procedures
- Linking Complaints to CAPA and Risk Assessments
- Reporting Adverse Events to Regulatory Authorities
- Conducting Trend Analysis on Complaint Data
- Using Complaint Insights for Design and Process Improvements
- Ensuring Complaint Investigation Timeliness
- Documentation of Complaint Files and Final Reports
- Training Customer Service Teams on Complaint Procedures
- Integrating Service Reports and Field Safety Notices
- Conducting Periodic Review of Post-Market Data
- Linking Field Corrective Actions to CAPA
- Using PMS for Management Review Inputs
Module 14: Change Control and Configuration Management - Establishing a Formal Change Control Process
- Types of Changes: Design, Process, Supplier, Software
- Conducting Impact Assessments on Proposed Changes
- Securing Cross-Functional Approvals
- Verifying Implementation and Effectiveness
- Updating Documentation and Records
- Communicating Changes Across the Organisation
- Using Change Control Logs and Tracking Systems
- Managing Emergency Changes with Documentation
- Linking Change Control to Risk Management
- Ensuring No Backward Compatibility Issues
- Configuration Management for Complex Devices
- Handling Legacy Device Change Documentation
- Reporting Significant Changes to Regulatory Bodies
- Periodic Review of Open and Closed Changes
Module 15: Preparation for Certification and Regulatory Audits - Understanding the ISO Certification Audit Process
- Selecting a Recognised Notified Body
- Conducting a Pre-Certification Readiness Review
- Gathering Audit Evidence and Documentation
- Preparing Site for Physical Audit (Records, Facilities, Staff)
- Conducting Internal Cross-Functional Audits
- Training Staff on Audit Interaction and Communication
- Handling Auditor Requests for Information
- Responding to Nonconformity Reports Effectively
- Developing a Corrective Action Plan for Major NCs
- Understanding Surveillance and Recertification Audits
- Preparing for FDA Inspections and Mock 483 Exercises
- Aligning Internal Processes with ISO 13485:2016 Clauses
- Documenting Audit Readiness Status
- Creating an Audit Survival Kit for Teams
Module 16: Advanced Implementation Strategies and Real-World Projects - Implementing ISO 13485 in a Startup Environment
- Scaling a QMS for Growth and New Markets
- Integrating Multiple Standards (ISO 13485, ISO 14971, IEC 62304)
- Managing QMS Across Multiple Sites and Jurisdictions
- Using Automation Tools for Document and Record Control
- Implementing eQMS Solutions with Cloud Platforms
- Leveraging AI for Risk and CAPA Trend Detection
- Managing Remote Teams and Virtual QMS Oversight
- Leading Cultural Change During QMS Rollout
- Conducting a Full QMS Gap Remediation Project
- Building a QMS for Software-Based Medical Devices
- Integrating Lean and Six Sigma with Quality Systems
- Creating a Sustainability Plan for Long-Term Compliance
- Running a Real-World QMS Simulation Project
- Presenting a QMS Implementation Case Study
Module 17: Certification, Career Advancement, and Next Steps - Final Verification Before Certification Audit
- Submitting Application to Notified Body
- Understanding the Certification Decision Process
- Maintaining Certification Through Surveillance
- Preparing for Recertification Every Three Years
- Updating Your Professional Profile with Certification
- Leveraging ISO 13485 Expertise in Job Applications
- Using the Certificate of Completion for Promotions
- Negotiating Higher Compensation Based on New Skills
- Joining Professional Quality and Regulatory Networks
- Continuing Education Pathways in Medical Device Compliance
- Pursuing Advanced Certifications (e.g., Lead Auditor)
- Mentoring Others in ISO 13485 Implementation
- Sharing Case Studies and Best Practices Publicly
- Accessing Alumni Resources and Future Learning Opportunities
- Establishing Controlled Production Environments
