ISO 13485 Medical Devices Quality Management Systems
The ISO 13485 Lead Implementer Certification in Germany demonstrates that professionals are capable of implementing MDQMS. Certified professionals engage in designing, maintaining, and managing the Medical Device Quality Management System as per the ISO standard. Organizations certified with ISO 13485 recruit certified ISO professionals for applying the standard. Professionals owning ISO 13485 Lead Implementer Certification assist businesses in meeting the requirements whilst applying the latest practices. The ISO 13485 Standard was designed to maintain the quality levels of medical devices and related services. Owning the certification further helps businesses to take advantage of foreign markets and clientele. The ISO 13485 standard was last revised in 2016. As a result, professionals comply with the requirements stated in ISO 13485:2016 while implementing the standard.
ISO 13485 Lead Implementer Training in Germany
The ISO 13485 Lead Implementer Training in Germany is offered by Unichrone through qualified trainers. Candidates enrolling in ISO 13485 Lead Implementer Training sessions are trained to be industry-ready while looking for career options. The ISO 13485 Certification is recognized across various nations. This assists individuals to look for opportunities on a global scale. The ISO 13485 Lead Implementer Training outline reflects the latest changes in the standard. As a result, professionals pursuing the certification can apply the best practices of quality management for medical devices. The prerequisite for pursuing the lead implementer certification in Germany is to obtain ISO 13485 Foundation Certification.
Key Features of ISO 13485 Lead Implementer Certification Training
ISO 13485 Lead Implementer Certification Training is hosted for 3 days across various cities in Germany. Candidates can opt for live online or in-class training methods. During the training sessions, individuals gain a comprehensive understanding of the standard, its approach, procedures, and techniques for implementation. The interactive sessions assist participants in grasping complex concepts easily. On completion of the training session, individuals can take up the ISO 13485 Lead Implementer Exam and score the required passing percentage. Candidates who clear the exam can obtain their ISO 13485 Lead Implementer exam.
- 4 Day Interactive Instructor –led Online Classroom or Group Training in Germany
- 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 in Germany
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 Certification Benefits
With this renowned credential, aspirants earn higher salary packages when compared to non-certified professionals in the field
Aspirants can look for higher career prospects at an early stage in their life with the most esteemed certification
Owning the certification makes it easier to earn the trust and respect of professionals working in the same field
Rigorous study plan
The course content is prescribed as per the exam requirements, covering the necessary topics to ace the exam in the first attempt
Diverse job roles
Attaining the certification enhances the spirit of individuals to pursue diverse job roles in the organization
With this certification, individuals acquire refined skills and techniques required to play their part in an organization
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
Frequently Asked Questions
How is ISO 13485 Lead Implementer Training conducted in Germany?
The ISO 13485 Lead Implementer Training in Germany is offered in live online method and in-class method by Unichrone.
How will I benefit from ISO 13485 Lead Implementer Training in Germany?
The ISO 13485 Lead Implementer Training sessions are provided in flexible modes. Our trainers provide real-time insights on the ISO standard. This helps candidates to gain a deeper understanding of the standard and its approach. Furthermore, the training sessions are designed to prepare individuals to be industry-ready through practical exercises.
What are the prerequisites for attending ISO 13485 Lead Implementer Training in Germany?
Individuals need to obtain ISO 13485 Foundation Certification before attending the ISO 13485 Lead Implementer Training sessions.
When can I take up mock tests?
Candidates can take up the mock tests at the end of the ISO 13485 Lead implementer Training session.
Which is better: self-paced learning vs instructor-led training for ISO 13485 Lead Implementer Certification?
Self-paced learning does not provide a clear understanding of ISO 13485 standards. However, instructors at Unichrone use real-life examples to demonstrate ISO 13485 standards that make candidates get a clear idea about ISO 13485 standards.
Why should I opt for online ISO 13485 Lead Implementer Training in Germany?
Online ISO 13485 Lead Implementer Training provides candidates the opportunity to interact with instructors to clear their doubts. This helps candidates to get thorough knowledge of ISO 13485 standards.
How long is ISO 13485 Lead Implementer Training in Germany?
ISO 13485 Lead Implementer Training is conducted for 4 days in Germany. During the training course, trainees will learn to implement ISO 13485 standard in Medical Device Quality Management System.
What are the steps in implementing ISO 13485 standard?
The steps in implementing ISO 13485 standard are as follows:
- Get management support
- Identify requirements
- Perform an ISO 13485 Gap Analysis
- Plan ISO 13485 Implementation project
- Deploy training and awareness programs
- Document Quality Management System
- Conduct internal audits
- Perform the certification audit
When is the ISO 13485 Lead Implementer Exam scheduled in Germany?
