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ISO 13485-Medical devices - Quality management systems

ISO 13485 - Introduction

ISO 13485 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of the QMS. It is requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities.


ISO 13485-Benefits

There are numerous benefits of implementing ISO 13485. These include: 

  • Improve customer satisfaction
  • Remain competitive in the global economy
  • Reducing downtime and the costs of disruption to operations
  • Ensure quality is the driving force behind business success and failure
  • Improving its ability to respond to regulatory compliance issues

ISO 13485: 2016-Clauses

  • 1 Scope
    2 Normative references
    3 Terms and definitions
    4 Quality management system
    5 Management responsibility
    6 Resource management
    7 Product realization
    8 Measurement, analysis and improvement

News & Update

ISO 31000:2018 (Risk management) published on 2018-02.It provides a common approach to managing any type of risk and is not industry or sector specific, and, can be used throughout the life of the organization and can be applied to any activity, including decision-making at all levels.

Aerospace QMS-AS9100/9110/9120 handbook Quality Associates provide a handbook for customers who book our in-house training on AS9100/AS9110/AS9120 course. This handbook is designed for our customers only.

ISO/TS 22163:2017 Railway applications - Quality management system - Business management system requirements for rail organizations: ISO 9001:2015 and particular requirements for application in the rail sector.