BS EN ISO 13485 - medical device quality management systems standard - ISO 9001 - BSI

BS EN ISO 13485:2003

Medical devices. Quality management systems. Requirements for regulatory purposes

Status : Withdrawn, Superseded, Revised   Published : July 2003 Replaced By : BS EN ISO 13485:2012,

*To ask about withdrawn titles contact the
Customer Relations, +44 345 086 9001

What is BS EN ISO 13485:2003?

BS EN ISO 13485 is a key standard to measure the quality of medical equipment, medical instruments and medical technology. This standard sets out the requirements for a quality management system and quality assurance systems relating to the design, development, production, installation and servicing of medical devices. BS EN ISO 13485 can also be used by internal and external parties, including certification bodies to test an organization’s ability to meet both customer and regulatory requirements.

How does it work?

Specifying the requirements for a quality management system, BS EN ISO 13485 helps organizations to provide medical devices and related services that live up to the expectations of customers and regulatory bodies. Its main objective is to deliver harmonised medical device regulatory requirements, and provide quality management system specifications that complement the technical aspects of related products and services.

What is new?

BS EN ISO 13485:2003 replaces BS EN ISO 13485:2001 which has been withdrawn.

Who should buy it?

Organizations dealing with the design, development, production, installation or servicing of medical equipment, devices and technology.

Why BSI?

We are global, we’re independent and we’re a trusted service provider to 80,000 businesses. We operate in 147 countries and are the number one certification body in the UK and US. We created 85% of our portfolio because we know standards and we know your business. We’re leaders and we can make you one too. 

Need guidance  on compliance with the medical devices directive?

Also available - the essential guide to medical devices compliance
Medical Devices: ISO 13485 and ISO 9001
Dr Dennis Green
Download a free sample Chapter and buy a copy

See more standards on medical devices. Visit BSI's healthcare website.

Want regular news from BSI for medical devices and healthcare?

You Tube LogoView the case study on YouTube and see how one MCS Medical uses ISO 13485 to enhance its business. 

Standard NumberBS EN ISO 13485:2003
TitleMedical devices. Quality management systems. Requirements for regulatory purposes
StatusWithdrawn, Superseded, Revised
Publication Date24 July 2003
Withdrawn Date24 August 2012
Normative References(Required to achieve compliance to this standard)ISO 9000:2000
Informative References(Provided for Information)ISO 13641:2002, ISO 13485:2003, 98/79/EEC, ISO 14971:2000, ISO 19011:2002, ISO 14155-1:2003, ISO 14937:2000, ISO 10012, ISO/TR 14969, 93/42/EEC, 90/385/EEC, ISO 14155-2:2003, ISO 14160:1998, ISO 11134:1994, ISO 11135:1994, ISO 11137:1995, ISO 13683:1997, ISO 9001:2000
ReplacesBS EN 46003:1999, BS EN ISO 13485:2001, BS EN ISO 13488:2001
International RelationshipsEN ISO 13485:2003/AC:2009,ISO 13485:2003/Cor 1:2009
Amended ByCorrigendum, January 2010; Corrigendum, February 2008
DescriptorsQuality management, Medical equipment, Management, Medical technology, Acceptance (approval), Quality assurance systems, Medical instruments
Title in FrenchDispositifs médicaux. Systèmes de manegement de la qualité. Exigences à des fins réglementaires
Title in GermanQualitätssicherungssysteme. Medizinprodukte. Systemanforderungen zur Erfüllung gesetzlicher. Anforderungen
ISBN978 0 580 68668 9
File Size1.506 MB

*To ask about withdrawn titles contact the
Customer Relations, +44 345 086 9001
 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents

Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version

Worldwide Standards
We can source any standard from anywhere in the world


Access, view and download standards with multiple user access, across multiple sites with BSOL

Customers who bought this product also bought

  • BS EN ISO 10993-5:2009
    Biological evaluation of medical devices Tests for in vitro cytotoxicity
  • BS EN ISO 14155-1:2009
    Clinical investigation of medical devices for human subjects General requirements
  • BS EN 556-1:2001
    Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" Requirements for terminally sterilized medical devices
  • BS EN ISO 14155-2:2009
    Clinical investigation of medical devices for human subjects Clinical investigation plans