Importance of ISO 13485 in auditing the Medical Device Quality Management System
Professionals owning ISO 13485 Lead Auditor Certification in Switzerland demonstrate their skills in auditing MDQMS. Organizations that implement the ISO 13485 standard are required to comply with the standard at all times. This necessitates businesses to recruit certified lead auditors who can carry out the audits of the Medical Device Quality Management System. ISO 13485 certified Lead Auditors acquire the skills to apply the latest methods while conducting audits and drafting reports. In addition, individuals showcase their competency in leading the audit team, applying the best practices, and performing follow-up activities on the audit of MDQMS. Any individual who has adequate knowledge of the ISO standard can pursue ISO 13485 Lead Auditor Certification in Switzerland.
ISO 13485 Lead Auditor Training in Switzerland
The ISO 13485 Lead Auditor Training in Switzerland is provided by Unichrone through expert trainers. The training session is hosted for 4 days across various cities of Switzerland. Candidates gain an in-depth understanding of the standard, its requirements, and the processes involved in conducting the audit. This helps professionals to be industry-ready on acquiring the ISO certification. Attending the ISO 13485 Lead Auditor Training sessions helps in pursuing a career path as an auditor of MDQMS. Organizations that hire certified lead auditors benefit from applying the latest practices of the ISO standard.
Key Features of The ISO 13485 Lead Auditor Certification Training in Switzerland
Unichrone offers ISO 13485 Lead Auditor Certification Training in various methods. Qualified trainers having vast experience in the field provide insights on auditing techniques. Candidates can engage in interactive sessions during the course of training to gain a deeper understanding of the standard. In addition, individuals can participate in case studies and discussions hosted by trainers. At the end of ISO 13485 Lead Auditor Certification Training in Switzerland, candidates need to attend the exam. The ISO 13485 Lead Auditor Exam is carried out for 2 hours, wherein individuals need to attempt the multiple-choice questions. On scoring the minimum pass percentage candidates can obtain their ISO 13485 Lead Auditor Certification in Switzerland.
- 4 Day Interactive Instructor–led Online/Classroom or Group Training in Switzerland
- 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 and present trends
- ISO 13485 Lead Auditor Course adhered with International Standards
- End-to-end support via phone, mail, and chat
- Convenient Weekday/Weekend Training Course schedule in Switzerland
Corporate Group Training
- Customized Training
- Live Instructor-led
- Onsite / Online
- Flexible Dates
|ISO 13485 Lead Auditor Exam Format|
|Exam Name||ISO 13485 Lead Auditor Certification|
|Exam Format||Multiple Choice|
|Exam Duration||120 Minutes|
ISO 13485 Lead Auditor 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 Auditor 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 Audit
- · Certification audits
5.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
- · Internal audit objectives
- · Records and follow-ups
- · Using correct procedures in reference to the 9001:2015 standard
- · Definition of scope, objectives, and policies of a QMS
- · Analysing implementation methodologies
- · Methods to operate a QMS efficiently
- · Planning, selecting and reviewing the implementation process
- · Different ways to detect problems
- · Roles and responsibilities of a Lead Implementer and quality team
8.Implementation process based on ISO 9001
- · Report reconciliation and documentation
- · How to maintain QMS structure through compliance policies
- · Sequential operation process
- · Measurement, monitoring and controlling of errors
9.Lead Auditor Training
- · Roles and responsibilities of a lead auditor
- · Lead Auditor requirements, scope, and procedures
- · Report preparation, findings, reconciliation, and conclusions
10.On-Site Lead Audit Techniques
- · Team selection and planning
- · Interactive meetings
- · Opening meeting
- · Daily discussion meetings
- · Closing meeting
- · Objective of an Audit Report
- · Presentation of reports
- · Techniques and processes of an audit
11.Closure of Audit
- · Prevention of errors
- · Rectifying errors efficiently
- · Reviewing audit strategies and plans
- · Follow ups
- · Checklist closure
- · Surveillance audit
12.Methods of Collecting Information
- · Visual observation
- · Examination of records
- · Employee interviews
Frequently Asked Questions
How is the ISO 13485 Lead Auditor Training conducted in Switzerland?
