It is essential for modern organisations to have Management Systems in place and to effectively audit them in a way that is organised, systematic and that also adds value.
This course will assist auditors, particularly those who audit internally against any standard, (for example ISO13485 and cGMP to do so from a process-based perspective to check for Effectiveness, Conformance and identify Improvement opportunities. This programme is applicable to both the private and public sector.
Who should attend?
- 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.
IMPORTANT
Please note that participants attending the Auditor course are expected to have some 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, however, if you are new to ISO 13485 please consider one of our Fundamental and Foundation training courses.
You are required to have a copy of the relevant ISO standard. Your organisation will be able to provide this or you can purchase your own personal copy here
As places are limited, book early to avoid disappointment.
Cancellations
Places cancelled within ten 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 in relation to ISO 13485.
- Understand the structure and key requirements of ISO standards and regulations.
- Interpret requirements of standards and regulations in the context of an audit.
- Describe the role of the internal audit in the maintenance and improvement of management systems.
- 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 to determine conformance with requirements, effectiveness, and areas for improvement.
- Report the audit, including writing valid, factual, and value-adding audit reports
- Undertake audit follow-up activities, including evaluating the effectiveness of corrective actions.
- Professionally consult with external auditors. During the two 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.
Day 1 (summary)
- Management Systems & Quality Management Systems - Plan-Do-Check-Act cycle
- Structure of ISO standards for example ISO 13485
- Understanding process management
- Audit objectives - Auditing conformance, effectiveness, and improvement
- Scheduling of the audit programme on key processes and not areas of the Standard
- Audit preparation – understanding the organisation and its key processes.
- Checklists, Audit plans, Productive meetings (Opening Meetings) ]
Day 2 (summary)
- Conducting the audit.
- Teamwork, Collecting information, Communications.
- Human behaviour, Audit sampling, Audit findings
- Evaluating the effectiveness of the Quality System in addition to conformance audits
- Opening and Closing Meetings
- Virtual / Live Audit - Participants put into practice what they learned on Days 1 and 2.
- Writing the audit report - Taking corrective action - Management of the audit programme.
- Examination.