ISO TR 14969 PDF

0 Comments

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.

Author: Meztigis Brakasa
Country: China
Language: English (Spanish)
Genre: Personal Growth
Published (Last): 2 October 2014
Pages: 180
PDF File Size: 13.14 Mb
ePub File Size: 5.13 Mb
ISBN: 177-2-16587-315-1
Downloads: 23272
Price: Free* [*Free Regsitration Required]
Uploader: Dair

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 This standard is withdrawn.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.

You can download and open this file to your own computer but DRM lso opening this file on another computer, including a networked server. Please first log in with a verified email before subscribing to alerts. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3. Systemes de gestion de qualite.

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.

  BC ACOUSTIQUE NIGER PDF

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

The faster, easier way to work with standards. We use cookies to make our website easier to use and to better understand your needs. History and related standards This International Standard includes the following cross-reference: As the voice of the U. Subscription pricing is determined by: Guidance on the development, implementation and maintenance of quality management systems for medical devices ISO This guidance can 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 Your Alert Profile lists the documents that will be monitored.

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

Standards Subscriptions from ANSI provides a money-saving, multi-user solution for accessing standards. This report does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.

  2004 YUKON DENALI OWNERS MANUAL PDF

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