Internal Quality Auditing Course for Manufacturers of Medical Devices

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This programme is available In-House and currently delivered through virtual classroom training. Internal auditing is fundamental to any quality improvement initiative. In particular, ISO 13485 and the FDA Quality System Regulation for Medical Device... Read More

This programme is available In-House and currently delivered through virtual classroom training.

Internal auditing is fundamental to any quality improvement initiative. In particular, ISO 13485 and the FDA Quality System Regulation for Medical Devices require that an organisation conducts internal quality audits to determine the effectiveness of its quality system. Trained auditors must carry out these audits.

Thousands of internal audits are performed each year providing little internal business benefit. This course focuses on auditing ISO 13485 or the FDA QSR for real quality improvement rather than just compliance.

This two day course provides detailed training in developing the skills necessary to be an effective internal auditor.

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Please Note: A practical audit within the company forms the basis of day 2. Audit areas within the company must be organised prior to the training so that effective preparation can commence on day 1. For this reason the numbers on this course are restricted to max 12 (4 audit groups of 3) to ensure all delegates get the attention needed to ensure they become effective Auditors.

Day 1:

Introduction to Quality Systems
Purpose of Internal Audits
The Audit Process
Selecting the Audit Team & Audit Behaviour (Assumptions, Effective Listening, Dealing with Conflict)
Tools available to Auditors
Review of Internal Quality Audit Procedure
Audit Preparation

Day 2:

Audit Preparation (follow on from day 1)
Practical on site audit
Evaluating & Reporting the Audit

Delegates must attend both days to receive a Certificate of Attendance

Any person in the organisation with responsibility for conducting internal audits
Departmental managers and supervisory staff
Quality Managers, quality engineers and supervisory staff
Staff with responsibility for designing and implementing quality systems
Personnel responsible for supplier / external audits

Participants achieve the following learning outcomes from the programme;

Understand the importance of internal auditing within a quality management system
Understand the responsibilities of Internal Auditors
Conduct an effective internal audit e.g. plan and prepare for an internal audit against the organisation’s documented procedures and specific sections of ISO 13485 or the FDA Quality System Regulation for Medical Devices
Collect and analyse evidence objectively
Evaluate and report the results of an internal audit

John Lafferty

John Lafferty is a Quality professional with over 25 years expe...

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Kevina O’Donoghue

Kevina takes great pride in the training she delivers. She unde...

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Snapshot

Course Code

LS019

Duration

2 training days

Delivery Mode

Available for In-House and delivered through virtual classroom training.

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