ISO 13485:2016 Lead Auditor Training

Kód kurzu: PD631845

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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