Improved quality and operational efficiencies, resulting in cost reductions and enhanced bottom-line profitably. Studies have shown that a break-even on your investment in ISO 9001 certification will be achieved within a relatively short period of time.
Entree to foreign markets where ISO 13485 registration is a requirement. Enhanced market appeal and competitiveness when supplying components to medical device manufacturers.
Enhanced customer satisfaction and a more agile, competitive organization. Adds value to company worth.
Easier to comply with regulatory requirements, such as FDA GMP and 21 CFR 820. Reduced worker comp claims.
We offer an affordable turnkey ISO 13485 certification solution to northern and southern California businesses and organizations, consisting of:
Performing a GAP Analysis to determine the amount of work required to become ISO 13485 certified.
Management orientation to achieve company buy-in and support.
Onsite training to minimize the impact on daily operations.
Templates for creating your ISO 13485 quality manual, procedures and work instructions.
Onsite assistance by an ISO 13485 expert in preparation of your unique quality manual and quality management system.
Internal audit to prepare for a certification audit by an ISO Registrar.
Rapid onsite assistance in responding to any non-conformances identified in the certification audit.
Ongoing maintenance and support to ensure high-quality and readiness for internal and re-certification audits.
How can your California business become certified to the ISO 13485 standard? This detailed, FREE report explains the steps involved and provides you with an estimate for consulting, Registrar and auditing fees. It also gives you an idea of the timeframe typically required for a company like yours to achieve ISO 13485 registration.