The ISO 13485 Lead Auditor Training in Switzerland is conducted in live online and in-class method.
Why should I pursue ISO 13485 Lead Auditor Training?
The ISO 13485 Lead Auditor Training in Switzerland is conducted through various methods. Individuals gain an in-depth understanding of the standard and its framework during the course of training. Experts having vast knowledge of the field provide their insights through case studies and discussions. This further helps individuals to ace the exam easily.
What are the eligibility criteria for attending ISO 13485 Lead Auditor Training?
Candidates enrolling in ISO 13485 Lead Auditor Training in Switzerland need to acquire ISO 13485 Foundation Certification.
How can I opt for in-class ISO 13485 Lead Auditor Training in Switzerland?
Candidates can choose their desired method of ISO 13485 Lead Auditor Training while enrolling for the program.
Can I get a course completion certificate for ISO 13485 Lead Auditor Training in Switzerland?
Yes, candidates will get a course completion certificate for ISO 13485 Lead Auditor Training in Switzerland.
What are the topics covered in ISO 13485 Lead Auditor Training in Switzerland?
ISO 13485 Lead Auditor Training in CON covers the fundamentals of ISO 13485 Audit concepts and principles that are essential to passing the ISO 13485 Lead Auditor Exam.
Is it mandatory to attend ISO 13485 Lead Auditor Training in Switzerland?
Yes, candidates can attempt the exam only after completing 4 days of ISO 13485 Lead Auditor Certification Training in Switzerland.
When can I take a practice test during ISO 13485 Lead Auditor Training?
Trainees can take a practice test at the end of the ISO 13485 Lead Auditor Training course in Switzerland.
What is the duration of ISO 13485 Lead Auditor in Switzerland?
The duration of the ISO 13485 Lead Auditor exam is 2 hours in Switzerland. Candidates are required to attempt multiple-choice questions to clear the exam and obtain their certification.
What is the re-examination policy?
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 Auditor Exam in Switzerland?
Participants need to score 70% or more to pass the ISO 13485 Lead Auditor Exam.
What is the ISO 13485 Lead Auditor Exam format in Switzerland?
ISO 13485 Lead Auditor Exam consists of multiple-choice questions with a time duration of two hours in Switzerland.
Is it possible to attempt ISO 13485 Lead Auditor Exam without fulfilling the requirements?
No, candidates need to meet the requirements before attempting ISO 13485 Lead Auditor Exam in Switzerland.
How to prepare ISO 13485 Lead Auditor Exam in Switzerland?
Individuals can enroll in ISO 13485 Lead Auditor Training course to get a clear undersatnding of the ISO 13485 Lead Auditor Exam to prepare for the exam.
What is the cost of the ISO 13485 Lead Auditor Exam?
The cost of the ISO 13485 Lead Auditor Exam is included in the training fee. Candidates do not need any separate fees for the exam.
Who conducts ISO 13485 Lead Auditor Exam in Switzerland?
Unichrone conducts ISO 13485 Lead Auditor Exam at the end of the training session in the Switzerland.
Is ISO 13485 Lead Auditor an online Exam in Switzerland?
ISO 13485 Lead Auditor Exam is an Online Exam in Switzerland. Candidates can take exams anywhere either from home or at the office.
When should I schedule for ISO 13485 Lead Auditor Exam in Switzerland?
Candidates can schedule for ISO 13485 Lead Auditor Exam after completing 4 days of ISO 13485 Lead Auditor Certification Training in Switzerland.
Who can be ISO 13485 certified Lead Auditor in Switzerland?
Any individual pursuing a career in medical device quality management and who has acquired the ISO 13485 Foundation Certification can pursue the certification of ISO 13485 Lead Auditor.
How can I earn ISO 13485 Lead Auditor Certification in Switzerland?
Individuals need to meet the prerequisites before pursuing the Lead Auditor Certification. Thereafter, participants can enroll in ISO 13485 Lead Auditor Training. At the end of the training program, individuals need to attend and clear the exam to obtain the ISO 13485 Lead Auditor Certification in Switzerland.
What are the benefits of owning ISO 13485 Lead Auditor Certification in Switzerland?
