Lecture summary: You probably heard the saying: “Commitment is the key to success”. So, in this case, the success of implementing a quality management system depends on the commitment of the top management. Top management This is about top management and their responsibilities. ISO 9001…
Management has an absolute responsibility to foster the quality policy, confirm its alignment, and communicates the mission to employees. They have a responsibility to plan, delegate authority, and communicate effectively. They are also in charge of a periodic review of operations and improvement within the organization, known…
You will see in the end, it’s all about documentation. If not in this part then by the end you will perceive the importance of documenting practically everything. Everything has to be documented, so it can be tracked. In this QMS world, there is an…
Lecture summary: A quality policy is a document that provides guidelines, intentions, and goals of your company referring to quality intentions. When creating one, you will describe your company’s strategy and policies that will serve various interested parties. Make it to be a more practical…
Every ISO standard has the system of requirements and each one of them is described in segments. In general requirements, it’s established what is meant by: QMS establishment The key point with QMS establishment is to be done in accordance with the requirements described in this exact standard. And by…
Lecture summary: Organizational structure The organizational structure is the definition of hierarchy in the organization and relates to the nature of the organization. Through the structure, you need to describe all the functions, roles, and relations in your company. Although there are no specific requirements…
Let’s say you have an idea of placing an innovative medical device on the market. That’s great, but you already know that going from idea to actual realization is not the whole picture, just the tip of the iceberg. Yes, there is a much larger part below…
1. What is an ISO 13485? ISO 13485 is an international standard for establishing quality management in the medical device industry. It is an effective explanation to meet the comprehensive requirements for a QMS in the medical device industry. The other well-known QMS requirements to follow…
qmsWrapper is a successful company promoting the organizational framework that provides structure to the processes, policies, procedures, and resources to implement the Quality Management System for medical device startups. Behind every successful company stands the skillful team. But the key role of such a team that leads to success is…
Lecture summary This part of the ISO 9001 standard highlights risk-based thinking. Why? Because it will help you by directing you to look and see opportunities, to address risks that will guide you to better and safe decisions. Risk-based thinking is a ground base for…
