Quality and safety is crucial when it comes to medical devices while regulations are becoming progressively demanding. The internationally recognised ISO 13485 Quality Management System for Medical Devices, was developed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
Expand your ability to effectively conduct internal audits within your company or train your audit team to ISO 13485 Medical Devices Management Systems standard with our Internal Auditor ISO 13485 training course.
Aims & Objectives
- Provide the key requirements and benefits of ISO 13485:2016
- Outline the steps towards effective Medical Devices Quality Management Systems
- Provide the application of risk-based thinking, frameworks and process management
Learning Outcomes
Having successfully completed this course you will be able to:
- Understand the key requirements, terms and definitions of ISO 13485:2016 and its structure
- Learn the importance and benefits of an ISO 13485:2016 MDQMS
- Apply methods and tools to manage Medical Devices Quality Management Systems
- Enhance skills to conduct effective internal audits
- Plan, conduct, report and follow up an internal audit
- Organise and direct, establish and plan the activities of an audit team
- Communicate effectively with the auditee and audit client
Who should attend?
Professional working in the Medical Devices Manufacturing Industry as:
- Management representatives
- Compliance Managers
- Quality Managers
- Management System auditors
- Consultants
Prerequisite skills & knowledge: None required
Available in-house/distant learning? Yes
Created by: LiberoAssurance Continuous Professional Development Training Centre Level 1 – Accredited by Univab
Part A Contents: ISO 13485:2016 Requirements
Annex ZA (informative)
Relationship between this European Standard and the Conformity Assessment Requirements of EU Directive 90/385/EEC (as amended)
Annex ZB (informative)
Relationship between this European Standard and the Conformity Assessment Requirements of EU Directive 93/42/EEC (as amended)
Annex ZC (informative)
Relationship between this European Standard and the Conformity Assessment Requirements of EU Directive 98/79/EC (as amended)
Terms & Definitions
For ISO 13485:2016 standard
Exam & Certification
- ISO 13485:2016 Internal auditor
- "ISO 13485:2016 Internal Auditor" Certificate
Teaching Methods
- Detailed seminar presentations (available for download)
- Terms and definitions
- No. of slides: 289
Resources
- Reading lists & Resources: Available in the presentations
Study time allocation
- Private study hours: 34
- Trainer contact hours: Availability and competence of instructors upon request
- Enrollment Duration: 90 days (starting from the date of purchase)
Credits
- CPD Points: 34
- ECTS/ECVET Points: 1.1
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Assessment methods
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Hours
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% contribution to final mark
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% Minimum passing grade
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Exam for ISO 13485:2016 Internal Auditor
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1
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100
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60
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Outcomes/Certificates
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On successful completion of the course assessment, participants will be issued with a ‘Certificate of Success’.
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