ISO 13485 Lead Auditor Training Conducted by Industry Experts,customized for you to 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. In fact, 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 LEAD AUDITOR
TRAINING
ISO 13485 Lead Auditor Training Features
ISO 13485 Lead Auditor Training is designed to give you the relevant skills and
knowledge to carry out audits of Quality Management Systems for Medical Devices
(QMS). The principles of ISO 13485 set out an explicit management system so that you
can audit, examine and continually improve systems for a QMS.
ISO 13485 Lead Auditor Training Outcome
● Understand the requirements of ISO 13485:2003, and the quality system
requirements of Directives 93/42/EEC and 98/79/EC
● Understand the role of internal audit in the maintenance and improvement of
management systems
● Possess in-depth knowledgeof theISO 13485:2003audit and certificationprocess
● Have the skills and knowledge needed to plan and conduct third party audits
against therequirementsof the ISO 13485:2003and report the complianceof the
management systems against the standard requirements so that any corrective
action can be undertaken.

5. ● Over five rigorous days, discuss background of the ISO 13485 and ISO 9001
standardsand go through every phaseof the audit – from planning to conducting
to following up – so you will be able to lead your own audits efficiently and
effectively.
● QA System Assessment: A proactiveapproach toqualityassurancein the medical
device industry; covers elements that comprise a total quality system, including
policy, manual, procedures, and instructions.
● Understanding theRequirements: Discussthe requirementsofISO 9001and ISO
13485, as well as applicable industry regulations.
● TheAudit Cycle: Using ISO 19011, with practicalhands-onworkshops, learnabout
audit functions: preaudit activities; conducting theaudit (assessment);post audit
and follow-up activities.
● Pre Audit Activities: Using interactive workshops (syndicated activities), learn to
plan audit activities, develop checklists, perform pre assessment visits, and
conduct opening meetings.
● Conducting the Audit (Assessment): Use hands-on workshops to learn how to
collect objective evidence; covers active listening and questioning techniques, as
well as methods to help handle confrontations.
● Post Audit and Follow-Up Activities: Through workshops and assignments, learn
how to conduct closing meetings, write effective audit reports, issue
nonconformance forms and corrective action reports, assess corrective action,
close out nonconformances, and conduct surveillances.
ISO 13485 Lead Auditor Training Content
● Overview of auditing
● Interpretation of ISO 13485
● Quality system documentation
● Quality manual and procedures
● The audit cycle and ISO 19011
● Pre audit activities: opening meeting and checklists
● Auditing practices; the psychology of auditing
● Nonconformity reporting
● Performing the audit
● Closing meeting
● Process auditing
● Report writing
● Final report
● Follow-up and corrective action
● Final examination (2 hours)

6. Who Should Attend ISO 13485 Lead Auditor Training
Although originally designed to train third-party auditors, most participants lead their
company’s quality system implementation and/or audit programs. Ideal for anybody
involved in a supplier quality assurance program.
ISO 13485 Lead Auditor Training Achievement
Upon SUCCESSFUL completionof the ISO 13485 Lead Auditor Traininga Certificateof
“ISO 13485 Certified Lead Auditor Training” will be issued.
CPD-40
CEU-4.0
ISO 13485 Lead Auditor Training Duration- 05 days
ISO 13485 Lead Auditor Training Calendar [ Click Here ]
Value added ISO 13485 Lead Auditor Training
Accelerate learning with the expert faculty Lead Auditors and Principal Trainers from
the Industry. ISO 13485 Lead Auditor Training from the "Specialist Expert" has many
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 Lead Auditor Training