ISO 13485:2016

IGC provides certification services such as ISO 13485 medical device quality management system provisional auditor, auditor, lead auditor, internal auditor, senior auditor based on cooperation with GPC (Global Personnel Certification), an accredited personnel certification body based on ISO/IEC 17024.

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  ISO 13485 Overview

  ISO 13485 is a standard that stipulates the requirements for the quality management system of organizations that provide medical device design and development, production, installation and additional services. Also, this standard can be applied to external organizations that provide services such as sterilization, calibration, and sales to medical device organizations, providing the basis for a quality management system to organizations that provide medical devices and related services.
  
  Medical devices directly affect human life and health, they need to guarantee a higher level of stability than any other product. Therefore, the medical device industry has a variety of regulations that must be met, including domestic regulatory systems, international standards and other requirements. In order to meet the requirements of the EU Medical Device Directive, a quality system must be established, and some countries, such as Canada, require ISO 13485 certification for product sales.
  
  With ISO 13485 system certification, medical device manufacturers can demonstrate that an organization's system meets the comprehensive requirements for a quality management system and specific requirements for medical devices.

• ISO 13485 Auditor Certification Requirements

  

  	Auditor	Lead Auditor	Senior Auditor	Internal Auditor	Provisional Auditor
  Education	Secondary education or higher
  Work experience	5 years and more (Including 2 years or more of experience in quality or environment field related to the standard)		10 years and more (Including 5 years or more of experience in quality or environment field related to the standard)	3 years and more (Including 1 year or more experience in quality or environment field related to the standard)	None
  Audit experience	Audit log of 20 M/D or higher as an auditor or lead auditor within the last 3 years	Audit log of 35 MD or higher as an auditor or lead auditor within the last 3 years (of which 15 M/D or more are audit log as lead auditor)	Audit log of 15 M/D or more as a lead auditor within the last 3 years (only the log after acquiring lead auditor certification from an accredited personnel certification body is acceptable)	Within the last 3 years awarded 5 times + audit log of at least 15 M/D	None
  Education training	* Completion of auditor training course within the last 3 years (Only a certificate of completion issued by an accredited personnel certification body or a training provider designated by it can be accepted)
  Exam	GPC knowledge and personality exam pass

  ✤ ISO 13485:2016 Auditor requirements

  • Education : University (4 years) graduation or higher
  • Majors : Biology, Microbiology, Chemistry, Biochemistry, Computer and Software Technology, Electrical, Electronics, Mechanical, Biological Engineering, Human Physiology, Pharmacy, Physics
  • Experience : Persons who have worked full-time for at least 4 years in medical devices and medical research fields

  ✤ Special requirements and technical competence

  • 1. Basic knowledge of medical devices and an understanding of related production activities, including :
    • purpose of use
    • Classification of medical devices including risk analysis
    • Legal regulatory framework and the role of the certification body
    • Medical device risk evaluation (ISO 14971)
    • Product standards related to medical device evaluation
    • ISO 13485 certification by certification body
    • Knowledge of medical device business/technology

  • 2. Statistical analysis
    • Basic knowledge of probability and statistics according to sampling and trend analysis considering reliability and standard deviation

  • 3. Knowledge of :
    • Sterilization technology and verification technology
    • Microbiology and BIO-Burden monitoring
    • Biocompatibility and validation
    • Clean room operation
    • Environmental monitoring and control
    • Packaging technology
    • Stability test
    • Risk management base
    • Cleaning and disinfection
    • Biological evaluation of medical devices
    • Clinical evaluation of medical devices
    • Physical and chemical evaluation of medical devices
    • Knowledge of process validation practices
    • Software verification technology

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  ISO 13485 Auditor Certification Procedure

  • 1. Receipt of application documents

    - The applicants fill out the application form and submit materials to prove their background.

  • 2. Review of application documents and other materials

    - After reviewing the submitted application documents and other materials, if they are not sufficient, applicants should prove their history by supporting additional data.

  • 3. Performing GPC exam

    - The applicants should take the knowledge and attribution test and are granted certification upon passing the test.

  • 4. Review by Certification Panel

    - Based on the submitted data and test results, the certification panel makes a certification decision.

  • 5. Certification issuance

    - When the certification is determined, a certificate is issued and delivered to the applicant.

  The certification is valid for 3 years from the date of issue, and maintenance fees must be paid annually in accordance with the certified cycle, and additional requirements must be met at the 3rd year in the renewal cycle.