The ISO 13485 Lead Auditor Certification in Switzerland is internationally recognized. Businesses look for professionals certified with lead auditor certification to assist them in conducting the audit of MDQMS. This offers a wide scope for professionals pursuing the ISO certification. In addition, certified lead auditors acquire higher salary packages when compared to non-certified professionals in the field.
Why do organizations hire certified ISO 13485 Lead Auditors?
Businesses that implement Medical Device Quality Management System require professionals to conduct frequent audits of the system. Certified ISO 13485 Lead Auditors assist organizations in applying the latest ISO 13485 audit procedures in compliance with the standard. Furthermore, certified lead auditors take the necessary steps to maintain and manage the MDQMS.
How to renew the ISO 13485 Lead Auditor Certificate in Switzerland?
Candidates do not need to renew ISO 13485 Lead Auditor Certificate as it is valid for a lifetime.
Is the ISO 13485 Lead Auditor Certificate worth it?
Earning the ISO 13485 Lead Auditor Certification is worth the time and effort since it enhances professionals' abilities to conduct MDQMS audits, giving their resumes a boost of value. As a result, ISO 13485 Lead Auditor certification holders have a better chance of getting a job and earning more salary.
Which is better: ISO 9001:2015 vs ISO 13485 standard?
ISO 9001 is an international standard that specifies the requirements for a quality management system in any business, regardless of industry, product, or service. However, ISO 13485 is a management system designed primarily for medical device manufacturing. It emphasizes regulatory compliance and limits the flexibility of an organization's processes.
What costs will I incur while pursuing ISO 13485 Lead Auditor Certificate?
Individuals will incur the cost of training and exam while pursuing the ISO 13485 Lead Auditor Certification.
Will ISO 13485 Lead Auditor Certificate help me to get a better job with a high salary package?
Yes, ISO 13485 Lead Auditor Certification holders will get job roles such as Quality Engineer, Quality Manager, Regulatory Affairs Specialist, Internal Auditor, Product Development Engineer, Quality Assurance Engineer, and Quality Assurance Director with a higher salary than non-certified candidates.
Is ISO 13485 Lead Auditor Certificate globally recognized?
Yes, ISO 13485 Lead Auditor Certificate is globally recognized. As a result, candidates will be able to pursue career prospects internationally.
What is the latest version of ISO 13485 standard?
The latest version is ISO 13485:2016 and was released in the year 2016. It is reviewed every five years and revised based on industry changes.
Is ISO 13485 standard mandatory?
No, ISO 13485 standard is not mandatory. The organization can develop its own QMS according to its specific requirements, but it should comply with the legal and regulatory requirements for manufacturing and selling of medical devices.
Who provides ISO 13485 Lead Auditor Certificate in Switzerland?
Unichrone provides ISO 13485 Lead Auditor Certificate in Switzerland.
ISO 13485 Lead Auditor Examination Procedure
Attend intense 4 day ISO 13485 Lead Auditor Training offered by Unichrone. Fulfil all the requirements before the examination.
Apply for the ISO 13485 Lead Auditor Exam, whilst filling up all necessary details. Attend the exam scheduled at the end of the training session.
On successfully passing the exam with required scores, earn the certificate of ISO 13485 Lead Auditor. You will receive an email confirming the status.
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- Prepare for the audit of MDQMS
- Apply best techniques while conducting MDQMS audit
- Draft the report of the findings during the audit
- Lead and prepare the audit team
Why Earn ISO 13485 Lead Auditor Certification in Switzerland?
ISO 13485 is the yardstick for measuring the precision in the quality of a medical device. Device manufacturers and suppliers yearn for achieving such perfection. This enables them to hire individuals who have been accredited with ISO 13485 Lead Auditor Certification. To acquire this certification, one must attend training in the respective field.
Is ISO 13485 Lead Auditor Training Essential?
Individuals undertaking ISO 13485 Lean Auditor Training in Switzerland are endowed with multiple skills. They not only get well-versed in ISO regulations but also understand them to the core. Trained individuals end up landing prestigious jobs that involve the creation of quality management systems in medical equipment enterprises. Here, are the other advantages of ISO 13485 Lead Auditor Training:Read More