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ISO 13485

ISO 13485 is an international standard that defines quality management system (QMS) requirements for manufacturers of medical devices. The primary objective of the standard is to facilitate harmonised QMS requirements for regulatory purposes within the medical device sector.

It is applicable to manufacturers of medical devices and to those organisations that support medical device manufacturers. Manufacturers have a duty to ensure that devices consistently meet customer requirements and meet all applicable regulatory requirements.

Last revised in 2003, this standard is based on the ISO 9001:2000 process model approach. However, it includes particular requirements for medical devices and excludes some of the requirements for ISO 9001. In particular, the requirements for customer satisfaction and continual improvement have been modified to make them more appropriate for regulatory purposes.

How can ISO 13485 benefit my organisation?

ISO 13485 promotes harmonisation of regulatory requirements for manufacturers of medical devices on an international scale.

A number of countries have incorporated ISO 13485 into their regulatory systems. Compliance with ISO 13485 can be used in support of regulatory compliance. It incorporates many of the quality management principles and delivers the benefits of an ISO 9001 based quality management system.

LRQA provides accredited assessment and certification to ISO 13485.

Need to know more?

Call 0800 783 2179 or complete our enquiry form for further information on our services.

Further information:

  • Business Assurance
  • Purchase Standards (external link - clickhere for terms and conditions)

    Skip Navigation LinksHome : Standards and Schemes : Quality : ISO 13485

    17 May 2012

    Lloyd's Register Quality Assurance
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