Online ISO 13485:2016 Internal Auditor Training Pack

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Overview

This fully online training pack is ideal for anyone that wants to gain an in-depth understanding of the process for performing internal audits of part of their QMS (based on ISO 13485:2016), in accordance with ISO 19011:2018.

This training pack includes two courses that must be completed in order to successfully complete gain their training certificate in ISO 13485:2016 Internal Auditor Training:

Online ISO 13485:2016 Foundation Training PLUS Online Auditing Competency based on ISO 19011:2018 Training!

If you are interested in this course, we recommend having a look at our free online ISO 13485:2016 introduction course. Check it out today!

  • 14 Hours
Online ISO 13485:2016 Internal Auditor Training Pack

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  € 6Hours
  • Module 0 - Course Introduction [ISO 13485:2016 Foundation]

    In this module, an introduction to the course will be provided. This includes important information regarding the course content & learning objectives, duration, assessment methodology & how to successfully complete the course.

  • Module 1 - Introduction to ISO 13485:2016 [ISO 13485:2016 Foundation]

    In this module we will explore the purpose, scope, benefits, structure and key terminology of ISO 13485:2016. We will also explore the process approach and the relationship between ISO 13485:2016 and relevant statutory/regulatory requirements.

  • Module 2 - Quality Management Systems [ISO 13485:2016 Foundation]

    In this module we will cover the requirements related to establishing the QMS including establishment of the QMS processes, change control and QMS documentation requirements including control of documentation and records.

  • Module 3 - Management Responsibility [ISO 13485:2016 Foundation]

    In this module we will explore the role of Top Management in relation to the QMS including coverage of the quality policy, quality objectives, responsibilities, authority and communication, and the management review.

  • Module 4 - Resource Management [ISO 13485:2016 Foundation]

    In this module we will explore the resources (human, infrastructure, work environment and contamination control) that are required to implement and maintain the QMS.

  • Module 5 - Product Realization, Part 1 [ISO 13485:2016 Foundation]

    In this module we will explore the requirements related to pre-production and service provision, namely: customer related processes, design and development and purchasing.

  • Module 6 - Product Realization, Part 2 [ISO 13485:2016 Foundation]

    In this module we will explore the requirements related to production and service provision and control of monitoring and measuring equipment.

  • Module 7 - Measurement, Analysis and Improvement [ISO 13485:2016 Foundation]

    In this module we will explore the requirement related to monitoring and measurement including feedback and complaint handling. We will also cover reporting, the internal audit and control of nonconforming products.

  • Module 0 - Course Introduction [Auditing Competency based on ISO 19011:2018]

    In this module, an introduction to the course will be provided. This includes important information regarding the course content & learning objectives, duration, assessment methodology & how to successfully complete the course.

  • Module 1 - Introduction to Management Systems [Auditing Competency based on ISO 19011:2018]

    In this module we will explore the purpose and benefits of a management system; the key concepts that underpin the common ISO management system standards and the significance of these for the auditor and some of the key management systems terms and definitions which are relevant to auditing

  • Module 2 - Introduction to Management System Auditing [Auditing Competency based on ISO 19011:2018]

    In this module we will explore the different types of management system audits, the principles of auditing, the 6 phases of the audit lifecycle, desired auditor behaviours and the key terminology associated with ISO 19011.

  • Module 3 - Initiation and Preparation [Auditing Competency based on ISO 19011:2018]

    In this module we will explore the audit program and the process for establishing the audit objectives, scope and criteria. We will also expand on the audit lifecycle by exploring the first two phases namely “Initiate the Audit and Prepare Audit Activities” – determination of audit feasibility, review of documented information, preparing the audit plan and audit work documents and assigning work to the audit team.

  • Module 4 - Conducting Audit Activities [Auditing Competency based on ISO 19011:2018]

    In this module we will explore the third phase of the audit lifecycle, namely conducting audit activities. Topics covered in this module will include the opening meeting, methods available to the management system auditor for collecting audit evidence, generating audit findings and the importance of effective communication throughout the audit.

  • Module 5 - Report, Close and Follow up the Audit [Auditing Competency based on ISO 19011:2018]

    In this module we will explore the final stages of the audit, namely: documenting the identified non-nonconformities and conducting the closing meeting. We will also explore, the last three phases of the audit lifecycle namely: preparing and distributing the audit report, completing the audit and performing follow up audit activities.

This course is fully certified by Comply Guru™.

In order to successfully complete the course, each Learner will need to obtain a grade of 70% or higher in the final examination of both courses [ISO 13485:2016 Foundation & Auditing Competency based on ISO 19011:2018].

Successful completion will entitle each Learner to receive a certificate of completion.

Custom Course Development

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