ISO 13485:2016 — Discovery and fundamental requirements
Audience Any medical-device quality professional
Learning objectives
- ▸ Situate the ISO 13485:2016 standard within its European regulatory context (MDR 2017/745, IVDR 2017/746) and identify the associated obligations according to the type of economic operator
- ▸ Describe the structure and logic of a quality management system (QMS) compliant with ISO 13485, chapter by chapter
- ▸ Distinguish the requirements specific to medical devices from those of a generic QMS (ISO 9001)
- ▸ Carry out a first simplified gap analysis on a real situation or a running case study
- ▸ Identify the priority actions to launch or consolidate a certification process
Expected outcomes
By the end of the course, participants can apply the requirements of the standard/regulation covered to their own cases and defend their choices in an audit.
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 formal prerequisites. Prior exposure to a quality or regulatory environment is an asset.
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
M1 — Regulatory context and the role of ISO 13485 [D1 – morning]
- ·Overview of European regulation of medical devices and IVDs (MDR 2017/745, IVDR 2017/746)
- ·Role and added value of the ISO 13485 standard for economic operators (manufacturer, authorised representative, distributor, supplier)
- ·Links with the ISO 9001:2015 standard: convergences and specificities
- 02
M2 — Architecture and logic of the ISO 13485 QMS [D1 – morning]
- ·Process-based structure and risk-based approach
- ·Reading the HLS structure — chapters 4 to 8 and their logical articulation
- ·Scope and authorised exclusions according to the type of organisation
- 03
M3 — Context, leadership and planning requirements (ch. 4–6) [D1 – afternoon]
- ·Analysis of the context and interested parties
- ·Quality policy, objectives and top management commitment
- ·Document control: structure, management of quality records
- ·QMS planning and quality risk management (ISO 14971 as an introduction)
- 04
M4 — Product realization and operational control (ch. 7) [D2 – morning]
- ·Contract review, design and development (design file)
- ·Control of purchasing and suppliers
- ·Production and service control: traceability, UDI, labelling, sterilization
- ·Work environment, equipment and process validation
- ·Introduction to change management
- 05
M5 — Measurement, analysis and improvement (ch. 8) [D2 – afternoon]
- ·Monitoring and measurement of processes and products
- ·Control of nonconforming product
- ·Complaint handling, post-market vigilance and field feedback
- ·CAPA: methodology and documentation
- ·Internal audit and management review: purposes and deliverables
- 06
M6 — Practical workshop: simplified gap analysis [D2 – afternoon]
- ·Work in subgroups on the running case study (non-sterile 0.9% nasal saline solution, Class IIa)
- ·Identification of gaps between the described situation and the ISO 13485 requirements
- ·Prioritization of actions and pooling of results
- ·Collective debriefing facilitated by the trainer
Assessment of learning
Assessment methods
Self-positioning questionnaire sent 5 days before the training. Continuous assessment during the session (round table, Q&A, exercises). Final 20-question QCM at the end of D2 (recommended pass threshold: 60%) with commented correction. Individual certificate of completion detailing name, dates, duration, reference, objectives and signature of the training manager.
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)
1 390 €
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.