The ISO 9001 is among iso’s (international organization for standardization) most widely known standards ever. ISO 9001 standards are implemented by some 610,000 organizations in 160 countries. ISO 9001 has become an international reference for quality management requirements in business-to-business dealings, and in enabling organizations to meet their environmental challenges.
The ISO 9001 family is primarily concerned with “quality management”. This means what the organizaiton does to fulfill:
- the customer’s quality requirements, and
- applicable regulatory requirements, while aiming to
- enhance customer satisfaction, and
- achieve continual improment of its performance in pursuit of these objectives.
The vast majority of ISO standards are highly specific to a particular product, material, or process. However, the standards that have earned the ISO 9001 which is a worldwide reputation are known as “generic management system standards”.
National Sanitation Foundation (NSF)
The Public Health and Safety Company™, a not-for-profit, non-governmental organization, is the world leader in standards development, product certification, education, and risk-management for public health and safety. For 60 years, NSF has been committed to public health, safety, and protection of the environment. While focusing on food, water, indoor air, and the environment, NSF develops national standards, provides learning opportunities through its Center for Public Health Education, and provides third-party conformity assessment services while representing the interests of all stakeholders. The primary stakeholder groups include industry, the regulatory community, and the public at large. KY Manufacturing and Technology produces many products that require NSF approval and are very familiar with design and manufacturing requirements.
The Good Manufacturing Practices (GMP)
The Good Manufacturing Practices are guidelines expected and required for manufacturing FDA medical devices. These stnadards vary depending on the class of device being manufactured. KY Manufacturing and Technology is very familiar with these practices.
What are GMPs?
Good Manufacturing Practices are guidelines that provide a system of processes, procedures, and documentation to assure the product produced has the identity, strength, composition, quality, and purity that it is represented to possess.
Management System Registration Mark (UL)
The UL Registered Firm Mark is a mark you will never see on a product. Instead, it indicates that a particular facility has passed UL’s evaluation to management system standards and is used in promotion and marketing by companies with management system programs audited by UL. KY Manufacturing and Technology is a listed UL manufacturer and are very familiar with the standards. We are audited regularly for compliance.
U.S. Food and Drug Association (FDA)
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. KY Manufacturing and Technology is very familiar with the FDA guidelines and GMP (good manufacturing requirements). KY Manufacturing and Technology is also familiar with the medical device regulations, 510K process and design and development protocol.