ISO 13485 Medical Devices Quality Management System

ISO 13485 Medical Devices Quality Management System (QMS) Awareness & Internal Audit Training

Our ISO 13485 Awareness and Internal Audit Training is designed for organizations in Malaysia’s medical device, healthcare, and biotech sectors, including manufacturers, distributors, OEMs, and SMEs. This program helps organizations build a solid understanding of medical device quality management requirements while developing internal capability to monitor, audit, and continuously improve their Medical Devices Quality Management System (QMS).

This training supports organizations preparing for ISO 13485 certification, improving product quality, ensuring regulatory compliance, meeting customer requirements, and enhancing operational efficiency in the medical device industry.

ISO 13485 Awareness Training

The ISO 13485 Awareness Training builds a clear understanding of medical device QMS principles, regulatory requirements, and risk-based approaches.

Participants will learn:

• Overview and structure of ISO 13485 Medical Device Quality Management System

• Roles and responsibilities of top management and quality teams

• Regulatory requirements (MDA, MOH Malaysia, FDA, EU MDR)

• Risk management for medical devices

• Product realization, design control, and process validation

• Corrective and preventive actions (CAPA) and non-conformity management

• Documentation, records, and common ISO 13485 non-conformities

ISO 13485 Internal Audit Training

The ISO 13485 Internal Audit Training focuses on developing effective internal auditing skills for medical device QMS.

Participants will learn:

• Purpose and planning of ISO 13485 internal audits

• Internal auditor roles, independence, and audit techniques

• Preparing QMS audit programs, checklists, and audit reports

• Auditing design control, production processes, supplier management, and CAPA

• Identification and reporting of non-conformities

• Follow-up and verification of corrective actions

• Alignment with ISO 13485 requirements and medical device best practices

Who Should Attend

Suitable for:

• ISO 13485 / Medical Device QMS Team Members

• Quality Managers & QA/QC Personnel

• Regulatory Affairs & Compliance Officers

• Production Supervisors & Managers

• Risk Management & Internal Audit Personnel

• Senior Management & Department Heads

• Organizations preparing for ISO 13485 certification in Malaysia

Training Benefits

• Improve medical device QMS compliance and audit readiness

• Reduce quality non-conformities and regulatory risks

• Enhance internal audit effectiveness

• Strengthen product quality, safety, and patient compliance

• Build strong awareness and accountability among staff

Certification

Participants will receive a Certificate of Attendance for ISO 13485 Awareness & Internal Audit Training.

Why Choose Our ISO 13485 Training

• Malaysia-focused, regulation-aligned content

• Covers MOH, MDA, FDA, and EU MDR requirements

• Conducted by experienced medical device QMS and audit trainers

• Practical, scenario-driven, and process-focused learning approach

• Available as in-house or public training