ISO13485: 2016 Internal Audit

Internal audit is a mandatory requirement of ISO 13485 2016 as it mandates the review and evaluation of the organisation’s quality management system QMS to evaluate its conformity with the ISO 13485 stipulated requirements, compliance with applicable regulatory requirements and whether the procedures within the QMS is effectively implemented.

An effectively conducted internal audit is crucial for the successful operation of a QMS as it provides documented audit results to the organisation which can provide inputs to the analysis aspect of business planning, and can contribute to the identification of improvement needs and necessary follow-up activities. And when an organisation closes the feedback loop it provides assurance that its product realisation processes are in a desired state of control.

This training is designed for participants who are new and also those seeking to enhance their auditing skill as it intends to produce a pool of internal auditors with the necessary skill and knowledge to conduct effective internal audits.

To provide participants with the necessary competence to plan, conduct, record, issue reports and perform the necessary audit follow-up activities. This training will be based on the ISO13485 2016 requirements with informative guidance from the ISO 19011 2018 Guidelines for Auditing Management System in extension from ISO 13485.

• Understand the ISO 13485 requirements for an internal audit.
• Knowledge on the principals of auditing, managing an audit, conducting the audit and guidance on the evaluation of an auditor competence and personality to add confidence to the audit performance.
• Optimise participants auditing skill in line with the ISO 19011 2018 standard.

Course outline

• ISO 13485 2016 requirements on internal audit.
• Terminology and Types of audits
• Principals of Auditing
• Establishing, Implementing and Managing an audit program
• Conducting the audit:
• Initiate the audit
• Preparation for the audit
• Develop the audit plan
• Assign audit responsibilities
• Audit work documents
• Determine the audit sequence flow
• Opening meeting
• Review of requested documents and communicate
• Audit evidence triangle and information verification
• Generate Findings
• Present Findings
• Audit follow up
• Auditors competence

At the end of the session, participants will:

• Gain an understanding to conduct an effective audit confidently to help your company to improve.
• Be knowledgeable on the perquisites prior to, during and after an internal audit.
• Gain practical knowledge and skill from the ISO 19011 2018 Guidelines for auditing management systems which reflects current ‘state of the art’.

Target audience

• This programme is designed for ALL functions and levels of an organization that need to gain knowledge and practical skills on internal auditing based on ISO 13485.
• This programme is particularly useful to those managing the quality management system, and internal auditors.

Pre-requisite

• Participants should have completed prior iso 13485 2016 qms training.