Quality Works in association with Lean ISO Management Systems has a team of dedicated experts to provide consulting, training and auditing for management systems meeting requirements of numerous standards and regulations:

We have developed unique and tested programs that result in improvement of processes and performance of the entire management system. This results in improvement of the effectiveness and reduction of cost of maintenance of an ISO management system. Our consultants and programs focus on optimization of client's management system while complying with applicable regulatory requirements. We offer comprehensive, easy to implement, cost effective and results-oriented programs for Lean quality, environmental and medical device manufacturing management systems.

Visit our Lean ISO Management Systems site to learn more about our programs

ISO 9001 Quality Management System

This standard was initially released in 1987 and specifies, in broad terms, the necessary elements of a quality management system. The standard can be used by wide range of organizations such as manufacturing, service, logistics and others regardless of their sizes and industries. As time passed, ISO 9001 quality management system standard became an internationally-recognized tool to assist organizations worldwide in establishing and managing their processes to become more efficient and cost-effective. Thousands of organizations are finding that ISO 9001 quality management system can offer genuine strategic advantage, especially when it is aligned with corporate missions, goals and objectives.

ISO 13485 Medical Devices — Quality Management System

This standard was designed for organizations that need to demonstrate their ability to deliver medical devices and associated services that consistently meet customer and applicable regulatory requirements. The organizations may be involved in various phases of the life-cycle of medical devices, including design, manufacture, logistics, installation, or servicing of medical devices. This Quality Management System compliant with ISO 13485 standard is mandatory for medical devices sold in the US, Europe, Canada and other countries.

ISO 14001 Environmental Management System

The standard provides organizations with a framework to protect the environment and respond to changing environmental conditions. It specifies requirements that allow an organization to achieve the planned results for its environmental management system. A systematic approach to environmental management can provide organizations with data to create options for contributing to sustainable development by:

CGMP 21 CFR 820 Quality System Regulation

The requirements in this part define the methods, facilities and controls used for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for human use. The requirements are intended to ensure that finished devices are safe and effective and in compliance with the Federal Food, Drug, and Cosmetic Act. This regulation is well aligned with the ISO 13485 Standard requirements. Very often medical device manufacturers design their Quality Management Systems to meet both the Standard and FDA 21 CFR 820 requirements.

Integrated Management Systems

To satisfy customer, corporate or regulatory requirements, increasingly companies need to maintain more than one ISO Management System. Often these systems are maintained as separate entities, while there are numerous common processes that can be managed without duplication. These processes may include management review, documentation management, audit, corrective action, customer complaints and others. While costs of development and maintenance of duplicate documents are difficult to estimate, they may be unexpectedly high. Another financial benefit of an integrated system is savings in certification costs. For example, a company can reduce the number of audit days by 20% - 30%, saving thousands of dollars per year by integrating their ISO 9001, ISO 14001 and ISO 45001 systems. An integrated management system allows businesses to efficiently and effectively improve business performance to reach organization's objectives.

We assisted dozens of companies worldwide to develop and implement effective ISO 9001, ISO 13485, ISO 14001, ISO 45001 and CGMP 21 CFR 820 Management Systems. Contact us to learn how you can make your management system Lean and efficient.

Visit our Lean ISO Management Systems site to learn more about our programs