BS EN ISO 13485:2016 - Tracked Changes Medical devices. Quality management systems. Requirements for regulatory purposes

BS EN ISO 13485:2016 - TC

Tracked Changes. Medical devices. Quality management systems. Requirements for regulatory purposes

Status : Current   Published : February 2019


What is a tracked changes standard?

A tracked changes version of a Standard indicates the changes made, during the standards revision process, between the active standard and its previous version. Additions, deletions, and other formatting and/or content revisions are clearly displayed as underlined and strikethrough texts, ensuring all changes made between the two documents are quickly and easily identified.

What is this standard about?

This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). This International Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Requirements of this International Standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

Standard NumberBS EN ISO 13485:2016 - TC
TitleTracked Changes. Medical devices. Quality management systems. Requirements for regulatory purposes
Publication Date21 February 2019
Normative References(Required to achieve compliance to this standard)ISO 9000:2015, EN ISO 9000:2015
Informative References(Provided for Information)N70:2011, N055:2009, IEC 62366-1, ISO 14698, ISO 19011, ISO 11607-2, N071:2012, ISO 14644, N4:2010, ISO 10012, ISO 11607-1:2006, ISO 14971:2007, ISO 9001:2015
Amended ByCorrigendum, February 2019
DescriptorsManagement, Quality assurance systems, Acceptance (approval), Medical instruments, Medical equipment, Quality management, Medical technology
Title in FrenchDispositifs médicaux. Systèmes de management de la qualité. Exigences à des fins réglementaires
Title in GermanMedizinprodukte. Qualitätsmanagementsysteme. Anforderungen für regulatorische Zwecke
ISBN978 0 539 03822 4
File Size5.296 MB

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