Master multiple standards with CQI & IRCA certified and other training courses from SGS 

Tailored courses to enhance understanding and application of the standards to meet specific organizational needs. 

How will these courses benefit you?

IRCA/CQI Accredited ISO 13485 Lead Auditor Training

• Accredited Training: Gain expertise in auditing Medical Device Quality Management Systems (MD QMS) against ISO 13485:2016 with our IRCA/CQI Accredited ISO 13485 Lead Auditor Training.

• Course Objectives: Learn to understand the purpose of MD QMS, interact with regulatory authorities, grasp quality management standards, and recognize the business benefits of QMS. Develop skills in planning, conducting, and reporting QMS audits in alignment with ISO 19011 and ISO 17021.

• Comprehensive Curriculum: Cover essential topics including process-based MD QMS, accreditation, certification, audit principles, and audit stages. Master audit preparation, checklist development, on-site audit execution, and post-audit activities.

• Expert Instruction: Benefit from expert guidance to comprehend roles and responsibilities of auditors, ensuring conformity with ISO 13485 and relevant regulatory documents.

For detailed information on our IRCA/CQI Accredited ISO 13485 Lead Auditor Training, download our brochure now. Elevate your auditing skills and enhance your career in the medical devices industry.

ISO 13485 Internal Auditor Training

• AccreditedTraining: Develop essential skills for internal auditing in the medical device industry, aligned with ISO 13485:2016 Medical Device Quality Management System (MD QMS) requirements.

• Course Objectives: Understand the purpose and benefits of MD QMS, grasp ISO 13485:2016 requirements, and comprehend audit principles and definitions. Learn roles and responsibilities of auditors, audit planning, on-site activities, reporting, and follow-up procedures.

• Comprehensive Curriculum: Cover key aspects including Quality Management System clauses (4 to 8), audit principles, and roles of auditors. Master the preparation, documentation, and conformity assessment against ISO 13485:2016 and local regulations.

• Enhanced Competence: Gain insights into how to improve MS performance, ensuring your organization's compliance and effectiveness in the medical devices sector.

For detailed insights into our ISO 13485 Internal Auditor Training, download our brochure. Equip yourself with the expertise to conduct impactful internal audits. Elevate your skills; download the brochure now.

As a leader in professional training, we draw on years of worldwide experience to provide effective learning and development opportunities, nurture talent and enable continuous organizational progression.

SGS is a global training organization with extensive testing capabilities across all medical device categories. We are a designated UKCA Approved Body, a CE Notified Body and a recognized MDSAP Auditing Organization.

Wherever you are, whatever your industry, our experts worldwide provide specialized solutions to make your business faster, simpler and more efficient.

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Why SGS Academy India?

Medical Device Regulation (EU) Implementation Course

• In-Depth Understanding: Gain insights into the additional requirements of the Medical Device Regulation (EU), existing directives, and ISO 13485. Understand terminology nuances and certification prerequisites.

• Course Objectives: Learn to establish links between EN ISO 13485:2016 (QMS) and MDR EU/2017/745. Grasp changes in terminology, identify gaps in compliance, and define new proactive post-market surveillance requirements.

• Smooth Transition: Outline the stages of transitioning from MDD to MDR, enabling clients to create customized transition plans.

• Strategic Insights: Define crucial deliverables for all economic operators, ensuring comprehensive knowledge of key responsibilities in compliance with the Medical Device Regulation.

For detailed information on our Medical Device Regulation (EU) Implementation Course, download the brochure now to enhance your regulatory expertise.

ISO 14971:2019 Risk Management for Medical Devices Introduction

• Comprehensive Overview: Understand the nuances of ISO 14971:2019, focusing on risk management application for medical devices and highlighting key differences from the 2012 version.

• Key Learning Objectives: Learn to identify essential elements crucial for medical device risk management as outlined in ISO 14971:2019. Understand the significant changes introduced in the third edition. Acquire skills to assess the lifecycle stage of medical devices and perform product risk assessments.

• Usability Focus: Grasp the specific risk management requirements related to usability, ensuring a holistic approach to product safety and effectiveness.

