Behavioral and relational dimensions of auditing
Mastering a standard is not enough to conduct an effective audit. The way the auditor listens, questions, rephrases and reports findings largely determines the quality of the exchanges and the buy-in of the auditees. This one-day training gives auditors and quality managers the behavioral and relational keys to turn every audit into a genuine improvement lever.
Audience Internal and supplier auditors, quality managers, anyone called upon to conduct or take part in audits in a medical device or ISO quality system environment.
Learning objectives
- ▸ Distinguish factual and interpretive registers within an audit interaction, in order to objectify one's findings.
- ▸ Apply active listening and open questioning techniques to encourage the auditee's cooperation.
- ▸ Adapt one's posture and communication style according to the profile and level of resistance of the interlocutor.
- ▸ Manage situations of tension, deadlock or disagreement without compromising the objectivity of the audit.
- ▸ Formulate and report findings in an assertive, constructive and acceptable manner.
- ▸ Integrate behavioral dimensions into audit preparation and debriefing.
Expected outcomes
- ✓ Operational behavioral reading grid, usable from the very next audit.
- ✓ Active listening and questioning techniques applied in a real-life situation.
- ✓ Ability to manage tensions and to report findings in an assertive and constructive manner.
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
Having already carried out or taken part in at least one audit (internal or supplier). Basic knowledge of the ISO 13485 or MDR 2017/745 standards is recommended, but not mandatory.
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
The relational foundations of auditing (1h30)
- ·Role of the relationship in the quality of an audit
- ·Distinguishing facts / opinions / interpretations
- ·Common cognitive biases in the auditor
- ·What the auditee perceives and how they react
- 02
Active listening and questioning techniques (1h30)
- ·The levels of listening
- ·Open, closed, follow-up and reframing questions
- ·Pair exercise: conducting an audit interview on a recurring medical device case
- ·Analysis of observed behaviors
- 03
Adapting your posture to your interlocutor (1h30)
- ·Auditee profiles and modes of resistance
- ·Assertiveness and non-judgment
- ·Managing silence, evasion, contradiction
- ·Role-play: audit scenario with auditor-observer
- 04
Managing difficult situations (1h)
- ·Tensions, disagreements, denial of non-conformity
- ·De-escalation techniques
- ·Staying on the objective course without entering into conflict
- ·Role-play: reporting a contested finding
- 05
Reporting and debriefing with impact (1h)
- ·Assertive formulation of findings
- ·Structure of constructive feedback
- ·The closing meeting as a key relational moment
- ·The words that close vs. the words that open
- 06
Individual progression plan (30 min)
- ·Behavioral self-assessment
- ·Identification of 2 to 3 personal areas for development
- ·Complementary Isofac resources
Assessment of learning
Assessment methods
Final practical exercise in the form of an audit role-play (10 to 15 minutes per participant), with an observation grid and trainer feedback. A QCM to consolidate the knowledge acquired may be offered as an option post-training on a digital medium. Training certificate issued by Isofac Group at the end of the training, subject to full attendance. This certificate does not constitute a certification recognized by the RNCP or the Specific Directory (RS).
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.