Detail kurzu

ISO 13485:2016 Auditor Training

EDU Trainings s.r.o.

Popis kurzu

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

Obsah kurzu

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

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
Certifikát Na dotaz.
Hodnocení




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