• Directive Comparison: Differentiate between directives and EN ISO 14971:2012 (Annex Z). Understand the continued applicability of these standards and why they are essential in the evolving landscape of medical device regulations

For in-depth insights into our ISO 14971:2019 Risk Management for Medical Devices Introduction Course, download the brochure now to elevate your expertise in this critical aspect of medical device compliance.

IVDR Technical Documentation Training Course 

• Comprehensive Understanding: Gain insights into the technical documentation requirements of the In Vitro Medical Device Regulation (IVDR) EU 2017/746, covering the entire product life cycle.

• Key Learning Objectives: Learn to differentiate between IVDD and IVDR in technical documentation. Understand the essential elements of technical documentation, including its structure, critical areas, and reports necessary for compliance.

• Notified Body Assessment: Familiarize yourself with how notified bodies evaluate technical documentation, ensuring you are prepared for assessments.

• Interactive Training: Prepare to create live documents that align with IVDR requirements. Understand the nuances of critical areas and the significance of up-to-date, comprehensive documentation.

Elevate your understanding of IVDR requirements and enhance your technical documentation skills. Download now to excel in IVDR compliance.

QMS Software Validation for MDQMS

• Trained over 3,00,000+ participants since the inception of SGS Academy India 
• Our professors are certified scheme trainers approved by global and UK bodies 
• The SGS Accredited Training Certificate is considered a benchmark in industry-preferred global auditor qualification programs

Are you looking for customized corporate training for your organization?

No time for classroom training? 

How can your personnel consistently acquire the up-to-date skills and knowledge they need, regardless of level or location? 

When it comes to tailored training, we can work with you to define your training needs and deliver customized training solutions that meet your exact learning requirements. Plus, with expert trainers that are experienced practitioners in their fields, our training moves beyond theory, giving you valuable real-world insights. Talk to us today about how SGS Academy can help you with your training requirements.

Explore our self-paced eLearning. Purchase once. Revisit unlimited times for 12 months. Get certificate on completion.

• Focused Training: Acquire skills to validate process software in medical device quality management systems (MDQMS).

• Key Topics: Explore software and software validation concepts. Understand critical thinking, software risk management, and phases like development, maintenance, and retirement.

• Specialized Knowledge: Gain expertise in determining appropriate activities for software validation.

Elevate your understanding of software validation in the medical devices industry. Download now for specialized training information.

About ISO 9001:2015 Training Courses 

Explore our ISO 9001:2015 training courses, which are designed to deepen understanding and application. These courses will introduce you to and familiarize you with the requirements of ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018 standards. You will gain a better understanding of the various management systems included in the standards and gain confidence in how to implement them effectively into your organization.  

What will you learn?

• Implement a unified set of procedures through an integrated management system (IMS).
• Gain comprehensive knowledge of the quality management system (QMS), environmental management system (EMS), and occupational health and safety (OH&S) management system requirements.
• Navigate the ISO framework and apply the plan-do-check-act (PDCA) cycle effectively in managing systems.
• Acquire the skills to integrate standards seamlessly into your organization using the appropriate IMS method.
• Develop the capability to align and harmonize processes across various management systems for enhanced organizational efficiency

IT Security Programs

These courses have been designed to equip learners with the knowledge and skills needed to assess and report on the conformance and effective implementation of an information and IT security management system to protect an organization and to ensure continuation of business.

Organizations that fail to operate coherent and comprehensive IT security strategies leave themselves open to potential security failures.

We offer a portfolio of training programs to help gear the IT & Information security professionals develop professional competence for implementing the essentials to safeguard information & privacy countering the cyber security challenges that loom largely over organizations. 

• Our ISO/IEC 27001 auditor training gives you the necessary skills to perform internal audits of an organization’s Information Security Management System (ISMS) and to contribute to its continual improvement. This training helps you identify and control the threats an organization faces from lapses in information security controls and learn how to effectively put in place measures to address those threats.
• ISO/IEC 27701 is the standard for methodically evaluating the sensitive data security risks and analyzing the possible impact of threats and vulnerabilities that could affect your business functions and customers.
• ISO/IEC 20000 is the IT service management system (SMS) standard, specifying the requirements for planning, establishing, implementing, operating, monitoring, reviewing, maintaining and improving your service management system.

