ISO 13485:2016 Training
Would you like to know what a Notified Body Auditor is looking for when they audit you against the 2016 versions of ISO 13485?
Well look no further. Our trainers trained the Notified Bodies.
We can offer a wide range of training, from 'clause by clause' through internal auditor to lead auditor. Not only that we can offer IRCA registered auditor courses for those seeking IRCA certification.
Our 2-day Internal Auditor course focuses on the application of key principles and practices in accordance with ISO 13485:2016 and ISO19011 “Guidelines for auditing management system”.
This course is designed to enhance the level of understanding for those actively utilizing and engaging in 1st Party Assessments. Our tutors give you the necessary skills to perform internal audits on an organization’s Quality Management Systems (QMS) for Medical Devices to the requirements of ISO 13485:2016 and to contribute to their continual improvement.
Our courses range from 1-day through to 5-day intensive training depending on your requirements.
Who should attend?
The content will have great value to individuals who are involved in any aspect of implementing or maintaining a QMS.
▪ Quality assurance professionals
▪ Quality Engineers
▪ Research and design Engineers
▪ Internal Auditors
▪ Quality Managers
▪ Manufacturing Engineers
▪ Regulatory professionals
Learning objectives include:
▪ Practical use of ISO13485:2016
▪ Principles of auditing, the audit cycle and audit objectives
▪ Auditing skills and techniques
▪ Planning - Use of checklists, resources and timing
▪ Selection of audit teams and training
▪ Interviewing and evaluation of information and findings
▪ Observation / Opportunities for Improvements –objective evidence
▪ Evaluating the significance of nonconformities
▪ Communicating and presenting audit reports
▪ Corrective actions and effective follow-up programmes
▪ Effective improvement – planning, monitoring and results