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ISO Internal Auditor Training

Complete our Internal Auditor ISO 13485 Training Course to guarantee the highest quality standards and remove barriers to market for medical devices in your business. Gain the necessary auditing skills to confidently guide your organization towards ISO 13485 accreditation – an essential standard for all medical device manufacturers.

ISO 13485 outlines quality management system requirements for design, development, production and servicing of medical devices and related services. Get to grips with the entire internal auditing process, learn to plan audits, report on results and lead on follow up action.

This training develops the skills needed to assess and report on the conformance and effective implementation of processes, and to contribute to the continual improvement of a quality management system based on the ISO 9001:2008 standard.

On completion of this training course you will be able to:

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

• Explain the purpose and structure of ISO 9001:2008

• Plan and prepare for an internal audit, gather audit evidence through observation, interview and sampling of documents and records

• Write factual audit reports that help to improve the effectiveness of the QMS

• Suggest ways in which the effectiveness of corrective action might be verified

The training comprises presentations, workshops and role-play exercises.

Please note: Participants are not expected to possess knowledge of auditing, quality management systems or ISO 9001:2008 before attending the course.

IRCA Accreditation

We are accredited by the International Register of Certified Auditors (IRCA) globally, but we offer a mix of accredited and non-accredited courses to meet your needs. Your local SGS office will have full details of courses available in your region.

Why choose ISO 9001 internal auditor training from SGS?

Our courses are delivered by tutors who are quality management system experts and experienced trainers. Your knowledge and skills will be developed through an interactive and practical approach to learning.

Learning Outcomes

On completion of the course participants will have an understanding of:

• How to establish an effective audit program

• How to schedule audits on the basis of risk and importance of processes

• How to prepare effective audit checklists

• How to conduct audits and prepare effective audit reports

• How to review and follow up corrective actions

Course Outline

This course covers the following topics:

• Introduction to the Principles and Practices related to Internal Auditing

• Overview of the Internal Audit Process

• Audit Scheduling including the various styles of auditing and how to maintain an audit schedule

• Audit Planning – setting and reviewing the audit criteria, preparing audit documents, review of the types of work documents, checklists and flow charts

• Characteristics of an Effective Auditor

• Conducting an Audit - the audit process, entry/opening meeting, information and evidence gathering, recording evidence, using various evidence gathering techniques, evaluating evidence, audit debrief preparation, conducting the audit debrief/closing meeting

• The Audit Report– who are the customers of the report, reviewing report writing styles, the content of the report, preparing the report, raising non-conformances

• Follow-up Actions – corrective and preventative action, internal audits and management reviews

• Establishment, implementation, monitoring, review and improvement of an audit program

The course includes a number of practical activities including role plays, cases studies, group discussions and team exercises.

Course Fee Inclusions

The fee for this course includes all pre-course administrative support, comprehensive course notes, lunch & refreshments.

Delegates will be issued with copies of the relevant Standards relating to Quality, Safety, Environment and Food Safety for use during the course. To support delegate learning and for post-course reference, hard copies may be purchased during the registration process for delivery during the course.