IRCA/CQI Accredited ISO/IEC 27001:2022 Information Security and Privacy Protection Lead Auditor Training Course

Course description: 

This training course is designed to give you the relevant skills and knowledge to carry out audits of information security management systems (ISMS) against ISO 27001. An ISMS compliant with the requirements of this standard allows an organization to examine and control information security risks, threats and vulnerabilities. 

Course objectives:

On completion, learners will be able to:

• Explain the purpose of an information security management system (ISMS) and the processes involved in establishing, implementing, operating, monitoring, reviewing and improving an ISMS as defined in ISO 27001, including the significance of these processes for ISMS auditors
• Explain the interrelationship among ISO 27001 and other relevant standards, their purpose and content, and the legislative framework relevant to an ISMS
• Apply in-depth knowledge of the ISO 27001 audit and certification process
• Conduct third party audits against the requirements of ISO 27001 Information Security Management Systems and report and follow-up on the results
• Meet the training requirements for registration as an ISMS Auditor or Lead Auditor with the IRCA

ISO/IEC 27001:2022 Information Security and Privacy Protection- Lead Implementor Course

Course Description:

A comprehensive review of the new and changed controls found in the ISO/IEC 27002:2022 including an in-depth examination of the application of the control of newly introduced attributes that facilitate the application of controls. 

• ISO/IEC 27002:2022 overview of changes 
• Understanding clause 5 controls in treating risks, governance and the use of cloud services, including the relationship to other ISO/IEC standards 
• Clauses 6 controls relating to risks related to physical objects 
• Clause 8 and the purpose of the new controls in treating risks relating to technology 

Course Objectives

Upon completion of this course, you will be able to:

• Define the changes in ISO/IEC 27002:2022. 
• Use the new control attributes to navigate and apply these controls effectively. 

Audience

This course is designed for: 

• Those responsible for maintaining existing ISO/IEC 27001 based Information Security Management Systems interested in incorporating the control changes with the ISO/IEC 27002. 
•  Managers, consultants and auditors, with prior knowledge of the ISO/IEC 27001/27002 that want to comprehend the new, changed security controls present in the ISO/IEC 27002:2022, and their corresponding attributes.

ISO/IEC 27701:2019 PIMS Requirements and Implementation Training Course

Course description:

The purpose of this course is to provide learners with the knowledge and skills to implement the requirements of ISO/IEC 22701:2019 Privacy Information Management System (PIMS). 

Course objectives:

On completion, learners will:

• Understand the intended outcome of a privacy information management system (PIMS)
  
• Be familiar with the requirements and guidelines of the ISO/IEC 27701:2019 standard
• Understand the relationship of the ISO/IEC 27701 standard to the ISO/IEC 27001:2013 and ISO/IEC 27002:2013 standards
• Be able to implement a PIMS on top of an ISMS
• Understand project management for a PIMS implementation
• Be able to perform information security and privacy risk management
  
• Be able to select the necessary controls in Annex _ of ISO/IEC 27001:2013 and Annex A and Annex B of ISO/IEC 27701  

ISO/IEC 27701:2019 PIMS Requirements Introduction Training Course

Course Description:

The purpose of this course is to familiarize learners with the ISO/IEC 27701:2019 Privacy Information Management System (PIMS) requirements.
Course Content:

•  Introducing Information
• The Relationship of ISO/IEC 27701 with ISO/IEC 27001:2013 and ISO/IEC 27002:2013
• PIMS-specific Guidance to ISO/IEC 27002:2013
• Additional Guidance
• PIMS-specific Controls

Objectives

• Understand the intended outcome of a Privacy Information Management System (PIMS).
  Be familiar with the requirements and guidelines of the ISO/IEC 27701:2019 standard.
• Clarify the relationship of the ISO/IEC 27701 standard with ISO/IEC 27001:2013 and ISO/IEC 27002:2013 standards.

ISO/IEC 27001:2022 Information Security, Cybersecurity and Privacy Protection- Internal Auditor Course

Course description: 

The purpose of this course is to equip learners with the knowledge and skills needed to perform an internal audit of an information security management system and to contribute to the continual improvement of the management system. Learners are expected to have knowledge of information security management systems and ISO/IEC 27001:2013 before attending this course. The required background knowledge is provided in our Information Security Management Systems Introduction and Awareness Course. 

