IBRATSA offers public training on:
(i) ISO 13485:2016: Understanding and Implementation course
(ii) ISO 13485: 2016 – Internal auditing.
(iii) ISO 9001: 2015: Understanding & Implementation Course.
(iv) ISO 9001: 2015: Internal Auditing.
(v) ISO 9004:2018: Improve the Effectiveness and Efficiency of QMS for Sustained Success Course.
ISO 13485:2016.
*Regulatory officers.
*Quality managers.
*Management Representatives.
*Professionals tasked with overseeing a management system meeting ISO 13485 standards.
*Medical device companies looking to set up their QMS and get ISO 13485:2016 certified.
*Managers or consultants seeking to master a Medical Devices QMS audit process
*Individuals responsible for maintaining conformance with Medical Devices QMS requirements
*Individuals interested in conducting first-party or second party audits
*Technical experts seeking to prepare for a Medical Devices QMS audit
ISO 9001:2015
*Individuals involved in Quality Management
*Individuals seeking to gain knowledge about the main processes of Quality Management Systems (QMS)
*Individuals interested to pursue a career in Quality Management
*Managers or consultants seeking to master a QMS audit process
*Individuals responsible for maintaining conformance with ISO 9001 QMS requirements
*Individuals responsible for maintaining conformance with QMS requirements
*Technical experts seeking to prepare for a Quality Management System audit
National Certificate: Quality Management Systems [SAQA ID: 66189 NQF Level :5 Credits: 120]
*Junior staff or senior staff requiring foundational knowledge in the field of Quality Management Systems.
*At minimum participants should be in possession of Grade 12.
ISO 13485: 2016: Understanding & Implementation
*5 Days [4 Days Mandatory Attendance 1 Day Exam]
ISO 13485: 2016: Internal Auditing
*3 Days [2 Days Mandatory Attendance 1 Day Exam]
ISO 13485: 2016: Lead Auditor
*5 Days [4 Days Mandatory Attendance 1 Day Exam]
ISO 9001: 2015: Understanding & Implementation
*5 Days [4 Days Mandatory Attendance 1 Day Exam]
ISO 9001: 2015: Internal Auditing
*3 Days [2 Days Mandatory Attendance 1 Day Exam]
ISO 9001: 2015: Lead Auditor
*5 Days [4 Days Mandatory Attendance 1 Day Exam]
National Certificate: Quality Management Systems [SAQA ID: 66189 NQF Level :5 Credits: 120]
Module 1: Communication.
Facilitation- 6 days. Workplace - 11 days. Assessment -4 days. Final Integrated Summative Assessment -2hrs.Module 2: Introduction to Quality Management System (QMS)
Facilitation- 9 days Workplace - 16 days Assessment -5 days Final Integrated Summative Assessment -2hrsModule 3: Enhance a Quality Management System (QMS).
Facilitation- 6 days Workplace - 11 days Assessment -4 days Final Integrated Summative Assessment -2hrsModule 4: Project Management.
Facilitation- 9 days
Workplace - 15 days
Assessment -5 days
Final Integrated Summative Assessment -2hrs
Module 5: Implement and Control a Quality Management System (QMS).
Facilitation- 14 days
Workplace - 24 days
Assessment -7 days
Final Integrated Summative Assessment -6hrs
Our physical facilatator-led training sessions are delivered from the IBRATSA training facility.
IBRATSA officies are located at:
222 Corobay Avenue,
Waterkloof Glen,
0010, Pretoria.
ISO 13485:2016 Understanding and Implementation
1.Introduction to ISO 13485:2016 Medical Devices Quality Management System [MDQMS].
*Standards & Regulatory Frameworks.
*Principles of QMS.
*Key Quality Concepts.
*ISO13483:2016 Clauses 4 to 8.
2.Initiation of & Planning for the Implementation of QMS [PLAN].
3.Implementation of QMS [DO].
4.Monitor, Measure & Analyse Data [CHECK].
5.Continually Improve MDQMS processes [ACT].
ISO 9001:2015 Understanding and Implementation
1.Introduction to ISO 9001:2015 Quality Management System [QMS].
*Standards & Regulatory Frameworks.
*Principles of QMS.
*Key Quality Concepts.
*ISO9001:2015 Clauses 4 to 10.
2.Initiation of & Planning for the Implementation of QMS [PLAN].
3.Implementation of QMS [DO].
4.Monitor, Measure & Analyse Data [CHECK].
5.Continually Improve MDQMS processes [ACT].
ISO 13485:2016 Internal Auditing
*Structure and Scope of ISO 13485 in relation to regulatory compliance.
*Fundamental audit concepts and principles
*The responsibilities of an auditor.
*Plan an internal audit that is based on evidence and risk.
*Understand the auditing process and the process approach to auditing
*Check for the effective implementation of corrective action.
The original ISO Standard is required for delegates attending our ISO standard-based QMS courses.
IBRATSA standard option is to purchase for delegates . Alternatively delegates can purchase the standard directly from South African Buruea of Standard and belongs to the delegate.
Delegates in possession of the Standard can bring their own standard and the standard fee is removed from their quotation.