Browse Learn PD631845

ISO 13485:2016 Lead Auditor Training PD631845

PD631845

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 where an organization needs to demonstrate its ability to provide medical devices and related services that consistently 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.  This 24-hour ISO 13485:2016 Lead Auditor course provides training on the standard itself, but also on how to lead or conduct internal audits and supplier audits using ISO 13485 and ISO 19011:2018.

Objectives

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

  • Navigate through the ISO 13485 standard and its appendices
  • Explain how the requirements can be interpreted/should be implemented in various industries
  • Identify if/when a non-conformance has taken place as related to compliance with a clause/clauses of ISO 13485:2016
  • Master the auditing techniques used for quality, environmental, and safety management system audits per ISO 19011:2018
  • Plan, conduct, interpret results, and lead quality management systems audits.
  • Assume a productive role in an audit of your organization’s quality management system as outlined in ISO 13485 and ISO 19011, or serve as a second or third party auditor of another organization’s QMS

Materials Provided

  • 365 days of online single-user access (from date of purchase) to the approximately 24 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
  • Upgrade knowledge and expertise from ISO 13485:2003 to ISO 13485:2016
  • Upgrade your expertise from auditing with ISO 19011:2011 to ISO 19011:2018
  • Conduct internal audits and supplier audits for your company
  • Improve your curriculum vitae and career opportunities with qualifications in quality assurance and leading first and second party audits

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).

  • Overview of quality management systems
  • Scope and definitions
  • Context of the organization
  • Leadership
  • Planning
  • Support
  • Operation
  • Performance evaluation
  • Improvement
  • ISO 19011:2018 overview and definitions
  • Managing an audit program
  • Performing an audit
  • Competence and evaluation of auditors
  • Additional guidelines for audit planning
  • Case studies on auditing to ISO 13485:2016

  • 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: 24 Hours
Members save up to 9% off list price.
Login to see discount.
X