Global Quality Consulting

Provide consulting services to organizations to build or maintain their quality system (ISO 9001 and ISO 13485). Process improvement. Cost Savings.

With 27 years of experience in the quality, lean manufacturing, and engineering organizations, I can help your firm in the following areas: A) Quality System • Obtain ISO certification or maintain your existing ISO9001 or ISO13485 certification. Create or maintain your "quality system", including documentation, auditing, management review, and training. • Assist your firm during your customer and registrar audits. • Perform Design and Process FMEA (Failure Mode & Effect Analysis) in order to eliminate the risk of failure in your new products and processes. • Evaluate your suppliers. • Risk management for medical devices per ISO 14971. B) Productivity • Use of Lean Manufacturing toots and Kaizen events to make your processes more efficient. * Reduction of product cost through the application of the Value Analysis methodology. C) Maquiladora Industrial zone (Tijuana, Mexico) product assembly * Coordination of equipment transfer * Installation and qualification of processes