ISO 13485:2016 Internal Auditor Course

This is a Practitioner level course, focused on delivery of effective internal audits of a medical device quality management system (MD-QMS) designed to meet the requirements of ISO 13485:2016. This practical and interactive 2-day course will help you get the best from your internal quality audits providing a clear understanding of the purpose of a Quality Management System (QMS) for the manufacture of medical devices.

To celebrate the launch of our new website we are offering this course at a discounted price of £600 compared to our normal cost £1,075! This is a limited time offer and is available for any course on our current programme.

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£600.00 +VAT per delegate

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Course Details

Course length:

2 Days

Course price:

£600.00 +VAT per delegate

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Course Overview

What will I learn?

This training course will cover the following topics:

How to get maximum benefits from your internal audits.
Basic understanding of a process-based quality/medical device management system.
Steps to ensuring you become a value-added internal auditor.
Key steps you should follow to plan, prepare and perform an effective audit.
How to effectively perform the audit by knowing the right questions to ask.
How to write a nonconformity to deliver effective corrective action every time.
Relationship between quality management, production service conformity, regulatory requirements, and customer satisfaction.

Who Should Attend?

This course is for anyone who wishes to conduct effective internal audits on their medical device quality management system. Specifically, this course is aimed at:

Anyone new to internal auditing
Anyone involved in the process of auditing or auditing systems
Anyone wanting to improve their existing audits or medical device management system.
Those who have completed our ISO 13485 Foundation Course.

Our ISO 13485 Foundation Course will give you a good one-day introduction in preparation for this audit training course.

Course Benefits

This ISO 13485 training course will give you a thorough understanding of how to perform value added internal audits of your organisation’s processes. This will help you and your organisation to identify gaps in your medical device quality management system as a basis for improvement of regulatory compliance and system effectiveness.

Completing this training also allows you to demonstrate to your certificate body that your internal auditors have been trained to a recognised standard.

Our experienced trainers will assist in the interpretation of ISO 13485:2016, sharing their knowledge and experience, combining both soft audit skills and an appreciation of the standard’s requirements and the likely evidence available to you as an auditor. The ability to plan for and to conduct an audit are key. Gaining this ability will support your audits time after time allowing you to benefit from a defined framework, structured to consistently allow you to undertake effective internal audits. A real ‘how to’ guide for the audit of management systems.

Certified Learning

We were the first training organisation in the UK/Europe to hold IRCA approval for our internal and lead auditor courses within the medical device sector and we continue to be the leader in preparing IRCA-registered auditor courses.

This course is both CQI and IRCA certified (18203). Our company and our trainers undergo intensive inspection and assessment every year with the International Register of Certificated Auditors (IRCA). This means that the qualifications obtained from completion of this course are valid and will be recognised by your customers and certification body.

Course Standards

BSI Standards

A copy of ISO 13485:2016 will be available to you for the duration of your training – you now have the opportunity to obtain your own copy of the standard for use during and after the course.

QCS International are an authorised BSI Distributor of publications including ISO standards and can make available to purchase a full, licenced copy of ISO 13485. This option will be available to you at checkout.

Available Discounts

On the launch of the new QCS website we are excited to offer special discounts on all our training. This ISO 13485 internal auditor course will be available for £600, compared to our normal cost of £1,075! This is available for a limited time and has been applied to all courses on our current programme.

Take advantage of this offer before it’s removed.

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What they have to say

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Trainer was great, helped me understand ISO 9001 and how to implement into my organisation

The assistance and support we received from QCS allowed us to develop a useful and effective quality system that would make Scotland East and Midland Bluebird depots among the few public service bus operators to gain ISO9001 certification. The development of a quality system reflects what we do within our business, adds value and ensures we measure and meet one of the core requirements of the standard – continual improvement

Vic Duddy

Quality and Environmental Manager, First Group