- Validating Production Processes (IQ, OQ, PQ)
- Defining Process Parameters and Control Limits
- Developing Work Instructions and Operator Training
- Implementing In-Process Inspection and Testing
- Calibration and Maintenance of Production Equipment
- Handling and Storage of Components and Finished Devices
- Packaging, Labeling, and Sterilisation Controls
- Traceability Requirements: UDI, Batch, and Serial Numbers
- Implementing Product Identification and Status Tracking
- Control of Monitoring and Measuring Equipment
- Handling Nonconforming Product During Production
- Change Control for Manufacturing Processes
- Cleanroom and Environmental Controls for Sensitive Devices
- Process Validation for Aseptic and Sterile Devices
Module 9: Monitoring, Measurement, and Analysis of QMS Performance - Identifying Key Performance Indicators for Quality Processes
- Tracking Quality Metrics: Yield, Rework, Defect Rates
- Monitoring Customer Complaints and Field Alerts
- Analysing CAPA and Nonconformance Trends
- Using Pareto Analysis and Control Charts
- Conducting Process Capability Studies (Cp, Cpk)
- Reporting Metrics to Management in Review Meetings
- Setting Targets and Improvement Goals
- Ensuring Data Integrity and Accuracy
- Linking Data to Risk and Patient Outcomes
- Using Dashboards for Executive QMS Oversight
- Establishing Alert and Escalation Triggers
- Monitoring Supplier and Vendor Performance
- Analysing Post-Market Surveillance Data
- Using Data for Management Review Inputs
Module 10: Internal Audits and Audit Preparation - Planning a Robust Internal Audit Program
- Selecting and Training Internal Auditors
- Developing Risk-Based Audit Schedules
- Creating Detailed Audit Checklists by ISO 13485 Clause
- Conducting Opening and Closing Meetings
- Gathering Objective Evidence During Audits
- Writing Clear, Factual, and Non-Emotional NC Reports
- Classifying Nonconformities: Major vs. Minor
- Ensuring Auditor Independence and Objectivity
- Auditing Document and Record Controls
- Conducting Process Audits Across Functions
- Tracking Audit Findings and Closure Verification
- Preparing for External Audits (Notified Body, FDA)
- Running Mock Audits and Management Tabletops
- Documentation of Audit Program Effectiveness
Module 11: Management Review and Continual Improvement - Planning and Conducting Effective Management Reviews
- Gathering Inputs: Audit Results, Customer Feedback, Metrics
- Reviewing Quality Objectives and Achievement Status
- Analysing Resource Adequacy and Competency Gaps
- Assessing QMS Performance and Regulatory Changes
- Reporting on Risk Management Activities
- Identifying Opportunities for Systemic Improvement
- Documenting Management Decisions and Action Items
- Tracking Follow-Up from Prior Reviews
- Ensuring Senior Leadership Engagement
- Linking Management Review to Strategic Planning
- Frequency of Reviews: Minimum Annual Requirement
- Handling Remote or Virtual Management Reviews
- Using Templates for Consistent Review Documentation
- Integrating Continual Improvement into Daily Operations
Module 12: Corrective and Preventive Action (CAPA) System - Establishing a Structured CAPA Process
- Identifying Triggers for CAPA: Complaints, Audits, Nonconformities
- Root Cause Analysis Techniques: 5 Whys, Fishbone, Fault Tree
- Distinguishing Between Correction, Corrective Action, and Preventive Action
- Setting Timelines and Escalation Procedures for CAPAs
- Verifying Implementation of Corrective Actions
- Ensuring Effectiveness Checks and Follow-Up
- Linking CAPA to Risk Management and FMEA Updates
- Preventing Recurrence Through Systemic Fixes
- Documenting CAPA Files for Audit Readiness
- Managing High-Risk CAPAs with Executive Escalation
- Using CAPA as a Proactive Improvement Tool
- Integrating CAPA with Change Control
- Minimising CAPA Backlog with Workflow Management
- Reporting CAPA Metrics in Management Reviews
