ISO 13485 Lead Auditor Training Classes
ISO 13485 LEAD AUDITOR Training
ISO 13485 Lead Auditor Class Objectives:
- Understand quality management definitions, concepts, and guidelines
- Understand the purpose of the ISO 9000 series
- Understand the requirements of the ISO 13485:2016 standard
- Understand the roles and responsibilities of the auditor
- Apply ISO 19011 definitions, concepts, and guidelines
- Recognize the principles, practices, and types of audits
- Conduct all phases of an internal audit
- Prepare and present effective reports
- Understand Exemplar Global’s certification scheme
- Understand the role of objectives, scope and criteria in the audit process
- How to plan audits
- Conduct audit team selection
- Initiate the audit and conducting opening meetings
- Understand audit team leader responsibilities
- Communicate effectively during the audit
- Conduct on-site activities
- Prepare audit conclusions
- Conduct closing meetings
- Report audit results
Outline (Typical Agenda)
Day 1
- Terminology and Definitions
- Background, History and Rationale for Quality Assurance
- Introduction to the ISO Family of Documents
- Analysis of the Contents of ISO 13485
- Audit of Active Medical (Audit #1)
Day 2
- Quality System Requirements
- Analyzing Findings
- Audit of Active Medical to ISO 13485 (Audit #2)
- Exemplar Global and U.S. Certification System
- Auditor Qualifications
- Roles and Responsibility of Auditors
- Creation of Effective Audit Checklists
Day 3
- Audit of Active Medical – Document Audits (Audit #3)
- Tips for the Professional Auditor
- Audit of Active Medical – Department Audit (Audit #4)
- Compiling Audit Findings
- Documentation in the Quality System
- Planning and Conducting Effective Audits
- Refining Interview and Note-Taking Skills
- Applicability of the Elements to Company Situations
- Prevention vs. Detection
Day 4
- Audit of Active Medical – Department and System Auditing (#5)
- Corrective Action Initiation and Closure
- Refining Audit Interview and Note-Taking Skills
- Creation of an Audit Report
- Conducting the Audit
- Preparation and Presentation of a Closing Meeting
Day 5
- Review and Exam
Who Should Attend?
- Individuals interested in conducting first-party, second-party, and third-party audits
- Management Representatives
- Quality Directors in Medical Device
- Managers
- Engineers
- Consultants
ISO 13485 Lead Auditor Certification
This course comprises the following three Exemplar Global TPECS Competency Units whose outcomes are certified by Exemplar Global:
- MD – Medical Device Systems
- AU – Management Systems Auditing
- TL – Leading Management Systems Audit Teams
Attendees successfully completing this course receive a Certificate of Attainment for each of Exemplar Global Competency Units listed above.
Special Features
- Online ISO 13485 Lead Auditor Training is not permissible. However, some courses combine an initial component over the Internet, and conclude with a 3-day classroom section under the guidance of an experienced trainer. (Online & Instructor Led)
- TPECS – Some organizations have the ability to provide TPECS modular instruction. TPECS: Training Provider Examination Certification Scheme.
- TPECS Ensures:
- Improved assessment and evidence of competence;
- A more effective and efficient personnel certification process; and
- Greater involvement of training providers in the personnel certification process.
- AATT.
- Other Special Features may vary.