FDA
This is issued at the end of an FDA inspection to document any conditions that the inspector believes may violate FDA regulations.
What is a 483?
This is the testing and certification organization used by Cook to maintain our ISO certification.
What is TÜV SÜD?
The framework for Cook's Quality Management System can be found in this document.
What is the Cook Incorporated Quality Manual (CIQM)?
This is the government agency that oversees the safety and health requirements that keep employees safe at work.
What is the Occupational Safety and Health Administration (OSHA)?
Most of FDA's medical device regulations are in this CFR Title.
What is Title 21?
This is the regulatory audit program that allows a medical device manufacturer to undergo a single audit to satisfy multiple regulatory authorities.
What is MDSAP?
The FDA requirements for a Quality Management System are grouped into this many subsystems
What is seven (7)?
The most common reason organizations enter lawsuits with their employees
What is discrimination/harassment?
If a warning letter is not addressed, the FDA may require this legal agreement for the organization to stay in business.
What is a consent decree?
This is the ISO certification used by organizations involved in the manufacturing of medical devices.
What is ISO 13485?
Quality management processes are a continuous loop of these 4 steps
What is plan, do, check, and act?
When an employer takes an adverse action against an employee who has engaged in a protected activity, it is called this.
What is retaliation?
What is the Center for Devices and Radiological Health (CDRH)?
ISO is named after the Greek word isos which means this.
What is "equal"?
The purpose of this is to collect and analyze information in order to identify, investigate, and determine the cause of nonconforming products and quality problems
What is Corrective and Preventive Action (CAPA)?
When an employee has exhausted their 12 weeks of FMLA, they may be eligible for up to 14 additional weeks of this.
What is Extended Major Medical Leave (EMM Leave)?
This law, passed in 1906, banned the adulteration and misbranding of food and drugs and helped establish the FDA
What is the Pure Food & Drugs Act
ISO specifies requirements for this to demonstrate an organizations ability to provide products or services that consistently meet customer and regulatory requirements.
What is a Quality Managment System?
Without this, a QMS is nothing more than a series of documents and policies.
What is Leadership?
Gender, race, color, religion, and age are all considered this.
What are protected characteristics?