Module 13: Customer Feedback, Complaints, and Post-Market Surveillance - Designing a Customer Feedback Collection System
- Handling Complaints in Accordance with MDR and FDA
- Distinguishing Reportable vs. Non-Reportable Events
- Establishing Complaint Investigation Procedures
- Linking Complaints to CAPA and Risk Assessments
- Reporting Adverse Events to Regulatory Authorities
- Conducting Trend Analysis on Complaint Data
- Using Complaint Insights for Design and Process Improvements
- Ensuring Complaint Investigation Timeliness
- Documentation of Complaint Files and Final Reports
- Training Customer Service Teams on Complaint Procedures
- Integrating Service Reports and Field Safety Notices
- Conducting Periodic Review of Post-Market Data
- Linking Field Corrective Actions to CAPA
- Using PMS for Management Review Inputs
Module 14: Change Control and Configuration Management - Establishing a Formal Change Control Process
- Types of Changes: Design, Process, Supplier, Software
- Conducting Impact Assessments on Proposed Changes
- Securing Cross-Functional Approvals
- Verifying Implementation and Effectiveness
- Updating Documentation and Records
- Communicating Changes Across the Organisation
- Using Change Control Logs and Tracking Systems
- Managing Emergency Changes with Documentation
- Linking Change Control to Risk Management
- Ensuring No Backward Compatibility Issues
- Configuration Management for Complex Devices
- Handling Legacy Device Change Documentation
- Reporting Significant Changes to Regulatory Bodies
- Periodic Review of Open and Closed Changes
Module 15: Preparation for Certification and Regulatory Audits - Understanding the ISO Certification Audit Process
- Selecting a Recognised Notified Body
- Conducting a Pre-Certification Readiness Review
- Gathering Audit Evidence and Documentation
- Preparing Site for Physical Audit (Records, Facilities, Staff)
- Conducting Internal Cross-Functional Audits
- Training Staff on Audit Interaction and Communication
- Handling Auditor Requests for Information
- Responding to Nonconformity Reports Effectively
- Developing a Corrective Action Plan for Major NCs
- Understanding Surveillance and Recertification Audits
- Preparing for FDA Inspections and Mock 483 Exercises
- Aligning Internal Processes with ISO 13485:2016 Clauses
- Documenting Audit Readiness Status
- Creating an Audit Survival Kit for Teams
Module 16: Advanced Implementation Strategies and Real-World Projects - Implementing ISO 13485 in a Startup Environment
- Scaling a QMS for Growth and New Markets
- Integrating Multiple Standards (ISO 13485, ISO 14971, IEC 62304)
- Managing QMS Across Multiple Sites and Jurisdictions
- Using Automation Tools for Document and Record Control
- Implementing eQMS Solutions with Cloud Platforms
- Leveraging AI for Risk and CAPA Trend Detection
- Managing Remote Teams and Virtual QMS Oversight
- Leading Cultural Change During QMS Rollout
- Conducting a Full QMS Gap Remediation Project
- Building a QMS for Software-Based Medical Devices
- Integrating Lean and Six Sigma with Quality Systems
- Creating a Sustainability Plan for Long-Term Compliance
- Running a Real-World QMS Simulation Project
- Presenting a QMS Implementation Case Study
Module 17: Certification, Career Advancement, and Next Steps - Final Verification Before Certification Audit
- Submitting Application to Notified Body
- Understanding the Certification Decision Process
- Maintaining Certification Through Surveillance
- Preparing for Recertification Every Three Years
- Updating Your Professional Profile with Certification
- Leveraging ISO 13485 Expertise in Job Applications
- Using the Certificate of Completion for Promotions
- Negotiating Higher Compensation Based on New Skills
- Joining Professional Quality and Regulatory Networks
- Continuing Education Pathways in Medical Device Compliance
