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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The era of human and robot interaction has begun, and it is changing the way we experience Retrieved from ” https: Check out our FAQs. New handbook helps medical devices sector improve its quality management system The medical devices industry is one of the most highly regulated sectors in the world.

Significant quality systems and product requirements must be satisfied to ensure the medical devices produced are fit for their intended purpose.

Proof sent to secretariat or FDIS ballot initiated: During this assessment, the existing processes and procedures within your organization are compared with the requirements of the standard. By Sandrine Tranchard on 25 September By Maria Io on 7 March View all our courses 1346 our training page to find out more. Final text received or FDIS registered for formal approval.


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.

This standard will be published in Augustand days after publication it will become mandatory for the industry. BSI was the first auditing organization authorized during the Pilot Phase. Robots to the rescue! Handbook intended to guide organizations in the development, implementation and maintenance of their quality management system in accordance with ISO The BSI website uses cookies.

The current ISO effective edition was published on 1 March Monday to Friday – Additionally, the ISO requirements regarding customer satisfaction are absent from the medical device standard. We have invested heavily in making sure that we provide our clients with the best service possible to transition early to the standard.

ISO 13485:2016 is here

If any requirement in Clauses 6, 7 or 8 of ISO Medical devices include products of the following categories: You can find our useful tools and resources below. Views Read Edit View history. X Find out what cookies we use and how to disable them.

Mexico has published in October 11, a national standard as a Norma Oficial Mexicana NOM to control manufacture of medical devices ieo the country. Life cycle A standard is reviewed every 5 years 00 Preliminary. SCC accredits organizations that certify the management systems of medical device manufacturers.


This page was last edited on 22 Octoberat For further information on this decision and how it impacts your ISO certification please visit the page: The processes required by ISO Standard harmonization allows manufacturers to use their compliance to the standard as evidence of conformity to the requirements of relevant legislation. From Wikipedia, the free encyclopedia. A very careful assessment of the company Quality Management System by the Notified Body, together with the review of the required Technical Documentation, is a major element which the Notified Body takes into account to issue the certificate of conformity to the company product s.

It is the responsibility of the organization to ensure that claims of conformity to ISO You may be interested in: Several registrars also act as Notified Body. For any clause that is determined to be not applicable, the organization records the justification as described in 4. Want to find out more?