What is the scope of ISO 13485 Lead Auditor Certification
The ISO 13485 Lead Auditor Certification validates that an individual has acquired the skillset for conducting audits of the Medical Device Quality Management System (MDQMS). The latest version of ISO 13485 which is being followed by organizations currently, was released in 2016. The standard was introduced to emphasize on safety and performance of medical devices. ISO 13485 standard specifies the requirements that have to be followed by organizations manufacturing medical devices and related services. In addition, this international standard is considered as a legal requirement for such organizations across various countries. As a result, there is huge scope for professionals pursuing the certification of ISO 13485 Lead Auditor.
ISO 13485 Lead Auditor Certification Training
Medical device professionals, management representatives, quality managers, and individuals who want to master the skill of auditing MDQMS can pursue the ISO 13485 Lead Auditor Certification. Individuals can take up the ISO 13485 Lead Auditor Exam on completing the training session. The ISO 13485 Lead Auditor Training offered by Unichrone assists candidates to comprehensively understand the procedures and policies of the audit. Earning the ISO 13485 Lead Auditor Certification empowers professionals to prepare and carry out audits of MDQMS instilled within the organization.
Key Features of ISO 13485 Lead Auditor Certification Training
Individuals enrolling for ISO 13485 Lead Auditor Training program can choose to opt for live online method or in-class method. Participants are familiarised with industry-standard auditing techniques during the training program. In addition, our highly qualified trainers provide their insights on MDQMS audit through real-life examples. This in turn prepares aspiring lead auditors to clear the exam and earn their ISO 13485 Lead Auditor Certification.
- 4 Day Interactive Instructor–led Online/ 5 day 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 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
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 Certification Body||TUV-SUD|
|Exam Format||Multiple Choice|
|Exam Duration||120 Minutes|
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
ISO 13485 Lead Auditor Certification Benefits
Frequently Asked Questions
What skillset will I earn by enrolling in ISO 13485 Lead Auditor Training?
On attending the ISO 13485 Lead Auditor Training course professionals will be able to:
- Obtain a comprehensive understanding of Quality Management System
- Compare and correlate ISO 13485 Standard with the other standards
- Interpret the different policies of ISO 13485
- Assess the requirements of the ISO Standard
What is the duration of ISO 13485 Lead Auditor Training?
The ISO 13485 Lead Auditor Training is conducted for a duration of 4 days globally.
Why do I need ISO 13485 Lead Auditor Training offered by Unichrone?
Unichrone offers flexible modes of ISO 13485 Lead Auditor Training. Experts having vast experience in the field provide practical insights that help professionals to understand complex terminologies.
Do you provide a course completion certificate?
Yes, we provide a course completion certificate for professionals on completion of ISO 13485 Lead Auditor Training.
How is the ISO 13485 Lead Auditor Exam conducted?
The ISO 13485 Lead Auditor Exam is conducted in online mode by Unichrone. Candidates have to attempt multiple choice questions within 2 hours.
Can I retake the exam, if I fail in the first attempt?
Yes, candidates can retake the exam free for the second time. Subsequent attempts after 2nd attempt, the re-examination fees to be paid.
Who administers the ISO 13485 Lead Auditor Exam?
The ISO 13485 Lead Auditor exam is administered by the TUV-SUD Certification body. It is one of the globally recognized and accepted certifying body for ISO Courses.
What is ISO 13485 Lead Auditor Certification?
The ISO 13485 Lead Auditor Certification is awarded to individuals who can audit the quality management system of medical devices. The certification validates their sophisticated skillset in conducting audits of the Medical Device Quality Management System. As a result, businesses look for certified lead auditors to manage and implement the standard.
How will I benefit from ISO 13485 Lead Auditor Certification?
On acquiring the ISO 13485 Lead Auditor Certification professionals will be able to:
- Acquire knowledge on the various requirements that are to be met for ISO 13485:2016 Standard,
- Carry out smooth functioning of MDQMS,
- Manage the position of MDQMS Auditor at ease.
What is the process of acquiring ISO 13485 Lead Auditor Certification?
In order to earn the certification of ISO 13485 Lead Auditor, professionals need to:
- Enroll in ISO 13485 Lead Auditor Training course
- Take up the Lead Auditor exam conducted by Unichrone
- Pass the exam with the required score to attain the certification
What is the role of an ISO 13485 Lead Auditor?
A certified ISO 13485 Lead Auditor performs the role of:
- Preparing for the audit of MDQMS
- Conducts the audit of quality management system in accordance with the standard
- Drafts report of the findings
- Leads the audit team
ISO 13485 Lead Auditor Examination Procedure
Attend intense 4 day ISO 13485 Lead Auditor Training offered by Unichrone. Fulfil all the requirements specified by the TUV-SUD before the examination.
Apply for the ISO 13485 Lead Auditor Exam, conducted by TUV-SUD certification body, 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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