Overview
EN ISO/IEC 17050-2:2004 (CEN) - "Conformity assessment - Supplier's declaration of conformity - Part 2: Supporting documentation" specifies general requirements for the supporting documentation that substantiates a supplier’s declaration of conformity. It complements ISO/IEC 17050-1 (general requirements) and applies where the object of a declaration may be a product, process, management system, person or body. The standard helps ensure transparency and confidence in supplier’s declarations used by markets and regulators.
Key topics and requirements
- Traceability: Supporting documentation must be developed, controlled and maintained to allow clear traceability to the supplier’s declaration of conformity.
- Availability: The issuer shall make supporting documentation available, on request, to relevant regulatory authorities and may provide it to other parties as appropriate.
- Retention period: Documentation retention must meet applicable laws and regulations; issuers may retain records longer to meet customer or stakeholder needs.
- Contents of supporting documentation (as applicable):
- Description of the object of the declaration (product, process, management system, person or body).
- Design documentation (e.g., descriptions, diagrams, drawings, specifications).
- Conformity assessment results: methods used (auditing, testing, inspection, sampling plans, verification/validation), results (audit reports, test reports), and evaluation of results including deviations and concessions.
- Identification and qualifications of first-, second- or third-party conformity assessment bodies involved, and accreditation status where relevant.
- Additional supportive information (where necessary): management system description, risk analysis, re-assessment procedures and schedules.
- Change control: Any changes in supporting documentation that affect the validity of the declaration must be documented.
Practical applications and users
- Who uses this standard:
- Suppliers and manufacturers preparing supplier’s declarations of conformity.
- Regulatory authorities assessing market surveillance evidence.
- Certification and conformity assessment bodies, auditors and testing laboratories.
- Procurement and quality assurance teams needing documented proof of conformity.
- Practical value:
- Enhances market and regulator confidence in self-attestations.
- Provides a structured approach for assembling supporting documentation for product launches, compliance files, audits and inspections.
- Clarifies documentation expectations for cross-border trade and regulatory inquiries.
Related standards
Keywords: supplier's declaration of conformity, supporting documentation, conformity assessment, EN ISO/IEC 17050-2:2004, traceability, retention period, conformity assessment results.
