Many companies want to help and produce products and create services that will reduce the spread of infection, support healthcare, help people in quarantine and make society cope with prevailing circumstances. Companies are starting to manufacture hand sanitizer and mouthguards or launch digital services to facilitate distance learning, for example. When crises arise, like the corona pandemic, the opportunity to think new and different is created. And you want to quickly launch your new idea. But don't forget to certify the new product. RISE assists SMEs with certification.
– Right now we see many companies that want protective equipment for healthcare approved. There is great shortage of several different types of protective equipment, so getting new safe products to the market quickly is of course extremely important. RISE has a dialogue with national authorities to facilitate the process of getting equipment available for healthcare without compromising safety and performance, says Dag Sjöholm, research and business developer for certification at RISE.
Multiple levels of certification
Certification is based on multiple levels. Sjöholm divides them into three different categories in terms of requirements: international, national and industry, with international requirements being superordinate:
“Basically, the international requirement supersedes the national, and the national supersedes industry requirements.”
The most common international certification is the CE marking.
“It’s a European certification mark required to sell products in Europe. It’s very good that a common regulatory framework exists for the whole of Europe, instead of every country having its own specific regulations, but you can’t take a CE-marked product and start selling it in the US, since there are different regulations there,” says Sjöholm.
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Government determines local requirements
When it comes to national requirements, it is often government agencies, such as the Swedish National Board of Housing, Building and Planning and the Swedish Energy Agency, that determine which requirements a product should fulfil.
“It may have to do with a product satisfying specific noise requirements or sealing requirements,” says Sjöholm.
The third level, in which industry sets the standard, can involve a trade association seeking to clarify and ensure that the products being sold meet specific requirements.
“So that, for instance, you don’t sell doors that lack certain fire safety properties or whatever it may be,” says Sjöholm.
Don't wait too long
In exceptional situations like what we have currently with the corona pandemic, development of new products may go faster than usual. That makes it even more important that you do not wait too long to begin the certification process.
“Sometime during prototype testing is a good time, I would say. If you’ve already begun production, it’s a bit too late if there are indications that something is wrong.”
If, prior to the process commencing, a company requests assistance and advice from another company that issues certification, it means that that company is precluded from issuing the certification.
“They are then no longer deemed impartial, so it’s something important to consider,” explains Sjöholm.
Once the certification process is underway, the actual product is thoroughly tested at the same time as production is inspected in order to ensure that all products maintain the same quality.
“You examine the process that the products undergo and, sometimes, a few samples are tested to ensure that the customer is not just sending products that look good,” says Sjöholm.
Valid for five years
When all steps are completed and approved, a certificate is issued and the company can label their product with a certification mark. A certificate usually applies for five years. If something about the product were to change, such as new materials used in manufacturing or if the product is to be sold in a new segment, new certification is required.
For those needing advice on and support with certification, help can be sought from, for example, trade associations and Almi.
“It’s possible to apply for funding while also receiving help regarding what to consider and where to go for certification,” says Sjöholm.