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. Although not required by the standard itself, third-party audits and certification can demonstrate to regulators that you have met the requirements of the standard.
Gain the knowledge and skills to conduct third party audits of Quality Management Systems for Medical Devices with our Lead Auditor ISO 13485:2016 e-course.
Aims & Objectives
- Outline the key requirements and benefits of ISO 13485:2016
- Offer information on how to plan, conduct and follow-up auditing activities that add real value
- Access the latest auditor techniques and identify appropriate use
Learning Outcomes
Having successfully completed this course you will be able to:
- Learn the scope,importance and benefits of an ISO 13485:2016 QMS for Medical Devices
- Demonstrate knowledge on the structure and key requirements of ISO 13485:2016
- Gain the skills to effectively plan, conduct, report and follow up an audit in accordance with ISO 13485
- Establish and plan the activities of an audit team, organise and direct audit team members
- 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)
Teaching Methods
- Detailed seminar presentations (available for download)
- Terms and definitions
- No. of slides: 301
Resources
- Reading lists & Resources: Available in the presentations
Study time allocation
- Private study hours: 35
- Trainer contact hours: Availability and competence of instructors upon request
- Enrollment Duration: 90 days (starting from the date of purchase)
Credits
- CPD Points: 35
- ECTS/ECVET Points: 1.2
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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 Quality Management System for Medical Devices Lead 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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