- Pursuing Advanced Certifications (e.g., Lead Auditor)
- Mentoring Others in ISO 13485 Implementation
- Sharing Case Studies and Best Practices Publicly
- Accessing Alumni Resources and Future Learning Opportunities
- Planning a Robust Internal Audit Program
- Selecting and Training Internal Auditors
- Developing Risk-Based Audit Schedules
- Creating Detailed Audit Checklists by ISO 13485 Clause
- Conducting Opening and Closing Meetings
- Gathering Objective Evidence During Audits
- Writing Clear, Factual, and Non-Emotional NC Reports
- Classifying Nonconformities: Major vs. Minor
- Ensuring Auditor Independence and Objectivity
- Auditing Document and Record Controls
- Conducting Process Audits Across Functions
- Tracking Audit Findings and Closure Verification
- Preparing for External Audits (Notified Body, FDA)
- Running Mock Audits and Management Tabletops
- Documentation of Audit Program Effectiveness
Module 11: Management Review and Continual Improvement - Planning and Conducting Effective Management Reviews
- Gathering Inputs: Audit Results, Customer Feedback, Metrics
- Reviewing Quality Objectives and Achievement Status
- Analysing Resource Adequacy and Competency Gaps
- Assessing QMS Performance and Regulatory Changes
- Reporting on Risk Management Activities
- Identifying Opportunities for Systemic Improvement
- Documenting Management Decisions and Action Items
- Tracking Follow-Up from Prior Reviews
- Ensuring Senior Leadership Engagement
- Linking Management Review to Strategic Planning
- Frequency of Reviews: Minimum Annual Requirement
- Handling Remote or Virtual Management Reviews
- Using Templates for Consistent Review Documentation
- Integrating Continual Improvement into Daily Operations
Module 12: Corrective and Preventive Action (CAPA) System - Establishing a Structured CAPA Process
- Identifying Triggers for CAPA: Complaints, Audits, Nonconformities
- Root Cause Analysis Techniques: 5 Whys, Fishbone, Fault Tree
- Distinguishing Between Correction, Corrective Action, and Preventive Action
- Setting Timelines and Escalation Procedures for CAPAs
- Verifying Implementation of Corrective Actions
- Ensuring Effectiveness Checks and Follow-Up
- Linking CAPA to Risk Management and FMEA Updates
- Preventing Recurrence Through Systemic Fixes
- Documenting CAPA Files for Audit Readiness
- Managing High-Risk CAPAs with Executive Escalation
- Using CAPA as a Proactive Improvement Tool
- Integrating CAPA with Change Control
- Minimising CAPA Backlog with Workflow Management
- Reporting CAPA Metrics in Management Reviews
Module 13: Customer Feedback, Complaints, and Post-Market Surveillance - Designing a Customer Feedback Collection System
- Handling Complaints in Accordance with MDR and FDA
- Distinguishing Reportable vs. Non-Reportable Events
- Establishing Complaint Investigation Procedures
- Linking Complaints to CAPA and Risk Assessments
- Reporting Adverse Events to Regulatory Authorities
- Conducting Trend Analysis on Complaint Data
- Using Complaint Insights for Design and Process Improvements
- Ensuring Complaint Investigation Timeliness
- Documentation of Complaint Files and Final Reports
- Training Customer Service Teams on Complaint Procedures
- Integrating Service Reports and Field Safety Notices
- Conducting Periodic Review of Post-Market Data
- Linking Field Corrective Actions to CAPA
- Using PMS for Management Review Inputs
Module 14: Change Control and Configuration Management - Establishing a Formal Change Control Process
- Types of Changes: Design, Process, Supplier, Software
- Conducting Impact Assessments on Proposed Changes
- Securing Cross-Functional Approvals
- Verifying Implementation and Effectiveness
- Updating Documentation and Records
- Communicating Changes Across the Organisation
- Using Change Control Logs and Tracking Systems
- Managing Emergency Changes with Documentation
