ISO TR 14969 PDF

The ISO and ISO/TR Quality Management Systems Medical Devices Package specifies the requirements and procedures to implement a quality. Dear all As the ISO disappears and will be converted in a iso handbook please change the forum title of this section:thanx: Xavier. Buy ISO/TR Medical devices – Quality management systems – Guidance on the application of ISO from SAI Global.

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ISO/TR 14969 Available with Guidance on ISO 13485

Accept and continue Learn more about the cookies we use and how to change your settings. Please download Chrome or Firefox or view our browser tips. Company organization, management and quality. We use cookies to make our website easier to use and to better understand your needs. You may experience issues viewing this site in Internet Explorer 9, 10 or You may find jso items within these categories 1499 selecting from the choices below:.

You may delete a document from your Alert Profile isoo any time. Already Subscribed to this document. This guidance yr be used to better understand the requirements of ISO and to illustrate the variety of methods and approaches available for meeting the requirements of ISO History and related standards This International Standard includes the following cross-reference: Guidance on the development, implementation and maintenance of quality management systems for medical devices ISO It does not add to, or otherwise change, the requirements of ISO Please first log in with a verified email before subscribing to alerts.


This standard is withdrawn.

Systemes de gestion de qualite. Abstract This International Standard Technical Report provides guidance to assist in the development, implementation and maintenance of quality management systems that aim to meet the requirements of ISO for organizations that design and develop, produce, install and service medical devices, or that design, develop and provide related services. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.

Find Similar Items This product falls into the following categories. As the voice of the U. Please first verify your email before subscribing to alerts. The guidance contained in this report can be useful as background information for those representing quality management system assessors, conformity assessment bodies and regulatory enforcement bodies.

ISO and ISO/TR Quality Management Systems Medical Devices Package

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ISO/TR Available with Guidance on ISO – Whittington & Associates

This standard is also available to be included in Standards Subscriptions. Take the smart route to manage medical device compliance. Subscription pricing is determined by: Ethylene oxide Requirements for development, validation and routine control of a sterilization process for medical devices.

This report does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. The requirements and process approach are relevant to any regulated organization that designs and develops, produces, installs or services medical devices or provides related services.

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Guidance on the application of ISO Proceed to Checkout Continue Shopping. If the document is revised or amended, you will be notified 1496 email.

It provides guidance related to quality management systems for a wide variety of medical devices and related services, such as active, non-active, implantable and non-implantable medical devices and in vitro diagnostic medical devices.

Lignes directrices pour l’application de l’ISO The faster, easier way to work with standards.