Let’s start by asking the question: What is quality?
In simplified terms, quality is the sum and/or the quality of all properties of an object, system or process.
The international standard for quality management systems DIN EN ISO 9000 goes a step further and describes quality as: “The capability of a totality of inherent characteristics of a product, a system or a process to meet the requirements of customers and other interested parties.”
Quality can have a positive impact on profitability and growth in two ways. The customer-related quality concept refers to the fulfilment of customer requirements. Only if higher quality guarantees more benefits for the customer, only then he is willing to pay a higher price for it. And only this can bring about a positive return on investment. So, for the time being, it is not a matter of purely technically understood quality standards.
The process-related quality concept refers to the higher production quality, which in turn ensures reduced costs for rejects, rework, etc., so that overall lower total production costs are achieved.
Quality as a necessity and a requirement
We can illustrate the previously defined differences in the concept of quality with the example of wine:
From the ripening process, the selection of the grapes, the processing during production to the shop presentation – all these processes represent a part of quality. In many sectors, such as ours in the pharmaceutical and medical industries, achieving excellent quality is a necessity. This ensures that associated standards and commitments are met and maintained at all times.
Quality can also be specified, for example as standards by organisations such as the ‘German Institute for Standardisation’ (DIN), ‘European Committee for Standardisation’ (EN) or the ‘International Organisation for Standardisation’ (ISO). From a business perspective, quality means the degree of overlap between the customer requirements “should”, the company orientation “want” and the company capabilities “can”.
Quality in everyday life
Quality is also used as a value in linguistic usage. Often as the counterpart to quantity. Everyone knows the saying: quantity does not equal quality. If a customer buys a product or service and it fulfils its purpose for the customer, it is generally considered to be of “good quality”. This subjective perception and the customer-related understanding of quality are difficult to capture, as it can differ greatly from individual to individual in this respect.
“Quality is when the customer comes back and not the goods.” – Hermann Tietz
Likewise, the term “quality” has established itself in everyday economic life as a general measure of value. For example, the term “quality” can be found in “product quality” and describes the value of a product. Product quality itself consists of many individual forms of quality, such as functional and technical quality, which areensured by quality controlling and quality management. Thesame applies to the quality terms in “service quality” or “process quality“.
The sum of planning, management and control of all factors and activities to achieve defined standards resulting in the “quality product” is called quality management.
Why is quality important?
Life science is concerned with the structures and processes of living organisms or in which living organisms are involved. It encompasses much more than biology, chemistry, medicine and pharmacy; likewise, nutrition and agricultural sciences are part of the life science industry. It is a vast field that has a formative influence on humanity.
There, mistakes can lead to critical events that can be far more tragic than financial deficits. There are many reasons why quality is important. But the most important one here is: quality means life.
This can be illustrated by the example of an operation: If a surgeon were to use non-sterile instruments (product quality), an infection could occur at the wound. Likewise, an incorrect cut could have fatal consequences (process quality). A high degree of precision and instruments that meet the requirements are essential components to ‘save lives’ in the truest sense of the word.
A few examples within Zamann Pharma Support illustrate this: To be rated as an FFP2 mask, the mask must achieve the legal filtering performance of 94%. For our ZAMED® FFP2 masks, we have gone one step further and raised the quality of these masks up to 99.9% filtration performance. The increased filtration performance offers more protection than current products, safeguarding your health in the best possible way, and all this through higher manufacturing quality alone.
Quality at Zamann Pharma Support
“We embody quality” is not only a slogan, it is also our claim to our activities, to our colleagues and to ourselves. We don’t just want to sell quality, we want to be quality. In order to always be up-to-date in our industry and in the life science industry in general, our colleagues are constantly trained and educated. One of our achievements in quality matters is the DIN EN ISO 9001:2015 certification. This is a globally recognized standard that defines the requirements for effective quality management in a company and distinguishes its fulfilment.
ZPS is a partner of the pharmaceutical industry and, like the industry, is committed to the German Medicines and Active Substances Manufacturing Ordinance – AMWHV §3: “The companies and facilities must operate a QMS that is functional according to the type and scope of the activities performed”. (QMS = Quality Management System)
A QMS drives continuous improvement and supports innovation. ZPS strives for an open dialogue with employees and customers to ensure a sustainable quality culture that supports innovation as well as scientific and technological developments.
Our certified quality management system
Our QMS ensures that all processes, systems and activities that affect the quality of our products and services are permanently monitored and improved where necessary.
But what does a certified QMS mean? It ensures that the respective company complies with a global standard and also offers a ‘high-level structure’, which simplifies the combined certification of other standards. It also provides other benefits such as improved harmonization of strategic direction and increased leadership commitment.
A certified QMS results in many positive factors for you and your company. In addition to strong customer orientation, you offer your customers and business partners a valuable decision-making aid. You increase efficiency within your company and sustainably improve your processes and structures. In this way, you can achieve considerable cost savings while minimizing your liability risk. You also benefit from increased employee motivation through better communication and more easily available information.
In short, it is a competitive advantage, a continuous improvement process.
Because a company and its employees can only be successful if both are constantly improving.
Likewise, our work culture is aligned with current GxP guidelines. A brief definition: GxP (G=Good, x=Manufacture, Distribution, Documentation etc., P=Practice) refers to all guidelines for good working practices, which are particularly important in our industry. These standards are set by the European (European Medicines Agency) and American (Food and Drug Administration, FDA) health authorities.
LMS as a bridge between quality and digitalization
Our most important resource is our colleagues; together with the digitalization, this creates synergies that are necessary to maintain compliance in pharmacy. To meet these enormous demands, we are using our own Learning Management System (LMS) todevelop a digital learning platform to train our colleagues. Our LMS is only one part of keeping the quality of our staff at the maximum.
The term ‘compliance’ stands for the adherence to legal provisions, regulatory standards and fulfilment of further, essential ethical standards and requirements, usually set by the company itself. The pharmaceutical industry is one of the most demanding industries.
To ensure compliance, we have developed our own e-learning system. This platform enables and encourages every person in the company to make use of the treasure trove of information and to further educate themselves individually. This continuous development ensures that we have up-to-date know-how in a constantly changing process landscape defined by high requirements and quality standards.
“We embody quality”
Quality is more than a seal, more than a certificate, it is something that accompanies us in all aspects of life.
In private life, in the family environment, at work, during the pursuit of hobbies, etc. We encounter quality everywhere. Of course, a certain amount of effort is needed to guarantee or ensure it.
In order to maintain said quality at all times, we have taken it upon ourselves to embody quality. As part of society, as a company, as people. Quality is our way to contribute our best to the life science industry.
For more information on ISO 9001 certification, please visit the TÜV-Süd website:
ISO 9001 Certification | DE | TÜV Rheinland (tuv.com)