The medical equipment industry is incessantly bringing innovations to the table. Devices come with various demographics. For example, wirelessly interconnected devices, cloud-based artificial intelligence, software-based equipment, 3-D printing devices, etc. All of them are coming up with a bevvy of benefits. The medical industry’s underlying demographics, innovation, and expansion doubled the sales, especially during the Covid-19 endemic. Another significant factor in massive growth is the quality consideration of medical devices such as medical syringes. All types of medical equipment pass through the QMS facility, which decides their further action.
This article will help you understand the basic concept behind the QMS and the further steps involved in this process. Let’s get started.
What Is A Quality Management System (QMS)?
A Quality Management System(QMS) is the backbone of the medical device manufacturing facility. The QMS department decides a product’s development cycle from day one. They gradually proceed to mitigate the risks involved and foster improvement. Medical devices are much more complex to manufacture but are easier to implement. The dynamic trend in medical device manufacturing made a huge leap during this pandemic.
Medical devices are controlling this multi-billion dollar medical industry. There is a threat to data as well. Some of the existing quality regulations are outdated and do not address cyber threats and issues related to the integrity of medical device data. One thing to remember is that quality assurance always requires an upgrade. It further helps to secure the critical data of patients for years.
When we talk about quality assurance, roles and responsibilities are not steady and constant. They keep varying and developing over time. A quality assurance management system mainly minimises the risk for all stakeholders involved in the process.
Classification of Quality Management System
Every medical device requires Quality Management System. It covers all the procedures and processes related to the device design, manufacturing, complaint handling, supplier & risk management, storage, distribution, etc. The complications involved in the process vary based on the device’s risk. There are three types of risks involved in the process. The categorization of QMS in terms of risks is as follows:
- Class I (low-risk),
- Class II (medium-risk),
- Class III (high-risk devices).
Companies making low-risk(Class I) devices, for example, non-sterile, non-measuring, non-reusable surgical instrument devices, require a simple process. On the other side, companies require a different QMS approach when dealing with medium-risk (Class II) or high-risk (Class III) devices. The medium and high-risk devices include blood pressure machines, sterile syringe, luer lock needles, etc. you will get to know more about this medical industry if you subscribe to our blogs. For that, you need to visit our website name Cheappinz. State tuned for weekly updates. And for now, we do not want to get into the further specifics of product these classifications. Remember that building a QMS is mission-critical to deliver quality products in the market.
Let’s now learn more about this quality management system and what it exactly does.
PDCA—Plan, Do, Check, Act
The PDCA cycle will help you understand how the quality assurance system operates in the manufacturing facility at various levels. The full form of the PDCA cycle is Plan, Do, Check, and Act.
Plan
Planning always comes first, whatever action we want to execute. The planning phase in the medical industry mainly focuses on the evaluation of existing procedures based on established industry standards. It also means using more advanced references. Planning helps us establish implementation strategies to improve existing practices for better results.
Experts affirm that predictive analytics at this stage plays an important role in improving the process and proposed changes that maintain accountability.
Planning is mainly responsible for the following undertakings:
- Planning resources
- Communication Set up
- Identifying competencies
- Identification of risks & opportunities
- Raising awareness
- Determining & implementing the support structure.
Do
The second stage—Do, is the implementation stage. It identifies and implements all the changes of the initial evaluation phase.
Check
The third stage—The check or review stage, involves rigorous evaluation and testing of the changes. It checks the changes made are sustainable and are good for the long run. These changes may or may not be beneficial. Non-beneficial changes will require instant exit from the system. Further, there is a need to reevaluate these checks. In some cases, the result of the changes proposed might vary with the initial Plan stage. Then comes the looped PDCA cycle that you have to run several times to compare the results and drive the feasibility of the proposed changes.
Act
In this stage, the fourth stage, the action is about taking full charge of the changes proposed by the facility. The plan follows the to-do list; it follows the checklist and ends with the act. Post the acting part comes the review part. Finally, you can take steps to optimise costs, increase efficiency, and implement changes to create situations that benefit both the enterprise and its customers/clients.
Implementing quality control and quality assurance procedures ensures you deliver the best products to your customers. Moreover, practising quality control has a positive impact on employee conduct. Quality control can inspire employees to create high-quality goods leading to greater customer satisfaction. Overall, quality plays a huge role in facilitating customers with accurate data.
