Product Inspection

What Are the Three Types of Conformity Assessments?

what are the 3 types of conformity

If you want to import or source goods from China as a foreign buyer, it’s essential to understand the significance of conformity assessments. The below guide provides critical information about the three different conformity assessments, allowing you to determine which one is best for your business needs.

The Importance of Conformity Assessments

Different countries have different standards in terms of safety and efficacy for various products and services. As an international business operating across borders, it’s up to you to know which standards are applicable in your region — and to ensure that any goods or services you import are in line with local regulations. Failing to meet standards can result in fines or lawsuits.

A conformity assessment refers to the processes used to prove that a service or product meets these set standards. When applied to a product, a conformity assessment might involve testing that item to ensure it meets predefined performance standards and quality management, accreditation, and inspection criteria.

Take a critical product like PPE (personal protective equipment), for example. These goods, like gowns and masks, help to prevent the spread of disease. Due to the COVID-19 crisis, healthcare providers globally have increased their demand for PPE. In some instances, this has resulted in dangerous shortages, leaving both workers and patients at risk.

Countries unable to manufacture sufficient amounts of PPE themselves have had to import these goods. Of course, they want to ensure that the PPE they equip their healthcare workers with is up to safety and performance standards. Conformity assessments ensure this is the case. However, not all conformity assessments are equal.

The Three Types of Conformity Assessments

There are three types of conformity assessments, and they are viewed differently in terms of trustworthiness. Depending on the product or service being marketed, the relevant regulatory body may not accept all conformity assessment forms. For example, the International Electrotechnical Commission manages conformity assessments for electrotechnical products.

Knowing which type of conformity assessment is relevant to your industry and understanding how that industry is regulated is critical. Here is the necessary information on conformity assessments to get you started.

First-Party Conformity Assessment or Self-Declaration

A first-party conformity assessment (CA) is also known as a self-declaration. In this case, the supplier or manufacturer declares that the product they’ve created adheres to the given specifications or standards required.

The supplier or manufacturer will deliver a so-called SDoC (a supplier’s declaration of conformity) towards this end. This type of conformity assessment is understandably considered the least reliable and trustworthy. After all, it’s merely taking the manufacturer’s word for it. It all depends on the credibility of the supplier. There is no third-party proof or assessment.

This type of conformity assessment is thus most common for products that are deemed low risk. An SDoC should be used only if the market allows it and is only recommended if the risks associated with non-compliance are low — and if there are options for swift recourse in the event of non-compliance.

An SDoC is essentially just a label that provides commercial partners with a confident assurance that the minimum standard has been met. It won’t be relevant for products with life-altering effects, like medical devices, for instance. In these cases, local governments and regulatory bodies have more stringent requirements in place to assure quality.

One example of an SDoC is the European CE mark. The CE mark is applied to specific products, confirming that they meet the European Union’s health, safety, and environmental regulations. It’s essentially one small piece of information telling you that the product meets the many different requirements outlined in the various EU directives.

While it’s the least trustworthy of all conformity assessments, a first-party conformity assessment is also the cheapest. It doesn’t require independent verification from a third party. Many businesses will still opt to utilize a more stringent type of conformity assessment because it guarantees their products’ safety and efficacy and protects their business interests.

Second-Party Conformity Assessment

A second-party conformity assessment is considered a step above a first-party evaluation in terms of trustworthiness. In this case, a person or organization with no direct interest in confirming the product’s performance conducts the conformity assessment.

A second-party conformity assessment is typically useful for large, significant, or demanding customers, such as a large-scale buyer, major manufacturer, or government entity. Such bodies will put the systems and operations needed to conduct conformity assessments for the products or services they purchase.

This ensures maximum efficiency and convenience while also giving the body some oversight of the processes and results. They may even establish their own test facilities and write particular assessment guidelines, overseeing the process from start to finish to verify the quality of any goods or products they have bought.

The main goal of such a second-party conformity assessment is to obtain an assurance that the supplier has indeed carried out their first-person conformity assessment in line with the client’s specifications. It’s like double-checking the self-declaration assessment. While this might seem like an added burden on the buyer, it’s actually in their best interests.

For example, say an automobile manufacturer buys their engines in China. They want to make sure those engines are manufactured in line with safety regulations. Otherwise, if there is some safety issue related to the engines, the company’s reputation might be tarnished. This could result in a loss of market share and a decrease in profits.

To avoid this nightmare scenario, the manufacturer may go ahead and request their engine supplier to perform a first-party conformity assessment. However, suppose the purchaser wants to be sure that the products they are receiving are up to par. In that case, they may then subject the engines to their additional second-party conformity assessment.

Third-Party Conformity Assessment

The final type of conformity assessment you need to know about is the third-party conformity assessment. This brings the highest level of trustworthiness with it. This is also referred to only as a “certification.”

Third-party conformity provides the highest level of trustworthiness and the most reliable form of assurance regarding a product’s state. A third-party assessment is generally the most expensive of the three options. Certification bodies, CBs, are usually for-profit companies and request higher fees to carry out the conformity assessment process.

Why might you spend the money on a third-party conformity assessment? There are a few reasons. First, in some instances, legislation may mandate a need for third-party conformity assessments. This occurs when a high-risk product is involved (for example, a medical device) or when the market is large enough to justify this kind of added expenditure.

Some companies may also opt for a third-party conformity assessment to gain a competitive edge in the market. This type of evaluation attests to the reliable quality of the product and can be seen as superior in consumers’ eyes. This can even be a boon to business, serving as an added marketing incentive when speaking to potential clients.

Another reason companies opt for third-party assessment is simply for their peace of mind. Carrying a certification from an official CB assures the business that the products they are putting onto the market are made with top-quality goods that are up to standard. This is a significant benefit for companies concerned with reputation management.

The Final Word on Conformity Assessments

As a foreign buyer importing goods from China, you must use conformity assessments to ensure the goods you receive are safe and fit-for-purpose in your local market. Depending on the types of goods or services you offer, the relevant regulatory agency may only accept certain types of conformity assessments. Do your research and know what’s required.

Jonble provides reputable product inspection and quality control services for foreign buyers who source or import products from China. As a trusted third-party provider, we cover everything from product testing to supplier audits and more. Find out more about our services or get in touch to discuss your business needs today.