Just send an e-mail to or, for other options, see Contact Us. ![]() Provided you have the required personal attributes, all you need to add is auditing experience. What else will I need to become a competent auditor? There is no time limit on the validity of your Certificate. Your Certificate will be forwarded to you as an email attachment that you may print as often as you like. Once you have completed the Examination, your Certificate is immediately available to you. What do I get when I’ve completed the Program? The Examinations are open-book (you can have the Standard and other notes open beside you), time-limited and taken online. The decision to award a Certificate is based on the combined scores achieved. In addition to the Quizzes at the end of each Module, there is at the end of each Course (set of Modules/Lessons) a formal Examination. Click on this link to view the Payment Process. You can pay by Debit Card, Credit Card or PayPal during the Program Enrolment procedure. Yes, details of discounts, based on numbers enrolled, can be found on the Corporate Discounts page. ![]() ![]() Yes, deGRANDSON Global is certified to ISO 29990:2010, the learning services organization standard, by BQAI, an internationally accredited Certification Body. More Audit Scenarios – Lead Implementers.Module 3: Practice with Scenarios, based on actual audits and includes advice on dealing with awkward situations and individuals. Advanced aspects of QMS Auditing (3 modules).Part 8: Measurement, Analysis & Improvement (2 modules).Part 7: Product Realisation (3 modules).Part 4: Quality Management System Requirements.Fundamentals of Medical Device Management Systems.Module 2: Knowledge of the Standard, ISO 13485:2016, Medical Devices – Quality management systems – Requirements for regulatory purposes.Module 1: Auditing Skills to Lead Auditor Level and based on the auditing standard ISO 19011:2018.Module 0: Introduction and background to the Standard and auditing.If candidate fails to the attribution interview, candidate has to wait another year to take an test.This comprehensive ISO 13485 Lead Auditor Certification course covers all aspects of Internal Auditing and is divided into five Courses: If one is failed in the test, another chance of attribution interview is given. Up to 4 points are given for each question and as the answer is further from the correct answer, 1 point each is deducted. The candidate should choose the answer that comes to mind first. It is based on ISO 19011:2011 and consists of 25 questions only. 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. If candidate fails to the consecutive examination, the candidate has to wait another year to take examination. If one is failed in the exam, candidate is given one more chance of examination. Time limitation is only 120 minutes for the examination and it is open-book condition. Lakshy Management Consultant is the leading ISO 13485 medical devices quality management system consultants,ISO 13485 audit,ISO 13485 training,ISO 13485 certificate,ISO 13485 audit,ISO13485 Certification,Training,Consultancy and Documentation India,USA,UAE,Saudi Arabia and gulf countries. * 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. The knowledge exam has a total of 100 questions and consists of 4 sections divided.ġ point for 1 correct answer and the pass criteria is as follows. 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. Please see the exam notification for the details about the examination location and contact information. If cheating is detected, the invigilator will ask the candidate to leave immediately and no more exam is allowed. 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.Īny 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. ![]() 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 exam consists of two types of written exams, Knowledge exam and Attribution test.
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