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Why our ISO 13485 Lead Auditor Training Course

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Page 1: Why our ISO 13485 Lead Auditor Training Course

Why our ISO 13485 Lead Auditor Training Course?

Page 2: Why our ISO 13485 Lead Auditor Training Course

●For over 10 years, Kelmac Group® was providing ISO 13485 based training to various organizations

including initially offering what was known as a variant of our IRCA Certified QMS Auditor/Lead

Auditor but with specific emphasis on ISO 13485 (and ISO 9001) under the IRCA variant scheme at

the time and offered this course for many years successfully.

●As a result, Kelmac Group® offer an IRCA Certified QMS Auditor/Lead Auditor based on ISO

13485:2012 Training Course under a unique course accreditation number – A17584.

●We were originally offering this course in Ireland and it was very well received by industry as the

course materials, delivery, case study and examples were tailored specific for the Medical Devices

Industry and of course taught by real experts with experience in the Medical Devices sector in terms

of industry experience, lead auditing and implementation projects for many, many years.

Page 3: Why our ISO 13485 Lead Auditor Training Course

What Kelmac Group Offer?

●Kelmac Group® are now offering this class publicly in Ireland, UK and U.S. It is also available to be

delivered onsite to clients for groups of 4 up to 20 per class.

●Where a class exceeds 10 students, a support instructor is required (IRCA requirement).

●Additionally with any lead auditor training course, it is strongly recommended that the individual

attending has a good working knowledge of the requirements of ISO 13485.

Page 4: Why our ISO 13485 Lead Auditor Training Course

What are some the benefits of our training?

●O e of ou o e t ai i g oto’s is o o e death y Po e Poi t – meaning very little slides but

more engagement, hands on and interactive – which is based on the latest best practices for

adult learning.

●Ou pe fo a e ased t ai i g goes eyo d IRCA e ui e e ts, o e i g all of Ki kpat i k’s level 2 and 3 and some of 4 which is a fine achievement.

●We also provide our students with access to an online library of relevant ISO standards,

additional reference and study material in advance of the training and available for a limited

period upon completion of the training too.

Page 5: Why our ISO 13485 Lead Auditor Training Course

Where can you learn more?

Well, if you navigate to our training section under ISO 13485, you will find a list of available

training courses which include training on the requirements, internal auditor, lead auditor courses

and some other tailored training. Not all courses are available for individual sign up on a public

course, but all training courses are available to be delivered onsite at a client facility for groups

and courses can also be tailored to meet specific needs and requirements.

Page 6: Why our ISO 13485 Lead Auditor Training Course

Contact Us

Kelmac I Group, Inc

+1 312.496.6607 (Local) Call: 1.800.847.1258 (Toll Free)

Email : [email protected]

Website: Kelmac USA : http://www.kelmacinternational.com Kelmac UK : http://www.kelmactraining.co.uk Kelmac Ireland : http://www.kelmacgroup.com

Address:

875 N. MICHIGAN AVE.,SUITE 3100, CHICAGO, IL 60611, UNITED STATES | PHONE: +1.312.496.6607