Time Zone: EASTERN Time
SAI Global Assurance Learning is an Exemplar Global certified TPECS provider. This course meets the knowledge examination requirements of the Medical Devices Quality Management Systems (MD) certification scheme.
Learn the necessary skills and activities required to successfully perform effective internal audits of your organization’s quality management system against ISO 13485:2016 Medical Devices.
This highly participative course is presented by SAI Global Assurance Learning’s instructors, each of whom have decades of experience in the medical devices industry and extensive experience conducting and leading audits in FDA regulated industries.
This course is based on quality management systems ISO 9001 and ISO 13485.
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Start Date - October 21, 2024
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End Date - October 23, 2024
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Duration - 3 Days
- Start Time - 8:00 AM
- Timezone - Eastern Time
This 3 day course is designed to provide participants with the knowledge and skills required to perform an internal audit of a quality management system based on ISO 13485. It will also provide a hands-on approach to planning, conducting and reporting on internal audits in accordance with ISO 19011 and meets the training requirements for Exemplar Global (TPECS) Auditor Certification for Quality Auditors.
- Quality coordinators/QMS management representatives
- Quality professionals
- Any personnel who will act as internal auditors
- Module 1: Quality Management Systems
- Module 2: Audit Fundamentals
- Module 3: ISO 13485:2016 Standard
- Module 4: Managing an Audit Program
- Module 5: Audit Planning and Preparation
- Module 6: Conducting Audit Activities
- Module 7: Preparing and Distributing the Audit Report
- Module 8: Completing the Audit and Conducting Follow-up
At the end of the course, participants will have obtained a sound appreciation of:
- Explain the purpose of a Quality Management System
- Explain the purpose of the ISO 9000 Standards
- Explain the audit process – plan, conduct, report and follow-up in accordance with ISO 19011
- Undertake an audit of a Quality Management System against the requirements of the ISO 13485 Standard
SAI Global Assurance Learning is an Exemplar Global certified TPECS provider. This course meets the knowledge examination requirements of the Medical Devices Quality Management Systems (MD) certification scheme.
Attendees who successfully demonstrate competence during this course will receive a Certificate of Attainment for the following knowledge competency units:
- Exemplar Global – MD – Medical Devices Quality Management Systems
- Exemplar Global – AU – Management systems auditing
Please note: Additional experience/qualification requirements must be met to achieve certification as an auditor. These are provided through Exemplar Global. Additional information can be found at https://exemplarglobal.org.
Before starting this course, it would be an advantage for participants to understand some of the quality management principles and concepts:
- The process approach used in quality management
- The Model of a Process Based Quality Management System
- The Plan, Do, Check, Act (PDCA) cycle
- The relationship between quality management and customer satisfaction
- Commonly used quality management terms and definitions and the 7 Quality Principles as given in ISO 9000
