All courses

This meticulously designed course aims to provide participants with a robust understanding of the MDSAP framework, which is essential for ensuring compliance with international regulatory requirements.Join us for an intensive two-day training course that offers a comprehensive deep dive into the Medical Device Single Audit Program (MDSAP) from an auditor’s perspective. This meticulously designed course aims to provide participants with a robust understanding of the MDSAP framework, which is essential for ensuring compliance with international regulatory requirements.During this course, participants will be guided through the intricate details of the MDSAP program, including its grading system, timing, and reporting procedures. The training will cover the step-by-step audit process sequence, providing insights into each stage of the audit. Special emphasis will be placed on auditing techniques based on ISO 19011:2018, preparing attendees to apply these methodologies effectively in their audit practices.Participants will also gain a thorough understanding of the various regulations under the MDSAP program, which encompass multiple jurisdictions including the United States, Canada, Brazil, Japan, and Australia. This course will provide an overview of the specific regulatory requirements of each participating country, ensuring that auditors are well-versed in the diverse regulatory landscapes they may encounter.

The objectives of this Course is to provide Learners with the knowledge and skills required to understand and implement an OHS Management system based on ISO 45001:2018.   Prior Knowledge There are no prior knowledge requirements for this session; however, it may be beneficial for learners to have knowledge of OHSAS 18001:2007 and Annex SL.

An effective risk management strategy is always evolving to meet global standards and requirements. for medical device manufacturers, this has meant developing a strategy that complies with both ISO 13485:2003 and the European Medical Device Directives. Risk Management includes all phases of risk: Risk Analysis, Risk Evaluation, Risk Control and Post Production Information. Proper risk management requires an organized approach to provide a road map for assessing, assigning and reducing risk through the life of the device. The first step is the development of a risk plan that identifies the intended medical use of the device and addresses the risks at each phase of the life cycle of the product. Management needs to assign responsibilites to develop and carry out the risk to qualified personnel. A Risk Management File documents the risk management process through records and other documents. You may include records as part of the file or reference records by the file. You will need to update the Risk Management File as you receive new information through the life of the product or the product family.    

The objectives of this Course is to provide Learners with the knowledge and skills required to perform first-party audits of Quality, Occupational Health & Safety Management Systems (QOHS) against ISO 9001:2015 & ISO 45001:2018 in accordance with ISO 19011 and ISO/IEC 17021, as applicable.Course ContentIntroduction to Quality, Occupational Health and Safety Management SystemUnderstanding the elements of ISO 9001 & ISO 45001P-D-C-A Cycle and Process ApproachSystem DocumentationEffective Integrated Management System Audit

The objective of this course is to provide Learners with the knowledge and skills required to perform first-party audits of Environmental, Occupational Health & Safety Management Systems (EHS) against ISO 14001:2015 & ISO 45001:2018 in accordance with ISO 19011 and ISO/IEC 17021, as applicable.Course ContentIntroduction to Environmental, Occupational Health and Safety Management Systems, Principles and DefinitionsUnderstanding the elements of ISO 14001 & ISO 45001System DocumentationEffective EHS Management System Audit

Effective problem-solving is a critical skill in today's competitive business landscape, particularly in industries that adhere to the IATF 16949 standard and customer-specific requirements. Organizations must ensure robust problem-solving capabilities to address issues systematically and drive continuous improvement. This training program links structured problem-solving methodologies, particularly the 8D approach, with IATF 16949 requirements and customer-specific expectations, ensuring compliance and enhanced operational efficiency.

ISO/IEC 42001 Lead Auditor training course enables you to gain the necessary expertise to audit artificial intelligence management systems (AIMS) by applying widely recognized audit principles, procedures, and techniques.Artificial intelligence (AI) has become integral to the success of many organizations by enhancing efficiency through automation and improving decision-making by utilizing advanced data analytics. However, organizations should ensure the appropriate and ethical use of AI. ISO/IEC 42001 enables organizations to implement appropriate processes and controls to ensure the responsible use and management of AI system.As the number of organizations seeking ISO/IEC 42001 compliance increases, there is a simultaneous surge in demand for skilled auditors possessing the necessary knowledge to assess and verify compliance. Therefore, PECB has developed the ISO/IEC 42001 Lead Auditor training course to empower participants with the knowledge and skills essential for planning and conducting ISO/IEC 42001 audits based on best audit practices.The ISO/IEC 42001 Lead Auditor training course is beneficial for professionals seeking to stay ahead of the competition. This training course equips you with the expertise needed to navigate the intricate realm of AI-influenced organizational frameworks, ensuring you are well-prepared to contribute to the success of organizations in this transformative era.By enrolling on this course you agree to your personal information being passed to PECB.CertificationAfter successfully passing the exam, you can apply for one of the following credentials with PECB. You will receive the certificate once you comply with all the requirements related to your selected credential.PECB Certified ISO/IEC 42001 Provisional AuditorPECB Certified ISO/IEC 42001 AuditorPECB Certified ISO/IEC 42001 Lead AuditorPECB Certified ISO/IEC 42001 Senior Lead AuditorGeneral informationParticipants will be provided with the training course material containing over 450 pages of explanatory information, examples, best practices, exercises, and quizzes.Learners may reach out to PECB to request the Attestation of Course Completion as proof of taking the course, this can be requested before taking the exam or after and is worth 31 CPD (Continuing Professional Development) credits..In case candidates fail the exam, they can retake it within 12 months following the initial attempt for free.PrerequisitesThe main requirement for participating in this training course is having a fundamental understanding of ISO/IEC 42001 and AI principles and concepts.The fee for this course covers:Course Materials (for lifetime, please note that updated course materials are not included)First ExamOne resit exam (if required)PECB Certification FeeFirst Year PECB Annual Maintenance Fee (AMF)

