Internal Auditor ISO 13485 Medical Devices
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Location options include, Basingstoke in Hampshire, Central London, Manchester, Nottinghamshire, Stratford Upon Avon, Cardiff and other UK locations. There are open course and dedicated course options. The Training Provider's course description is included below. Please click the Course Dates Tab above to see current course dates, or click a category link above to see more course and location options. Internal Auditor ISO 13485 Medical Devices
 
Course Description
BSI’s “Internal Auditor: ISO 13485” course is intended for medical device quality professionals aiming to build on their current knowledge of ISO 13485:2003 and evaluate the effectiveness of the quality management system in their organization. This intensive two-day course teaches the principles and practices of effective quality management systems process audits in accordance with the ISO 13485 and ISO 19011:2002. An experienced instructor guides students through the internal audit process, from planning an audit to reporting on audit results and following up on corrective actions. Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, and group workshops.

Learning Objectives
Upon completion of the training, participants will be able to:
-Explain the structure and scope of ISO 13485 management system standard and how it applies to the organization aiming for regulatory compliance worldwide
-Identify the principles of auditing and auditor responsibilities
-Plan an internal audit
-Conduct informal opening and closing meetings
-Conduct an audit based on process identification, sampling and questioning
-Provide verbal and written feedback
-Document concise nonconformities
-Effectively report on an audit
-Follow-up on corrective actions

Who Should Attend?
-Medical Device Quality professionals with knowledge of quality management systems and ISO 13485
-Individuals interested in conducting first-party or second-party audits
-Management representatives
-Internal auditors
-Managers
-Consultants

Prerequisites
This course does not detail the requirements of ISO 13485:2003.
Prior knowledge of the ISO 13485 standard, such as the overview provided in BSI’s ‘Introduction to ISO 13485 or previous work with ISO 13485 in an organization, is strongly recommended as a prerequisite for this course.




 
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Key Details
Duration2 days
 
£1,150
per delegate
 
 
Bookings Helpline: 01933 233884 (Monday to Thursday - 8:00am to 5:30pm and Friday 8:00am to 5:00pm).