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Lead Auditor ISO 13485

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Lead Auditor ISO:13485. December 06, 07, 10, 11, 12

Dublin €985

Lead Auditor

Please note that participants attending the Lead Auditor are expected to have prior knowledge of quality management principles and concepts, and, the requirements of the relevant QMS standard. IQC will provide this knowledge to you at no extra cost.

This course typically includes either an on-site or a Virtual Audit. Almost 100% of our participants have confirmed this is an invaluable part of the training allowing them consolidate their leanings. All learning is through case study work and discussions; there is no PowerPoint.

As places are limited, book early to avoid disappointment.

All Dublin courses are held in the Maldron Hotel, Newlands Cross, Dublin.

Please check for other locations

Places cancelled within 10 working days of commencement must be paid in full. Substitutions may be made at any time at no additional charge.

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Lead Auditor – ISO 13485 Course Background

It is essential that personnel involved in the development, implementation and auditing of quality management systems understand standards such as ISO 13485 and Good Manufacturing Practices (GMP’s) in detail. It is also necessary to be able to liaise appropriately with outside regulatory bodies and to represent your organisation in auditing suppliers in a professional, thorough and fair manner against regulatory or Quality Management Standards.

This intensive IRCA certified course will evaluate and focus on the requirements of the ISO 13485 and GMP’s in great detail and will demonstrate good auditing practice that reflects best in class standards.


  • Describe the purpose of a quality management system and explain the 7 principles of quality management.
  • Explain the purpose, content and interrelationship of ISO 9000, ISO 13485, GMP’s, ISO 9004 and ISO 19011.
  • Interpret requirements  of ISO 13485 and GMP’s in the context of an audit.
  • Manage an audit programme.
  • Understand the different types of audits.
  • Describe the roles and responsibilities of auditors and lead auditors.
  • Plan and conduct an audit in accordance with ISO 19011, demonstrating ability to…
    • Plan and prepare effectively
    • Gather objective evidence, through effective interviewing, observation, sampling and note taking.
    • Analyse and interpret information in order to determine conformance with requirements.
    • Report the audit, including writing valid, factual and value-adding non-conformity reports.
    • Undertake audit follow-up activities, including evaluating the effectiveness of corrective action.
    • Professionally liaise with external auditors.

During the 5 days participants will acquire knowledge and skills in auditing. However, auditing like any other acquired skill requires practice. The best place to practice and extend your experience is during actual audits.

Course Itineary

Day 1

  • Fundamentals of Quality & Quality Management Systems
  • Understanding ISO 13485 and GMP’s – Case Study
  • Using Process Management to manage and improve the business
  • Establishing Key Performance Indicators (KPI’s)
  • Measuring process performance
  • Continual Improvement
  • Integrating 13485 and GMP’s with the business needs.

Day 2

  • Exercises on applying ISO 13485 and GMP’s
  • Exercises on objectivity.
  • Introduction to Quality Auditing
  • Planning the audit programme…
    • scheduling audit programme by process and not clause of standard
    • how to select internal and external auditors
    • Audit preparation and looking at the critical success factors for your organisation.
    • Understanding the organisation and its key processes – teamwork.
    • Exercise on preparing a checklist.

Day 3

  • Exercises on applying ISO 13485 and GMP
  • Guidelines for productive meetings.
  • Opening meeting exercises.
  • Improvement Audits
  • Carrying out the audit…
    • teamwork
    • collecting information
    • communications
    • human behaviour
    • audit sampling
    • evaluating the effectiveness of the Quality Management System in addition to conformance audits
    • Audit findings
  • Exercise on Closing Meeting
  • Preparing an audit plan relating ISO 9001 and GMP’s

Day 4

  • Participants carry out a live audit in an organisation and put into practice what they learnt on Days 1-3
  • Feedback from live audit and learning points.
  • Writing the Audit Report
  • Taking corrective action
  • How to interpret different situations during an audit.

Day 5

  • Case Study on auditing the effectiveness of processes.
  • How to deal with external auditors.
  • Examination
  • Course Evaluation


December 6
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Philip Byrne


Maldon Hotel Newlands Cross, Naas Road, Newlands Cross
Dublin 22,Co. DublinD22 V6Y6Ireland
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