CQI / IRCA Accreditation We are accredited by the Chartered Quality Institute (CQI) and  International Register of Certified Auditors (IRCA) globally. This course is accredited by IRCA, 1910 - PR 357.This is a Chartered Quality Institute and International Register of Certificated Auditors Certificated Training Course.This course is recognised by APSCA for CPD purposes, aligned with the APSCA Competency Framework and is worth 36 CPD credits.DisclaimerFor learners undertaking the CQI and IRCA Online Assessment, all aspects relating to examination, proctoring, disqualification decisions, appeals and the issuance of results to the Approved Training Partner (ATP) are the sole responsibility of CQI and IRCA. SGS does not have oversight of, or involvement in, these processes.PRIOR KNOWLEDGEBefore starting this course, delegates are required to have the following prior knowledge:Knowledge of the following OHS management principles and concepts:The concept of OHS sustainable development whereby an organisation must ensure that actions of today do not degrade the environment of the future.The purpose of an initial review as the basis for establishing an OHS management system where none currently exists.Evaluation of activities, products and services in order to establish the risks and hazards associated with normal operating conditions, abnormal conditions such as start-up and shutdown and emergency situations and accidents.Considerations of risks and hazards in respect of:workplace locations;workplace activities;work-related activities carried out away from the normal place of work or base;employees, visitors and other interested parties in areas where the organisation has control and influence over health and safety;vulnerable individuals within the workplace or control of the organisation.Occupational Health and Safety legislation and how legal compliance forms part of an OH&S management system.A good appreciation of typical methods for evaluation of risks and hazards and their mitigation and the identification of improvements (e.g., risk assessments and method statements).

This highly participative training course provides an introduction and overview of Food Defence and explores guidelines, legal requirements and standards in use alongside GFSI expectations. The course explores authenticity plans to help map your supply chain and the importance of Food Defence plans.

This course aims to provide a structured training to impart knowledge of effective Business Continuity Management System – ISO 22301:2019, which provides participants the framework and total program approach for analyse and implement strategies, processes and procedures to address the organisations’ concerns of its survival against threats (unintentional / intentional, and naturally / emergencies, crises, and disasters that disrupt its functions).  This course is suitable for any personnel interested to establish and enhance the responsiveness, resiliency and recoverability of its organization’s business and the protection of critical assets, human, environmental, intangible and physical. It focuses on continuity management and recovery of critical business functions.Course ContentIntroduction to Business Continuity Management System, Principles and DefinitionsUnderstanding the elements of ISO 22301System Documentation and Develop a Business Continuity PlanPlan, Prepare, Execute, Implementation and Relevancy update of Business Continuity Plan

The course aims to provide a structured training to impart knowledge of effective Business Continuity Management System – ISO 22301 which provides participants the framework and total program approach for analyze and implement strategies, processes and procedures to address the organizations’’ concerns of its survival against threats (unintentional / intentional, and naturally / emergencies, crises, and disasters that disrupt its functions).  This course is suitable for any personnel interested to establish and enhance the responsiveness, resiliency and recoverability of its organization’s business and the protection of critical assets, human, environmental, intangible and physical. It focuses on continuity management and recovery of critical business functions.  Delegates will acquire the knowledge and skills required to perform internal audits of their organization’s business continuity management systems in accordance with ISO 19011.Course ContentIntroduction to Business Continuity Management System, Principles and DefinitionsUnderstanding the elements of ISO 22301System Documentation and Develop a Business Continuity PlanPlanning, conducting, reporting and follow-up on an audit