Competence and trust: key factors in conformity assessment

Whether carried out by testing laboratories, inspection bodies or certification bodies, conformity assessments take many forms:

• They can be performed by suppliers (first party), users (second party) or independent third parties (third party).
• They can be based on certified management systems or accreditation, or take place without any certification.
• When performed by an accredited body, they can take the form of testing, inspection or certification.

The choice of an appropriate conformity assessment depends largely on the degree of trust to be established in the object being assessed. Examples include:

• a supplier’s declaration,
• testing of an identical product by an independent testing laboratory,
• comprehensive inspection of the product and its associated manufacturing and testing processes by an inspection body,
• product certification by a certification body, including the option of using certificates or conformity marks in communications with customers.

Trust, the intended audience and conformity assessment

The choice of conformity assessment may depend on whom the statement is intended to reach, such as markets, specific users, particular consumers or authorities. Trust in the conformity assessment itself is also crucial, for example with regard to:

• the competence of the organisations and individuals carrying out the assessment,
• the reproducibility of the investigations that lead to the statement of conformity,
• the precision of testing and measuring equipment and the resulting findings,
• the careful handling of records and confidential information, including data security,
• the comparability of statements of conformity, particularly in terms of determination and evaluation.

Economic considerations also play a part, as the effort involved in conformity assessment increases with the complexity and scope of the activities required. Supplier’s declarations under DIN EN ISO/IEC 17050, testing under DIN EN ISO/IEC 17025, inspections under DIN EN ISO/IEC 17020 and product certifications under DIN EN 45011 with recurring surveillance naturally involve different costs.

Example: damage analysis

When a particular form of conformity assessment, such as damage analysis, is required, the question arises: “Who should carry out the damage analysis?” Possible options include:

• a “widely known” expert,
• a publicly appointed and sworn expert,
• a testing laboratory accredited to DIN EN ISO/IEC 17025,
• an inspection body accredited to DIN EN ISO/IEC 17020.

The expert

The German term “Sachverständiger” (“Gutachter”, or expert) is not a protected professional designation. It describes a person with particular expertise and above-average specialist knowledge, similar to the requirements for the personnel of an inspection body providing expert judgements. The choice of individual or institution therefore depends on the desired level of trust:

• in the object of the conformity assessment,
• in the competence of the people carrying out the analysis,
• in the conformity assessment process and the environment in which it takes place,
• and in the confidence to be established among the recipients of the statement of conformity.

Testing laboratory or inspection body?

If damage analysis is performed by an accredited body, the question arises: a testing laboratory or an inspection body? In principle, damage analysis is an expert assessment activity and therefore an inspection task. Although testing laboratories also carry out damage analyses in practice, this does not reflect the intentions of DIN EN ISO/IEC 17020 and 17025.

Regardless of the type of conformity assessment, it must always be ensured that procedures for damage investigations are included in the scope of accreditation. Only then can an accredited body claim competence to carry out damage analyses within its accreditation.

***

Further information: In Part 10 of our article series “Conformity assessments in materials testing”, we summarise the key points and draw our conclusions. (opens in new tab)