Quality management is the act of overseeing all activities and tasks that must be accomplished to maintain a desired level of excellence. This includes the determination of a quality policy, creating and implementing quality planning and assurance, and quality control and quality improvement. Quality Management comprises the processes for incorporating the organization’s policy regarding planning, managing, and controlling project and product quality requirements in order to meet stakeholders, and sponsors objectives (PM-Body Of Knowledge book). During the planning phase of a project, it is important to understand the quality requirements (what customer is expecting), the quality organizational policies (what is expected by organization) and the industry quality requirement (What the PM needs to consider executing a project in a specific area, industry, sector, or environment).
Quality applies to products or services whose measurable characteristics satisfy a fixed set of specifications that are usually numerically defined. (American Society for Quality). In order to achieve these norms, there are several quality standards. ANSI, UNI, IEC, ISO, CEN as an example of international quality standards. It is vital to comply with international quality standards in our project. Our project I-insulin is about diabetic patient, that is why we are using FDA, DTSec quality certificate. And also, other parts of our project consist of AI, data security, that is why we choose ISO 9001, ISO27001 quality certificate for the I- insulin project. These quality standards protect final users and guarantee the satisfaction of customer needs. We set our quality tolerances for this I-insulin project as 8%. Our mentality is the cost of avoiding mistakes is less than the cost of correcting them.
The Food and Drug Administration (FDA): Is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations. FDA is responsible for protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices. The FDA is also responsible for the safety and security of most of our nation’s food supply, all cosmetics, dietary supplements, and products that give off radiation.
ISO/IEC 27001 : 2013 specifies the requirements for establishing, implementing, and continually improving an information security management system within the context of the organization. It also includes requirements for the assessment and treatment of information security risks tailored to the needs of the organization. The requirements set out in ISO/IEC 27001:2013 are generic and are intended to be applicable to all organizations, regardless of type, size, or nature.
ISO 9001: sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001.
This standard is based on several quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. These principles are explained in more detail in ISO’s quality management principles. Using ISO 9001 helps ensure that customers get consistent, good-quality products and services, which in turn brings many business benefits.
We are going to work with AMD (Associazione Medici Diabetologi – association of diabetologists), ECDC (European Centre for Disease Prevention and Control), FAND (Italian Diabetic Association) University of Siena, sensor and pump machine producers, data storage company, software development company, and AI firms. In order to succeed these objectives and to meet expectations of sponsors, and stakeholder’s quality management of the project is of great importance.