Training | Consultancy | Auditing 

 PR 369: MD-QMS ISO 13485:2016 Lead Auditor 5 days Course ID: 2431 Virtual Classroom 9 Delegates Maximum per training 

4,5,8,9,10 Aug 2022 ATP Number:11800057   

€1,195   Price includes training, all training materials, pre-course study materials, IRCA registration, refreshments during the training where applicable.  Need a quote for In-house Training e mail us today  

It is essential that personnel involved in the development, implementation and auditing of quality management systems understand standards such as ISO 13485. 
It is also necessary to be able to liaise appropriately with outside bodies and to represent your organisation when auditing suppliers. IRCA certified auditors conduct audits in a professional, thorough and fair manner against regulatory or Quality Management Standards. 
This intensive 5-day IRCA certified course will evaluate and focus on the requirements of the ISO 13485 in detail and will demonstrate good auditing practice that reflects best in class. 
Learn how to effectively perform internal, supplier and third party audits of quality management systems. On completion of the examination and continuous assessment delegates will receive a certificate of achievement that satisfies the formal training requirement for certification as a CQI/IRCA* auditor or lead auditor. 
* (Chartered Quality Institute and International Register of Certificated Auditors) 
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 learnings. All learning is through case study work and discussions; there is no PowerPoint. 
Who should attend? 
Lead Auditors. 
Internal auditors. 
Quality Managers and those with internal auditing / self inspection responsibilities across all departments. 
Senior Departmental Management and Area/Process Owners. 
Those who want to pursue a career as an Auditor/Lead Auditor. 
Anyone responsible for or aspiring to conduct internal QEHS Management System audits. 
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 7 days before the training commences, however, if you are new to ISO 13485 please consider one of our Fundamental and Foundation training courses. 
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. 
Course Objectives 
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. 
Course Itinerary (Summary) 
Fundamentals of Quality & Quality Management Systems and Aligning ISO 13485 to core business objectives. 
Using Process Management to manage and improve the business. 
Establishing Key Performance Indicators (KPI’s) and Measuring process performance. 
Introduction to Quality Auditing. 
Planning the audit programme. 
Scheduling audit programme. 
Selecting internal and external auditors. 
Audit preparation and looking at the critical success factors for your organisation. 
Understanding the organisation and its key processes. 
Using Checklists. 
The Audit Lifecycle. 
Participants carry out either a live audit in an organisation or a detailed virtual audit. 
Guidelines for productive Opening and Closing meetings. 
Carrying out the audit. 
Objective Evidence. 
Audit findings and Classification. 
Writing the Audit Report. 
Corrective action and effectiveness. 
How to deal with external auditors. 
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