PECB Certified ISO/IEC 37301 Lead Implementer (EN)
Master the implementation and management of Laboratory Management Systems (LMS) based on ISO/IEC 17025
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Master the implementation and management of Laboratory Management Systems (LMS) based on ISO/IEC 17025
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If you want to learn more about the training, check out the official training brochure!
The benefits of implementing a compliance management system (CMS) based on ISO 37301 are manifold: helping the organization avoid or mitigate the costs, risks, and damage of noncompliance, ensuring the long-term sustainability of the organization, promoting trust and confidence, encouraging good governance practices, due diligence, and ethically sound business dealings, etc.
The PECB ISO 37301 Lead Implementer training course provides the knowledge needed to establish, implement, manage, maintain, and continually improve a CMS. It aims to provide an in-depth understanding of ISO 37301 requirements, as well as the best practices and approaches used for the implementation and subsequent maintenance of the compliance management system.
The training course enables you to help organizations establish processes needed to adhere to all compliance obligations and establish controls that proactively prevent noncompliance and contribute to the creation of a culture of integrity, transparency, and openness.
The training course is followed by the certification exam. If you pass, you can apply for the “PECB Certified ISO 37301 Lead Implementer” credential. The “PECB ISO 37301 Lead Implementer” certificate is internationally recognized. It validates your professional capabilities and competences to implement a CMS in an organization based on the requirements of ISO 37301.
The ISO 13485 Lead Implementer training course is intended for:
Module 1: Introduction to ISO 37301 and the initiation of a CMS implementation
Module 2: Implementation plan of a CMS
Module 3: Implementation of a MDQMS
Module 4: CMS monitoring, continual improvement, and preparation for the certification audit
Certification Exam
Upon successfully completing the training course, you will be able to:
The “PECB Certified ISO 28000 Lead Auditor” exam fully meets the requirements of the PECB Examination and Certification Program (ECP). It covers the following competency domains:
Duration: 3 hours
Location: Online through the PECB app OR in person in one of the PECB exam centers
Preparation: PECB Exam Preparation Guides
Language: The exam is available in multiple other languages and does not need to be taken in the same language as the training material. Additional time can be requested when your native language is not available in your mother tongue (to be requested by candidates on the exam day)
Retake: In case you fail the exam, you can retake it within 12 months following the initial attempt for free
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.
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 the ISO 28000 certifications and the PECB certification process, please refer to the Certification Rules and Policies..
The requirements for PECB Implementer Certifications are:
| Credential | Exam | Professional experience | MDQMMS project experience | Other requirements |
| PECB Certified ISO 13485 Provisional Implementer | PECB Certified ISO 13483 Lead Implementer Exam or equivalent | None | None | Signing the PECB Code of Ethics |
| PECB Certified ISO 37301 Implementer | PECB Certified ISO 13483 Lead Implementer Exam or equivalent | Two years, of which one in compliance management | At least 200 hours of activities | Signing the PECB Code of Ethics |
| PECB Certified ISO 37301 Lead Implementer | PECB Certified ISO 13483 Lead Implementer Exam or equivalent | Five years, of which two in compliance management | At least 300 hours of activities | Signing the PECB Code of Ethics |
| PECB Certified ISO 13485 Senior Lead Implementer | PECB Certified ISO 13483 Lead Implementer Exam or equivalent | Ten years, of which seven in compliance management | At least 1,000 hours of activities | Signing the PECB Code of Ethics |
To be considered valid, these implementation activities should follow best implementation practices and include the following activities:
Note: PECB certified individuals who possess the Lead Implementer and Lead Auditor credentials are qualified for the respective PECB Master credential, given they have taken four additional Foundation exams related to the scheme. For more information about the Foundation exams and the overall Master credential requirements, go to https://pecb.com/en/master-credentials.
Contact us on [email protected] if you have other questions
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