There are six steps to achieving registration with BSI.
Step 1 - Establish a quality management framework as identified in the appropriate standard (ISO 13485, ISO 13488 or ISO 13485:2003).
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 of 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 - On successful completion of the audit, a certificate of registration is issued which clearly identifies the scope of the Registered Quality Management System. This certificate is supported by continual assessments visits and normally no re-certification assessment is required.
For more information on implementing a medical device manufacturing QMS, please contact us.