- Linking Change Control to Risk Management
- Ensuring No Backward Compatibility Issues
- Configuration Management for Complex Devices
- Handling Legacy Device Change Documentation
- Reporting Significant Changes to Regulatory Bodies
- Periodic Review of Open and Closed Changes
Module 15: Preparation for Certification and Regulatory Audits - Understanding the ISO Certification Audit Process
- Selecting a Recognised Notified Body
- Conducting a Pre-Certification Readiness Review
- Gathering Audit Evidence and Documentation
- Preparing Site for Physical Audit (Records, Facilities, Staff)
- Conducting Internal Cross-Functional Audits
- Training Staff on Audit Interaction and Communication
- Handling Auditor Requests for Information
- Responding to Nonconformity Reports Effectively
- Developing a Corrective Action Plan for Major NCs
- Understanding Surveillance and Recertification Audits
- Preparing for FDA Inspections and Mock 483 Exercises
- Aligning Internal Processes with ISO 13485:2016 Clauses
- Documenting Audit Readiness Status
- Creating an Audit Survival Kit for Teams
Module 16: Advanced Implementation Strategies and Real-World Projects - Implementing ISO 13485 in a Startup Environment
- Scaling a QMS for Growth and New Markets
- Integrating Multiple Standards (ISO 13485, ISO 14971, IEC 62304)
- Managing QMS Across Multiple Sites and Jurisdictions
- Using Automation Tools for Document and Record Control
- Implementing eQMS Solutions with Cloud Platforms
- Leveraging AI for Risk and CAPA Trend Detection
- Managing Remote Teams and Virtual QMS Oversight
- Leading Cultural Change During QMS Rollout
- Conducting a Full QMS Gap Remediation Project
- Building a QMS for Software-Based Medical Devices
- Integrating Lean and Six Sigma with Quality Systems
- Creating a Sustainability Plan for Long-Term Compliance
- Running a Real-World QMS Simulation Project
- Presenting a QMS Implementation Case Study
Module 17: Certification, Career Advancement, and Next Steps - Final Verification Before Certification Audit
- Submitting Application to Notified Body
- Understanding the Certification Decision Process
- Maintaining Certification Through Surveillance
- Preparing for Recertification Every Three Years
- Updating Your Professional Profile with Certification
- Leveraging ISO 13485 Expertise in Job Applications
- Using the Certificate of Completion for Promotions
- Negotiating Higher Compensation Based on New Skills
- Joining Professional Quality and Regulatory Networks
- Continuing Education Pathways in Medical Device Compliance
- Pursuing Advanced Certifications (e.g., Lead Auditor)
- Mentoring Others in ISO 13485 Implementation
- Sharing Case Studies and Best Practices Publicly
- Accessing Alumni Resources and Future Learning Opportunities
- Establishing a Structured CAPA Process
- Identifying Triggers for CAPA: Complaints, Audits, Nonconformities
- Root Cause Analysis Techniques: 5 Whys, Fishbone, Fault Tree
- Distinguishing Between Correction, Corrective Action, and Preventive Action
- Setting Timelines and Escalation Procedures for CAPAs
- Verifying Implementation of Corrective Actions
- Ensuring Effectiveness Checks and Follow-Up
- Linking CAPA to Risk Management and FMEA Updates
- Preventing Recurrence Through Systemic Fixes
- Documenting CAPA Files for Audit Readiness
- Managing High-Risk CAPAs with Executive Escalation
- Using CAPA as a Proactive Improvement Tool
- Integrating CAPA with Change Control
- Minimising CAPA Backlog with Workflow Management
- Reporting CAPA Metrics in Management Reviews
Module 13: Customer Feedback, Complaints, and Post-Market Surveillance - Designing a Customer Feedback Collection System
- Handling Complaints in Accordance with MDR and FDA
- Distinguishing Reportable vs. Non-Reportable Events
- Establishing Complaint Investigation Procedures