The ISO 13485 Lead Implementer Exam is scheduled at the end of the training session.
Can I retake the exam if I fail to clear the exam in the first attempt?
Yes, candidates can retake the exam without incurring any cost for the second time. For the subsequent attempts after 2nd attempt, candidates have to pay the re-examination fees.
How can I pass the ISO 13485 Lead Implementer Exam in Germany?
Individuals need to score 70% or more to clear the exam and obtain the ISO certification.
How is ISO 13485 Lead Implementer Exam conducted in Germany?
ISO 13485 Lead Implementer Exam consists of 100 multiple choice questions with a time duration of 120 minutes in Germany.
How long should I prepare for ISO 13485 Lead Implementer Exam in Germany?
Candidates’ preparation for the ISO 13485 Lead Implementer Exam entirely depends on their commitment and effort. However, taking ISO 13485 Lead Implementer Training offered by Unichrone allows them to prepare and assess their chances of passing the exam.
Is there any separate fee for ISO 13485 Lead Implementer Exam in Germany?
No, candidates do not have to pay a separate fee for ISO 13485 Lead Implementer Exam in Germany. It is included in the training fee.
Is ISO 13485 Lead Implementer Exam difficult?
No, Candidates can easily pass the ISO 13485 Lead Implementer Exam in their first attempt, if they have a solid understanding of the exam content and a well-prepared study plan.
Who conducts ISO 13485 Lead Implementer Exam?
Unichrone conducts ISO 13485 Lead Implementer Exam at the end of the training course.
Can I get a certificate without attempting the ISO 13485 Lead Implementer Exam?
No, candidates cannot get an ISO 13485 Lead Implementer certificate without attempting the ISO 13485 Lead Implementer Exam.
What is ISO 13485 Lead Implementer Certification?
ISO 13485 Lead Implementer Certification enhances the skills of individuals. The certification is designed to help individuals in broadening their knowledge of the standard, its requirements, approach, procedures, tools, and techniques. In addition, the certification also helps individuals to interpret the relation of ISO 13485 with other regulatory frameworks.
Who can pursue the ISO 13485 Lead Implementer Certification in Germany?
Managers, expert advisors, MDQMS team members, and any individual who is involved in maintaining MDQMS can pursue the certification in Germany.
What is the process of earning ISO 13485 Lead Implementer Certification in Germany?
Individuals who meet the eligibility criterion can enroll for the ISO 13485 Lead Implementer Training in Germany. Upon completion of the training session, participants can take up the exam. Individuals who score the required minimum passing percentage can acquire the certification.
What is the role of ISO 13485 certified Lead Implementer?
A certified ISO 13485 Lead Implementer is responsible for:
- Developing and maintaining a medical device quality management system
- Analyzing the requirements of the ISO standard
- Interpreting the connection of ISO 13485 with other standards and frameworks
- Help organizations in implementing the standard its requirements.
When will I get ISO 13485 Lead Implementer Certificate in Germany?
Candidates will get their ISO 13485 Lead Implementer Certificate after passing ISO 13485 Lead Implementer Exam in Germany.
Is ISO 13485 the same as ISO 9001 standard?
ISO 13485 is based on the ISO 9001 standard but it is mainly for the manufacturing of medical devices in the Quality Management System.
Will ISO 13485 Lead Implementer Certificate expire in Germany?
No, ISO 13485 Lead Implementer Certificate is valid for a lifetime in Germany.
Is ISO 13485 standard applied globally?
ISO 13485 standard can be applied globally. However, it is mandatory for countries such as Europe, Canada, USA, Japan, Australia, Singapore, and Malaysia.
Who provides ISO 13485 Lead Implementer Certificate in Germany?
Unichrone provides ISO 13485 Lead Implementer Certificate in Germany.
Will obtaining ISO 13485 Lead Implementer Certificate be beneficial to me?
ISO 13485 Lead Implementer Certificate holders will gain practical skills in implementing ISO 13485 in any organization. Since it is a globally recognized certificate, professionals can get high-paying jobs in any country.
What are the sections of ISO 13485 standard?
The following are the sections of ISO 13485 standard:
- Normative References
- Terms and Definitions
- Quality Management System
- Management Responsibility
- Resource Management
- Product Realization
- Measurement, Analysis, and Improvement
Which organization needs to implement MDQMS?
MDQMS should be implemented by organizations that manufacture medical devices, organizations that provide goods to medical device manufacturers, quality management organizations that engage with medical device manufacturers, and organizations that provide services to medical device manufacturers.
What are the other ISO 13485 Certificates offered by Unichrone in Germany?
ISO 13485 Lead Implementer Examination Procedure
Attend intense 4 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.
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