Kurs haqqında
ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures, and techniques.
Course Agenda
Day 1: Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485
Day 2: Audit principles, preparation and launching of an audit
Day 3: On-site audit activities
Day 4: Closing the audit
Day 5: Certification Exam
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
For specific information about the exam type, languages available, and other details, please visit the List of PECB Exams and the Examination Rules and Policies.
Certification
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.
The requirements for PECB Auditor Certifications are:
Credential | Exam | Professional experience | MS audit/assessment experience | Other requirements |
PECB Certified ISO 13485 Provisional Auditor | PECB Certified ISO 13483 Lead Auditor Exam or equivalent | None | None | Signing the PECB Code of Ethics |
PECB Certified ISO 13485 Auditor | PECB Certified ISO 13483 Lead Auditor Exam or equivalent | Two years: One year of work experience in Medical Devices Quality Management | Audit activities: a total of 200 hours | Signing the PECB Code of Ethics |
PECB Certified ISO 13485 Lead Auditor | PECB Certified ISO 13483 Lead Auditor Exam or equivalent | Five years: Two years of work experience in Medical Devices Quality Management | Audit activities: a total of 300 hours | Signing the PECB Code of Ethics |
PECB Certified ISO 13485 Senior Lead Auditor | PECB Certified ISO 13483 Lead Auditor Exam or equivalent | Ten years: Seven years of work experience in Medical Devices Quality Management | Audit activities: a total of 1,000 hours | Signing the PECB Code of Ethics |
Note: PECB Certified Individuals who do possess the Lead Implementer and Lead Auditor Credentials are qualified for the respective PECB Master Credential, given they have taken 4 additional Foundation Exams which are related to this scheme. For more detailed information about the Foundation Exams and the overall Master Requirements, please go to the following link: https://pecb.com/master-credentials.
To be considered valid, these audits should follow best audit practices and include the following activities:
Audit planning
Audit interview
Managing an audit program
Drafting audit reports
Drafting non-conformity reports
Drafting audit working documents
Documentation review
On-site audit
Follow-up on non-conformities
Leading an audit team
General Information
Certification and examination fees are included in the price of the training course
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.
In case of exam failure, you can retake the exam within 12 months for free
For additional information, please contact us at info@bonegaconsulting.com.
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