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Select one of the faculties below for more information on courses offered and proceed to make an enquiry, request a quote or book online

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Course Detail
  • Course Title:
    ISO 13485:2016 UNDERSTANDING AND IMPLEMENTATION OF MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS
  • Course Description:
    This is a Module 1 Implementers course and includes a free copy of the SANS 13485:2016 standard for all learners. Practitioners, implementation team members and custodians from key functional areas of your business will gain sound knowledge and skills to effectively implement maintain and improve your organizations' Medical Devices' Quality Management System. Key areas of learning include: Understanding the Process approach; Incorporating a Risk Based culture to business & developing an in-depth knowledge of all clauses and requirements of the standard
  • Duration:
    Module 1 : 5 days consecutive with MANDATORY 100% attendance. Requires a minimum result of 70% to progress into the Lead Auditor Module 2 level. NOTE: This course is also available via e-learning. Refer to the Online Learning faculty for additional event dates
  • Requirements For Entrance To Attend This Course:
    Please note that adequate literacy in English is required to grasp the extensive content of this course and participate in the written examination. An NQF level 4 education or equivalent is an advantage.
  • Bulk Booking Discounts:
    • 3-8 delegates : 2.5% discount
    • 9-15 delegates : 7.5% discount
    • 16-50 delegates : 12.5% discount
    Number of Delegates:
  • Groenkloof Pretoria Calendar:
    Current Price R16,816 All Prices are Vat Exclusive
    Course Start Date Duration (Days) Price (Per Delegate) Discounts
    Bulk  Early Promo
    Action
    20/01/2025 5 Days R16,311.52 0% 3% 0% Quote | Book
    12/05/2025 5 Days R16,311.52 0% 3% 0% Quote | Book
    NOTE: This booking will only be confirmed upon receipt of official purchase order document or proof of payment

TRAINING ACADEMY

Our beloved teacher and leader of all time, Nelson Rolihlahla Mandela once said “Education is the most powerful weapon one can use to change the world. It is the engine of personal development. Through it, a daughter of a peasant can become a doctor, a son of a miner can become the head of a mine, a child of a farmer can become the president of a great nation. It is what we make of what we have, and not what we are given, that separates one person from another”.

It is with this philosophy that we take pride in our Training Academy. As the leader in professional training, we draw on our 70 years of global experience to provide effective learning and development opportunities. We make a difference to individuals, teams and businesses, nurturing talent and enabling continuous organisational progression.

The SABS Training Academy continues to maintain valid accreditation to offer management systems courses. Please refer to the Accreditation Tab for more information.

For this reason, all courses offered can be presented at your organisation’s facilities or suitable venue. These are more cost effective since group discounts apply and in cases where a suite of courses are required,  pricing is specially designed. For more information or a quote select the “Group Booking Request” on any of the courses in our faculties or send an email to: TCPSales@sabs.co.za

All courses listed in the brochure can be presented at your premises by arrangement with SABS Training Academy. This requires a minimum number of 10 delegates per class.

Please send any training enquiries to TCPSales@sabs.co.za