Enhancing people 
and businesses

This course aims to provide learners with the knowledge and skills required to perform first, second and third-party audits of environmental management systems against (EMS) ISO 14001, in accordance with ISO 19011 and ISO 17021, as applicable.Learners who successfully complete this CQI and IRCA Certified Auditor/Lead Auditor (EMS) Training course (within the five years before making an application to become a certificated auditor) will satisfy the training requirements for initial certification as a certified IRCA EMS auditor. For full training and requirements, please refer to quality.org/IRCA-grades.This course is recognised by APSCA for CPD purposes, aligned with the APSCA Competency Framework and is worth 36 CPD credits.Recommended Prior Knowledge Management systemsThe Plan, Do, Check, Act (PDCA) cycleThe core elements of a management system and the interrelationship between top management responsibility, policy, planning, implementation, measurement, review and continual improvementEnvironmental management - The intended outcomes of an environmental management system:Enhancement of environmental performanceMeeting compliance obligationsAchievement of environmental objectivesISO 14001Knowledge of the requirements of ISO 14001 and the commonly used environmental management terms and definitions, which may be gained by completing a CQI and IRCA Certified ISO 14001:2026 Foundation (EMS) (FD135) Training course or equivalent.Enrolment informationBy enrolling on this course you agree to your personal information being passed to CQI and IRCA.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.Trusted ISO 14001 Lead Auditor training from a leading course providerOur courses are delivered by tutors who are environmental management system experts and experienced trainers. Your knowledge and skills will be developed through an interactive and practical approach to learning. Case study materials and role-play exercises are used to develop and practice skills in all phases of auditing. Participants are continually assessed and required to complete an end-of-course written examination.Contact your local SGS office for full details of the courses available in your region.

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).

Introduction to sustainability reporting and the GRI Standards 2021 updateReporting with GRI Standards 2021 updateReporting on Human Rights with GRI Standards 2021 updateIntegrating the SDGs into sustainability reportingQuiz

This course is certificated by the Chartered Quality Institute and International Register of Certificated Auditors (CQI/IRCA; Course Certification Number, 2428 - PR 369)Course Criteria - ObjectivesUpon completion of this course, learners will be able to:Explain the purpose of a medical device quality management system (MD QMS), interaction with appropriate medical device regulatory authority requirements, quality management systems standard, third-party certification, and the business benefits of the quality management system;Explain the role and responsibilities of an auditor to plan, conduct, report and follow-up a quality management system  in accordance with ISO 19011 (and ISO 17021 where appropriate);Plan, conduct, report and follow-up an audit of a medical device quality management system to establish conformity (or otherwise) with ISO 13485 and applicable medical device regulatory requirement documents in accordance with ISO 19011, ISO/IEC 17021.Learners will need to demonstrate acceptable performance in these areas to complete the course successfully.Prior knowledge Before starting this course, learners are expected to have the following prior knowledge:ISO 13485Knowledge of the requirements of ISO 13485, which may be gained by completing a CQI and IRCA Certified MD QMS ISO 13485:2016 Foundation (FD 132) course or equivalent.Medical Device management System AuditThe Plan, Do, Check, Act (PDCA) cycle.The relationship between ISO 13485 and applicable international regulatory requirements for medical devices.Commonly used quality management terms and definitions within ISO 13485 and ISO 9000.The process approach used in MD QMS.A working knowledge of medical device regulatory process applicable to countries the course is designed to cover, including device regulations, regulatory auditing standards and their relationship with ISO 13485.  This knowledge may be gained by successfully completing a CQI and IRCA course relating to individual regulatory authority standards, which will be available subject to demand (e.g. MD QMS Comprehensive EU Medical Device Regulation 2017/745 (EU MRD) Practitioner - PT 219)A working knowledge of risk management principles related to the design of a medical device, for example ISO 14971

SMETA (Sedex Members Ethical Trade Audit) is a highly recognised audit methodology trusted globally for assessing sites on their labour, health and safety, environmental, and business ethics practices. It empowers businesses to deeply engage in responsible sourcing, safeguard workers’ rights, and maintain ethical practices throughout their supply chains. Employing a systematic approach, SMETA incorporates central ETI Base Code clauses and local labour laws, focusing on sustainable and responsible supply chain related social and environment issues, such as working hours, working environments, labour rights, health and safety, waste management, energy saving and other materialities.SMETA is currently used in more than 180 countries and regions and is used among more than 40+ industries. Sedex continuesly reviewing and updating SMETA, so to adapt to the latest trends in global sustainability and meet the real needs of members and stakeholders. SMETA audit updated to Version 7.0 in the 3rd quarter of 2024.Only Sedex authorized organization (AAC) and authorized trainer are qualified to conduct Sedex & SMETA 7.0 Awareness Introduction and SMETA Basic Internal Auditor Workshop.This course is HRDC claimable under SBL-Khas scheme.