Conformity assessment by the supplier: responsibility and requirements

According to DIN EN ISO/IEC 17050-1, a first-party declaration (for example, by a supplier, manufacturer or provider) is an established form of attestation of conformity. It serves to strengthen market confidence in the conformity of products, processes or services.

In the declaration of conformity, the supplier gives a binding assurance that the subject of the declaration fulfils specified requirements. Although the supplier may rely on the results of first-, second- or third-party conformity assessments, responsibility for the declaration always remains with the supplier. To strengthen its evidential value, the standard recommends substantiating the declaration of conformity with suitable supporting documentation (DIN EN ISO/IEC 17050-2). This makes an important contribution to confidence in the declaration.

Requirements for the supplier

DIN EN ISO/IEC 17050-1 defines clear organisational and procedural requirements. The supplier must ensure that:

• provisions exist for responsibilities and for issuing, maintaining, amending, cancelling and withdrawing the declaration of conformity,
• the declaration of conformity is preceded by appropriate determination and review of conformity (for example, through testing, audits or inspections),
• procedures are implemented to ensure continued fulfilment of the underlying requirements,
• procedures exist for reassessing conformity, particularly when the object of conformity assessment or the relevant requirements change.

These requirements make clear that a declaration of conformity is not a one-off act, but must form part of systematic and continuously effective quality management.

Minimum content of the declaration of conformity

To give the declaration of conformity the necessary binding force and establish an appropriate level of confidence, the standard specifies mandatory minimum information. This includes, in particular:

• unique identification of the declaration of conformity,
• clear identification of the subject of the declaration,
• specification of the underlying requirements (for example, standards or technical rules),
• the actual statement of conformity, including any limitations on its validity where applicable,
• unambiguous identification of the responsible person or organisation.

Practical context

The supplier’s declaration of conformity is a flexible and economical instrument of conformity assessment. At the same time, it requires a high level of internal competence, clearly defined processes and transparent documentation. Its standing in the market depends largely on the strength of the underlying evidence and how consistently the standard’s requirements are implemented.

A declaration of conformity in accordance with DIN EN ISO/IEC 17050-1 is the supplier’s assurance that the subject of the declaration meets specified requirements. The supplier may rely on conformity assessments by another first, second or third party, but always retains responsibility for its own declaration of conformity. The standard recommends using supporting documentation to strengthen the declaration’s evidential value and, consequently, confidence in it (DIN EN ISO/IEC 17050-2).

Under DIN EN ISO/IEC 17050-1, the supplier must ensure that:

• provisions exist for responsibilities and for issuing, maintaining, amending, cancelling or withdrawing the declaration of conformity,
• the declaration of conformity is preceded by appropriate determination and review of conformity (for example, through testing, audits or inspections),
• procedures exist to ensure continued fulfilment of the requirements to which the declaration of conformity refers,
• procedures for reviewing conformity exist in the event of changes to the object of conformity assessment or to the requirements to which the declaration of conformity refers.

The supplier’s declaration of conformity must meet certain minimum requirements to provide sufficient binding force and thereby establish an appropriate level of confidence. It must therefore include at least the following information:

• unique identification of the declaration of conformity,
• identification of the subject of the declaration of conformity,
• the requirements (for example, standards) on which the declaration is based,
• the actual statement of conformity, including any limitations on its validity where applicable,
• unambiguous identification of those responsible for issuing the declaration.

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Further information: Part 3 of the series “Conformity assessments in materials testing”: “Accredited testing laboratories: the role and limits of conformity assessment”.(opens in new tab)