Which perspective facilitates us on this challenging path while creating a QMS?


Which perspective facilitates us on this challenging path when creating and/or managing the Quality Management System of living products such as surgical power tool systems?

The Quality Management System is a system based on legislation, standards and requirements. The fact that it is based on authoritative documents can often make us believe that we do not have a choice in design, production and lifelong control, on the contrary, we will lose our company if we do not follow the directives to the letter. When it comes to products that are dangerous due to electrical safety requirements, such as surgical power tools, what are the concerns when preparing QMS documents?

1- Worry of not knowing what to do

Most standards, which are difficult to understand when read, are not meant to be understood or so that the manufacturer does not know what to do. They are meant to give the manufacturer the gaps it needs to fulfill demand with high variation in production and design. Technology and engineering differences arise from these gaps. Otherwise, the products of all companies producing surgical power tools in accordance with the standard would not be similar, but identical. Standards are very clear in stating the obligation. The manufacturer understands what to do as soon as they read it. However, it offers the designer the opportunity to act according to the risk foreseen in the sections that do not contain clarity. The design can be realized in a unique way by meeting the demands of the target audience, ensuring the safety of the device and complying with the legislation.

2- Concern that requirements cannot be met

Electrical devices such as surgical power tools have common risks. What is expected in the field of electrical safety is to ensure user, patient and device safety. The demands of the standard are the ways that every engineer who is currently designing electrical medical devices applies in terms of product safety. Since a team designing a medical device will perform R&D on the device according to the expectations of the target audience, failure to meet the requirements means that the product will not be sold. No company produces a product that will not be sold.

3- Concern about documenting QMS requirements even though they are fulfilled

All your actions, the design of which you have completed and the requirements of which you have fulfilled, are valid only when they are in writing and declared. All actions that are not declared are considered as not done. Contrary to popular belief, documentation is not additional work, it is a kind of user manual of actions that reveals the work done. The clearer, more concise and more accurate the manual is and the more it reflects reality, the more effective, memorable and guiding it will be.

4- Concern that QMS documents are not used effectively within the company

If QMS documents are prepared as a brochure rather than a user’s guide for their actions, the personnel who receive general information about the action will not prefer to use the document because it does not support them. People prefer to spend their time on things that will benefit them and will not tire them while doing so. In all documents prepared for the use of staff, the use of the possible format contributes to finding what they are looking for, short text saves time, colors help to focus and accessibility contributes to the enthusiasm to access the document.

QMS documents are like the biographies of the medical devices produced. The biggest advantage here is that reproducible and sustainable biographies are written.

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