- Linking Complaints to CAPA and Risk Assessments
- Reporting Adverse Events to Regulatory Authorities
- Conducting Trend Analysis on Complaint Data
- Using Complaint Insights for Design and Process Improvements
- Ensuring Complaint Investigation Timeliness
- Documentation of Complaint Files and Final Reports
- Training Customer Service Teams on Complaint Procedures
- Integrating Service Reports and Field Safety Notices
- Conducting Periodic Review of Post-Market Data
- Linking Field Corrective Actions to CAPA
- Using PMS for Management Review Inputs
Module 14: Change Control and Configuration Management - Establishing a Formal Change Control Process
- Types of Changes: Design, Process, Supplier, Software
- Conducting Impact Assessments on Proposed Changes
- Securing Cross-Functional Approvals
- Verifying Implementation and Effectiveness
- Updating Documentation and Records
- Communicating Changes Across the Organisation
- Using Change Control Logs and Tracking Systems
- Managing Emergency Changes with Documentation
- Linking Change Control to Risk Management
- Ensuring No Backward Compatibility Issues
- Configuration Management for Complex Devices
- Handling Legacy Device Change Documentation
- Reporting Significant Changes to Regulatory Bodies
- Periodic Review of Open and Closed Changes
Module 15: Preparation for Certification and Regulatory Audits - Understanding the ISO Certification Audit Process
- Selecting a Recognised Notified Body
- Conducting a Pre-Certification Readiness Review
- Gathering Audit Evidence and Documentation
- Preparing Site for Physical Audit (Records, Facilities, Staff)
- Conducting Internal Cross-Functional Audits
- Training Staff on Audit Interaction and Communication
- Handling Auditor Requests for Information
- Responding to Nonconformity Reports Effectively
- Developing a Corrective Action Plan for Major NCs
- Understanding Surveillance and Recertification Audits
- Preparing for FDA Inspections and Mock 483 Exercises
- Aligning Internal Processes with ISO 13485:2016 Clauses
- Documenting Audit Readiness Status
- Creating an Audit Survival Kit for Teams
Module 16: Advanced Implementation Strategies and Real-World Projects - Implementing ISO 13485 in a Startup Environment
- Scaling a QMS for Growth and New Markets
- Integrating Multiple Standards (ISO 13485, ISO 14971, IEC 62304)
- Managing QMS Across Multiple Sites and Jurisdictions
- Using Automation Tools for Document and Record Control
- Implementing eQMS Solutions with Cloud Platforms
- Leveraging AI for Risk and CAPA Trend Detection
- Managing Remote Teams and Virtual QMS Oversight
- Leading Cultural Change During QMS Rollout
- Conducting a Full QMS Gap Remediation Project
- Building a QMS for Software-Based Medical Devices
- Integrating Lean and Six Sigma with Quality Systems
- Creating a Sustainability Plan for Long-Term Compliance
- Running a Real-World QMS Simulation Project
- Presenting a QMS Implementation Case Study
Module 17: Certification, Career Advancement, and Next Steps - Final Verification Before Certification Audit
- Submitting Application to Notified Body
- Understanding the Certification Decision Process
- Maintaining Certification Through Surveillance
- Preparing for Recertification Every Three Years
- Updating Your Professional Profile with Certification
- Leveraging ISO 13485 Expertise in Job Applications
- Using the Certificate of Completion for Promotions
- Negotiating Higher Compensation Based on New Skills
- Joining Professional Quality and Regulatory Networks
- Continuing Education Pathways in Medical Device Compliance
- Pursuing Advanced Certifications (e.g., Lead Auditor)
- Mentoring Others in ISO 13485 Implementation
- Sharing Case Studies and Best Practices Publicly
- Accessing Alumni Resources and Future Learning Opportunities
- Establishing a Formal Change Control Process
- Types of Changes: Design, Process, Supplier, Software
