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  3. PECB Certified ISO/IEC 37301 Lead Implementer (EN)
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Nouveau !
PECB Certified ISO/IEC 37301 Lead Implementer (EN)

PECB Certified ISO/IEC 37301 Lead Implementer (EN)

Master the implementation and management of Laboratory Management Systems (LMS) based on ISO/IEC 17025

Matériel de cours (PDF/en ligne) Anglais Gouvernance, risque et conformité
$ 699,00 $ 699,00 (Hors taxes)
599,00 € (Hors taxes)

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Terms and Conditions

Examen de certification : Inclus (éligibilité de 12 mois) + option de reprise

Matériel de cours e-book : Inclus

Cours vidéos: Inclus uniquement pour les cours eLearning 

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What is included?

  • You have 12 months time as of reception of the learning material to learn, do the exam and get your certification
  • Certification and examination fees are included in the price of the training course 
  • Training material containing over 400 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. 
  •  If candidates fail the exam, they can retake it for free within 12 months of the course completion.
  • + 20% reduction on the first year subscription for our all-in-one ISMS/GRC management solution


Why should you take this training course?

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.

Who should attend?

The ISO 13485 Lead Implementer training course is intended for:

  • Managers, consultants, and compliance officers wishing to develop a thorough understanding of ISO 37301 requirements for a compliance management system
  • Managers and consultants seeking a comprehensive CMS implementation framework
  • Compliance officers responsible for practicing due diligence with regard to compliance risks
  • Individuals wishing to contribute in maintaining organizational integrity by supporting ethical behavior
  • Managers and members of governance, risk management, and compliance teams
  • Individuals aspiring to become compliance officers or compliance management consultants

Training course structure

Module 1: Introduction to ISO 37301 and the initiation of a CMS implementation

  • Training course objectives and structure
  • Standards and regulatory frameworks
  • Fundamental concepts and principles of compliance management
  • Initiation of the CMS implementation
  • Leadership and commitment
  • Compliance policy
  • Roles, responsibilities, and authorities

Module 2: Implementation plan of a CMS

  • Context of the organization
  • CMS scope
  • Compliance obligations
  • Risks, opportunities, and compliance objectives

Module 3: Implementation of a MDQMS

  • Resources and competence
  • Awareness and communication
  • Management of documented information
  • Controls and procedures
  • Monitoring, measurement, analysis, and evaluation

Module 4: CMS monitoring, continual improvement, and preparation for the certification audit

  • Internal audit
  • Management review
  • Nonconformities and corrective actions
  • Continual improvement
  • Preparation for the certification audit
  • Closing of the training course

Certification Exam


Learning objectives

Upon successfully completing the training course, you will be able to:

  • Explain the concepts, approaches, methods, and techniques used for the implementation and effective management of a CMS
  • Explain the relationship between ISO 37301 and other standards and regulatory frameworks
  • Interpret the requirements of ISO 37301 from the perspective of an implementer
  • Support organizations in establishing, implementing, maintaining, and continually improving their CMS based on ISO 37301
  • Prepare an organization to undergo a third-party certification audit

Examination

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:

  • Domain 1: Fundamental principles and concepts of a compliance management system 
  • Domain 2: Initiation of a CMS implementation
  • Domain 3: Planning of a CMS implementation based on ISO 37301
  • Domain 4: Implementation of a CMS based on ISO 37301
  • Domain 5: Monitoring and measurement of a CMS based on ISO 37301
  • Domain 6: Continual improvement of a LMS based on ISO/IEC 17025
  • Domain 7: Preparation for a CMS certification audit

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.

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 the ISO 28000 certifications and the PECB certification process, please refer to the Certification Rules and Policies..

The requirements for PECB Implementer Certifications are:

CredentialExamProfessional experienceMDQMMS project experienceOther requirements
PECB Certified ISO 13485 Provisional ImplementerPECB Certified ISO 13483 Lead Implementer Exam or equivalentNoneNoneSigning the PECB Code of Ethics
PECB Certified ISO 37301 ImplementerPECB Certified ISO 13483 Lead Implementer Exam or equivalentTwo years, of which one in compliance managementAt least 200 hours of activitiesSigning the PECB Code of Ethics
PECB Certified ISO 37301 Lead ImplementerPECB Certified ISO 13483 Lead Implementer Exam or equivalentFive years, of which two in compliance managementAt least 300 hours of activitiesSigning the PECB Code of Ethics
PECB Certified ISO 13485 Senior Lead ImplementerPECB Certified ISO 13483 Lead Implementer Exam or equivalentTen years, of which seven in compliance managementAt least 1,000 hours of activitiesSigning the PECB Code of Ethics

To be considered valid, these implementation activities should follow best implementation practices and include the following activities:

  1. Drafting a CMS implementation plan
  2. Managing or leading CMS implementation projects
  3. Implementing the CMS
  4. Managing documented information
  5. Implementing corrective actions
  6. Establishing performance indicators and evaluating the CMS performance
  7. Performing continual improvement 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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