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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Requirements of ISO Talk to us to find out more. Several registrars also iao as Notified Body. 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.

This standard will be published in Augustand days after publication it will become mandatory for the industry. 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 kso Notified Body takes into account to issue the certificate of conformity to the company product s.

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This identifies any potential oversights or weaknesses so that you can take immediate action, ahead of the audit process. The processes required by ISO You can find out more about the standard’s harmonization in our recent blog post.

For further information on this decision and how it impacts your ISO certification please visit the page: Significant quality systems and product requirements must be satisfied to ensure the medical devices produced are fit for their intended purpose.

This standard contributes to the following Sustainable Development Goals: By Maria Lazarte on 7 March It is the responsibility of the organization to ensure that claims of conformity to ISO By Sandrine Tranchard on 25 September These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. If any requirement in Clauses 6, 7 or 8 of ISO BSI, the business standards company, has become the first certification body to achieve accreditation for the issue of quality management certificates against the requirements of ISO Additionally, the ISO requirements regarding customer satisfaction are absent from the medical device standard.


The current ISO effective edition was published on 1 March By Clare Naden on 7 April Mexico has published in October 11, a national standard as a Norma Oficial Mexicana NOM to control manufacture of medical devices inside the country. 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.

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Here, as the Chair of the ISO technical committee for quality management and related general aspects for medical devices, Dr View all our courses on our training page to find out more. SCC accredits organizations that certify the management systems of medical device manufacturers. This page was last edited on 22 Octoberat By using this site, you agree to the Terms of Use and Privacy Policy.

Retrieved 19 October ISO standards by standard number.

ISO 13485:2016 is here

Medical device, to the substance, mixture of substances, material, apparatus or instrument including the computer program necessary for its proper use or applicationused alone or in combination in the diagnosis, monitoring or prevention of human or auxiliary diseases in the treatment of the same and of the disability, as well as the employees in the replacement, correction, restoration or modification of the anatomy or human physiological processes.

Life cycle A standard is reviewed every 5 years 00 Preliminary. Such organizations can be involved in one or more stages of the life-cycle, including kso and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities isi. Want to find out more?


The operational phase of this program is scheduled to begin in January For those medical devices requiring the pre-market involvement of a Notified Body, the result of a positive assessment from the Notified Body is the certificate of conformity sio the CE mark and the permission to sell the medical device in the European Union.

Retrieved from ” https: From Wikipedia, the free encyclopedia. Monday to Friday – BSI is now able to issue both UKAS and SCC accredited certificates to the latest edition of ISOthe internationally recognized quality management systems standard for the medical device oso, to its clients.

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. Compliance with ISO is often seen as the first step in achieving compliance with European regulatory requirements.

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Caring about health and safety Uncover how ISO Standards help doctors treat patients and keep people safe at work, at home, wherever. During this assessment, the existing processes and procedures within your organization are compared with the requirements of the standard. By Barnaby Lewis on 27 August This standard is partially in line with ISO The Cofepris is the body assigned to its control, verification and to grant the records of compliance to the companies that implement this Standard of Good Manufacturing Practices.