ISO 9001:2015 - Advanced Insights

Virtual Learning

Course Overview

ISO 9001 is a global standard used to establish a quality management system that is widely adopted across industries and organizations of any size. Using ISO 9001 allows a business to standardize its customer satisfaction results by ensuring consistent, high-quality products and services.

This one-day virtual instructor-led training provides advanced insights into the requirements of the ISO 9001 standard, and the application of the standard within a quality management system. Learners will also gain skills for the assessment of a quality management system against the requirements of ISO 9001.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this course you should be able to:

  • Understand the requirements in the ISO 9001:2015 Standard
  • Identify key documents to help you understand ISO 9001:2015
  • Apply the concepts and requirements as outlined in the ISO 9001:2015 Standard.
  • Develop skills to evaluate the requirements of the organization against these requirements

Price: $800.00

Additional Recommended Courses

ISO 13485:2016 Fundamentals of Medical Devices QMS Requirements for Regulatory Purposes

This virtual instructor-led two-day course covers the requirements of ISO 13485:2016, including the intent, meaning, and interrelationship of the ISO 13485:2016 clauses. This course will also introduce learners to ISO 13485:2016 Medical Devices – A Practical Guide. This guide was developed by ISO TC 210 (the developers of ISO 13485:2016) to assist medical device manufacturers in the practical application of the requirements of ISO 13485:2016 within a quality management system. Learners will demonstrate comprehension through individual and group activities throughout the course as well as a final course challenge.

This course pairs well as a prerequisite to Design Controls for Medical Devices and IVDs (2 day).

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Identify key documents to help you understand ISO 13485:2016
  • Recognize the primary elements of ISO 13485:2016
  • Identify terms and definitions relative to the application of ISO 13485:2016
  • Recognize similarities and differences between ISO 13485:2016 and the Quality System Regulation
  • Demonstrate practical application of ISO 13485:2016 requirements through inspection scenarios

Price: $1200.00

ISO 14971:2019 Risk Management for Medical Devices and IVDs-Practical Application

ISO 14971:2019 provides guidelines for manufacturers to establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks associated with the identified hazards, control risks and monitor the effectiveness of the controls. An effective risk management program applies to all stages of the medical device lifecycle and is an integral part of a manufacturer’s quality management system.

This virtual instructor-led two-day course presents the key foundations of the risk management process defined in ISO 14971:2019 and provides expert tips on how to navigate the process including review of TIR 24971:2020.

This course is highly interactive and includes practical instruction, case study exercises and a competency assessment.

This course also includes a self-paced two-hour ISO 14971:2019 overview eLearning module that must be completed prior to the start of the live instruction.

This course pairs well as a prerequisite to Design Controls for Medical Devices and IVDs (2 day).

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Identify regulatory requirements for risk management:
    • European Regulation EU 2017/745 (EU MDR)
    • European Regulation EU 2017/746 (EU IVDR)
    • 21 CFR 820.30(g)
  • Identify requirements of key International Standards relative to risk management:
    • ISO 14971:2019
    • ISO 13485:2016
  • Recognize risk management definitions and principles
  • Identify how risk management affects quality management system practices
  • Recognize one method for the practical application of risk management principles


Who Should Attend
This course is vital for any medical device professional looking to expand their knowledge on comprehensive risk management processes and explain their interactions with the entire lifecycle of a medical device from conception to decommissioning and disposal.

Price: $1200.00

CAPA Considerations: Problem Statement Writing and Investigation Techniques

Utilizing proven methodologies, this highly interactive medical device CAPA writing course provides learners

with the tools and skills needed to identify root causes of existing nonconformities from complaints, process deviations, audits and other feedback mechanisms. 

This 2-day virtual instructor-led course covers how to effectively write concise, understandable problem statements and specific corrective action plans relative to problem statements. Learners are provided with instruction and guidance as they conduct hands-on medical device writing exercises, working through case studies of investigation data and summarizing key findings. Our highly experienced instructor will provide real-time feedback to help learners write concise medical device nonconformity statements.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Define the purpose of Corrective and Preventive Action (CAPA)
  • Identify and analyze data inputs for CAPA
  • Compose a proper and complete problem statement
  • Apply investigation techniques to identify root causes and define the appropriate corrective action
  • Identify effectiveness criteria and perform an effectiveness check
  • Recognize how to close the CAPA loop and the requirements to close CAPAs in a timely and complete manner.

Price: $1200.00