Diploma program · Quality for medical devicesISO 13485:2016
Quality that protects the people who use the device.
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Two academic certificates. The same person.
Each diploma program awards two academic certificates after its assessments are passed: system design and internal auditing. Each document retains its standard, edition and completed stage.
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Where to apply what you learn
ISO 13485 organizes quality in the design, manufacture and traceability of medical devices.
31.215
ISO 13485 management system certificates worldwide · Global adoption 2024ISO Survey 2024 · G-CERTI observatory
Where it applies
Where it applies
Manufacturing · Manufacturers of medical equipment and devices.
Your professional contribution
Controls at every manufacturing stage.
- Manage product risks
- Validate processes
- Control changes
Where it applies
Laboratory and control · Quality control laboratories in the sector.
Your professional contribution
Release product with evidence.
- Inspect and test
- Record results
- Manage nonconformities
Where it applies
Supply chain and distribution · Distributors and component suppliers.
Your professional contribution
Traceability to the user.
- Identify batches
- Manage complaints
- Prepare recalls
Examples of areas of application. Each position has its own training and experience requirements.
See sources and context
The ISO Survey 2024 counts management system certificates by standard, not jobs or graduates. Its coverage changed with the use of IAF CertSearch, so we do not present comparisons with previous years.
ISO Survey 2024 · G-CERTI observatory · ISO methodology. The images in this section are illustrative.
How the training is rated
“Excelente institución con una calidad educativa y humana sobresaliente.”
Nicolás CernadasExperience with G-CERTI · Institutional review “La atención de los asesores de cuenta es muy cordial.”
Yamil MaidanaExperience with G-CERTI · Institutional review “Excelente la calidad de gente. El profesor Alfredo, un genio.”
Andrea MoralesExperience with G-CERTI · Institutional review “Excelente formación y disposición para enseñar.”
Noelia RojasExperience with G-CERTI · Institutional review “Excelente experiencia.”
Estrella CarizzaExperience with G-CERTI · Institutional review
Public Google reviews of G-CERTI LATAM, quoted verbatim. They rate the experience with G-CERTI; they do not refer to a particular cohort.
When will the ISO 13485 diploma program open?
The program is under academic review. Ask about availability and we will let you know when there is a confirmed intake.
Which edition is covered?
The reference is ISO 13485:2016, an edition confirmed by ISO in 2025.
Can I start with another diploma program?
Yes. You can explore the available diploma programs, such as ISO 9001, while the ISO 13485 program is under review.
Ask about ISO 13485 availability
We will let you know when the program has a confirmed intake.
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