Certificate in ISO 13485 for Quality Managers

Name: Certificate in ISO 13485 for Quality Managers
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The Certificate in ISO 13485 for Quality Managers course is a comprehensive program designed to equip learners with the essential skills needed to excel in the medical device industry. This course focuses on ISO 13485, an international standard for quality management systems specific to this industry.

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AboutThisCourse

By completing this course, learners will gain a deep understanding of the requirements for establishing and maintaining a quality management system in compliance with ISO 13485. This certification is highly valued in the medical device industry, as it demonstrates a proficiency in quality management systems and a commitment to regulatory compliance. As such, there is significant industry demand for professionals who have completed this course. By earning this certificate, learners will be well-positioned for career advancement and will have the skills needed to effectively manage quality within their organization. In summary, this course is essential for anyone looking to build a career in the medical device industry or for those looking to enhance their existing skill set. With a focus on practical application and real-world examples, learners will leave this course with the knowledge and skills needed to succeed in this demanding and rewarding field.

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CourseDetails

Here are the essential units for a Certificate in ISO 13485 for Quality Managers:

• ISO 13485:2016 Overview
• Understanding Quality Management Systems (QMS)
• ISO 13485:2016 Requirements and Implementation
• Risk Management in Medical Devices
• Documentation Control and Record Keeping
• Management Responsibilities and Management Review
• Resource Management and Training
• Product Realization and Design Control
• Measurement, Analysis, and Improvement of the QMS
• Internal and External Audits for ISO 13485 Certification

These units cover the critical aspects of ISO 13485 and provide a comprehensive understanding of the Quality Management System for medical devices. By mastering these units, Quality Managers can effectively implement and maintain a QMS compliant with ISO 13485:2016.

CareerPath

As a quality manager with an ISO 1

EntryRequirements

BasicUnderstandingSubject
ProficiencyEnglish
ComputerInternetAccess
BasicComputerSkills
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FastTrack GBP £140

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AcceleratedLearningPath

ThreeFourHoursPerWeek
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StandardMode GBP £90

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FlexibleLearningPace

TwoThreeHoursPerWeek
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CERTIFICATE IN ISO 13485 FOR QUALITY MANAGERS

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London School of International Business (LSIB)

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05 May 2025

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