ISO 13485 Quality System and Audits Postgraduate Diploma
Online 800-hour Postgraduate Diploma in ISO 13485 Quality System and Audits. 8 modules covering ISO 13485 (quality management systems for medical devices), ISO 19011 (management system auditing) and Greenlight Guru. Assigned tutor and open enrolment.
Take the controls.
Run a real engineering trade-off from this field. Move the sliders, watch the model react in real time and beat the challenge.
What you will be able to do
Explain the requirements of ISO 13485 and their relationship with the MDR and the IVDR.
Structure the system documentation: manual, procedures and records.
Control design and development through inputs, outputs, verification and validation.
Validate production processes and manage change control.
Evaluate and control suppliers and outsourced processes.
Manage non-conformities, CAPA actions and quality data analysis.
Plan and carry out an internal audit in accordance with ISO 19011.
Who it's for
- Medical device quality manager who wants to specialise in ISO 13485 Quality System and Audits.
- ISO 13485 auditor who wants to specialise in ISO 13485 Quality System and Audits.
- Regulatory affairs technician who wants to specialise in ISO 13485 Quality System and Audits.
- Regulatory compliance officer (PRRC) who wants to specialise in ISO 13485 Quality System and Audits.
- Supplier quality engineer who wants to specialise in ISO 13485 Quality System and Audits.
- Quality systems consultant who wants to specialise in ISO 13485 Quality System and Audits.
- Engineering or science graduates seeking to enter the medical device industry.
What you'll work with
- ISO 13485 (quality management systems for medical devices)
- ISO 19011 (management system auditing)
- Regulation (EU) 2017/745 (medical devices)
- Regulation (EU) 2017/746 (in vitro diagnostic medical devices)
- ISO 14971 (risk management)
- 21 CFR Part 820 (QMSR, FDA)
- MDSAP (Medical Device Single Audit Program)
8 modules · 800 h
1.1ISO 13485:2016 and its scope1.2Relationship with the MDR and the IVDR1.3Requirements of Article 10 of the MDR1.4FDA QMSR and 21 CFR 8201.5MDSAP single audit programme1.6Risk-based approach1.7Differences from ISO 90011.8Roles of manufacturer, importer and distributor1.9Person responsible for regulatory compliance1.10Case study: gap analysis of a manufacturer
2.1Quality manual2.2Product file2.3Document control2.4Record control2.5ALCOA+ data integrity2.6Electronic signatures and 21 CFR Part 112.7Electronic document management2.8Validation of quality system software2.9Record retention2.10Workshop: documentation structure of a quality system
3.1Design planning3.2Design inputs and outputs3.3Design reviews3.4Design verification3.5Design validation3.6Transfer to production3.7Design change control3.8Design history file3.9Integration with ISO 149713.10Practice: requirements traceability matrix
4.1Production control4.2Process validation: IQ, OQ and PQ4.3Sterilisation according to ISO 11135 and ISO 111374.4Cleanrooms according to ISO 146444.5Traceability and UDI4.6Control of measuring equipment4.7Identification and status4.8Handling, storage and delivery4.9Non-conforming product4.10Laboratory: sealing process validation protocol
5.1Supplier evaluation and selection5.2Quality agreements5.3Control of outsourced processes5.4Incoming inspection5.5Supplier audits5.6Critical and crucial suppliers5.7Performance monitoring5.8Supplier changes5.9Software and cloud suppliers5.10Case study: quality agreement with a sterilisation provider
6.1Feedback and complaints6.2Surveillance and incident reporting6.3Corrective and preventive actions (CAPA)6.4Root cause analysis6.5Statistical sampling techniques6.6System indicators6.7Management review6.8Product recall6.9Trend analysis6.10Practice: complete CAPA file
7.1ISO 19011: audit principles7.2Internal audit programme7.3Audit planning7.4Interview and sampling techniques7.5Writing non-conformities7.6Audits of notified bodies7.7Unannounced audits7.8FDA inspections and Form 4837.9Audits under the MDSAP programme7.10Workshop: internal audit simulation
8.1Description of the company and product8.2Gap analysis8.3Process map8.4Key system documentation8.5Validation plan8.6Audit programme8.7Certification plan8.8Implementation schedule8.9Report and presentation8.10Final review with the tutor
How you'll learn
Fully 100% online training on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. No fixed timetables: students progress at their own pace within the enrolment period, which makes it possible to combine study with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is Greenlight Guru, MasterControl, Minitab, Jira, advanced Excel, in free, academic or evaluation versions. Tests are studied using real procedures from simulated internal audits of quality systems, drafting of procedures and records, and management of non-conformities and CAPA. Assessment is continuous by module, plus the final integrating project.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Explain the requirements of ISO 13485 and their relationship with the MDR and the IVDR.
Structure the system documentation: manual, procedures and records.
Control design and development through inputs, outputs, verification and validation.
Validate production processes and manage change control.
Evaluate and control suppliers and outsourced processes.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. A university degree is not required.
- Internet connection and a computer capable of running the programme’s software.
- Sufficient level of Spanish to follow technical regulatory texts.
Ready to start?
Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.
Frequently asked questions
The programme consists of 800 hours in total, spread over 6 to 8 months. That is between 10 and 15 hours per week on average, compatible with a full-time job.
The programme uses Greenlight Guru, MasterControl, Minitab, Jira and advanced Excel. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.
An own diploma from SEIUM upon passing the continuous assessment and the integrating project. It is in-house training, not an official Ministry qualification.
Yes. Modules passed in a course or postgraduate diploma in the same area are credited towards the advanced programme. Check the credit transfer policy when you enrol.
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