Build and deploy your ISO 13485 QMS from A to Z
You need to build a functional ISO 13485 QMS, not just one that is “compliant on paper”. This training gives you the complete architecture, the right tools and the reflexes of a quality manager who knows how to defend their choices in front of an auditor. Two intensive days, grounded in your field realities, led by a consultant actively engaged on assignments in the medical device industry.
Audience Quality managers in post or taking up their role, future quality managers, quality directors wishing to structure or overhaul their QMS.
Learning objectives
- ▸ Analyse the requirements of the ISO 13485:2016 standard and identify how they articulate with the MDR 2017/745 regulation
- ▸ Build the documentary architecture of your QMS: quality policy, manual, procedures, records
- ▸ Write the key procedures and operational instructions tailored to your organisational context
- ▸ Deploy a prioritised implementation plan, with milestones and owners
- ▸ Prepare your organisation for a certification audit: evidence management, handling of nonconformities, management review
- ▸ Defend your documentary and organisational choices in front of a third-party auditor
Expected outcomes
- ✓ Read and interpret the ISO 13485:2016 requirements in your operational context
- ✓ Build from A to Z the documentary architecture of a compliant QMS
- ✓ Write the key procedures and records without outside help
- ✓ Steer the implementation: prioritisation, milestones, team involvement
- ✓ Prepare for and behave in a certification audit situation
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
No specific regulatory prerequisite. Intended audience: Quality managers in post or taking up their role, future quality managers, quality directors wishing to structure or overhaul their QMS..
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.
Detailed programme (2 days (14h)) provided on request, tailored to the participants' starting level.
Any open-enrolment programme can be delivered in-house and personalised from your organisation's own procedures, files and real cases (under NDA). Quote within 48 hours.
Assessment of learning
Assessment methods
Entry quiz to position the level, intermediate exercises during the session, final assessment (MCQ or role-play depending on the course). A certificate of completion detailing the objectives achieved is issued to each participant within 5 working days.
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)
1 490 €
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.