Free Online ISO 13485 Certification Training Course
Learn about all the clauses and requirements of QMS for Medical Devices including some important regulatory aspects in this free online ISO 13485 course.
This free online ISO 13485 certification training course will teach you about quality management systems for medical devices. You will study the ISO 13485:2016 standard, learn how it was developed, and look into the practical steps to company certification on ISO 13485. You will cover the types of available personal certifications and look closely at standard terminologies related to stakeholders, product, QMS, Risk and Sterilization, and more!
What You Will Learn In This Free Course
Introduction to ISO 13485:2016 (Medical Devices’ QMS)
This module explains the existing relevant standards and regulation for medical devices’ industry and enlightens the revision of ISO 13485. It also presents some important terminologies with related definitions as defined by ISO 13485; which are arranged in separate groups. It also covers the comparison of ISO 13485 to FDA 21 CFR Part 820. All mandatory documents required by different clauses of the ISO 13485:2016 standard are also enumerated in this module along with its given clause reference.
Operations of Quality Management System (QMS)
In this module you will learn the operations of the QMS for a medical devices company. It covers top management requirements and offers ideas to manage resource requirements in the organization. It enlightens the concept of medical devices’ product realization. It covers all elements of product realization such as quality planning, customer related processes, design and development, purchasing and production etc.
Measurement, Analysis and Improvement
In this module, Clause – 8 of the ISO 13485:2016 standard is taught. Clause – 8 specifies the general requirements, management of monitoring and measurement issues, nonconforming product management, data analysis etc. Within this clause – 8, Clause – 8.5 is on improvement which paves out ways for the organization to improve its system, products, and processes through the framework of corrective and preventive actions.
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