Category Archives: 2 days Internal Auditor Training on ISO 13485 medical devices

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.

Additional Information:

Item Code: ISO13485
Pay Mode Terms: L/C (Letter of Credit),T/T (Bank Transfer),D/A,Other

2 days Internal Auditor Training on ISO 13485 medical devices

2 days Internal Auditor Training on ISO 13485 medical devices

Posted on by owner
15
Feb

Certainly! Training as an internal auditor for ISO 13485, which is the international standard for quality management systems for medical devices, is crucial for ensuring compliance and effective quality management within a medical device manufacturing organization. Here’s an outline for a 2-day training program: Day 1: Understanding ISO 13485 and Quality Management Systems Morning Session: […]

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