ISO 13485 : 2016 Internal auditor Training

Training Topic

MedAccred Introduction Training

Duration

2 Day

Course Overview

Two-day course will improve the effectiveness of the Quality Management System and help you understand the best practices to conduct an effective internal audit in accordance with the requirements of ISO 13485:2016

Topics Covered

• Relationship between ISO 13485, ISO 9000 series & ISO 14971
• ISO 13485 compliance with worldwide regulatory requirements
• Introduction to auditing
• Process approach & process auditing
• Managing an audit programme
• Audit activities
• Auditor competence & responsibilities
• Plan an internal audit
• Creating work documents
• Conducting an opening meeting
• Collecting & verifying audit information
• Audit techniques
• Gathering & verifying information
• Audit findings & nonconformities
• Conducting the audit
• Generate audit findings
• Identify & define nonconformities
• Prepare audit conclusions
• Write an audit report
• Closing meeting
• Conduct audit follow-up
• Course review & questions

Whom To Attend

• Individuals needing to conduct an effective QMS audit in accordance with the requirements of ISO 13485:2016 and ISO 91011:2018
• Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016
• Individuals interested in conducting first-party or second-party audits
• Senior Management
• Quality Managers
• Regulatory Affairs Managers
• Management representatives
• Consultant

Learning Objectives

• Understand the requirements of ISO 13485:2016, and the quality system requirements of Directives 93/42/EEC and 98/79/EC Know how to conduct internal quality system audits
• Understand the role of internal audits in the maintenance and improvement of management systems
• Plan and prepare for an internal audit
• Learn to gather evidence by observation, questioning and sampling
• Write factual reports on the compliance of the management system against the audit standards
• Participate in the corrective action process

Certificate

• There is a 1 hour open book exam at the end of this course.
• The exam demonstrates the successful delegate has attained a minimum level of competence in the ISO 13485:2016
• Upon completion of the course and passing the end of course exam you will receive a Safeworthy ISO 13485:2016 Internal auditor Certificate

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