Course objectives:

On completion, learners will be able to:

• Explain the process-based information security management system model for ISO/IEC 27001, with reference to the plan-do-check-act (PDCA) cycle, and the role of internal audits in the maintenance and improvement of information security management systems

• Explain the role and responsibilities of an auditor in planning, conducting, reporting and following-up an information security management system internal audit, in accordance with ISO 19011

• Plan, conduct, report and follow-up an internal audit of part of an information security management system based on ISO/IEC 27001 in accordance with ISO 19011

Get Started with Data Safety eLearning Course in accordance with GDPR

Course description:

This course provides an overview of data safety in the workplace. Learn how to lawfully collect, use and store data safely and appropriately.

Completion criteria: Learners will be required to complete the entire course. Upon completion, learners will receive notification with instructions on how to download a certificate of completion.

You will be granted 12 months access to this course, effective from the date of purchase.

Course objectives:

On completion, learners will be able to:

• Identify different types of personal data
• Understand how to lawfully obtain and maintain personal data
• Recognize who should work with personal data

ISO/IEC 20000 IT Service Management System Implementation Course

Course description: 

This course is primarily aimed at anyone who requires an understanding in ITSM in general and in ISO/IEC 20000 SMS. IT professionals working in an organization which is implementing or already has ISO/IEC 20000 certification will also find this course useful to improve not only their understanding of the subject but also the application of ISO/IEC 20000 within their organization. 

Course Content:

• The fundamental requirements for an IT SMS and the need for continual improvement 

• The processes, their objectives and high-level requirements 

• Applicability and scope definition requirement 

• The purpose of internal and external audits, their operation and the associated terminology 

The relationship with best practices, ITIL, and related standards, ISO 9001 and ISO/IEC 27001 

We offer training courses for the following:

Get in touch

Medical Devices

Gain expertise in Medical Device Quality Management System auditing

IMS training courses from SGS

Get trained for ISO 9001, ISO 14001 and ISO 45001 with our world recognized training programs

Understand the nuances of ISO 14971:2019, focusing on risk management application for medical devices and highlighting key differences from the 2012 version.

ISO 14971:2019 Risk Management for Medical Devices Introduction 

Gain insights into the technical documentation requirements of the In Vitro Medical Device Regulation (IVDR) EU 2017/746, covering the entire product life cycle.

IVDR Technical Documentation Training Course 

QMS Software Validation for MDQMS

Acquire skills to validate process software in medical device quality management systems (MDQMS).

Gain expertise in auditing Medical Device Quality Management Systems (MD QMS) against ISO 13485:2016 with our IRCA/CQI accredited ISO 13485 Lead Auditor Training.

ISO 13485 Lead Auditor Training

Develop essential skills for internal auditing in the medical device industry, aligned with ISO 13485:2016 Medical Device Quality Management System (MD QMS) requirements.

ISO 13485 Internal Auditor Training

Medical Device Regulation (EU) Implementation Course

Gain insights into the additional requirements of the Medical Device Regulation (EU), existing directives, and ISO 13485. Understand terminology nuances and certification prerequisites.

This ISO 9001 training course provides
participants with the knowledge and
skills to perform first, second and third
party audits of quality management
systems against ISO 9001 in
accordance with ISO 19011 and
ISO/IEC 17021, as applicable.

ISO 9001:2015 Lead Auditor Training

The aim of this course is to provide students with the knowledge and skills required to perform an internal audit of part of a quality management system based on ISO 9001 (or equivalent), and report on the effective implementation and maintenance of the management system in accordance with ISO 19011.

ISO 9001:2015 Internal Auditor Training

ISO 9001:2015 Awareness course

This course may be valuable as
preparation for learners planning to complete other ISO 9000 series-based training courses, such as the QMS Lead Auditor the Internal QMS Auditor Training Course. This course does not address the skills of auditing although it is useful as
an introduction to anyone involved in the development, implementation and
management of a ISO 9001:2015.

This course will familiarise you with the process of how to implement a common set of procedures using an integrated management system process based on the framework and requirements of ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018 standards.

