There are six steps to achieving registration with BSI.
Step 1 - Establish a quality management framework as identified in the appropriate standard (ISO 13485).
Step 2 - BSI will then provide an estimate of costs and time-scales for formal assessment.
Step 3 - Submit a formal application to BSI.
Step 4 - BSI will undertake an on-site pre-audit to review the Quality Manual and the Quality Systems. This will then identify any weaknesses and omissions in your quality management system that need to be resolved and your readiness for the main assessment.
Step 5 - BSI will then conduct an on-site initial assessment and make recommendations.
Step 6 - Upon successful completion of the audit, a certificate of registration is issued clearly identifying the scope of the Certified Quality Management System. This certificate is supported by continual assessment visits and normally re-certification assessment is not required.
