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ISO Quality and Environmental Management Systems
ISO 9001 - ISO 13485 - ISO 14001

ISO Quality Management is a commitment to excellence. You reach it by teamwork and a process of continual improvement. Quality Works is dedicated to helping you reach that goal. If you are looking for an expert source for ISO Quality Management System (QMS) or ISO Environmental Management System (EMS) manuals or the entire documentation sets for ISO 9001, ISO 13485 or ISO 14001 standards, then Quality Works can help both product- and service-oriented organizations achieve ISO Quality standards that are recognized and respected throughout the world. We can show you how to develop your ISO Quality Management System or ISO Environmental Management System at a fraction of the cost of doing it yourself or hiring an outside consultant.

Proven ISO Quality Management Manuals and Documentation Systems

More importantly, we show you a tested approach to putting together an ISO quality management manual and a documentation system for any ISO standard. Every publication includes sample manuals and key supporting procedures, developed by certification experts in their field while working with dozens of companies around the world. Whether your goal is to improve an existing ISO Quality Management or Environmental Management manual or documentation or create a new system, our publications will guide you through the process. Significant parts of our publications are available for preview.

ISO 9001:2000 Quality Management System

ISO 9001 is a well-known and accepted standard for setting up quality management systems. ISO 9001:2000 focuses on process flows, customer satisfaction, and the continual improvement of quality management systems than did the 1994 revision. ISO 9001:2000 specifies requirements for a quality system that can be applied to any size or type of organization. Registration to the standard shows a company's ability to advance customer satisfaction and provide products that meet customer and applicable regulatory requirements. "Product" applies equally to services, hardware, software, and processed material intended for consumers.

ISO 13485:2003 Quality Management System

ISO 13485 is an international standard that specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation, and servicing of medical devices. This standard can also be used by international and external parties, including certification bodies, for assessment of the organization's ability to meet customer and regulatory requirements. The quality management system requirements specified in the ISO 13485:2003 standard complements technical requirements for products. The primary purpose of the ISO 13485:2003 standard is to facilitate harmonized medical device regulatory requirements for quality systems. All requirements of the ISO 13485:2003 standard are specific to organizations providing medical devices, regardless of the type or size.

ISO 14001:2004 Environmental Management System

ISO 14001 is an international standard that specifies requirements for an environmental management system to enable an organization to develop and implement a policy and objectives for significant environmental aspects. The success of an ISO 14001 environmental management system depends significantly on commitment of all levels and functions within the organization specifically top management. An ISO 14001 system helps an organization to develop and implement environmental policy, objectives, and processes to reach its environmental goals, take action when needed to improve performance and demonstrate conformity of the system to the ISO 14001 standard. The purpose of the ISO 14001 standard and corresponding environmental system is to support environmental protection and prevent pollution of the environment.

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