- Conducting Impact Assessments on Proposed Changes
- Securing Cross-Functional Approvals
- Verifying Implementation and Effectiveness
- Updating Documentation and Records
- Communicating Changes Across the Organisation
- Using Change Control Logs and Tracking Systems
- Managing Emergency Changes with Documentation
- Linking Change Control to Risk Management
- Ensuring No Backward Compatibility Issues
- Configuration Management for Complex Devices
- Handling Legacy Device Change Documentation
- Reporting Significant Changes to Regulatory Bodies
- Periodic Review of Open and Closed Changes
Module 15: Preparation for Certification and Regulatory Audits - Understanding the ISO Certification Audit Process
- Selecting a Recognised Notified Body
- Conducting a Pre-Certification Readiness Review
- Gathering Audit Evidence and Documentation
- Preparing Site for Physical Audit (Records, Facilities, Staff)
- Conducting Internal Cross-Functional Audits
- Training Staff on Audit Interaction and Communication
- Handling Auditor Requests for Information
- Responding to Nonconformity Reports Effectively
- Developing a Corrective Action Plan for Major NCs
- Understanding Surveillance and Recertification Audits
- Preparing for FDA Inspections and Mock 483 Exercises
- Aligning Internal Processes with ISO 13485:2016 Clauses
- Documenting Audit Readiness Status
- Creating an Audit Survival Kit for Teams
Module 16: Advanced Implementation Strategies and Real-World Projects - Implementing ISO 13485 in a Startup Environment
- Scaling a QMS for Growth and New Markets
- Integrating Multiple Standards (ISO 13485, ISO 14971, IEC 62304)
- Managing QMS Across Multiple Sites and Jurisdictions
- Using Automation Tools for Document and Record Control
- Implementing eQMS Solutions with Cloud Platforms
- Leveraging AI for Risk and CAPA Trend Detection
- Managing Remote Teams and Virtual QMS Oversight
- Leading Cultural Change During QMS Rollout
- Conducting a Full QMS Gap Remediation Project
- Building a QMS for Software-Based Medical Devices
- Integrating Lean and Six Sigma with Quality Systems
- Creating a Sustainability Plan for Long-Term Compliance
- Running a Real-World QMS Simulation Project
- Presenting a QMS Implementation Case Study
Module 17: Certification, Career Advancement, and Next Steps - Final Verification Before Certification Audit
- Submitting Application to Notified Body
- Understanding the Certification Decision Process
- Maintaining Certification Through Surveillance
- Preparing for Recertification Every Three Years
- Updating Your Professional Profile with Certification
- Leveraging ISO 13485 Expertise in Job Applications
- Using the Certificate of Completion for Promotions
- Negotiating Higher Compensation Based on New Skills
- Joining Professional Quality and Regulatory Networks
- Continuing Education Pathways in Medical Device Compliance
- Pursuing Advanced Certifications (e.g., Lead Auditor)
- Mentoring Others in ISO 13485 Implementation
- Sharing Case Studies and Best Practices Publicly
- Accessing Alumni Resources and Future Learning Opportunities
- Implementing ISO 13485 in a Startup Environment
- Scaling a QMS for Growth and New Markets
- Integrating Multiple Standards (ISO 13485, ISO 14971, IEC 62304)
- Managing QMS Across Multiple Sites and Jurisdictions
- Using Automation Tools for Document and Record Control
- Implementing eQMS Solutions with Cloud Platforms
- Leveraging AI for Risk and CAPA Trend Detection
- Managing Remote Teams and Virtual QMS Oversight
- Leading Cultural Change During QMS Rollout
- Conducting a Full QMS Gap Remediation Project
- Building a QMS for Software-Based Medical Devices
- Integrating Lean and Six Sigma with Quality Systems
- Creating a Sustainability Plan for Long-Term Compliance
- Running a Real-World QMS Simulation Project
- Presenting a QMS Implementation Case Study