Objective

The objective of the “BEST PCB Certified ISO13485 Lead Auditor/Auditor/Internal Auditor” examination is to ensure that the candidate possesses the necessary expertise to perform a Medical Device  Management System (MDMS) audit and to manage an audit team by applying widely recognized audit principles, procedures and techniques. The aim of the exam is to evaluate that the candidate possesses the knowledge and skills to proficiently plan and carry out internal and external audits in compliance with ISO 19011 and ISO/IEC 17021-1 certification process.
FDA FSMA  CFR - Code of Federal Regulations Title 21 21 CFR Part 820 -

The target population for this examination is:

  • Auditors seeking to perform and lead Medical Device Management System (MDMS) certification audits
  • Managers or consultants seeking to master a Medical Device Management System audit process
  • Individuals responsible for maintaining conformance with MDMS requirements
  • Technical experts seeking to prepare for a Medical Device Management System audit
  • Expert advisors in MDMS

The exam content covers the following competency domains:

  • Domain 1: Fundamental principles and concepts of a MDMS
  • Domain 2: Medical Management System (MDMS)
  • Domain 3: Fundamental audit concepts and principles
  • Domain 4: Preparation of an ISO i3485 audit
  • Domain 5: Conducting an ISO 13485 audit
  • Domain 6: Closing an ISO 13485 audit
  • Domain 7: Managing an ISO 13485 audit program
  • Domain 8 : special requirement ( FDA,CE.......)

Assessment and exam Guide for Certified  ISO 13485
Lead Auditor/Auditor/Internal Auditor


  • 5.1 Lead Auditor and Internal auditor test critical
    Based on these 8 domains and their relevance, One hundred (100) questions are included in the exam, as summarized in the following table:
  • The passing score is 85 points  for Lead auditor and ８0 points for internal auditor. Each Domains need more than ６0 %.
    After successfully passing the exam, candidates will be able to apply for the credential of “ BEST PCB Certified ISO 9001 Lead Auditor”, depending on their level of experience.

  • 5.2 Auditor:
    Based on these 5 domains and their relevance, Eighty (80) questions
  • The passing score is ７0 points for auditor. Each Domains need more than ６0 %.
    After successfully passing the exam, candidates will be able to apply for the credential of “ BEST PCB Certified ISO Auditor”, depending on their level of experience.
           5.3 Special requirement for CE or FDA
           need take the different test material for the special requirements and got the special MD 

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