Non-conformities, deviations, CAPA — Mastering the complete cycle in the medical device industry
In the medical device industry, a poorly managed NC means an audit that goes off the rails. A CAPA whose effectiveness is not verified means a recurrence and a major non-conformity at the end of the line. This day equips QA, production and RA teams to rigorously handle every step of the cycle — from detection to closure — in full alignment with ISO 13485 §8.3/§8.5 and the requirements of MDR 2017/745.
Audience QA (Quality Assurance) teams, production managers and operators, regulatory affairs (RA) officers, and anyone involved in the detection, handling or follow-up of NCs/deviations/CAPA in a company that manufactures or distributes medical devices.
Learning objectives
- ▸ Distinguish between non-conformity, deviation and customer complaint according to the ISO 13485 and MDR definitions, and apply the handling process appropriate to each case.
- ▸ Apply a structured root-cause analysis method (5 whys, Ishikawa diagram, fault tree) to identify the true origin of a discrepancy.
- ▸ Write a complete and documented NC/CAPA file that meets the expectations of notified bodies during an ISO 13485 audit.
- ▸ Calibrate the appropriate level of response: immediate correction, corrective action or preventive action — depending on the severity and systemic nature of the discrepancy.
- ▸ Verify the effectiveness of a CAPA by defining measurable closure criteria and a control deadline.
- ▸ Integrate the specific requirements of MDR 2017/745 (Article 83 — FSCA, Article 87 — reporting of serious incidents) into the organization's NC/CAPA process.
Expected outcomes
- ✓ Method applicable from the very next day to qualify, analyze and handle a non-conformity or a deviation.
- ✓ ISOFACADEMY NC/CAPA file template directly usable in the participant's professional context.
- ✓ Root-cause analysis memo sheet and CAPA audit checklist according to ISO 13485 §8.5.
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. Suggested level: basic knowledge of how a quality organization operates in the medical device sector. The training is accessible to QA, production and RA profiles with no prior CAPA experience.
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
Normative and regulatory framework: what ISO 13485 and MDR actually require (1h)
- ·ISO 13485 §8.3: control of nonconforming product — requirements and expected evidence
- ·ISO 13485 §8.5.2 / §8.5.3: corrective and preventive actions — scope and documentary obligations
- ·MDR 2017/745 Art. 83 (FSCA) and Art. 87 (reporting of serious incidents): articulation with the internal CAPA system
- ·Expectations of notified bodies: what is checked as a priority during a surveillance audit
- ·Entry quiz on definitions and the regulatory framework
- 02
Identifying and qualifying a discrepancy: NC, deviation, complaint (1h)
- ·Operational definitions: product non-conformity, system non-conformity, process deviation, customer complaint
- ·Severity and criticality criteria: assessing the impact on patient safety and regulatory compliance
- ·Triggering the handling process: who, when, how — QA / production / RA roles
- ·Traceability from the moment of detection: minimum records required
- ·Qualification exercise on 5 real anonymized cases
- 03
Root-cause analysis: methods and pitfalls to avoid (1h30)
- ·The 5 whys: method, limits, frequent mistakes
- ·Ishikawa diagram (cause-and-effect): structuring a multi-factor investigation
- ·Fault tree analysis (FTA): when to use it, how to document it
- ·Distinction between correction / corrective action / preventive action: a classic poorly mastered in audits
- ·Recurring pitfalls: confusing symptom and cause, closing a CAPA without verifying effectiveness
- ·Workshop on root-cause analysis based on a typical MD industry NC case
- 04
Writing and managing a complete CAPA file (1h30)
- ·Structure of an auditable CAPA file: NC description, root-cause analysis, action plan, responsible persons, deadlines
- ·Closure criteria: defining a measurable and defensible effectiveness verification
- ·Managing CAPAs in series: prioritization, follow-up dashboard, escalation to management
- ·Documentary best practices: what satisfies an auditor vs. what generates an observation
- ·ISOFACADEMY CAPA template handed out to participants
- 05
Cross-cutting practical cases and field feedback (1h)
- ·Case study 1: product NC detected in production — complete handling from A to Z
- ·Case study 2: customer complaint with FSCA potential — NC/CAPA/vigilance interface
- ·ISOFACADEMY feedback: the most frequently observed mistakes during certification audits
- ·Open Q&A on the participants' situations
Assessment of learning
Assessment methods
Oral verification questions at the end of each module · self-assessment on the qualification of practical cases · final QCM of 15 questions (definitions, CAPA method, ISO 13485/MDR regulatory framework — pass threshold: 60%) · Individual deliverable: NC/CAPA file template personalized on the basis of a situation drawn from the participant's professional context, qualitatively assessed by the trainer. A training certificate is issued subject to full attendance. This certificate does not constitute an RNCP/RS certification and does not amount to 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.