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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Standard harmonization allows manufacturers to use their compliance to the standard as evidence of conformity to the requirements of relevant legislation.

For further information on this decision and how it impacts your ISO certification please visit the page: Life cycle A standard is reviewed every 5 years 00 Preliminary. Talk to us to find out more. The BSI website uses cookies. Mexico has published in October 11, a national standard as a Norma Oficial Mexicana NOM to control manufacture of medical devices inside the country.

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. By Sandrine Tranchard on 25 September Check out our FAQs. We have recently updated our suite of ISO courses to reflect the requirements of the new standard, including: ISO standards by standard number.

BSI was the first auditing organization authorized during the Pilot Phase. The processes required by ISO Monday to Friday – It is the responsibility of the organization to ensure that claims of conformity to ISO Views Read Edit View history.

Manufacturers with products on the market in Canada cannot wait until 29 February to transition to the ISO Soon, our mobile companions will provide everything from coaching to communication to companionship, keeping us independent as we grow older.


Proof sent to secretariat or FDIS ballot initiated: Handbook intended to guide organizations in the development, implementation and maintenance of their quality management system in accordance with ISO For any clause that is determined to be not applicable, the organization records the justification as described in 4.

View all our courses on our training page to find out more. By Maria Lazarte on 7 March X Find out what cookies we use and how to disable them. This standard will be published in Augustand days after publication it will become mandatory for the industry.

ISO Revision and update | BSI Group

This page was last edited on 22 Octoberat The current ISO effective edition was published on 1 March Robots to the rescue! We have invested heavily in making sure that we provide our clients with the best service possible to transition early to the standard.

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 industry, to its clients. 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. The Cofepris is the body assigned to its control, verification and to grant the records of compliance isl the companies that implement this Standard of Good Manufacturing Practices.

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

ISO 13485:2016 is here

This standard contributes to the following Sustainable Development Goals: People also sio ISO SCC accredits organizations that certify the management systems of medical device manufacturers. You can find out more about the standard’s harmonization in our recent blog post. Use our transition resources to support you as you plan and implement your transition. Additionally, the ISO requirements regarding customer satisfaction are absent from the medical device standard.


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 allowing the CE mark and the permission to sell the medical device in the European Union.

Final text received or FDIS registered for formal approval. 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. These 14386 requirements can kso alternative approaches that are to be addressed in the quality management system.

Medical devices include products of the following categories: Here, as the Chair of the ISO technical committee for quality management and related general aspects for medical devices, Dr You can find our useful tools and resources below.

By continuing to access the site you are agreeing to their use. Archived from the original on By Clare Naden on 7 April The operational phase of this program is scheduled to begin in January The era of human and robot interaction has begun, and it is changing the way we experience 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