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ISO 13485 Lead Auditor

60 hours
All levels
5 lessons
0 quizzes
0 students

During this training course, you will acquire the knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and ISO/IEC 17021-1 certification process.

Based on practical exercises, you will be able to master audit techniques and become competent to manage an audit program, audit team, communication with customers, and conflict resolution.

After acquiring the necessary expertise to perform this audit, you can sit for the exam and apply for a “PECB Certified ISO 13485 Lead Auditor” credential. By holding a PECB Lead Auditor Certificate, you will demonstrate that you have the capabilities and competencies to audit organizations based on best practices.

Understanding of Python programming language 

Program and games creation using Python 2 & 3 

Knowledge of GUI creation 

Advanced Python features such as collections module & timestamps 

Students and freshers with interest in coding 

IT professionals looking for a domain with utmost job security 

Non- IT professionals willing to enter into IT with easy coding  


Organizations focusing on leveraging Python on a large scale 

Information

General Information

Understanding of Python programming language 

Program and games creation using Python 2 & 3 

Knowledge of GUI creation 

Advanced Python features such as collections module & timestamps 

Students and freshers with interest in coding 

IT professionals looking for a domain with utmost job security 

Non- IT professionals willing to enter into IT with easy coding  


Organizations focusing on leveraging Python on a large scale 

Certification fees are included on the exam price

Training material containing over 450 pages of information and practical examples will be distributed

An attestation of course completion worth 31 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.

Attend

Who can attend?

Auditors seeking to perform and lead Medical Devices Quality Management System (MDQMS) certification audits 

Managers or consultants seeking to master a Medical Devices Quality Management System audit process

Individuals responsible for maintaining conformance with Medical Devices Quality Management System requirements

Objectives

Learning objectives

Understand the operations of a Medical Devices Quality Management System based on ISO 13485

Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks

Understand an auditor’s role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011

Learn how to lead an audit and audit team

Education

Examination

The “PECB Certified ISO 13485 Lead Auditor” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP). The exam covers the following competency domains:

Domain 1 |  Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

Domain 2 |  Medical Devices Quality Management System (MDQMS)

Domain 3 |  Fundamental audit concepts and principles

Domain 4 |   Preparation of an ISO 13485 audit

Domain 5 |  Conducting an ISO 13485 audit

Domain 6 |  Closing an ISO 13485 audit

Domain 7 |  Managing an ISO 13485 audit program

Course

Certificate

After successfully completing the exam, you can apply for the credentials shown on the table below. You will receive a certificate once you comply with all the requirements related to the selected credential. For more information about ISO 13485 certifications and the PECB certification process, please refer to the Certification Rules and Policies.

Course

Prerequisites

A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.

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