ISO 13485 Lead Auditor Practitioner (Classroom & Asynchronous)
About This Course
LO1. Interpret the requirements of ISO 13485 in the context of an audit.
LO2. Describe the purpose of a quality management system and explain the 8 principles of quality management.
LO3. Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011.
LO4. Plan, conduct, report and follow-up on a QMS audit in accordance with ISO 19011 and by interpreting ISO 13485.
LO5. Manage the duties of a lead auditor in their organization or for a third-party.
What You'll Learn
Consolidate your expertise with the latest developments and contribute to the continuous improvement of your quality system, leading to greater patient safety. You’ll grasp the key principles and practices of effective QMS audits in line with ISO 13485:2016 and ISO 19011 “Guidelines for auditing management systems”.
Using a step-by-step approach, you’ll be guided through the entire audit process from initiation to follow-up on a QMS audit that establishes conformity and enhances overall organizational performance.
Entry Requirements
• Aged 21 and above;
• Have minimum GCE “N”, “O” or “A” Level / NITEC or a diploma qualification and minimum 1 year of working experience; and
• Have an English language proficiency equivalent or higher of any of the following - GCSE N/O Levels pass in English / WPLN Level 5 / IELTS 5.5 / TOEFL (internet based total) 46-59.