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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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ISO Revision and update | BSI Group

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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. You can find out more about the standard’s harmonization in our recent blog post.

Talk to us to find out more. 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 SCC accredits organizations that certify the management systems of medical device manufacturers. 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.


You can find our useful tools and resources below. We have invested heavily in making sure that we provide our clients with the best service possible to isoo early to the standard. BSI was the first auditing organization authorized during the Pilot Phase.

The operational phase of this program is scheduled to begin isl January Manufacturers with products on the market in Canada cannot wait until 29 February to transition to the ISO For further information on this decision and how it impacts your ISO certification please visit the page: During this assessment, the existing processes and procedures within your organization are compared with the requirements of the standard.

This identifies any potential oversights or weaknesses so that you can take immediate action, ahead of the audit process.

ISO – Wikipedia

Discuss your needs with our team. We have recently updated our suite of ISO courses to reflect the requirements of the new standard, including: View all our courses on our training page to find out more.


X Find out what cookies we use isl how to disable them. Use our transition resources to support you as you plan and implement your transition. Want to find out more?