Lecture summary: Customer communication Communication with the customer is one of the most important activities in organizations. It’s on you to develop the method for communicating with the customers. But be aware, whatever you choose, stick to it, because during the audit you will be…
Lecture summary: What does this mean? What does it include? It represents master planning. It means that you have to include objectives of planning, realizing, controlling, leading, guiding, and instructing all participants on the different functions and roles that are involved in the realization of a product. Make…
Lecture summary: Documented information is the key element of your QMS and it has to be controlled. In ISO 9001:2015 standard, everything is now known as documented information whether that’s records, procedures, processes, etc. and in whatever form e.g. paper, electronic, etc. Examples of documented information are things as a description of…
Lecture summary: Communication is also one of the key elements of QMS implementation and business success. As much as lousy communication can make a mess in a way of doing business, so much good and effective communication can lead to successful outcomes and positive results. To avoid any inconvenience…
Lecture summary: How important it is to be aware of the quality management system, you can see by the fact that it has it’s own clause in the ISO 9001 standard. And if you wonder why is it so important to be aware, it’s because awareness of…
Lecture summary: In a quality management system, competence represents appropriate qualifications, skill set, and knowledge with the goals of achieving the intended results. According to an ISO 9001 standard, each employee in your company should be competent to do their job, and which is practically a must,…
With the aim to keep track of where healthcare technology is going, studying tech trends is essential. The MedDev industry is always looking for alternative ways to improve their performance, productivity, and efficiency in order to better identify, diagnose, and treat diseases. Software as a…
As a requirement within ISO 13485, the management must ensure that adequate resources are available to perform continuous work by the organization. Providing resources can refer to personnel, infrastructure, consumables, equipment, etc. Human resources In this part, the standard focuses on the improvement of human…
Work environment and contamination control are important and critical for effective and compliant medical device business run. Definition of the Working Environment Work conditions and environments must be under effective control. And by the ISO 13485 standard, it undoubtedly means, it must be documented as…
Naturally, planning goes ahead of realization. And this part of the standard explains how important is for you to be consistent in planning throughout all parts of your quality management system. Plus, it refers to all phases of the life-cycle of your medical device. Quality…
