ISO 13485 Requirements-Quality Management Systems for Medical Devices

  • Overview
  • Course Content
  • Requirements & Materials
Overview

ISO 13485 Requirements-Quality Management Systems for Medical Devices

Course Description

Learn the ISO 13485:2016 standard requirements and ways you can utilize a Quality Management System (QMS) to improve customer relationships, operations, and corporate culture. As an internationally agreed standard, ISO 13485 sets QMS requirements for the medical device industry and is incorporated by reference within 21 CFR 820. In addition to analyzing industry guidance and implementation strategies for adopting ISO 13485, learners receive sample documents that can be customized for their home facilities. The course also touches on the relationship between ISO 13485 and applicable U.S. Food and Drug Administration regulations. Participants are responsible for purchasing the ISO 13485 standard, which is not included in the course tuition, prior to the start of the training.

Course Content

Quality Management System

  • Detailed review of the process approach
  • Risk-based approach to the QMS
  • Documents and specific records required for regulatory compliance

Management Responsibility

  • Specific requirements for leadership including organizational responsibilities and authorities and management reviews

Resource Management

  • Specific requirements for human resource management, infrastructure/work environment management, and contamination control

Product Realization

  • Specific requirements for the entire product realization lifecycle, including planning, risk management process documentation, purchasing controls, production controls, contaminating controls, process validations, and sterilization process controls
  • Specific requirements for design and development, including design transfers, design files, and more

Monitoring and Measuring

  • Specific requirements for feedback processes, control of non-conforming products and corrective actions including complaint handling and reporting to regulatory authorities

Application

  • Identification of non-conformities
  • How to write non-conformities
Requirements & Materials

Materials

REQUIRED (Student must provide):

  • Attendees must obtain a copy of the standard ISO 13485:2016 Medical Devices – Quality Management System Requirements for Regulatory Purposes, which will be used during the course.

    The standard may be purchased through the American National Standards Institute (ANSI) (www.ansi.org) and/or American Society for Quality (ASQ) (www.asq.org).

PROVIDED (Student will receive):

  • Student book with resources

Who Should Attend

This course is designed for anyone responsible for quality, corporate compliance, and risk management in a medical device manufacturing facility. Quality managers, engineers, regulatory specialists, internal auditors, and supplier auditors will also benefit from this training.

Female at white board adjusting process mapping sticky notes.

What You Will Learn

  • Review of ISO 13485 and its benefits
  • How ISO 13485 compliance relates to 21 CFR 820 Compliance
  • Practice in identifying and writing non-conformities
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How You Will Benefit

  • Describe the requirements and structure of ISO 13485:2016.
  • Interpret and apply requirements relevant to your organization.
  • Appreciate how a QMS can be applied as a framework to produce safer medical devices.
  • Evaluate how requirements can be effectively implemented to meet and maintain regulatory compliance per 21 CFR 820.
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TRAIN AT YOUR LOCATION

We enable employers to provide specialized, on-location training on their own timetables. Our world-renowned experts can create unique content that meets your employees' specific needs. We also have the ability to deliver courses via web conferencing or on-demand online videos. For 15 or more students, it is more cost-effective for us to come to you.

  • Save Money
  • Flexible Schedule
  • Group Training
  • Customize Content
  • On-Site Training
  • Earn a Certificate
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