Medical device supplier audit — Assessing and qualifying your subcontractors under MDR
Your subcontractors fall within the regulatory scope of your CE marking. MDR 2017/745 makes you directly responsible for them. This training gives you the methods, tools and second-party auditor posture to assess, qualify and steer your critical suppliers with rigour and traceability.
Audience Buyers, QA managers, regulatory affairs officers, and anyone involved in the selection, assessment or monitoring of suppliers and subcontractors in a medical device environment.
Learning objectives
- ▸ Identify the MDR 2017/745 requirements applicable to the control of suppliers and subcontractors (Article 10 §1, Annex IX).
- ▸ Build a supplier criticality matrix and rank suppliers according to their quality and regulatory risk level.
- ▸ Plan and structure an annual supplier audit programme compliant with notified bodies' expectations.
- ▸ Conduct a second-party audit by applying the ISO 19011:2018 methodology (opening, investigation, closing).
- ▸ Write a second-party audit report with findings, objective evidence and an associated action plan.
- ▸ Set up a supplier qualification monitoring and periodic reassessment mechanism.
Expected outcomes
- ✓ Deliverables completed in session that are directly reusable in the quality system: criticality matrix, audit question guide, report template.
- ✓ Immediate ability to plan and conduct a second-party supplier audit.
- ✓ A structured monitoring and periodic reassessment mechanism to steer the supplier panel over time.
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
Basic knowledge of ISO 13485 recommended. No formal eliminatory prerequisite. Experience in a medical device quality 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
MDR regulatory framework and supplier responsibilities (2h)
- ·MDR Article 10 §1 and Annex IX requirements relating to suppliers
- ·Distinction between manufacturer / subcontractor / critical supplier
- ·Link with ISO 13485 §7.4
- ·Consequences of a supplier failure during a notified body audit
- 02
Supplier risk mapping and scoring (2h)
- ·Criticality criteria: nature of components, impact on safety, volume, available alternatives
- ·Building a qualification matrix and a supplier dashboard
- ·Practical exercise: scoring a panel of fictitious suppliers
- 03
Planning and preparing the supplier audit (2h)
- ·Annual audit programme
- ·Defining the scope and audit criteria
- ·Drawing up the audit plan
- ·Building the pre-audit documentary file
- ·Role and posture of the second-party auditor (ISO 19011:2018)
- 04
Conducting the audit on site or remotely (4h)
- ·Opening meeting
- ·Interview and investigation techniques
- ·Collecting objective evidence
- ·Identifying and qualifying deviations
- ·Role play: supplier audit simulation in pairs
- 05
Audit report and action plan (2h)
- ·Structure of the second-party report
- ·Drafting findings and non-conformities
- ·Requirements relating to the corrective action plan (CAPA)
- ·Monitoring and closing deviations
- ·Integration into the QMS
- 06
Reassessment and steering over time (2h)
- ·Periodic reassessment criteria
- ·Updating the qualification status
- ·Supplier performance indicators
- ·Managing critical situations: failing supplier, unnotified change
Assessment of learning
Assessment methods
Final QCM of 20 questions covering modules 1 to 6 · written case study: analysis of an audit case with the drafting of a finding and a CAPA, assessed qualitatively by the trainer. Training certificate issued by ISOFACADEMY subject to full attendance over the two days. This certificate does not constitute an RNCP/RS certification; it attests to participation and to the assessment of skills acquired in continuing education.
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.