Integrated Management Systems -Introduction course

This course will introduce you to the implementation process of a unified set of procedures within an integrated management system, following the framework and requirements outlined in ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018 standards 

Integrated Management Systems -Implementation course

Integrated Management Systems -Bundled course

Whether you are new to your field and learning your role, or you are looking to strengthen your core skills within your organisation, SGS Bundled Courses will provide you with access to the training you need. These courses can be completed at your own pace and in any order.

ISO 9001:2015, ISO 14001:2015, ISO 45001: 2018

ISO 9001:2015, ISO 14001:2015, ISO 45001: 2018

ISO 9001:2015, ISO 14001:2015, ISO 45001: 2018

This training course is designed to give you the relevant skills and knowledge to carry out audits of information security management systems (ISMS) against ISO 27001. An ISMS compliant with the requirements of this standard allows an organization to examine and control information security risks, threats and vulnerabilities. 

ISO/IEC 27001:2022 Information Security and Privacy Protection Lead Auditor Training Course

A thorough analysis of ISO/IEC 27002:2022's updated controls, with a focus on newly introduced attributes aiding application of controls.  The review covers risk management, governance, cloud services, physical asset, and technological risks, exploring their implications and interconnections with other ISO/IEC standards, providing insights into enhanced control applicability. . 

ISO/IEC 27001:2022 Information Security and Privacy Protection- Lead Implementer Course

ISO/IEC 27701:2019 PIMS Requirements and Introduction Training Course

This course aims to acquaint learners with ISO/IEC 27701:2019 Privacy Information Management System (PIMS) requirements. It covers topics such as introducing information, the relationship between ISO/IEC 27701 and ISO/IEC 27001:2013, PIMS-specific guidance to ISO/IEC 27002:2013, additional guidance, and PIMS-specific controls. 

The purpose of this course is to provide learners with the knowledge and skills to implement the requirements of ISO/IEC 22701:2019 Privacy Information Management System (PIMS).

ISO/IEC 27701:2019 PIMS Requirements and Implementation Training Course

The purpose of this course is to equip learners with the knowledge and skills needed to perform an internal audit of an information security management system and to contribute to the continual improvement of the management system. Learners are expected to have knowledge of information security management systems and ISO/IEC 27001:2013 before attending this course. The required background knowledge is provided in our Information Security Management Systems Introduction and Awareness Course. 

ISO/IEC 27001:2022 Information Security, Cybersecurity and Privacy Protection- Internal Auditor Course

Get Started with Data Safety eLearning Course in accordance with GDPR

This course provides an overview of data safety in the workplace. Learn how to lawfully collect, use and store data safely and appropriately.

Completion criteria: Learners will be required to complete the entire course. Upon completion, learners will receive notification with instructions on how to download a certificate of completion.

You will be granted 12 months access to this course, effective from the date of purchase.

This course is primarily aimed at anyone who requires an understanding in ITSM in general and in ISO/IEC 20000 SMS. IT professionals working in an organization which is implementing or already has ISO/IEC 20000 certification will also find this course useful to improve not only their understanding of the subject but also the application of ISO/IEC 20000 within their organization. 

ISO/IEC 20000 IT Service Management System Implementation Course

ISO/IEC 42001:2023 IT Artificial Intelligence - Management System (AIMS) Foundation Training Course

Our ISO/IEC 42001:2023 Information Technology — Artificial Intelligence - Management System (AIMS) Foundation Training Course is designed to provide you with a comprehensive understanding of the management systems approach and the specific requirements of ISO/IEC 42001:2023. This course will equip you with the knowledge and skills needed to implement effective AI management systems, ensuring compliance with international standards.. 

We offer training courses for the following:

ISO/IEC 42001:2023 IT Artificial Intelligence - Management System (AIMS) Foundation Training Course

Our ISO/IEC 42001:2023 Information Technology — Artificial Intelligence - Management System (AIMS) Foundation Training Course is designed to provide you with a comprehensive understanding of the management systems approach and the specific requirements of ISO/IEC 42001:2023. This course will equip you with the knowledge and skills needed to implement effective AI management systems, ensuring compliance with international standards.. 

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SGS India Private Limited, 4B, Adi Shankaracharya Marg, Vikhroli (West), Mumbai, Maharashtra, 400083, India 

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