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How We Implement ISO Quality Standards
Once a decision has been reached to implement one or more of the international standards, we (QED Consulting Group) make an executive presentation to management about the process of implementation and help them decide on the implementation team.
We assist them in documenting, in a series of procedures, their quality (or environmental and/or safety) processes: those processes that need to be performing consistently in order to produce their product(s). These processes also include requirements of the standard, such as management's responsibilities, what the organization wants to monitor and measure to ensure the achievement of the goals, how they will handle the internal auditing function and what they will do with product/service that isn't 'perfect' (called non-conforming product), and how they will perform corrective and preventive actions so that a problem, or a mistake never happens twice. This is one of the ways that a management system brings about continual improvement.
Work instructions and/or standard operating procedures may be required for an organization if the lack of instructions may result in a problem. So, we determine with the implementation team whether or not work instructions are needed.
If any forms are used in the business, they must also be included in the documented system so that they are also controlled. This is to prevent inadvertent use of obsolete forms (a problem in the governmental and healthcare areas).
Next, we perform a GAP Analysis, to ascertain if there are any gaps between the newly implemented system and the standard's requirements. When all the loops are closed, the gaps filled, we train the workforce in their roles and responsibilities and train an internal audit team.
The internal audit team then begins their auditing function, to make sure that we are doing what we say we are doing in our procedures, and to find opportunities for improvement. At this point, the management system or systems is/are in operation. To be certified means that a third party Registrar audits the organization in relation to the requirements of the standard. If the organization is meeting the criteria of the standard(s), they receive ISO Certification. The Registrar provides ongoing surveillance to ensure that the system is continuing to perform and achieve its business goals. It is the way the marketplace is assured that product produced by this business will consistently conform to the requirements of the customer.
Our Team
Dr. Judith E. Luchsinger
Judy is the owner and principal consultant of QED Consulting Group. Judy has held a variety of positions in management and administration over the past 30 years, and for the past 15 years has specialized in working with the food and wine industry, manufacturing and service organizations to implement world class Quality, Environmental and Food Safety Management Systems, with emphasis on creating ISO compliant processes. Experience in this area has included training and implementation for ISO 9001, ISO 14001 and ISO 22000 including internal auditor training, workforce training, GAP Analysis, pre-certification auditing and project management. Judy has also integrated process mapping, process improvement, strategic planning, consensus facilitation, and change management into the quality consulting services provided to her clients.
She has served as consultant to the Corporation for Public Broadcasting (PBS), the Rockefeller Foundation, Motorola and Kaiser Group, Inc. In addition to working with a wide variety of industries, she is the pioneer in the application of ISO 9001, ISO 14001 and ISO 22000 to wineries.
Dr. Luchsinger has served as the main speaker and workshop leader at international seminars.
George Zalatan
George Zalatan has over 30 years of Quality Management experience at Caterpillar Solar Turbines, and General Electric. He has spent his career successfully implementing quality systems and improving business processes. George was a leader of the team that won the 1998 Malcolm Baldrige award at Solar Turbines.
As an Associate Professor at San Diego State University, he spent twenty years developing and teaching courses in Manufacturing Systems and Technology and Lean Manufacturing.
In addition, George Zalatan is an independent consultant leading ISO 9001, ISO 14001 implementations and Lean/Six-Sigma improvement projects. He has provided project leadership for over 40 companies including Qualcomm, Toppan Optical Systems, Inphi Corp., K Tube, Advanced Electromagnetics, Chevron, SKF Condition Monitoring, Applied Data Technology, Sorrento Electronics, Verari Systems, Graphic Communications, Innovative Nitrogen, HM Electronics, Logicon Tactical Systems, Schumacher, Koch Membrane Systems, Asymtek, Wadkins Manufacturing and L-3 Communications.
George Zalatan worked with Solar Turbines for over 20 years, managing a group of Six-Sigma internal consultants and affecting the testing procedures for engine performance that saved the company over one million dollars. He was the leader of a process improvement team that won Solar Turbine’s President’s Award and went on to win the Caterpillar Annual Quality Award. He directed the company–wide implementation of the ISO 9001 Quality System Standard.
George earned a MBA and a BSIE from Syracuse University and is a Six - Sigma Black Belt and a Professional Manufacturing Engineer.
J. Stephen Lewis, M.S., M.H.A.
Stephen holds an undergraduate degree from Stanford University and graduate degrees from Boston University and Georgia State University, in Quantitative Research Methods and Health Care Administration respectively. He is also a graduate of the Intermountain Health Care (IHC) executive training program in Quality Improvement. He has over 15 years' experience in management with an emphasis on performance measurement and direction of continuous quality improvement (CQI). He currently manages member relations for Health Plan of the Redwoods in Santa Rosa, California, with responsibility for member satisfaction and regulatory/accreditation compliance with member rights and responsibilities. He also holds an adjunct faculty appointment to the University of San Francisco graduate degree program in Health Services Administration.
