ISO 13485 Auditor Training Seminar

For Internal Auditors (4 Days) and Certified Lead Auditors (4 1/2 Days)

This comprehensive course enables participants to develop the necessary expertise to audit a Quality Management System (QMS) based on ISO 13485:2003 and to manage a team of auditors by applying widely recognized audit principles, procedures and techniques. During this training, the participant will acquire the necessary knowledge and skills to proficiently plan and perform internal and external audits in compliance with the certification process of the ISO 19011 and ISO 17021 standards.

Based on practical exercises, the participant will have an opportunity to develop the skills (mastering audit techniques) and competencies (managing audit team and audit program, communicating with customers, conflict resolution, etc.) necessary to efficiently conduct an audit of a Quality Management System for Medical Devices. The daily course agenda appears below.

Lead Auditor Certification Examination and Registration by the Professional Evaluation and Certification Board, an IAS Accredited Program for Personnel Certification #1003 Class
Dates
Location Class Fee
ISO 13485 Internal Auditor Course, 4 Days (excludes PECB Certification Examination) TBA Anaheim, California $1495.00
ISO 13485 Lead Auditor Course, 4 1/2 Days (includes PECB Certification Examination) TBA Anaheim, California $1995.00

Payment Plan options are available through PayPal Financial Services. 

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To Register a Participate for the Class …

  • In the table below select the Order Pre-class Registration to order/register for 1 or more participates. You will be invoiced 10 days for the balance due one week prior to the class date, or
  • Select Order Pre-class Registration & Self-study kit if you wish to order/register for 1 or more participates and receive the course training materials in advance. You will be invoiced 10 days for the balance due one week prior to the class date, or
  • Select Order Class & Pre-pay Fee if you wish to earn a discount of $100.00 for each participate, or
  • Call us at (800) 840-9439 for other registration and payment methods.
  • ISO 13485 Lead Auditor Training Course Fees
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    (a) ISO 13485 Internal Auditor Class, 4 Days (excludes PECB Certification Examination)

    (b) ISO 13485 Lead Auditor Class, 4 1/2 Days (includes PECB Certification Examination)
  • ISO 13485 Lead Auditor Training Course

    Course Agenda (Monday - Thursday 8 AM to 5 PM; Friday 8 AM to Noon)

    Internal Auditor Track

    Lead Auditor Track

         

    Day 1: Introduction to Quality Management System (QMS) concepts as required by ISO 13485

       
    • Normative frameworks and methodologies related to Quality and Medical Devices
    • Fundamental principles of Quality and Medical Devices
    • ISO 13485 certification process
    • Quality Management System (QMS)
    • Detailed presentation of the clauses 4 to 8 of ISO 13485
    • Evening Case Study Assignment
    Participate must attend Participate must attend

    Day 2: Planning and Initiating an ISO 13485 audit

       
    • Fundamental audit concepts and principles
    • Audit approach based on evidence
    • Preparation of an ISO 13485 certification audit
    • QMS documentation audit
    • Conducting an opening meeting
    • Evening Case Study Assignment
    Participate must attend Participate must attend

    Day 3: Conducting an ISO 13485 audit

       
    • Communication during the audit
    • Audit procedures: observation, document review, interview, sampling techniques, technical verification, corroboration and evaluation
      Audit test plans
    • Formulation of audit findings
    • Documenting nonconformities
    • Evening Case Study Assignment
    Participate must attend Participate must attend

    Day 4: Concluding and ensuring the follow-up of an ISO 13485 audit

       
    • Audit documentation
    • Quality review
    • Conducting a closing meeting and conclusion of an ISO 13485 audit
    • Evaluation of corrective action plans
    • ISO 13485 Surveillance audit
    • ISO 13485 Internal Audit management program
    • Evening Case Study Assignment
    Participate must attend Participate must attend

    Day 5: Certification Exam

       

    Approximate Duration: 3 hours

    The “Certified ISO 13485 Lead Auditor” exam is available in different languages (the complete list of languages can be found in the examination application form)

      Participate must attend