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ISO 13485:2016 Auditor Training PD631844

PD631844

ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system, and how to demonstrate compliance to meet customer and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation, and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.  Estimated to take up to 15-hours to complete.

Objectives

By participating in this online course, you will be able to:

  • Explain the high level requirements and intent of this international standard
  • Explain how the requirements can be interpreted/should be implemented in various industries
  • Identify the requirements for managing an organization’s QMS in compliance with ISO 13485:2016
  • Interpret how the requirements can be interpreted/should be implemented within an organization
  • Assume a productive role in an audit of your organization’s quality management system as outlined in ISO 13485 and ISO 19011

Materials Provided

  • 365 days of online single-user access (from date of purchase) to the approximately 15 hours of instruction
  • Continuous assessment to check knowledge and application of key concepts
  • Follow-up to your content questions

Is this On Demand Course for You?

This course is for you if you want to:

  • Quickly and efficiently learn how to conduct an ISO 13485:2016 audit
  • Focus on the application of requirements specified in the standard by completing case studies using ISO 13485
  • Improve your curriculum vitae and career opportunities with qualifications in ISO 13485:2016
  • Upgrade your internal auditing expertise from ISO 13485:2003 or ISO 9001:2018 to ISO 13485:2016

Find answers to FAQs.

For More Details

Email CustomerService@sae.org, or call 1-877-606-7323 (U.S. and Canada) or 724-776-4970 (outside US and Canada).

  • ISO 13485
  • Introduction to ISO 19011:2018
  • Managing an audit program
  • Planning and conducting an audit
  • Competence and evaluation of auditors
  • Additional guidelines for planning and conducting audits
  • Case studies on auditing to ISO 13485

  • Windows 7, 8, 10 (other operating systems and mobile platforms are not supported but may work)
  • Internet Explorer 11, Mozilla Firefox 37, Google Chrome 42 (other browsers are not supported but may work)
  • Broadband-1Mbps minimum

Access Period:365 Days

Duration: 15 Hours
Members save up to 9% off list price.
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