Types of conformity assessment
First-party conformity assessment (CA) - self-declaration: lowest level of trustworthiness
The manufacturer or supplier declares that a product conforms to a given standard or specification and delivers an SDoC (supplier's declaration of conformity).
This form of CA is quite common for products that are low risk. It provides commercial partners with the reassurance that a standard has been followed. It’s basically a form of information. The European CE mark is an example of an SDoC. By applying the CE mark on a product, the manufacturer confirms that the product meets EU safety, health or environmental requirements and addresses the conformity assessment requirements of the EU Directives.
This is the cheapest and simplest form of CA because there is no independent verification; trustworthiness directly depends on the credibility of the supplier.
Second-party CA - mid-level of trustworthiness
A person or organization who has a direct interest in verifying the performance of a product performs this type of CA activity.
Typically, a very large, important, or demanding customer (government, major buyer or manufacturer) will put in place their own CA for products or services they purchase. This may include test facilities and special assessment procedures that are conducted to verify the quality of the supplied goods.
The aim is usually to obtain assurance that a supplier has carried out a first-party CA according to customer specifications.
Third-party CA - high level of trustworthiness
This CA activity is performed by a person or organization that is independent of the seller or the buyer. This is usually called certification and provides the highest level of assurance regarding the state of a given product
Third-party CA is more expensive than first-party CA, since certification bodies (CBs) are usually for-profit companies. Third-party CA is applied when legislation mandates it for example due to the level of risk, or when a market is big enough to justify the expenditure.
The IEC supports all three forms of CA and also runs the IEC CA Systems, whose members provide 3rd-party CA. The IEC CA Systems offer the only globally standardized form of conformity assessment covering electrotechnology and represent the biggest working multilateral agreement in the world.
IEC Conformity Assessment terminology explained
- Conformity: compliance with the relevant technical specification.
- Test report: a document detailing the results of testing that a product has undergone to check whether it meets the technical specifications it is being tested against.
- Certification: a determination by an independent third party that a product meets the requirements detailed in the technical specification, based upon the test report.
- Mark: symbol used to identify that a product is compliant.
- Mutual recognition: reciprocal acceptance of results among the system participants.
- Peer assessment: assessing the competence and capability of a body carried out by a “peer”, i.e. another participating body of the same type.
Key concepts of IEC Conformity Assessment Systems
Three major principles govern the IEC CA (Conformity Assessment) Systems: openness, democracy (including transparency), and obligatory mutual recognition.
- Free use of the services offered and results produced by the IEC CA Systems by anyone in the world. It is not necessary to be a member or even to be situated in an IEC-member country; any manufacturer may request a certificate for his products and anyone may access and derive benefit from the Systems’ certificates (publicly available on the Internet) to determine whether particular products have been certified.
- Any organization which undertakes to follow the rules may join the IEC CA Systems, even if it is situated in a country outside the IEC membership. Members of the Systems are organizations, at most one per country, which on being admitted to a System become responsible for their country’s testing and certification activities within that System.
- Any certification body or testing laboratory may be proposed by a member body to participate in a System, provided that it conforms to the criteria laid down in the rules.
This involves both governance and transparency.
All significant decisions in the Systems are taken by the full membership. These decisions, as well as all rules and information relevant to the activity of the Systems, are published and freely available to all members of the System.
This is where the Systems add major value. The principle of obligatory recognition of the other members' certificates and test results implies that no repeat tests are necessary. It enables faster and more economic entry into distant markets for manufacturers and provides a global assurance that, no matter where a test was carried out or a certificate was issued, it has the same value.
In order to accept the results of a distant laboratory – with which it has no direct relationship – as a basis for a certificate for which it must assume responsibility, the CB (Certification Body) must have a high level of confidence in the accuracy and impartiality of the laboratory’s work.
In the IEC this is achieved through peer assessment. When a new laboratory would like to join a System, it will be reviewed by an assessment team of experts from different labs that are already members of the IEC CA System and able to carry out similar tests. The team will examine the competence and independence of the new testing laboratory.
Laboratories already registered in the system will undergo periodic reassessments and additional assessments in case of significant changes, such as relocation, scope extension or similar. The peer assessment process is a continuous activity to ensure competence independence and compliance with the requirements. A similar process is used for other participating bodies operating in the CA System, such as Certification Bodies and Inspection Bodies.
Although the team members are employees of organizations which may be in competition with the one being assessed, the mutual nature of the system will encourage them to be thorough and honest in their assessment. This is because their own organization will later be subjected to a similar assessment involving its competitors. An additional advantage is that the team members are likely to be experienced experts in precisely those issues which they must examine for the assessment.