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.