What is the ISO 13485:2016 Standard?
ISO 13485 Lead Implementer Certification is designed to validate the skill set of designing, managing, and implementing a quality management system for medical devices. The latest version of the ISO 13485 Standard was released in 2016. Organizations require certified professionals while applying this standard and its requirements into their structure. As a result, professionals certified with ISO 13485 Lead Implementer Certification get recognition from organizations that manufacture medical devices and related services. It is mandatory for medical device manufacturers to comply with the ISO 13485 Standard requirements. Organizations that are certified with ISO 13485 standard further reap the benefits of untapped markets and overall performance.
ISO 13485 Lead Implementer Certification Training
Pursuing ISO 13485 Lead Implementer Certification requires individuals to first attain the ISO 13485 Lead Auditor Certification. Professionals can apply for ISO 13485 Lead Implementer Training sessions offered by Unichrone. On completing the training sessions, candidates can take up the exam and score the required marks to obtain the certification of ISO 13485 Lead Implementer. During the training session, candidates gain a comprehensive understanding of the standard and its requirements. In addition, professionals can master the skills of maintaining MDQMS in conformance with the ISO standard. Individuals who are willing to broaden their scope and gain knowledge on ISO 13485:2016 standard can enroll for the training sessions conducted globally.
Key Features of ISO 13485 Lead Implementer Certification Training
ISO 13485 Lead Implementer Certification is designed to enable individuals in implementing the standard. Candidates enrolling for ISO 13485 Lead Implementer Certification Training gain practical knowledge of implementing the standard. Our certified trainers further assist professionals in attaining insights through real-time scenarios. This entitles certified Lead Implementers to implement the standard as per the requirements specified by ISO. Furthermore, candidates can enroll in live online method or in-class method of ISO 13485 Lead Implementer Training.
- 4 Day Interactive Instructor –led Online Classroom or Group Training
- Course study materials designed by subject matter experts
- Mock Tests to prepare in a best way
- Highly qualified, expert & accredited trainers with vast experience
- Enrich with Industry best practices and case studies
- ISO 13485 Lead Implementer Course adhered with International Standards
- End-to-end support via phone, mail, and chat
- Convenient Weekday/Weekend ISO 13485 Lead Implementer Training Course schedule
Corporate Group Training
- Customized Training
- Live Instructor-led
- Onsite / Online
- Flexible Dates
|ISO 13485 Lead Implementer Exam Format|
|Exam Name||ISO 13485 Lead Implementer Certification|
|Exam Format||Multiple Choice|
|Total Questions||100 Questions|
|Passing Score||70% of Total Score|
|Exam Duration||120 Minutes|
ISO 13485 Lead Implementer Course Curriculum
1.Introduction to ISO 13485:2016
- · What is ISO 13485:2016?
- · Importance of ISO 13485 for an organisation
2.A Overview of ISO 13485:2016 Requirements
- · General requirements
- · Documentation requirements
- · Management responsibility
- · Resources
- · Product realisation
- · Infrastructure
- · Risk management
3.Implementation Phases of the ISO 13485 Frameworks
- · Stages to implementation
- · Gap analysis
- · Process mapping
4.Conducting an ISO 13485 Certification Audit
- · Certification audits
5.The Relationship Between ISO 13485 and ISO 9001
- · Scope
- · Focus
- · Continual improvement
- · Terminology
- · Differences between the standards
- · Similarities between ISO 13485 and ISO 9001
- · Internal audit objectives
- · Auditing skills
- · Internal audit objectives
- · Records and follow-ups
- · Using correct procedures in reference to the 9001:2015 standard
7.Internal Audit Plan
- · The audit plan
- · Criteria
8.The Audit Process
- · Conducting process audits
- · Internal audit scope and criteria
- · Reporting audit findings
9.Internal Audit Evidence and Findings
- · Classification
- · The closing report
- · Nonconformities
- · Documented procedure
10.Roles and Responsibilities
- · Internal Auditor responsibilities
- · Closing meeting
- · Management responsibilities
11.Resource Management and Product Realisation
- · Provision of resources
- · Infrastructure
- · Planning and development of products
12.ISO 13485 and Quality Management Systems
- · ISO 13485 and Quality Management Systems
13.Principles of Quality Management System
- · Customer and regulatory focus
- · Leadership
- · Involvement
- · The process approach
- · Common tools
- · Decision making
- · Supplier management
- · System management
- · Continuous improvement
14.Fundamentals of Quality Management Systems
- · Fundamentals of Quality Management Systems
15.Requirements and Quality Systems
- · Requirements and Quality Systems
16.Measurement, Analysis, and Improvement
- · Monitoring and measurement
- · Control of non-conforming products
- · The performance of the QMS
- · Analysis of data
- · Improvement of quality
- · Corrective action
- · Preventive action
- · Identification of improvement opportunities
- · Risk management principles
- · The risk management process
- · Risk lifecycle
- · Risk management tools
- · Risk management culture
- · Assessments and control of risk management
ISO 13485 Lead Implementer Certification Benefits
Frequently Asked Questions
How will I benefit from ISO 13485 Lead Implementer Training?
