ISO 13485 — Maintaining and optimizing a QMS in operation
Audience Experienced quality managers, quality directors, QA managers in post who have already deployed an ISO 13485 QMS
Learning objectives
- ▸ Diagnose the weak areas of a QMS in operation using a process-based analysis grid.
- ▸ Manage the quality dashboard: select relevant indicators, interpret trends, and trigger proportionate corrective actions.
- ▸ Run an effective, decision-oriented management review, compliant with ISO 13485 §5.6 requirements.
- ▸ Manage the complete cycle of a CAPA (identification, root cause analysis, implementation, effectiveness verification) while avoiding the most common pitfalls.
- ▸ Integrate the post-MDR 2017/745 regulatory impacts on the existing QMS without rebuilding the system.
- ▸ Prepare for a surveillance audit or certification renewal by relying on the review criteria of notified bodies.
Expected outcomes
- ✓ Personalized QMS consolidation plan, applicable as soon as you return to work (3 priority areas, identified resources, deadlines).
- ✓ QMS self-diagnosis grid usable periodically to measure the evolution of maturity.
- ✓ Quality dashboard template and surveillance audit preparation checklist that are directly usable.
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
ISO 13485 QMS deployed and in operation within the participant's organization. At least 1 year of experience as a quality manager or quality officer in the medical device sector. A positioning form is sent upon registration to tailor the practical cases to the participant's context.
Disability access
Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →
Funding
- ·OPCO (all sectors)
- ·Skills development plan
- ·CPF (subject to the course being listed)
- ·Company self-funding
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
Maturity diagnosis of the existing QMS (1 h 30)
- ·Self-assessment grid by process: identifying areas of strength and weakness
- ·The most common documentary drifts after 2–3 years of operation
- ·Link between QMS maturity and surveillance audit results
- ·Self-diagnosis workshop based on each participant's real context
- 02
Management through indicators and management review (1 h 30)
- ·Building a useful dashboard: which indicators to monitor, at what frequency
- ·ISO 13485 §5.6 management review: mandatory inputs, expected outputs, frequency
- ·Turning the management review into a strategic decision-making tool rather than a documentary formality
- ·Management review preparation grid provided by ISOFACADEMY
- 03
Control of nonconformities and CAPA (1 h 30)
- ·Complete CAPA cycle: NC → root cause analysis (5 whys, Ishikawa) → action → effectiveness verification
- ·Notified bodies' assessment criteria for the robustness of the CAPA system
- ·Systemic CAPAs vs one-off CAPAs: knowing how to choose the right level of response
- ·Documentary management of CAPAs: required evidence of effectiveness
- ·CAPA case study on a realistic scenario
- 04
Managing regulatory changes and QMS modifications (1 h 30)
- ·MDR 2017/745 impacts on existing QMS processes: what has changed, what remains pending
- ·Change control procedure: when to document, how to qualify the impact
- ·Operational regulatory monitoring: organizing surveillance without being overwhelmed
- ·Checklist of MDR points to verify in the QMS
- 05
Preparation for the surveillance audit and feedback (1 h)
- ·What a notified body checks as a priority during an ISO 13485 surveillance audit
- ·Most frequently identified nonconformities: field analysis
- ·Sharing of experiences: feedback from real situations (anonymized ISOFACADEMY cases)
- ·Individual consolidation plan: each participant formalizes their 3 action priorities
Assessment of learning
Assessment methods
Oral checkpoints at the end of each module (question-and-answer sessions led by the trainer) · Final QCM of 15 questions focused on the practical situations of the day (pass threshold: 60% correct answers) · Individual deliverable: QMS consolidation plan sheet (3 priority areas, resources, deadlines) qualitatively assessed by the trainer. Training certificate issued subject to full attendance. This certificate does not constitute an RNCP/RS certification and does not amount to a renewal of ISO 13485 certification.
Certificate
A certificate of completion is issued to each participant, detailing the objectives, duration, learning assessed and the result of the final assessment. The document can be kept in a skills record.
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.
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
- ·OPCO (all sectors)
- ·Skills development plan
- ·CPF (subject to the course being listed)
- ·Company self-funding
Personalised quote and OPCO funding application prepared 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.