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"All is flux, nothing stays still. Nothing endures but change."--Heraclitus 540-480BC ISO 9001:2000 is a very basic commonsense-based standard. It is not complicated. Its ideas are accessible and applicable to any business or organization. Quantum Associates’ comprehensive ISO 9001:2000 implementation process includes strategic meetings with your management team to develop your quality policy and objectives, a gap analysis to determine the scope of the project, documentation and training of your staff to implement the policy and procedures. Finally, we will conduct a cost of poor quality analysis to establish a baseline and determine your “Quality Performance Index.” Read more about the simplicity of ISO 9000. Key Benefits
CapabilitiesLean9000 A new service which combines some of the methods of Lean thinking with ISO 9000 implementation to deliver a value-added quality management system (QMS). Lean processes are a must. Processes that don't create value in the eyes of the customer must be minimized or eliminated. Lean 9000 takes a lean approach to QMS implementation by mapping your procedures and analyzing them for wasteful activities. New procedures are designed based on the elimination or reduction of the wasteful steps. The waste is eliminated and the new waste-free procedures are implemented resulting in a streamlined and more effective QMS.This program is available to organizations who are already registered to ISO 9000 as well as to organizations who are not registered but are considering implementing ISO 9000. Please read about how you can leverage ISO 9000 to jump start your Lean implementation. ISO 9000 Design and Implementation We can work within your budget constraints to help design and implement your quality system. We can offer you our accelerated plan, which limits the time your staff is diverted from their everyday responsibilities and gets you ready for your registration audit within 4 to 6 months. Our traditional plan includes working with your implementation team to ensure your documentation complies with the standard and to facilitate implementation. The traditional approach usually takes 8-12 months to achieve registration readiness. ISO 9000 Quality System Maintenance Many organizations either do not have the resources to maintain their quality management system or need to deploy their available resources to more pressing business problems. We offer customized maintenance and support as well as full service programs to help you maintain your quality system. We assign an ISO 9000 maintenance coordinator who usually reports to your Management Representative. The fee for this service is calculated on an “as used” basis or can be established as a periodic retainer depending on your needs. Above all our ISO 9000 coordinators are experienced lead auditors. ISO 9000 Internal Auditor Training Our internal auditor workshops will help prepare your staff to conduct internal audits of your ISO 9000 quality system. We offer two workshops based on your needs. Our two-day workshop is designed for participants who are basically unfamiliar with the ISO 9000 standard and the process approach to auditing. Workshop participants acquire the tools to plan, prepare and conduct internal audits. Our one-day workshop is for experienced internal auditors. Participants acquire the tools to audit quality system processes, identify and correct problem areas and continually improve the quality system. ISO 9000 Internal Audit Service If you are short on resources or your staff is laboring under a heavy workload making it difficult for you to meet the internal audit requirements of the standard then our internal audit service is designed just for you. We can help verify the adequacy, implementation and effectiveness of your ISO 9000 quality management system. Internal auditing is one of the most critical activities in the ISO 9000 program. Registrars audit this activity almost every time they audit your company. We offer pricing plans to fit your budget. ISO /IEC 17025 and ISO 14001 Do you need to understand how to implement ISO 17025 and/or ISO 14001:2004. Quantum Associates can help you implement these two ISO standards to improve the proficiency of your organization to provide testing and calibration activities or to improve your environmental management process. See what you need to know about ISO 17025 and ISO 14001:2004 (DNV White paper). Quality Systems & GMP Consulting We can conduct quality assessments and help you implement GMP improvement programs in FDA and international regulated manufacturing facilities located in Asia, Europe and Latin America. Our associate is fluent in Spanish and has ten years of experience conducting GMP improvement programs and quality assessments in 22 countries. Quality, Environmental and Safety Management Systems Integration There is strong support for organizations to integrate environmental and safety with quality management efforts. Highly successful quality, environmental and safety management programs share a number of common organizational features. An integration of OHSAS 18001:1999, ISO 14001:2004 and ISO 9001:2000 helps your people become more responsible for working safely and identifying workplace hazards; identifying and managing environmental issues; and producing defect free products or services. The integration of OHSAS 18001, ISO 14001 and ISO 9001:2000 fundamentally delivers four major enterprise-wide benefits: controlling business risks, reducing total occupational health and safety related costs, reduction of environmental waste, and producing competitive advantage. Other benefits include an optimized management system, better utilization of resources and streamlined system audits. Assess Your Organization for Compliance to ISO 9001:2000. Can a good quality management system pay? Studies by the National Institute of Standards and Technology and the U.S. General Accounting Office found companies adopting quality management practices experienced overall improvement in employee relations, higher productivity, greater customer satisfaction, increased market share and improved profitability.- Jan Kosko, "Quality Management Proves To Be A sound Investment, Says NIST", NIST press release, February 1995.
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