1. General Requirements


The medical device industry is affected by a complex array of regulatory systems, national and international standards and other requirements. ISO 13485 system certification helps manufacturers understand what they need to do to place compliant devices on markets throughout the world. The purpose of GPC Medical devices -- Quality management systems - Requirements for regulatory purposes (ISO 13485: 2003) is to provide confidence to accredited certification and to business and industry that auditors certified to this program are competent.


Its primary objective is to facilitate harmonized medical device regulatory requirements.


The standard contains specific requirements for manufacture, installation and servicing and calls for:

• Implementation of a Quality Management System with several enhancements
• Risk Management approach to product development and product realization
• Validation of processes
• Compliance with statutory and regulatory requirements
• Effective product traceability and recall systems



2. Medical Device Quality Management System Auditor Requirements


1) Basic Requirements





* The requirements of training certificate are as followings:

• Certificate of successful completion of applied management system lead auditor training course from GPC approved, which meet the procedure of training provider.
• Certificate of successful completion of applied management system lead auditor training course provider by ISO 17024 accredited as a personnel certification body.
• Certificate of successful completion of applied management system lead auditor training course from IRCA approved as a training provider.
• The training provider should implement the requirements either ISO 9001 or ISO 29990 in order to keep the quality management as a training provider.



2) Medical Device Quality Management System Auditor Scheme, Specific (Additional) Requirements and Technical competencies

Regulatory requirements: Knowledge of the medical device regulatory requirements of the recognizing Regulatory Authority to enable an assessment of the applicability and compliance with such laws, regulations, and standards.  Including knowledge of the principles and applications of medical device quality management system requirements, risk management system requirements, etc.


1) Medical devices: Knowledge of medical devices and the related manufacturing activities, including:

• Intended use
• Types of medical devices including their complexities, technologies, and risk classifications
• Safety and risks of medical devices
• Processes and technologies used by medical device manufacturers
• General quality management system practices
• Legal framework of regulations and role of the certification body
• Medical device risk management, e.g. ISO 14971
• Relevant product standards in the assessment of medical devices
• Certification body’s ISO 13485 certification processes
• Knowledge of Medical Device business/technology
2) Auditing Standards and Techniques: Knowledge of standards and techniques for auditing quality management systems.
3) Statistical Analysis: Knowledge of the basic concepts of probability and statistics including mean, median, confidence level and standard deviation as it relates to representative sampling and trend analysis.
4) Additionally, the following knowledge of advanced topics should be checked:
• Knowledge of sterilization techniques and their validation Picture2.jpg
• Knowledge of microbiology and bio-burden monitoring
• Knowledge of biocompatibility and its evaluation 
• Knowledge of clean-room processing
• Knowledge of environmental monitoring and controls 
• Knowledge of packaging technologies 
• Knowledge of stability testing 
• Knowledge of risk management practices 
• Knowledge of 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 validation techniques
5) Each auditor shall undertake continuing professional development activities such as training, participation in scientific meetings, and self-study. Such activities should ensure timely awareness of new or modified regulatory requirements, policies, procedures, etc., as well as emerging technologies.
6) It is recognized that medical device manufacturing constitutes a highly specialized technology driven and fast evolving sector. Additionally, new regulatory requirements, standards, policies, and procedures are introduced, and existing ones are modified from time to time.
7) Advanced training elements for auditors are requested. As auditors gain competence in   conducting audits, advanced and specialized training is recommended.





4. Examination


1) About the exam


The exam consists of two types of written exams, Knowledge exam and Attribution test.


The exam is performed at a place that GPC evaluated and finally approved in advance, and generally it starts at 10:00 am on Saturday (it will be notified prior to the exam).


The applicants should be arrived at the examination site at least 10 minutes before the start and if late or absent, 0 score is automatically given.


Any ID with picture on it for the identification of the candidate has to be presented, and any prohibited items at the examination site have to be left with the invigilator before the star of the exam.


If cheating is detected, the invigilator will ask the candidate to leave immediately and no more exam is allowed.


Please see the exam notification for the details about the examination location and contact information.


2) Knowledge exam


This exam questions were set up based on ISO 13485:2003 standard and the purpose of the exam is to evaluate the qualifications and competence of the candidate who wants to conduct audit activity by the standard the candidate is applying for.


The knowledge exam has a total of 100 questions and consists of 4 sections divided.


1 point for 1 correct answer and the pass criteria is as follows.



* Even if the total points are more than 70 points, the applicant cannot pass the exam without meeting the minimum points required for each section.


Time limitation is only 120 minutes for the examination and it is open-book condition.


If one is failed in the exam, candidate is given one more chance of examination. If candidate fails to the consecutive examination, the candidate has to wait another year to take examination.


3) Attribution test


The purpose of the attribution test is to evaluate the characteristics and the qualification as an auditor and it asks how much the application understandable agree with the questions.


It is based on ISO 19011:2011 and consists of 25 questions only. The candidate should choose the answer that comes to mind first.


Up to 4 points are given for each question and as the answer is further from the correct answer, 1 point each is deducted. (0 point for no answer)


The pass criterion is 70 points


If one is failed in the test, another chance of attribution interview is given. If candidate fails to the attribution interview, candidate has to wait another year to take an test.