Conformity assessment by certification bodies: processes and requirements

The core competence of an accredited certification body is carrying out certifications. These are conformity decisions and attestations establishing whether specified requirements relating to products, processes, systems or persons are fulfilled.

Certifications by an accredited certification body are always third-party conformity assessments and are relevant to various areas of materials testing:

• Some testing laboratories are not accredited but certified to DIN EN ISO 9001 by certification bodies accredited to DIN EN ISO/IEC 17021;
• non-destructive testing (NDT) personnel may be certified under relevant standards, such as DIN EN 473, by bodies accredited to DIN EN ISO/IEC 17024;
• products or testing procedures may be certified by certification bodies accredited to DIN EN 45011.

Scope and systematic approach of certification

The scope of accreditation is defined in the certification body’s accreditation certificate, which specifies the areas and procedures for which its competence has been confirmed. Certification, for example under DIN EN 45011, follows the functional approach of DIN EN ISO/IEC 17000 particularly comprehensively. It comprises:

• determination and review of the conformity of products or processes against clearly defined normative requirements,
• a decision on conformity that must not be made by the people who determined or reviewed conformity,
• attestation of conformity in the form of a certificate,
• regular surveillance of the certified products or processes.

Methods for determining conformity

For determining conformity under DIN EN 45011, the certification body can use various examination methods. These include, in particular:

• testing, such as initial testing and surveillance testing,
• audits, such as assessment of quality management systems,
• assessment of technical records and development documentation.

Inspections may also form part of conformity determination. Individual activities, such as testing or audits, may be subcontracted. The following conditions apply:

• the certification body must assess the subcontractors’ competence;
• overall responsibility remains with the certification body;
• the conformity decision must always be made by the certification body’s own qualified personnel.

A distinctive feature of certification: a period rather than a point in time

Unlike testing or inspection reports, certification relates not merely to a point in time but to a defined period. This gives rise to additional requirements:

• procedures for regular surveillance of conformity,
• an obligation for clients to report changes to the object of certification,
• assessment of whether changes require additional examinations,
• rules governing the use of certificates and conformity marks.

Requirements for independence and integrity

The requirements for a certification body under DIN EN 45011 go beyond those for an accredited inspection body. Independence, impartiality and confidence are central. Key requirements include:

• freedom from commercial or financial influence, and evidence of financial stability and capability,
• a formal application procedure with clearly defined rights and obligations for all parties. This ensures that applicants understand their own rights and obligations, those of the certification body, and the certification process.
• separation of the personnel responsible for conformity assessment from those responsible for the conformity decision,
• protection of confidential information and records,
• independent oversight to ensure compliance and integrity and monitor the financial situation.

Key areas of certification work

The work of an accredited certification body focuses on:

• determination and review of the conformity of products, processes or systems,
• an independent decision on conformity,
• issuing certificates as formal attestation of conformity,
• continuous surveillance of certified entities.

An accredited certification body’s attestation of conformity applies not only at the time of initial determination and review, but also to subsequent periods where regular surveillance takes place.

Position within the overall conformity assessment system

Certification bodies integrate various elements of conformity determination. Testing, inspections and audits work together to provide the basis for a reliable conformity decision. Certification bodies therefore play an overarching role in the conformity assessment system: they bring together results from different sources and convert them into formal, widely recognised attestation.

A typical practical question

A typical question for an accredited certification body is: “Can a generally recognised certificate be issued confirming that components made from material W123 using process V456 consistently fulfil the requirements of standard N789?”

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Further information: Part 6 of the series “Conformity assessments in materials testing”: “Conformity assessment by the national accreditation body”. (opens in new tab)