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#ISO 13485 LEAD AUDITOR CERTIFICATION HOW TO#
#ISO 13485 LEAD AUDITOR CERTIFICATION SOFTWARE#
#ISO 13485 LEAD AUDITOR CERTIFICATION ISO#

Plan and conduct an interview with top management and evaluate an organisation’s quality policy and objectives.

Roles and responsibilities of an auditor / lead auditor.

#ISO 13485 LEAD AUDITOR CERTIFICATION ISO#

To analyse ISO 13485 clauses and suggest examples of evidence that would show conformance with these requirements.Purpose of a QMS based on ISO 13485 and the ISO 9000 principles of quality management.Individuals within the medical devices sector who wish to add credibility with a widely accepted qualification.Auditors or Quality System Managers who need to audit against ISO 13485 requirements.This four day course is designed to provide a detailed understanding of the role and responsibilities of an Auditor/Lead Auditor, covering topics including audit processes and planning, gathering objective evidence and evaluation of audit findings. United Arab Emirates (English) United Arab Emirates (English).South Africa (English) South Africa (English).Singapore (English) Singapore (English).Saudi Arabia (English) Saudi Arabia (English).Portugal (Português) Portugal (Portuguese).Norge (Nynorsk) Norway (Norwegian Nynorsk).Nederland (Nederlands) Netherlands (Dutch).Magyarország (Magyar) Hungary (Hungarian).Indonesia (Indonesian) Indonesia (Indonesian).Hong Kong SAR (English) Hong Kong SAR (English).Australia (English) Australia (English).United States (English) United States (English).Česká republika (čeština) Czech Republic (Czech).United Kingdom (English) United Kingdom (English).He has presented hundreds of toastmaster speeches and also won the 2009 District 31 humorous speech contest. He is an active member of Toastmasters International and has received two advanced communicator gold awards.

#ISO 13485 LEAD AUDITOR CERTIFICATION SOFTWARE#

In 2005, the Quality Engineer (CQE) certification in 2009, and the Software Quality Engineer (CSQE) certification in 2010. He earned the American Society of Quality (ASQ) Six Sigma Black Belt (SSBB) certification He is an expert in medical device quality management systems and an experienced quality manager. While at Molnlycke, Waters, and Covidien. He is an experienced trainer that has led multiple training workshops in process validation, CAPA, failure investigation, and quality auditor He has over 15 years of medical device manufacturingĮxperience which includes 10 years of compliance auditing and 9 years managing quality teams. He has worked with a wide range of medical devices from simple class I disposable medical devices to advanced class III surgical instruments. Prior to Molnlycke, he worked at Waters Corporatoin, Covidien, Cardinal

Please note: T his course is being held virtually.Īaron Snyder currently works at Molnlycke Healthcare as the Global Quality Systems Director located in Gothenburg Sweden.

access to the AAMI Alumni community group.

a QMS auditing exam qualification record.

OnDemand access to the recordings following the event (you don’t have to be available live to take advantage of all the learning).

The latest on MDSAP and EU MDR status and best practices for working with Notified Bodies.

#ISO 13485 LEAD AUDITOR CERTIFICATION HOW TO#

Hands-on advice on how to meet FDA expectations for audit procedures, auditor qualifications and audit records.(This is “must-have knowledge” during this pandemic!) How to conduct effective “remote/virtual” QMS audits.Best practices in the interpretation and application of AAMI and other standards.Current requirements for internal audits in today's international medical device market.Over two information-packed, interactive days, participants will learn… We’ll also provide coverage of ASQ/ANSI/ISO 19011:2018, Guidelines For Auditing Management Systems. Now, auditors can also benefit from the expertise and rigor of AAMIįaculty as they learn today’s best practices for conducting internal audits and supplier audits for compliance with FDA, ISO, MDSAP and EU MDR requirements. International Standards Conference 2022įor years, AAMI courses have been the gold standard for training on the implementation of FDA 21 CFR Part 820 Quality System Regulation and ANSI/AAMI/ISO 13485: 2016/(R)2019.