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“…SofMedica is a reliable partner that any client would like…”

Today, we talk to Gabriela Cretu, Auditor and Consultant in the field of Quality Management

Mrs. Gabriela Cretu, you are a well-known and respected consultant in the field of implementation and auditing of quality standards. Quality management, risk analysis, environmental management and information security are just some of your areas of expertise. But why do companies need quality certification?

20 years ago, I set out on this path of involvement both as an auditor and later as a consultant, in standardizing the activities of organizations in various fields of activity and their recognition through the certification process. The experience of these 20 years, through the organizations and people from these organizations I worked with, helped me to build a certain image and approach on the implementation of management systems. I can say that any company, regardless of field and size, needs to implement as many management systems regulated by different standards (Quality, environment, health and occupational safety, information security plus many others specific to the field of activity such as the one in the area of medical devices). Standards, management systems, are leading tools for the management of the organization. These are the tools that align them in a business world and help them speak the same language. When two organizations with a quality management system implemented start business negotiations, they will have some common expectations on how to communicate, on delivery, evaluation, feedback, etc. This is the role of standardization… to respect certain norms. You will probably ask me… well, organizations can implement for example a quality management system, but why do they have to certify it? Very simple, because through the certification process a third party, totally independent, confirms compliance with the requirements, and when we talk about the requirements, they are not only standard, but also the legal and regulatory requirements applicable to the business sector, the internal requirements of an organization (Corporate) and last but not least, customer requirements. Certification helps to recognize this process, to differentiate in the market the companies that have in practice, implemented and maintain a management system from those left only at a declarative level, certification is a guarantee to the client/business partner/beneficiary of the service/well made product, respecting all the rules. Certification, through the annual verifications performed, obligates to maintenance and continuous improvement, to the increase of performance and, why not admit it, even to the increase of efficiency and productivity. Accredited certification means international recognition.

 

So an ISO certification is more than a diploma that we display on a wall? How is this a guarantee for customers and business partners?

As I mentioned, the process of obtaining a certification is carried out by a totally independent organization, a Certification Body. These in turn are monitored and verified on the correctness of the entire certification process: from contracting an organization, conducting certification audit, file analysis, issuing certification decision and finally issuing certificates, by an Accreditation Body. So the job and a mechanism behind granting a certification is very well controlled. The Lead Auditor has a great responsibility, because based on the documented evidence provided by the organization, studied and analyzed, they formulate an audit opinion and the certification recommendation that can be conditioned or unconditional. They may also decide to suspend certification. The Lead Auditor has almost all the responsibility for the certification process, so, yes, a certification is much more than a diploma, it is a culmination of hard teamwork, it is a recognition of merits, compliance with the rules, it is a guarantee both to customers, as well as to all other interested parties.

 

But doesn’t all the documentation that a quality management system entails – processes, procedures, forms and records – limit creativity and agility within a company? Is the implementation, maintenance and functioning of this system another form of bureaucracy?

Certainly not! Management standards have evolved a lot in the last 20 years. In the beginning, really… a lot of papers, signatures, stamps were required. Real bureaucracy! Now, in the age of technology, we are talking about “documented evidence”. What does this thing mean? Any information on any medium is evidence of the fact that something happened. We are talking about Word, Excel, PDF files, we are talking about software applications such as CRM, ERP, Service desk, etc., we are talking about e-mails, intranet platform, online communication channels… look at what is happening to us for 8 months now. The entire document system is scalable depending on the nature of the activity and the size of the organization, its needs. At present, the Quality Standard, for example, requires only one “documented procedure” – that of “control of documented information”. This is the basic procedure that defines absolutely all the rules of documentation and approval, storage and archiving within an organization. It is the guideline that governs bureaucracy”. The standard only requires that rules be defined, how we define them… here it is up to each organization to choose according to the aspects mentioned earlier plus the infrastructure it has. I have audited companies in which I have not seen any paper… In short… bureaucracy is a myth, creativity is encouraged in order to find the easiest ways to demonstrate compliance through evidence.

 

In April 2020, you audited SofMedica on behalf of the certification body (Bureau Veritas) in order to re-certify the system implemented within SofMedica Group in Romania, Greece and Cyprus as well as the expansion in Bulgaria. What is your opinion as an expert who has audited an impressive number of organizations in a wide variety of fields? Are we in the “diploma on the wall” category, or in the “bureaucracy” category?

It was a real honor and pleasure for me to audit SofMedica Group. It was an intense audit in pandemic conditions, an online audit with a team of professionals who demonstrated how well they know and manage the processes for which they are responsible, a team that demonstrated that the organization has implemented not only a Quality system but also measures related to a business continuation system by replying to online work without interruptions. SofMedica is not in the category of “diploma on the wall” nor in the category of “bureaucracy”, but it is in the category of “CHAMPIONS IN QUALITY ASSURANCE” for the services offered to its clients.

Let’s imagine that a manufacturer of medical devices and equipment would ask you for references about SofMedica. What would you tell them?

I wholeheartedly recommend and guarantee the quality of SofMedica services! SofMedica is a partner that any manufacturer of medical devices would like. And I would add to take care of the products delivered to SofMedica because it has a very well developed system for evaluating and monitoring suppliers, so it will have to rise to the level of its requirements.

 

What can you say to a medical unit that is looking for medical technologies and devices? What should be considered besides the price, which out of the (justified) desire to reduce costs, is looking for the lowest price?

SofMedica is a reliable partner that any client would like. It knows how to respond to all their needs and expectations by finding the best solutions from a technological point of view, even if they are not always the cheapest, but they are by far the best. SofMedica offers not only technology but also added services that come to strengthen the partnership relations. Satisfaction of customer requirements is for SofMedica a priority and a direction. A team of specialists will always advise and guide the clients towards the best solution so as to provide safety to the chosen technologies, ease in their use in order to obtain the best results. SofMedica guarantees for the marketed products through a process of selection of suppliers, transport and storage conditions in accordance with the norms in force, monitoring, permanent trainings and participation in employee specialization programs, programs organized by medical device manufacturers and many others. SofMedica invests in people and infrastructure precisely in order to be able to offer Quality solutions and services. SofMedica is not a “product store” but must be seen as a solution provider that includes both medical technologies and devices and specialized staff for consulting and training of medical staff, service and maintenance of equipment. Obviously, all these efforts are translated into a financial effort, nothing is free and obviously it is reflected in the price to the customer, but precisely through this price the customer “buys” a guarantee/quality assurance for the purchase made. Cheap solutions are not always the best, and the hospitals which look for low budgets should also make a time-based analysis… they might come to the famous conclusion “I’m too poor to dress badly” and so on, and reconsider the option to buy only what is cheap. Quality costs!