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:
2. Medical Device Quality Management System Auditor Requirements
1) Basic Requirements
* The requirements of training certificate are as followings:
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:
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.