Conducting the ISO 13485 internal audit — Method, practice and reporting
Do you carry out or manage internal audits in a medical device context? This training gives you a complete and immediately operational method: from preparing the annual programme to writing the audit report, including conducting interviews and qualifying findings. Two intensive days, real-case scenarios, zero theoretical filler.
Audience Internal auditors in post or taking up the role, Quality Managers (QM), any professional involved in the internal monitoring framework of an ISO 13485 QMS.
Learning objectives
- ▸ Build an annual audit programme compliant with the requirements of ISO 13485 §8.2.4 and with the expectations of notified bodies.
- ▸ Prepare an internal audit by developing an audit plan, a checklist and an interview guide tailored to the process being audited.
- ▸ Conduct audit interviews by applying the questioning and active listening techniques derived from ISO 19011.
- ▸ Qualify and formulate audit findings (non-conformities, observations, strengths) according to documented and defensible criteria.
- ▸ Write a structured, factual audit report that can be used by management and process owners.
- ▸ Ensure the follow-up of corrective actions arising from the audit in connection with the QMS continuous improvement process.
Expected outcomes
- ✓ Immediate take-up or strengthening of the internal auditor role the day after the training.
- ✓ Directly reusable tools: report templates, checklists, questioning guide, findings qualification grid.
- ✓ Ability to argue your findings during a surveillance or renewal audit before the notified body.
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 the ISO 13485 standard recommended. Suggested level: having completed an ISO 13485 training course or working for at least 6 months in a medical device QMS environment.
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
Regulatory framing and the role of the audit within the QMS (1h30)
- ·Requirements of ISO 13485 §8.2.4 relating to internal audit
- ·Alignment with the expectations of MDR 2017/745 and notified bodies
- ·Responsibilities of the internal auditor and independence of the role
- ·Annual audit programme: coverage and recurrence logic
- 02
Audit preparation (2h)
- ·Developing the audit plan: scope, criteria, objectives, team
- ·Building a checklist focused on process risks
- ·Prior documentary review techniques
- ·Practical exercise: prepare an audit of the “non-conformity control” process
- 03
Conducting the audit and interview techniques (3h)
- ·Opening meeting: posture and communication
- ·OQPDCCC questioning and active listening
- ·Evidence gathering: field observation, sampling, triangulation
- ·Managing difficult situations during an audit
- ·Role-play scenario: auditor / auditee on a medical device process
- 04
Qualifying and formulating findings (2h)
- ·Qualification criteria: major non-conformity, minor, observation, strength
- ·Formulating a factual and defensible finding: OAR method (Observation, Analysis, Reference)
- ·Workshop: rephrase poorly written findings from real anonymised reports
- 05
Writing the audit report (2h)
- ·Structure of the audit report compliant with ISO 19011
- ·Closing meeting: presenting findings without creating resistance
- ·In-session writing workshop: each participant produces a report excerpt on their case
- 06
Follow-up of corrective actions and audit closure (1h30)
- ·Integration of corrective actions into the QMS
- ·Effectiveness verification and documented closure
- ·Performance indicators of the audit programme
- ·Summary and questions / answers
- 07
Knowledge assessment — QCM + scenario (2h)
- ·QCM of 20 questions on normative requirements and methodology
- ·Written scenario: drafting a finding and a report excerpt based on a provided scenario
- ·Feedback and commented corrections by the trainer
Assessment of learning
Assessment methods
Practical exercises throughout the modules (role-plays, writing workshops, rephrasing of findings) with individual feedback from the trainer · Final QCM of 20 questions (normative requirements and methodology) · Written scenario: drafting a finding and a report excerpt based on a provided scenario, assessed qualitatively. Training certificate issued by ISOFACADEMY subject to full attendance of both days. This certificate does not constitute an RNCP/RS 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)
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.