Process Risk Analysis — Mapping and Operational Control
In a QMS compliant with ISO 13485 and MDR 2017/745, each process must be identified, managed and subject to a documented risk analysis. Yet process mapping often remains a formal exercise, disconnected from operational control actions. This training gives you the methods and tools to build a usable process risk map, score risks consistently and define effective control barriers, all anchored in the requirements of the medical device framework.
Audience Quality managers and engineers, production managers, methods and process engineers.
Learning objectives
- ▸ Build or revise your organisation's process map according to the requirements of ISO 13485 and the expectations of MDR 2017/745
- ▸ Identify the inputs, outputs, interactions and risks inherent to each process of the QMS
- ▸ Apply a process risk scoring method (occurrence, severity, detectability) and calculate a usable criticality level
- ▸ Define appropriate operational control measures and integrate them into existing procedures
- ▸ Build or update the process risk dashboard for management reviews and audits
- ▸ Distinguish process risk analysis from product risk analysis (ISO 14971) and position both approaches within the QMS
Expected outcomes
- ✓ By the end of the training, participants have a structured methodology and a process risk table template directly applicable in their organisation, and are able to present their results during an ISO 13485 audit or an MDR inspection.
Accessibility & entry conditions
Access lead time
Registration up to 10 working days before the start of an open-enrolment session. In-house sessions can be scheduled within 3 to 4 weeks.
Prerequisites
Knowledge of the basics of the ISO 13485 QMS or at least one year of experience in a quality, production or methods role in a medical device company. No prior risk analysis skills are required.
Disability access
Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →
Funding
- ·This training is not Qualiopi-certified and is not eligible for OPCO funding
- ·Funding from own funds or the company's training budget
Detailed programme
A phone interview or positioning questionnaire is sent ahead of the session to calibrate the level, identify expectations and tailor the case studies to participants' real situations.
- 01
Regulatory and normative foundations (1 h)
- ·ISO 13485 requirements relating to the process approach and QMS risk management
- ·Alignment with MDR 2017/745 (Annex IX, manufacturer's quality system)
- ·Difference between product risk (ISO 14971) and process risk
- ·Positioning of process risk analysis within the continuous improvement cycle
- 02
Process mapping: method and practice (1 h 30)
- ·Process typologies: management, realisation, support
- ·Building or revising the map: identifying processes, interaction links, inputs and outputs
- ·Practical workshop: map a process from your organisation (running case study)
- ·Completeness criteria expected during an ISO 13485 certification audit
- 03
Risk analysis and scoring by process (2 h)
- ·Process FMEA methodology applied to the medical device sector
- ·Identification of failure modes, causes and effects for each process
- ·Scoring grid: occurrence, severity, detectability, calculation of the risk priority number (RPN)
- ·Workshop: complete a risk analysis on the running case study
- ·Acceptability thresholds and risk treatment policy
- 04
Defining operational control measures (1 h 30)
- ·Hierarchy of control barriers: prevention, detection, correction
- ·Integration of actions into procedures, instructions and surveillance plans
- ·Verification of the effectiveness of measures and reassessment of residual risk
- ·Links with CAPA and management review
- 05
Management and documentation (45 min)
- ·Building the process risk dashboard
- ·Monitoring indicators by process
- ·Updating the analysis during process reviews or organisational changes
- ·Documentary format expected by notified bodies and inspectors
- 06
Summary, questions and answers and final QCM (15 min)
- ·Review of key points
- ·Assessment of knowledge acquired
- ·Handover of summary documents
Assessment of learning
Assessment methods
End-of-training QCM (15 questions covering modules 1 to 5). Results are communicated individually at the end of the session. A practical exercise (running case study) allows formative assessment during the day.
Certificate
Certificate of completion issued by ISOFAC Group at the end of the training, subject to full attendance of the session. This certificate does not constitute a certification recognised by the RNCP or the Specific Register (RS); it attests to attendance and the assessment of knowledge acquired within the framework of continuing professional training.
Satisfaction and results
Satisfaction rate: Being measured
First learner survey campaign under way — data published once the statistical threshold is reached.
Training team
Training delivered by the ISOFAC ACADEMY teaching team, made up of consultants specialised in medical devices, quality and regulatory affairs. Depending on the module, the session is led by a specialist with hands-on operational expertise in MDR compliance, ISO 13485 quality management systems, ISO 14971 risk management, clinical evaluation, technical documentation, regulatory audits and CE marking strategy.
Our trainers support manufacturers, distributors, importers, authorised representatives and other economic operators on a daily basis in bringing their medical devices into compliance. See the team's profiles →
Technical resources
In-person
Room equipped at the client site or in a partner centre (Montpellier, Lyon, Paris). Video projector, flipchart, printed materials.
Remote
Zoom (corporate) platform for the virtual classroom. Materials provided in PDF + access to additional resources for 12 months after the session.
Learner equipment
A connected computer with camera and microphone for remote sessions. No software to install.
Materials provided
- ·Teaching materials in PDF format
- ·Process map template
- ·Process FMEA table template
Post-course follow-up
Advice line
Hotline included for 30 days after the session for operational questions arising back on the job. Reply within 48 working hours.
Follow-up review
3-month review sent to the sponsor for in-house courses: feedback on the skills put into practice and any residual points.
Open-enrolment price (excl. VAT)
790 €
EU VAT applicable depending on the buyer's status.
In-house price
On request, depending on headcount and location.
Funding
- ·This training is not Qualiopi-certified and is not eligible for OPCO funding
- ·Funding from own funds or the company's training budget
Personalised quote within 48 hours.
Would you like to attend this course?
Tell us your preferred format (open-enrolment, in-house or virtual classroom), the number of participants and your schedule. We will get back to you within 48 hours with the next available dates and a firm quote.