BS EN ISO 13485:2016

SKU: 1482200
Stock Status: Out of Print
This standard is no longer available. Please CLICK HERE to view our full British Standards range.
Description

Official BSI Distributor

What is this standard about?

This is the internationally recognised quality management system (QMS) standard for the medical device industry. It has more than 27,000 accreditations worldwide. It specifies requirements for a QMS for organizations involved in one or more stages of the lifecycle of a medical device. It provides the basis for ensuring consistent design, development, production, installation and delivery of products that are safe for their intended purpose. 

Who is this standard for?

It can be used by any organization involved in one or more stages of the lifecycle of a medical device, including:

  • Design and development
  • Production
  • Storage and distribution
  • Installation or servicing
  • Final decommissioning
  • Design, development or provision of associated activities (such as technical support)

In addition, the standard can be used by other internal and external parties, such as certification bodies, to help them with their certification processes, or by supply chain organizations that are required by contract to conform.

Why should you use this standard?

ISO 13485:2016 can be used to test an organization's ability to meet both customer and regulatory requirements. Certification is not a requirement and organizations can reap the benefits of the standard without being certified.

Its use shows a commitment to quality, however, and users will be able to:

  • Demonstrate compliance with regulatory and legal requirements
  • Ensure the establishment of quality management system practices that consistently yield safe and effective medical devices
  • Manage risk effectively
  • Improve processes and efficiencies
  • Gain a competitive advantage

What's changed since the last update?

This revision ensures that the standard provides a quality management system that's kept up with the evolving directives and other international regulatory changes that have occurred since 2003. Some of the key changes include:

  • Harmonization of regulatory requirements
  • Inclusion of risk management throughout the quality management system
  • Additional clarity with regard to validation, verification and design activities
  • Strengthening of supplier control processes
  • Increased focus regarding feedback mechanisms
  • Harmonization of the requirements for software validation for different software applications
Product Information
ISBN 9780580967702
Publication Status Out Of Print
Publication Date 29/02/2016
Format (Paperback, Hardback etc) A4
Total Pages 66
Brand / Publisher BSI
Publisher BSI
Delivery

Upgrade to Next Day Delivery for Same Day Shipping up to 5pm

  • Delivery is within 3 working days* of your order being placed
  • Delivery is Monday to Friday, and Saturday (excluding Public Holidays)

Extra delivery charges are applied for international deliveries

Returns

Here is our returns information...

  • Returns from the UK are free and trackable
  • You have 28 days from the date your order was delivered or made available for collection to return it
100% Genuine Publications
  1. Free standard delivery
  2. Best price guaranteed
  3. Fast same-day shipping
  4. Over 20 years experience
  5. Family-run business