Postgraduate Diploma in Risk Analysis and CE Technical File
Online 800 h Postgraduate Diploma in Risk Analysis and CE Technical File. 8 modules covering Machinery Regulation (EU) 2023/1230, ISO 12100:2010 and Pilz PAScal. Assigned tutor and open enrolment.
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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
Identify the product legislation applicable to a machine.
Carry out risk analysis according to ISO 12100.
Apply hierarchical risk reduction measures.
Interpret the new requirements of Regulation 2023/1230.
Prepare the technical file of a machine.
Draft instructions for use compliant with ISO 20607.
Issue the EU declaration of conformity and the CE marking.
Who it's for
- CE marking technician looking to specialise in Risk Analysis and CE Technical File.
- Machine safety engineer looking to specialise in Risk Analysis and CE Technical File.
- Technical documentation manager looking to specialise in Risk Analysis and CE Technical File.
- Product conformity consultant looking to specialise in Risk Analysis and CE Technical File.
- Machinery design engineer looking to specialise in Risk Analysis and CE Technical File.
- Technical auditor looking to specialise in Risk Analysis and CE Technical File.
- Engineering or science graduates looking to enter machinery manufacturing.
What you'll work with
- Machinery Regulation (EU) 2023/1230
- ISO 12100:2010
- Directive 2006/42/EC
- ISO 13849-1:2023
- IEC 60204-1:2016
- ISO 20607:2019
- ISO 7010:2019
- Royal Decree 1215/1997
8 modules · 800 h
1.1New EU legislative framework1.2Machinery Regulation (EU) 2023/12301.3Transition from Directive 2006/42/EC1.4Machinery, partly completed machinery and assemblies1.5Essential health and safety requirements1.6Use of harmonised standards in design1.7Conformity assessment procedures1.8Annex I machinery and notified bodies1.9Other directives: low voltage and EMC1.10Workshop: identifying applicable legislation
2.1Iterative process of ISO 121002.2Machine limits2.3Hazard identification2.4Risk estimation2.5Risk evaluation and acceptance criteria2.6Three-step method2.7Residual risk and information2.8Intended use and reasonably foreseeable misuse2.9HAZOP, FMEA and what-if methods2.10Practice: risk analysis of a press
3.1Inherently safe design3.2Guards and protective devices3.3Safety-related control systems3.4Electrical equipment to IEC 60204-13.5Ergonomics and design principles3.6Noise, vibration and emissions3.7Thermal and substance risks3.8Signage and warnings3.9Complementary protective measures3.10Case study: risk reduction in a cell
4.1Systems with self-evolving behaviour4.2Cybersecurity and protection against corruption4.3Safety software and updates4.4Mobile machinery and movement hazards4.5Human-machine interaction and psychological stress4.6Criteria for substantial modification4.7Instructions in digital format4.8Obligations of importers and distributors4.9Application deadlines4.10Laboratory: analysis of a case with integrated AI
5.1Contents of the technical file5.2General description and drawings5.3Risk assessment documentation5.4List of applied standards5.5Test reports and calculations5.6Validation of safety functions5.7Instructions and their content5.8Retention and availability5.9Partly completed machinery file5.10Practice: technical file index
6.1Requirements for instructions for use6.2ISO 20607 for machinery manuals6.3Structure and clear drafting6.4Warnings and residual risk information6.5Pictograms and ISO 7010 signs6.6Assembly instructions for partly completed machinery6.7Languages and translations6.8Digital formats and accessibility6.9Review and version control6.10Workshop: drafting a safety chapter
7.1EU declaration of conformity7.2Declaration of incorporation7.3Affixing the CE marking7.4Nameplate7.5Market surveillance and authorities7.6Penalties and product withdrawal7.7Manufacturer's liability7.8Second-hand machinery and compliance with RD 1215/19977.9Documentary audit of the manufacturer7.10Case study: review of a defective declaration
8.1Machine description and limits8.2Applicable legislation and standards8.3Complete risk analysis8.4Risk reduction measures adopted8.5Validation of machine safety8.6Complete technical file8.7Instructions and declaration8.8Follow-up plan8.9Report and presentation8.10Final review with the tutor
How you'll learn
Training 100 % online 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 intake, making it possible to combine with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is Pilz PAScal, CE-Manager by Docufy, IFA SISTEMA, Safexpert, Microsoft Excel, in free, academic or evaluation versions. Assessments are based on real machine risk analysis procedures, technical file audits, and reviews of instructions and declarations. 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.
Identify the product legislation applicable to a machine.
Carry out risk analysis according to ISO 12100.
Apply hierarchical risk reduction measures.
Interpret the new requirements of Regulation 2023/1230.
Prepare the technical file of a machine.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. No university degree is required.
- Internet connection and a computer capable of running the programme's software.
- Sufficient command 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 totals 800 hours spread over 6 to 8 months. That is an average of 10 to 15 hours per week, compatible with a full-time job.
The programme works with Pilz PAScal, CE-Manager by Docufy, IFA SISTEMA, Safexpert, Microsoft Excel. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.
An SEIUM own diploma on passing the continuous assessment and the final integrating project. It is in-house training, not an official qualification from the Ministry.
Yes. Modules passed in a course or postgraduate diploma in the same area can be credited towards the advanced programme. Check the credit transfer policy when you enrol.
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