Unichrone offers ISO 13485 Lead Implementer Training in flexible modes. Our trainers engage in hosting case studies and discussions related to the ISO standard. This assists professionals to gain a deeper understanding of the policies and procedures involved in ISO 13485:2016 standard.
Do you provide mock tests?
Yes, candidates can take up the mock tests on completion of ISO 13485 Lead Implementer Training.
Will I receive any certificate on completion of ISO 13485 lead Implementer Training?
Yes, candidates will receive a course completion certificate at the end of ISO 13485 Training.
How long is the ISO 13485 Lead Implementer Training?
The ISO 13485 Lead Implementer Training is conducted for 3 days in various countries.
How is the ISO 13485 Lead Implementer Exam conducted?
The ISO 13485 Lead Implementer Exam is conducted by Unichrone in online mode. The exam consists of multiple-choice questions which have to be completed within 120 minutes.
What is the passing score set for ISO 13485 Lead Implementer Exam?
The passing score for ISO 13485 Lead Implementer exam is set at 70%
What is the re-examination policy?
Yes, candidates can retake the exam free for the second time. Subsequent attempts after 2nd attempt, the re-examination fees to be paid.
Who is a ISO 13485 Lead Implementer?
An ISO 13485 Lead Implementer is a professional who has the necessary skills to establish, implement and maintain an MDQMS. Certified lead implementers are responsible for analyzing the requirements of the standard. The requirements are then applied to the quality management system developed for medical devices. ISO 13485 Lead Implementation Certificate holders are hence known for assisting organizations with the standard.
Why do I need ISO 13485 Lead Implementer Certification?
The ISO 13485 Lead Implementer Certification is a globally recognized credential for quality management systems. Pursuing this certification broadens the scope of individuals looking for career opportunities in this field. In addition, professionals can land their dream jobs across various nations.
How can I obtain ISO 13485 Lead Implementer Certification?
Candidates opting for earning the ISO 13485 Lead Implementer Certification need to:
- Enroll in ISO 13485 Lead Implementer Training course
- Attempt the exam and score required minimum marks
- Attain the certification on clearing the exam.
What next after getting certified as ISO 13485 Lead Implementer?
Individuals who have obtained the ISO 13485 Lead Implementer Certification can pursue a career in organizations that manufacture medical devices or related services. Certified professionals can assist businesses in designing a state-of-the-art MDQMS as per the standard. Lead Implementers are often offered the roles of quality analysts, quality engineers, operation managers, and quality specialists.
ISO 13485 Lead Implementer Examination Procedure
Attend intense 3 day ISO 13485 Lead Implementer Training offered by Unichrone. Fulfil all the requirements before the examination.
Apply for the ISO 13485 Lead Implementer Exam, conducted by Unichrone, whilst filling up all necessary details. Attend the exam scheduled at the end of the training session.
Score the minimum score to get certified after in the exam. You will receive an email confirming the status.
What our customers say
Very engaging course with real world context and wonderful examples. Helped to expand my knowledge as a direct result of it.
Super awesome faculty! The best part of the training was lots of real time case studies and interactive sessions. Learnt many new concepts.
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Interesting, Focused, Real life case studies. The material was a comprehensive presentation of Lean principles and Six Sigma.
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I opted for Instructor led Online Session. The training was very well executed. It was awesome and exceeded my expectations.
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