Overview
ISO/IEC 17050-2:2004 is an international standard developed by ISO and IEC that defines general requirements for supporting documentation to substantiate a supplier's declaration of conformity. This declaration demonstrates that a product, process, management system, person, or body complies with specified requirements such as standards, regulations, or technical specifications. As a complementary part to ISO/IEC 17050-1, this standard enhances transparency and confidence by detailing the documentation needed to verify a supplier’s claims of conformity.
Key Topics
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Scope and Application
ISO/IEC 17050-2 applies to the supporting documentation corresponding to any object covered by a declaration of conformity-including products, processes, management systems, personnel, or organizations. It clarifies that the documentation must provide traceability and transparency to support the initial declaration issued by the supplier.
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Traceability and Control
The standard mandates systematic development, control, and maintenance of documentation to ensure traceability from the declaration to the underlying evidence. This ensures the documentation can be reliably linked to the conformity claims over the lifecycle of the declared item.
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Documentation Availability
Suppliers must provide supporting documentation upon request to relevant regulatory bodies and, optionally, to other interested parties. This promotes regulatory compliance and facilitates market surveillance activities without compromising proprietary information unnecessarily.
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Retention Period
Documentation must be retained according to applicable legal and regulatory requirements. Suppliers can decide to maintain records for longer periods as necessary for customer or market needs.
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Contents of Supporting Documentation
The standard specifies detailed content requirements, including:
- Description of the object of declaration (product, process, etc.)
- Design documentation such as diagrams, specifications, and competence areas
- Conformity assessment methods and results (e.g., audit reports, test outcomes)
- Identification and qualification of assessment bodies involved, including accreditation details
- Additional supporting information like relevant management system descriptions, risk analyses, and reassessment schedules
- Documentation of any changes affecting declaration validity
Applications
ISO/IEC 17050-2 is crucial for industries and organizations requiring a reliable framework to support supplier declarations. Its practical applications include:
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Product Compliance Verification
Manufacturers can demonstrate that their products meet regulatory and market requirements by providing detailed documentation supporting their conformity claims.
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Process and Management Systems Certification
Organizations seeking to verify their internal processes or management systems benefit from structured documentation supporting conformity declarations.
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Market Surveillance and Regulatory Oversight
Regulators and authorities utilize the standard to verify compliance claims during audits or inspections, enhancing market transparency and consumer protection.
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Quality Assurance and Risk Management
Detailed supporting documentation contributes to quality control and helps identify and manage potential risks related to conformity.
Related Standards
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ISO/IEC 17050-1:2004 – Conformity assessment – Supplier's declaration of conformity – Part 1: General requirements
Defines the general principles for supplier's declarations and forms the foundation for the supporting documentation specified in Part 2.
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ISO/IEC 17000:2004 – Conformity assessment – Vocabulary and general principles
Provides fundamental definitions and concepts used throughout conformity assessment standards including supplier declarations.
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ISO/IEC Guides related to conformity assessment and supplier declarations
Offer guidance on specific aspects of conformity assessment, certification, and attestation.
By adhering to ISO/IEC 17050-2:2004, suppliers can provide clear, transparent, and traceable documentation that substantiates their declarations of conformity-facilitating regulatory compliance, enhancing market confidence, and supporting effective conformity assessment practices worldwide.
Open preview (PDF)Conformity assessment — Supplier's declaration of conformity — Part 2: Supporting documentation