Lead Auditor ISO 13485 Training – 5 Days - Virtual Classroom
March 18, 19, 22, 23, 24 -2021
This five day course is designed to give participants the tools, knowledge and skills necessary to perform EFFECTIVE audits of Management Systems.
This course includes either an on-site visit to an organisation to carry out an audit, or a specifically designed virtual audit. Almost 100% of our participants have confirmed this is an invaluable part of our training allowing them consolidate their leanings. All learning is through case study work and discussions.
Please note that participants attending the Lead Auditor course are expected to have prior knowledge of quality management principles and concepts, and the basic requirements of the relevant QMS standard. IQC will provide a “Pre-course” pack to all delegates approximately 10 days before the training commences.
We also offer an online LIVE Webinar for those that are new to the standard or those that need a refresher on the basics with our 3 hour fundamentals and one day foundation course.
As places are limited, book early to avoid disappointment.
Places cancelled within 10 working days of commencement must be paid in full. Substitutions may be made at any time at no additional charge.
Describe the purpose of a quality management system and explain the 8 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.