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Through D’Angelo ADVANTAGE, we bring significant experience that will assist leaders develop a highly efficient quality management system in both anatomic and clinical laboratory settings.

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D’Angelo ADVANTAGE will bring practicality and value to your organization by adding a “simplistic,” approach for development of all aspects of a laboratory quality management system. We will assist your organization develop elements under the umbrella of quality management.  We will develop  a robust regulatory Quality Management System by implementation or redesign of missing or current processes in preparation for ISO 15189 accreditation.

Based on Lean principles we will identify and suggest the elimination of waste and inefficiency by implementationof  a culture of continuous improvement by the enlistment of worker empowerment.

D’Angelo ADVANTAGE offers 20+ years of experience through personal learning’s of failures and successes that ultimately yield the assistance you require to develop the program necessary for success.

Our Aim – to assist you to meet strategic goals through professional assessment, planning, design,  development and implementation of a system all customized to meet your needs. We will tailor our engagement to your goals, objectives, resources, level of leadership support and cultural environment.

Quality Management System (QMS) – we will assist you to develop a robust QMS composed of policies, procedures, processes, organizational structures, risk analysis and much more that will serve to lead the organization in regard to quality.  and designed to meet all pertinent regulatory requirements.  order to maintain the advances made during the engagement, we also offer long and short-term support arrangements in all aspects of process improvement and redesign of laboratory and healthcare operations.

Lean Management – D’Angelo ADVANTAGE brings significant experience and solutions to guide those just beginning their lean journey; to those who have met the commonly encountered obstacles to progress and to those frustrated by false starts and failure. Don’t give up, we will show you how to succeed based on our years of experiences creating a highly successful Lean enterprise in one of the largest hospital-based laboratory operations in the USA.

ISO 15189 – if your goal is ISO 15189 accreditation or to comply with pending regulatory requirements for manufacture of Laboratory Developed Tests, we will guide you on a rapid path to identify and close the common quality gaps that impede this voluntary high bar in quality through my direct experiences as the architect of ISO 15189 accreditation in large integrated laboratory systems in the USA. Our engagement with clients is tailored to your specific strategic goals so they are achieved and owned by you and your team.

 

 

 

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