ISO 13486 PDF

ISO 13486 PDF

ISO Medical devices — Quality management systems — Requirements for regulatory purposes is an International Organization for Standardization (ISO). ISO. First edition. Road vehicles — Hydraulic braking systems —. Part 1: Double-flare pipes, tapped holes, male fittings and tube seats. BS ISO Road vehicles. Hydraulic braking systems. Double-flare pipes, tapped holes, male fittings and tube seats. standard by.

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Wherever requirements are specified as 13468 to medical devices, the requirements apply equally to associated services as supplied by the organization.

By Maria Lazarte on 7 March Monday to Friday – Archived from the original on If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system.

Views Read Edit View history. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system.

ISO – Wikipedia

isl The processes required by ISO Retrieved from ” https: This page was last edited on 22 Octoberat Final text received or FDIS registered for formal approval. Compliance with ISO is often seen as the first step in achieving compliance with European regulatory requirements.

Discuss your needs with our team. For those medical devices requiring the pre-market involvement of 134866 Notified Body, the result of a positive assessment from the Notified Body is the certificate of conformity allowing the CE mark and the permission to sell the medical device in the European Union. You may be interested in: InThe Farmacopea de los Estados Unidos Mexicanos United Mexican States Pharmacopoeiamedical industrial sectors and Cofepris are working together for updating NOM Standard, putting special attention on manage of risks during manufacture and regulating by manufacturing lines some of the most important medical devices manufacturing processes.


ISO Revision and update | BSI Group

This identifies any potential oversights or weaknesses so that you can take immediate action, ahead of the audit process. The operational phase of this program is scheduled to begin in January People also bought ISO We have invested heavily in making sure that we provide our clients with the best service possible to transition early to the standard. By using this site, you agree to the Terms of Use and Privacy Policy. Significant quality systems and product requirements must be satisfied to ensure the medical devices produced are fit for their intended purpose.


ISO 13485:2016 is here

By Clare Naden on 7 April From Wikipedia, the free encyclopedia. Talk to us to find out more. Life cycle A standard is reviewed every 5 years 00 Preliminary.

Caring about health and safety Uncover how ISO Standards help doctors treat patients and keep people safe at work, at home, wherever.


ISO Medical devices — Quality management systems — Requirements for regulatory purposes is an International Organization for Standardization ISO standard published for the first time in ; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

Check out our FAQs. For further information on this decision and how it impacts your ISO certification please visit the page: Proof sent to secretariat or FDIS ballot initiated: Standard harmonization allows manufacturers to use their compliance to the standard as evidence of conformity to the requirements of relevant legislation.

Medical devices include products of the following categories: By continuing to access the site you are agreeing to their use.

Mexico has published in October 11, a national standard as a Norma Oficial Mexicana NOM to control manufacture of medical 134486 inside the country. Use our transition resources to support you as you plan and implement your transition. Requirements of ISO Retrieved 19 October If any requirement in Clauses 6, 7 or 8 of ISO Here, as the Chair of the ISO technical committee for quality management and related general aspects for medical devices, Dr By Barnaby Lewis on 27 August