ISO 13485:2016 Medical Devices Internal Auditor Course - North America
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.
Duration: 3 Days | Cost: $1395 USD | CEUs: 2.4
This course will 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.
SAI Global 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'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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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
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
Any personnel who will act as internal auditors
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
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 exemplarglobal.org.