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

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BS EN ISO 13485:2003

Medical devices. Quality management systems. Requirements for regulatory purposes

Status : Revised, Withdrawn   Published : July 2003 Replaced By : BS EN ISO 13485:2012

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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BS EN ISO 13485:2003 replaces BS EN ISO 13485:2001 which has been withdrawn.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
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See more standards on medical devices. Visit BSI's healthcare website.

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Standard NumberBS EN ISO 13485:2003
TitleMedical devices. Quality management systems. Requirements for regulatory purposes
StatusRevised, Withdrawn
Publication Date24 July 2003
Withdrawn Date24 August 2012
Cross ReferencesISO 9000:2000, EN ISO 9000:2000, ISO 9001:2000, ISO 10012, ISO 11134:1994, ISO 11135:1994, ISO 11137:1995, ISO 13641:2002, ISO 13683:1997, ISO 14155-1:2003, ISO 14155-2:2003, ISO 14160:1998, ISO 14937:2000, ISO/TR 14969, ISO 14971:2000, ISO 19011:2002, 90/385/EEC, 93/42/EEC, 98/79/EEC
Replaced ByBS EN ISO 13485:2012
ReplacesBS EN 46003:1999, BS EN ISO 13485:2001, BS EN ISO 13488:2001
International RelationshipsEN ISO 13485:2003,ISO 13485:2003
Amended ByCorrigendum, January 2008. Corrigendum, February 2008. Corrigendum, January 2010.
Draft Superseded By02/560598 DC
DescriptorsMedical equipment, Medical instruments, Medical technology, Quality management, Quality assurance systems, Acceptance (approval), Management
ICS03.100.70
03.120.10
11.040.01
Title in FrenchDispositifs médicaux. Systèmes de manegement de la qualité. Exigences à des fins réglementaires
Title in GermanQualitätssicherungssysteme. Medizinprodukte. Systemanforderungen zur Erfüllung gesetzlicher. Anforderungen
CommitteeCH/210/1
ISBN978 0 580 68668 9
PublisherBSI
FormatA4
DeliveryNo
Pages72
File Size1.506 MB
Price£244.00


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