2-Day ISO 13485 Internal Auditor
Days: 2 • CEU Hrs: 1.9
7:30 a.m.- 5:30 p.m.
Audience: Beginner to Advanced
This course prepares you to perform internal QMS audits using industry-proven techniques and to apply proper interpretation of the ISO standard to real life audit situations. You’ll follow the full audit process including: audit tools and preparation, opening meetings, audit interviews, closing meetings, and reporting. This is a very practical class that is not “bogged-down” with academic discussions of quality topics that have limited utility for class attendees.
This class teaches Internal Auditing for ISO 13485 Quality Management Systems.
This Internal Audit class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing to the ISO 13485 standard. Since people “lock” new understanding into long-term memory much better when they apply it, lecture time is held to a minimum providing you time to grasp and then practice your newly acquired skills in simulated real-life audit situations.
Who Should Attend
Individuals who will perform audits to ISO 13485 Standards or Quality Management Systems, individuals assisting their organizations toward ISO 9000 registration, or individuals who are frequently audited should attend this training. Quality directors, managers, engineers, auditors, ISO coordinators, laboratory quality professionals, and anyone engaged in quality audits will benefit from this training.
There are no required prerequisites. This course is routinely taught to quality novices and life-time professionals. All attendees are required to bring their own copy of the ISO 13485 Quality Management Standard Requirements to this training course. These will not be provided for you. We strongly advise you bring a “paper” copy.
- Prepared to conduct a solo internal audit at successful course completion
- Fully understand and interpret the ISO 13485 requirements.
- Apply the proper interpretation of the standard in actual audit situations.
- Understand process auditing tools leading to substantive quality system improvements
- Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
- Follow-up and resolve “audit trails that present themselves during the audit interviews
- Conduct audits that result in real improvements to the quality system
- Plan and execute the entire audit process including: audit preparation, opening meetings, auditing, closing meetings, and reporting.
Part 1: Introductions and Self-Assessment
- Course requirements
- How to get the most from this experience
- Networking with class mates (industry professionals)
- Self-assessment of audit skills and internal audit programs Exercise #1
Part 2: Quality Terminology and Definitions
- Quality industry vernacular from ISO 9000, ISO 19011
- Differentiating between Verification and Validation
- Understanding Corrective and Preventive Actions
- How to converse with external auditors
- Terminology Exercise #2
Part 3: Requirements of ISO 13485
- Demystifying the ISO 13485 standard
- Interpreting and cross-referencing the quality standard
- Analyzing audit findings
- Audit exercises for application of ISO 13485 to quality events
- Exercise #3-#7: Short case studies in quality events
Part 4: The Audit Process: Roles and Duties
- Roles of Auditors, Auditees, and Management during Internal Audits (IAs)
- Qualifying Auditors
- Duties of the IA staff
- Exercise #8: Preparing to be audited
Part 5: The Audit Process: Performing the Audit Process
- Audit Tools – checklists, process maps, findings, reports
- Conducting Audit Interviews Exercise #9
- Exercise #10 Quality event case studies
Part 6: The Audit Process: Audit Skills and Techniques
- Audit Interviewing techniques
- Continual improvement techniques
- Process Auditing methods
- Developing a “continual improvement” attitude in the organization
- Exercise #11 Writing Audit Findings
- Exercise #12 Evaluating the effectiveness of Audits
- Exercise #13 Application of Process Auditing techniques
Part 7: The Audit Process: Finalizing the Audit
- Writing the audit report
- Opening and Closing Meetings
- Exercise #14 Writing and audit report
- Exercise #15 Writing Non-Conforming Reports
- Exercise #16 Conducting a Closing Meeting
Review and Examination for Certificate