We are all aware of the purpose and value of quality standards and quality management systems (QMSs), especially when it comes to our wellness and safety. When a product or service is labeled by some internationally-acclaimed standard, it increases our confidence in product credibility. But do we really understand what a QMS represents? How important is it, and is it important at all? What if it is nothing but bureaucracy or a tedious anachronism?
Let’s first elucidate a few perspectives.
Imagine you are a user of a medical device – for example, a cardiology medical center patient. You receive regular health examinations and undergo prescribed treatment. The center recommends that you wear a smart band. The instruction for this simple device indicates that it is tested in accordance with ISO 13485 and ISO 14971. When you wear the band, it monitors your heartrate and pulse, reminds you to administer drugs on time and alerts at first signs of dangerous conditions (myocardial infarction, stenocardia, aortic stenosis, etc.). It informs the physician about all deviations and stores data for the entire treatment period somewhere “in the clouds.” Your experience with the band is quite positive: You have not noticed any malfunctions or breakdowns, and the device fully corresponds to its stated characteristics. As a patient, you do not think much about ISO and QMSs.
But what if you are a customer – for example, the customer of a simple medical device that monitors a user’s heartrate and pulse? The device is as described above, tested in accordance with ISO 13485 and ISO 14971. You know how important it is to “catch” a crisis at the very beginning and take timely actions. You invested reasonable funds in the acquisition of these devices, distributed them to patients, and received positive feedback. You have accumulated a big database, reduced routine workload of the medical center’s personnel, increased efficiency, and decreased the number of adverse events in the provision of medical care. The patient satisfaction level is growing, and your customer focus is set as an example to others. Nothing special – just a well-functioning device.
Finally, imagine you a medical software development company like Auriga Inc. You have been provided with the requirements for the medical device software, and you have proved to be fully qualified to meet the customer requirements in terms of technical characteristics, reliability, and safety. The customer has chosen you not only because you have been on the market for a long time and have years of experience in the industry, but also because you are compliant with the ISO 13485 and ISO 14971 standards. This means you have a QMS for medical software development and testing in place. The system has been tested by external accredited auditors (without this, certification cannot be obtained) in accordance with the highest international standards (the certification body is widely acknowledged in the field), and is verified annually (certification has consistently been successfully extended by regulatory authorities).
Accordingly, the customer is sure that:
- the project will be successfully implemented on time;
- the process of software development is transparent and easily monitorable at every stage;
- mandatory requirements are clearly documented and conveyed to all engineers involved.
A QMS is a set of techniques, approaches, and methods to allocate resources critical to ensuring the highest quality and reliability of a product. A QMS allows arranging all internal processes in a coherent sequence of actions aimed at achieving the customer’s goals. However, it is not enough to implement such system; it is necessary to demonstrate it’s applicability and usability in daily practice to the competent legislative body. Only after a proper on-site assessment may companies attain the coveted ISO 13485 and ISO 14971 certificates of compliance.
As a result, customers of certified organizations face much lower risk of unexpected defects or missed deadlines. As ISO certification (and, thus, the company’s QMS) requires annual verification, all engineers are constantly trained and tested on how to meet the quality standards. If we put aside non-familiar abbreviations, there is a simple meaning to adherence to a QMS: sustainable, predictable professional, service. In other words, efficiency, reliability, and aggregation of many years of international experience assembled to achieve the customer’s business objectives.
Quality Management System at Auriga
Auriga, one of the leading custom software development companies, constantly strives to improve the quality, reliability, and security of its solutions—this is especially true for medical software. The healthcare solutions developed by Auriga are widely used in operating units and intensive care units, which means that people’ lives and wellness depend on them directly.
It took us almost two years of systematic efforts to create a robust and complete QMS in accordance with the ISO 13485 requirements for medical device software development and testing, including an ISO 14971 risk management system. In November 2017, Auriga was assessed by a team of globally recognized auditors and awarded the Certificate of Compliance. In December 2018, the certification was successfully prolonged.