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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If the document is revised or amended, you will be notified by email. This standard is withdrawn. Accept and continue Learn more about the cookies we use and how to change your settings. The requirements and process approach are relevant to any regulated organization that designs and develops, produces, installs t services medical devices or provides related services. Please first verify your email before subscribing to alerts.
Company organization, management and quality.
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Standards Subsctiption may be the perfect solution. Already Subscribed to this document. Lignes directrices pour l’application de l’ISO Need more than one copy? Medical equipment, Quality assurance systems, Design, Production management, Quality, Medical technology, Acceptance approvalMedical instruments, Quality assurance, Quality management, Installation, Maintenance. You may delete a document from your Alert Profile at any time.
ISO/TR Available with Guidance on ISO – Whittington & Associates
Ethylene oxide Requirements for development, validation and routine control of a sterilization process for medical devices. Proceed to Checkout Continue Shopping. You may find similar items within these categories by selecting from the choices below:. Find Similar Items This product falls into the following categories.
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. Your basket is empty.
ISO/TR 14969 Available with Guidance on ISO 13485
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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.
Learn more about the cookies we use and how to change your settings. 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 ixo.
Take the smart route io manage medical device compliance.
ISO and ISO/TR Quality Management Systems Medical Devices Package
Click to learn more. Search all products by. You may experience issues viewing this site in Internet Explorer 9, 10 or Guidance on the application of ISO This standard is also available to be included in Standards Subscriptions. Please download Chrome or Firefox or view our browser tips. 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.
It does not add to, or otherwise change, the requirements of ISO