ISO 13485:2016 Overview

About ISO 13485
ISO 13485 is the most common medical device QMS regulatory standard in the world. It is focused on maintaining QMS effectiveness and meeting regulatory and customer requirements. Since different countries often have different standards, ISO 13485 is intended to provide a globally harmonized model of QMS requirements for international markets.

The guidelines for maintaining effective quality management processes outlined in ISO 13485 are all geared toward the safe design, manufacture and distribution of effective medical devices. In addition to being a regulatory requirement, an ISO 13485-compliant QMS makes good business sense because it helps device manufacturers minimize variation. This in turn provides economic benefits in the form of reduced scrap and general process efficiencies.

The FDA’s QSR is structured differently than ISO 13485 but they have no conflicting requirements. And because the QSR is a regulation, it is often more specific than ISO 13485. For instance, the QSR has more detailed requirements in the areas of complaint handling and reporting requirements. Therefore, conformity to ISO 13485 does not sufficiently demonstrate to the FDA that a manufacturer is in full compliance with the QSR.

The FDA is in the process of harmonizing U.S. quality system requirements with ISO 13485, and plans to issue a notice of proposed rulemaking in 2021. For the time being, separate guidance remains in effect. Until the QSR’s shift to ISO 13485 requirements is fully completed, compliance with the QSR is required for manufacturers planning to distribute medical devices in the U.S. Additionally, if a device maker based in the U.S. wishes to market its products internationally, it must comply with both the QSR and ISO 13485 manufacturing standards.

Key requirements of ISO 13485:2016 include:

  • Alignment of global regulatory requirements
  • Inclusion of risk management and risk-based decision making throughout the quality management system
  • Requirements and clarity with validation, verification, and design activities
  • Supplier control processes
  • Focus regarding feedback mechanisms
  • Explicit requirements for software validation for different applications
  • Alignment of global regulatory requirements
  • Validation using pre-clinical and clinical evaluations
  • Validation of packaging and distribution requirements
  • A feedback section, including a new complaint-handling section and other guidance for customer communications
  • Additional improvement measures: adding the use of post-market surveillance, risk-based decisions, and timelines

QSG’s Overview of the Essentials of ISO 13485:2016
This 1-day workshop from QSG provides a comprehensive review/explanation of this standard. ISO 13485:2016 is explained clause-by-clause with examples from various industries to illustrate individual concepts. This workshop provides a general understanding of the necessary concepts of the standard and its impact on day-to-day operations of organizations in the medical devices industry.

Learning Objectives:

  • Detailed review of ISO 13485:2016
  • Understand the purpose and concepts of ISO 13485:2016
  • Know the requirements of the standard and how they relate to your business
  • Review Risk Management requirements (with an overview of ISO 14971)
  • Understand the process-based and process effectiveness principles
  • Understand the PDCA model for Improvement
  • Learn the relationship between ISO 14971:2019 Risk Management and ISO 13485:2016
  • Understand how ISO 13485:2016 relates to regulatory requirements

Who Should Attend
Anyone who wishes to learn about the changes to ISO 13485:2016 standard or anyone beginning at the introductory level of ISO 13485:2016.

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