An Internal QMS Auditor Course based on ISO 13485:2016 for the Medical Devices industry.
This interactive and practical ISO 13485 internal auditor course will equip participants with the knowledge and skills they need to carry out effective, value adding audits of their ISO 13485 quality management systems.
It will help individuals understand the purpose of the quality management system, the structure and content of ISO 13485 and its relationship with regulatory requirements including the European Medical Devices Regulations (MDR) and the USA’s FDA Quality System Regulation (QSR).
Participants will learn how audits can support the implementation and improvement of the management system and will develop audit skills and techniques to evaluate the conformance and effectiveness of processes.
This training course focuses on internal audits and will also be helpful for those conducting supplier audits or preparing for certification/ notified body audits.
- An overview of quality management systems and the purpose, structure and content of ISO 13485:2016
- What an internal audit is and the benefits they can bring
- Internal audit requirements of ISO 13485
- A structured, step by step approach to planning and preparing for an audit
- Auditing skills, including;
- Preparing a checklist and sampling plan
- Building rapport with the auditee and creating a constructive environment for the audit
- Questioning, listening and note taking
- Gathering audit evidence and evaluating it against defined criteria/requirements
- Writing clear, concise audit reports
- The correction and corrective action process
- Follow up and close out of non conformances
An overview of the Medical Device Requirements 2017 and current FDA QSR requirements and how they relate to ISO 13485 internal audits.
Who Should Attend
This course will be helpful for anyone who is tasked with carrying out audits, particularly internal but also supplier audits and those who may be involved in audits as an auditee, helping them prepare for the audit and demonstrate their understanding of the quality management system. This may include:
- Internal quality management systems auditors
- Supplier auditors
- Quality / Audit / Compliance / Regulatory Affairs managers
- Auditees preparing for certification audits, including
- Top management
- Heads of departments
- Process owners
ISO 13485 Internal Auditor Training Outcomes
By the end of this two day internal auditor training course, participants will be able to:
- Explain the purpose, structure and content of ISO 13485
- Outline the content of EU MDR and the USA FDA requirements for medical devices and their relationship with ISO 13485
- Describe the roles and responsibilities of an auditor
- Plan, conduct, report and follow up an internal audit
- Evaluate conformance of processes to ISO 13485 related internal and regulatory requirements