ISO 13485 Lead Implementer Certification Online Course

Duration: 30 hours approximate (including Certification Examinations)

By taking this course, you’ll learn:

• How to devise and structure the extensive documentation required (incl. sample documents, procedures, and forms);
• Step-by-step Path to ISO 13485 Certification – the detailed steps needed to get you from where you are now to being ISO 13485 Certified;
• Implementation Handbook (100+ pages) on implementing and maintaining a Medical Device Management System (MDMS);
• How to meet the requirements of the 2016 Standard (knowledge of the Standard);
• How to implement risk-based thinking for the delivery of products and services;
• How to implement risk management regarding medical device safety;
• How to maintain an MDMS (incl. Auditing Skills);
• Details of the Certification Process and how to prepare for it;
• And all in language that’s easy to follow and understand.

• • The Program is intended for those who:

    • need to develop and implement a medical device management system for their organization,
    • wish to offer MDMS Consulting Services in the development and implementation of medical device management systems,
    • are required to perform internal audits within your organization,
    • are required to perform supplier audits,
    • wish to improve your career prospects, and
    • wish to understand the processes of conducting an internal audit or external audits.
    • It is also recommended for the management involved in the audit process.
    audits.

Module 0: Introduction and background to the Standard and auditing.

Module 1: Auditing Skills based on the auditing standard ISO 19011

Module 2: Knowledge of the Standard,ISO 13485:2016, Medical Devices – Quality management systems – Requirements for regulatory purposes

Module 3: A Study of the Risk Management process

Module 4: Practice with Scenarios, based on actual audits and includes advice on dealing with awkward situations and individuals.

Online Final Examination and Certification

These materials, invaluable when implementing ISO 13485:2016, include:

• -ISO 13485:2016 Medical Device Management System Implementation Handbook – 100+ pages of detailed step-by-step instruction
• -Diagram: The 33-step Path to ISO 13485:2016 Certification
• -Documented Information Requirements of ISO 13485:2016
• -Determining the Context of the Organisation
• -ISO 13485:2016 and Risk Management
• -Risk Assessment Tools and Methodologies (with examples)
• -Terms & Definitions
• -Typical Process Map
• -Sample MDMS Policy Manual

Sample MDMS Maintained Documentation (procedures), including…

Sample Procedures, Sample Records, Sample Audit Plan, Sample Audit Work Order, Sample Nonconformity Report, Sample Working Document & Checklist, Sample Management Review Record

• -Diagram: Auditor Certification Process
• -Diagram: 6-Stage Audit Process
• -Sample Code of Ethics
• -Management of an Audit Programme