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 standard to consider for registration, ISO 13485:2003.
ISO 13485:2003, published in July 2003, is based on the ISO 9001:2008 process model approach. 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.
Certification to ISO 13485 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 ISO 13485. ISO 13485 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 ISO 13485 standards, BSI also offers the full range of complementary assessment services such as ISO 9001, ISO 14001 and OHSAS 18001. BSI can also assess special processes such as sterilization using appropriately qualified microbiologists and the sterilization standards.