ISO 13485
Internal Auditor Training
Master ISO 13485 auditing skills to ensure medical device quality and compliance
What is ISO 13485?
ISO 13485 is the international standard that specifies requirements for a quality management system (QMS) for organizations involved in the design, production, installation, and servicing of medical devices. It focuses on ensuring the consistent design, development, manufacture, and delivery of safe medical devices that meet both customer and regulatory requirements.
Key Features of ISO 13485
- Based on ISO 9001 principles but tailored specifically for medical devices
- Emphasizes risk management and process control throughout the product lifecycle
- Addresses regulatory compliance for global markets, including FDA, EU MDR, and other authorities
- Covers documentation, traceability, supplier management, and post-market activities
- Supports continual improvement of medical device quality and safety
Why ISO 13485 Certification Matters?
- Required by regulatory agencies worldwide for medical device manufacturers
- Enhances product safety, reliability, and customer confidence
- Facilitates market access and acceptance in global healthcare sectors
- Helps reduce risks related to product recalls, defects, and noncompliance
- Demonstrates commitment to quality and patient safety
Who Needs ISO 13485?
- Medical device manufacturers and suppliers
- Contract manufacturers and testing labs
- Companies providing installation, servicing, or distribution of medical devices
- Organizations seeking to meet regulatory and customer requirements in healthcare
Steps to ISO 13485 Certification
- Understand ISO 13485 requirements and implement a compliant QMS
- Conduct internal audits and management reviews
- Address gaps and nonconformities through corrective actions
- Choose a certification body and undergo a third-party audit
- Maintain certification through ongoing compliance and surveillance audits
ISO 13485 Internal Auditor Training
Develop Expertise to Audit Medical Device Quality Management Systems – Our ISO 13485 Internal Auditor Training equips quality professionals, auditors, and team members with the skills needed to perform effective internal audits aligned with the ISO 13485:2016 standard. This course is essential for organizations in the medical device industry aiming to maintain regulatory compliance and improve their quality management system (QMS).
What You Will Learn?
- Overview of ISO 13485:2016 requirements and structure
- Principles of effective internal auditing based on ISO 19011 guidelines
- How to plan, conduct, report, and follow up on internal audits
- Identifying nonconformities and driving corrective actions
- Techniques for risk-based auditing and continual improvement
Who Should Attend?
This training is designed for:
- Quality managers and professionals
- Internal auditors and compliance officers
- Production and process engineers
- Anyone involved in maintaining or auditing medical device QMS
No prior auditing experience is required, but familiarity with ISO 13485 is helpful.
Course Benefits
- Ensure audit competency and compliance with ISO 13485 requirements
- Prepare your team for internal and external audits
- Enhance product safety and regulatory compliance
- Support continuous improvement and risk management
Ready to enroll?
Enroll today for our 16 hours ISO 13485 Internal Auditor Training.
Any further questions?
Contact us for any further details.