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