QMS for medical devices (ISO 13485)

BSI offers a full range of quality management assessment services for manufacturers of medical devices (and suppliers/subcontract manufacturers) to satisfy both regulatory and voluntary requirements.

Currently there is one published standards to consider for registration, ISO13485:2003.

ISO13485:2003, published in July 2003, is based on the ISO9001:2000 process model approach. This standard will fully replace ISO13485:1996 and ISO13488:1996 by the summer of 2006.  These standards provide a good base model for compliance with the EU CE marking medical device directives, Health Canada CMDCAS, Taiwan Medical device Regulations and other international requirements.

Registration to ISO13485 takes place when an accredited third party such as BSI visits an organization, assesses the quality management system and if satisfactory issues a certificate confirming that the organization’s quality management system meets the requirements of the Standard.

So your BSI quality management systems certificate is objective, accredited, recognized evidence of your company’s commitment to quality and helps you demonstrate this to customers. BSI is accredited by UKAS (the United Kingdom Accreditation Service) and its USA and Canadian equivalents for ISO 9001 and ISO13485. ISO13485:2003 is becoming widely accepted as the international standard to address medical device regulations around the world.

In addition to assessing quality management systems to the ISO13485 standards, BSI also offers the full range of complementary assessment services such as ISO9001:2000, ISO14001 and ISO18001. BSI can also assess special processes such as sterilisation using appropriately qualified microbiologists and the sterilisation standards.

For more information on implementing a medical device manufacturing QMS, please Contact Us.