Why Certificates Are Important in The Field of Medical Textile?

What is a certificate and why it is important in the field of medical textiles?

When it comes to doing business, it is important to know who you are doing business with has quality and reliability. So how can we be sure that our exchange partner is reliable? This is exactly what certificates are for. They serve to reassure customers of the serious approach of the company. It is therefore always better to choose those that have them.

Certificates are even more important in fields such as medical textiles and food because these have direct links to human life. Which means that it is difficult to obtain them. During and after the period of COVID-19, the process of obtaining a certificate, which is also called certification, has become even more important and hardened.

What is a certificate, one would ask? In general, a certificate is a written, official, or duly signed document from an authorized person that attests to a fact. The principle of a certification is to give a company's customers an assurance of quality. That is to say that the certification proves, testifies, establishes that the certified company (or the certified personnel) responds, for some of these aspects/procedures/products/services/etc. to a certain frame of reference. A certification also indicates that the company has followed an approach that complies with the regulations of international organizations such as the European Union.

Thus, during this reading, it will be a question of reflecting and answering the following problem: What is a certificate and how to obtain it?

To answer this problem, we will proceed as follows: First it will be a question of seeing in a general way the certification process, and then to know some of the most important certificates in the field of health and those which matter more when it's about doing business focusing on the field of medical textiles.

As we said, a certificate is a written document that proves, that assures customers of the quality of a company and a product. Before the COVID-19 pandemic, obtaining certificates was simple, which obviously posed problems because a certificate is a document which shows, apart from quality assurance, that products are in conformity with Union regulations. European, so you must have rather good products to be able to obtain a certificate. Following the pandemic, the process of obtaining certificates became tougher, as we could no longer accept products manufactured in an unregulated manner. Thus, this tightening of the process has closed many companies that did not behave in accordance with the regulations. Which means that earning a certification gives companies a competitive advantage over others. In some cases, obtaining certification is not free. To obtain certification, it is generally necessary to take training before taking the certification exam, which costs from €400 to €1,200. So, it is better to be sure to have prepared for it.

To give an overview of the course of the certification process, we can briefly say that, first the company sends a sample of its product to the certification body. He submits the product to certain tests, then he deduces the attributes such as water permeability. The most important role of a certification body is therefore control and verification.

In addition, it is also important to check that the products correspond to the correct certificates with the correct dates. Certificates must be genuine. During the passage of the customs, if it is realized that the products and the certificates do not correspond, the products will be destroyed by the customs officers.

So, we should ask ourselves, who has the authority to issue these certificates? There are many certifications and many certifying bodies. It is difficult to draw up an exhaustive list. To name just a few of the certifying bodies:

• ISO = International Organization for Standardization: This is the organization that develops standards recognized internationally.

The one that concerns us the most, in our case, is obviously ISO.

It would then be appropriate to see some of the most important certificates that our company Mayamed Medical has. It should be noted the scope of our certificates, which is: medical and protective consumables (gloves (surgical and protective-nitrile, vinyl, latex, TPE, PE, synthetic), mask (surgical and fabric), respirator (FFP2, FFP3 models with valve and without valve), visors, goggles, protective clothing ( apron and overalls), Disinfectant, Test Kits, Beanie, Shoe Covers, Body Bag, Stretcher Cover, Manufacturing, Import, Export, Sales and Marketing, Brokerage Services.

• ISO 9001:2015: Quality management systems
• Good Hygiene Practices (BPH)
• Good Manufacturing Practices
• ISO 45001:2018: Occupational health and safety management systems
• ISO 14001:2015: Environmental management systems
• ISO 22000:2015: FOOD SAFETY MANAGEMENT
• OIC/SMICC 1: General requirements for halal food
• SA 8000:2014: Social Accountability
• ISO13485:2016: Medical devices