Who it’s for
Who should attend
Internal and supplier auditors, quality managers, management representatives, regulatory and quality consultants, and experienced auditors moving into an audit team leader role.
Curriculum
Course modules
- Audit principles and types of audit
- The audit programme: establishing, resourcing, monitoring and improving
- Roles of the audit team leader, auditors and technical experts
- Initiating the audit and establishing feasibility
- Preparing the audit plan, work documents and checklists
- The opening meeting
- Collecting evidence: interviewing, observation, document review, sampling and traceability
- Auditing against ISO 9001 and/or ISO 13485 requirements
- Identifying, grading and writing nonconformities
- The closing meeting and audit conclusions
- Audit reporting
- Audit follow-up, corrective action review and effectiveness verification
- Auditor competence, behaviour and professional judgement
- Practical workshops and role plays throughout
- Assessment
Outcomes
What you’ll be able to do
- Lead an audit team through a complete audit cycle
- Write clear, defensible nonconformities
- Evaluate corrective action effectiveness
How it works
Delivery, group size and what’s included
Delivery formats
On-site at your premises, live remote, or public open course.
Duration
The durations shown are minimums. Most courses run from 2 to 5 days, and longer or combined programmes can be arranged to suit the course and your requirements.
Group size
No minimum for remote or private on-site training. Public courses run with a minimum of 10 attendees. There is no fixed maximum; above 20 we normally split into groups, though this is open to discussion.
Assessment
Courses include an assessment.
Tailoring
Private training can be tailored to your products and your quality system. Where a course is tailored, specific documents may be requested in advance. Public courses are general in scope, though relevant worked examples are provided.
Languages
English and Italian. German and Russian available on request through an associate.
Included in the fee
- Full course slides (PDF)
- Workshops
- Practical exercises
- Case studies
- Open Q&A throughout
- Certificate of attendance (PDF), issued by ALPA Medical
- Up to 4 hours of post-course support
Get in touch
Enquire about “Auditor / Lead Auditor course”
Ask about dates, on-site or remote delivery, group size, or tailoring this course to your products and quality system.