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ISO 13485 Lead Auditor Training Features

ISO 13485 Lead Auditor Training is designed to give you the relevant skills and knowledge to carry out audits of Quality Management Systems for Medical Devices (QMS). The principles of ISO 13485 set out an explicit management system so that you can audit, examine and continually improve systems for a QMS.


ISO 13485 Lead Auditor Training Outcome

  • Understand the requirements of ISO 13485:2003, and the quality system requirements of Directives 93/42/EEC and 98/79/EC

  • Understand the role of internal audit in the maintenance and improvement of management systems

  • Possess in-depth knowledge of the ISO 13485:2003 audit and certification process

  • Have the skills and knowledge needed to plan and conduct third party audits against the requirements of the ISO 13485:2003 and report the compliance of the management systems against the standard requirements so that any corrective action can be undertaken.

  • Over five rigorous days, discuss background of the ISO 13485 and ISO 9001 standards and go through every phase of the audit – from planning to conducting to following up – so you will be able to lead your own audits efficiently and effectively.

  • QA System Assessment: A proactive approach to quality assurance in the medical device industry; covers elements that comprise a total quality system, including policy, manual, procedures, and instructions.

  • Understanding the Requirements: Discuss the requirements of ISO 9001 and ISO 13485, as well as applicable industry regulations.

  • The Audit Cycle: Using ISO 19011, with practical hands-on workshops, learn about audit functions: pre audit activities; conducting the audit (assessment); post audit and follow-up activities.

  • Pre Audit Activities: Using interactive workshops (syndicated activities), learn to plan audit activities, develop checklists, perform pre assessment visits, and conduct opening meetings.

  • Conducting the Audit (Assessment): Use hands-on workshops to learn how to collect objective evidence; covers active listening and questioning techniques, as well as methods to help handle confrontations.

  • Post Audit and Follow-Up Activities: Through workshops and assignments, learn how to conduct closing meetings, write effective audit reports, issue nonconformance forms and corrective action reports, assess corrective action, close out nonconformances, and conduct surveillances.


ISO 13485 Lead Auditor Training Content

  • Overview of auditing

  • Interpretation of ISO 13485

  • Quality system documentation

  • Quality manual and procedures

  • The audit cycle and ISO 19011

  • Pre audit activities: opening meeting and checklists

  • Auditing practices; the psychology of auditing

  • Nonconformity reporting

  • Performing the audit

  • Closing meeting

  • Process auditing

  • Report writing

  • Final report

  • Follow-up and corrective action

  • Final examination (2 hours)


Who Should Attend ISO 13485 Lead Auditor Training

Although originally designed to train third-party auditors, most participants lead their company’s quality system implementation and/or audit programs. Ideal for anybody involved in a supplier quality assurance program.


ISO 13485 Lead Auditor Training  Achievement

Upon SUCCESSFUL completion of the ISO 13485 Lead Auditor Training a Certificate of “ISO 13485 Certified Lead Auditor Training” will be issued.




ISO 13485 Lead Auditor Training Duration- 05 days


Value added ISO 13485 Lead Auditor Training

Accelerate learning with the expert faculty Lead Auditors and Principal Trainers from the Industry. ISO 13485 Lead Auditor Training from the "Specialist Expert" has many advantages:-


  • It will drastically change the way of thinking and basic approach towards the Management System Standards.