Description

What you will gain:
Higher Effectiveness and Efficiency on their Job Excellent
Career Enhancement Opportunity
Internationally Recognized Qualification
Photo-identity Card from ASCB(Europe) Ltd. – UK Listing among an International list of Quality Professionals.

Lead Auditor: ISO 13485” course teaches the principles and practices of effective quality management systems and process audits in accordance with ISO 13485:2003 and ISO 19011:2002, “Guidelines for Quality and/or Environmental Management Systems Auditing.”

Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results. Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, and open forum discussions.

Important to delegates

This examination is ‘closed book’.
Participants may use their copy of the requirement standard and a dictionary – these are the only items permitted for reference.

Training course objectivesLearning objectives

Upon completion of the training, participants will be able to:
• Interpret the requirements of ISO 13485 in the context of an audit
• Explain the relationship with ISO/TR 14969 and the ISO 9000 series
• Describe the purpose of a quality management system and explain the 8 principles of quality management
• Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011
• Plan, conduct, report and follow-up on a QMS audit in accordance with ISO 19011 and by interpreting ISO 13485
• Manage the duties of a lead auditor in their organization or for a third-party

Prerequisite

This course teaches auditing principles using ISO 13485, therefore a basic knowledge of ISO 13485:2003 and its application within a Medical Device organization is strongly recommended together with internal audit experience.