ISO 13485:2016 AWARENESS FOR MEDICAL DEVICES

INTRODUCTION FOR ISO 13485:2016 AWARENESS FOR MEDICAL DEVICES

Medical device quality management system (MDQMS) is a structured system of procedures and processes covering all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labelling, and more. Most medical devices will require some form of a QMS; the complexity of the QMS will vary based on the classification of the device.

ISO 13485:2016 was published in March 2016. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a quality management system (QMS). Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices. ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

COURSE OBJECTIVES

• To define the term Quality and Quality Management System
• To interpret the specific requirements of ISO 13485:2016 and its relevance to ISO 9001:2015 & ISO 14971.
• To be able to apply the requirements of the LATEST standard in day to day operations towards compliance with the standard
• To interpret and implement new requirements on Risk Assessment, Software Validation & Process Validation.

WHO MUST ATTEND

Quality Management Representative (QMR), Middle Management (Executives, Engineers & Supervisors) and Manager/Head of Quality Department.

COURSE CONTENT

DAY 1

• Definition of Quality & Medical Device QMS?
• Malaysian Medical Device Regulatory Requirement [Medical Device Act 737, Medical Device Regulation 2012]
• Medical Device Authority (MDA) MOH Conformity Assessment Requirements for Medical Device Premise Registration in Malaysia
• Mandatory Requirements on Documents & records
• QMS Components:

• • Quality Management System

• • • SOFTWARE VALIDATION [NEW!] CLAUSE 4.1.6
    • APPLICATION OF RISK [NEW!] CLAUSE 4.2.1
    • Medical Device File
    • Quality Manual

• • Management Responsibility

• • • Responsibility, Authority, Communication
    • Management Review
    • Customer focus

Interactive Group Discussions-

• Application Case Study 1: Mandatory Documentation Gap Analysis
• Application Case Study 2: Management Commitment Checklist

DAY 2

• POP QUIZ and RECAP OF DAY 1!
• QMS Components

• • 6.0 Resource Management:
    • Infrastructure
    • Work Environment
    • Contamination Control

• • Product Realization
    • Purchasing
    • Production and service provision Clause 7.5.6:
      • Retrospective, Prospective and Concurrent Validation principles
      • Validation Master Plan and What to be validated
      • Sample Validation Protocol (IQ/OQ/PQ)

• • Measurement, Analysis & Improvement
    • Complaint Handling
    • Mandatory Reporting to regulatory
    • Control of non-conforming
    • Corrective and Preventive action

• Introduction to Risk Management ISO 14971 & Application of Concepts [NEW!]

• General requirements for risk management
• Risk management process

• • RISK ANALYSIS
  • RISK EVALUATION
  • RISK CONTROL
  • PRODUCTION & POST PRODUCTION
  • INFORMATION

• Management responsibilities
• Qualification of personnel
• Risk management plan
• Risk management file

Interactive Group Discussions- Application:

• Application Case Study 3: Application of Risk Management To Manufacturing Process [Clauses 6.2, 7.1 AND 4.2.1]

POST TRAINING WRITTEN ASSESSMENT [1.0 HOUR: MCQ AND SHORT ANSWER QUESTIONS]