ISO 13485: What, Why and How

ISO 13485 is an international quality management system (QMS) standard which has been developed specifically for the medical device industry and is one of the fastest growing ISO standards.  It outlines the requirements for establishing a QMS that demonstrates an organisation’s capability (through the entire lifecycle, from design to disposal) to consistently and safely deliver medical devices and related services to meet patient safety and regulatory requirements. Unlike ISO 9001, which is a general QMS standard, ISO 13485 is tailored to meet the stringent regulatory environment of the medical device sector, with a particular focus on risk management, regulatory compliance, and product safety.  

URM Consulting Services is hosting this webinar where we will be discussing the importance of this Standard to organisations looking to enter or maintain their presence in this highly regulated marketplace, with expert technical insight from BSI, the world leading Notified Body and UK Approved Body for medical devices. A key focus of the webinar will be the key steps organisations need to take to achieve and maintain certification and the pitfalls to avoid.  

In this webinar, URM and BSI will be looking to address the following questions:

• What is ISO 13485?
  • What is the purpose of the Standard?
  • Why are there 2 versions of ISO 13485?
  • How does it map to the various regulatory requirements in the UK, Europe and internationally?
• Why is ISO 13485 such a fast-growing standard?  
  • We examine some of the contributory factors, e.g., the expanding global medical device market, increased regulatory scrutiny, and the growing expectations around quality and safety in healthcare products.  
• Who does it apply to?  
  • What types of product and service organisations should be looking to certify?  What benefits can be accrued?  What is a typical scope?  How do you determine which of your services and processes should be in scope?
• How do you achieve and maintain certification?
  • We provide insights and guidance into the key steps involved in not just achieving but maintaining certification.
• What are the pitfalls to avoid in achieving certification?
  • URM and BSI share their experiences of issues encountered by organisations in their certification journeys
• Can ISO 13485 be integrated with other standards such as ISO 27001?
  • We discuss some of the challenges as well as the benefits of integrating management systems.
• What is the future for ISO 13485?
  • URM and BSI share their thoughts on trends and developments in technology, regulations and industry practices that could shape future updates of the Standard.

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