ISO 13485 Internal Auditor  training Conducted by Industry Experts,customized for you & connect with relevance to your Industry & Processes

1. “If you do not know the subject well enough
You can not explain it simply enough”
Albert Einstein

2. With decades of hands on Industry Experience, and hundreds of
ISO audits, our Principal Trainers help you translate:-

3. Infact we do not teach you, but involve you and engage you one
hundred percent. To ideate, to discuss, to brainstorm.
Are you Ready to get involved?

4. www.isocertificationtrainingcourse.org
registrar@isocertificationtrainingcourse.org
ISO 13485 Internal Auditor
training
ISO 13485 Internal Auditor training Objectives
ISO 13485 InternalAuditor training suitablefor thosewishing toconductinternalaudits
to ISO 13485. This 3-day ISO 13485 Internal Auditor training enables delegates to
interpret therequirementsof the ISO 13485 medicaldevices standard from an auditing
perspective, conduct effective audits and produce audit findings.
Delegatescompleting theISO 13485 internalauditing trainingwillbe able to audit their
quality management system for conformity to ISO 13485, the effectiveness of their
business processes, and to identify opportunities for improvement. Improving Medical
Devices-QMS performance and continual improvement are key elements of this ISO
13485 Internal Auditor training.
ISO 13485 Internal Auditor training will help you understand the underlying
philosophy, principles, concepts, and requirements of the ISO 13485 Standard, the
application of this International Standard within your organization and the skills
necessary to conduct an ISO 13485 management system audit.
ISO 13485 Internal Auditor training Course Content Outline
Audit Fundamentals
Definitions, purpose, types
Quality Management Systems (Medical Devices)
In-depth discussion on ISO 13485:2003 Standard requirements
GMP background and FDA requirements
What is auditing. Audits: Definition, Principles
Defining an Internal audit process Audit Planning & Preparation
Conducting the Audit & Audit Review
Audit Reporting and Follow-Up
Types of audits – 1st, 2nd & 3rd party audits?

5. 3rd party auditing process and certification requirements
Definitions of key words in ISO 13485 and GMP Standards
Review of Standard Requirements and Summary of Key Points
General requirements
Changes from old Standard and newly emphasized points
General review of 5 major categories
Quality Management System
Management Responsibility
Resource Management
Product Realization
Measurement, Analysis and Improvement
Type of Findings
Minor non-compliances
Major non-compliances
Recommendations
Corrective actions/follow-up
ISO 13485 Internal Auditor training Course Format
The format of the ISO 13485 Internal Auditor utilises accelerated learning techniques
and is therefore highly interactive, with tutor-led sessions interspersed with individual
and group exercises. A realistic case study and role-play activities provide an excellent
opportunity to practice ISO 13485 auditing skills.
Who should attend ISO 13485 Internal Auditor training
ISO 13485 Internal Auditor training is valuable for delegates involved in the planning
and implementation of ISO 13485:2003 based quality management systems as well as
for personnel who will manage, conduct or participate in ISO 13485:2003 audits.
ISO 13485 Internal Auditor training Achievement
Upon SUCCESSFULcompletionoftheISO 13485 InternalAuditor training a Certificate
of “ISO 13485 Certified Lead Auditor Training” will be issued.
CPD-16
CEU-1.6
ISO 13485 Internal Auditor training Duration- 02 days
ISO 13485 Internal Auditor Training Calendar [ Click here ]
Value added ISO 13485 Internal Auditor training

6. Accelerate learning with the expert faculty Lead Auditors and Principal Trainers from
theIndustry. ISO 13485 InternalAuditor training from the"Specialist Expert"hasmany
advantages:-
● It will drastically change the way of thinking and basic approach towards the
Management System Standards.
● You would cherish & Benchmark our training for a very long time to come.
● No fictitious case studies you can not connect with.
● Real time examples, real time scenarios you can quickly relate to.
● Complete Focus on your systems, processes and line of businesses.
● 100% involvement and engagement of the participants
● Learn to make the ISO Standard sweat to:-
A). Improve the profits.
B). Reduce rework, defects, customer rejections, wastage,& cost of operation
C). Enhance customer delight
D). Reduce attrition of customers and employees
E). Enhance confidence of all stakeholders
ISO 13485 Internal Auditor training