Station 10: Declaration of conformity and technical documentation
The Annex VII file, the EU declaration of conformity and how long the paperwork must be kept.
The station guide
Working guides in this station
Conformity and documentation Annex VII Technical Documentation: The Complete Contents Checklist General description, design data, composition, the requirement-by-requirement evidence index, test reports, calculations and supplier documentation. Annex VII turned into an assembly checklist with the traps marked. Conformity and documentation Common Documentation Gaps: What Audits and Authorities Actually Find The recurring findings, ranked by how often they appear: orphan reports, expired certificates, boilerplate declarations, missing applicability reasoning, stale standards. A self-audit list drawn from the pattern. Conformity and documentation Digital Documentation Systems: Holding Hundreds of Files Without Losing Them Registers, structured data and workflow for the conformity archive at scale: what to digitise first, the register fields that matter, and the line between a document store and a compliance system. Conformity and documentation Documentation Across the Supply Chain: What Flows, to Whom, in What Form Declarations down, evidence up, certificates sideways: the document flows that connect manufacturer, importer, distributor, filler and brand - with the confidentiality structures that let composition data travel without leaking. Conformity and documentation Documentation for Imported Packaging: The Importer's Assembly The importer holds a file assembled from someone else's evidence: the manufacturer's declaration and documentation, the verification record, and the translation and traceability layers. Assembling it so it answers in the importer's name. Conformity and documentation Internal Production Control: Keeping Production Married to the Assessed Design The declaration covers production, not a prototype. Specification control, incoming-goods verification, process monitoring and the nonconformity loop that keeps placed packaging identical in law to the assessed packaging. Conformity and documentation Keeping the File: Retention for Five and Ten Years Declarations and documentation live five years from placing for single-use packaging, ten for reusable. Retention architecture: what 'available' means in year nine, format migration, and the company-events that destroy archives. Conformity and documentation Self-Assessment Under the PPWR: Conformity Without a Notified Body No third-party approval stands between a manufacturer and the market - which places the whole weight on internal rigour. How self-assessment works, what presumption of conformity does, and the internal challenge function that replaces the external examiner. Conformity and documentation Test Reports and Evidence Standards: What Makes Proof Count Accreditation, method currency, sample identity and the report's chain to the specification. Judging the evidence in the file - your laboratories', your suppliers' and your own. Conformity and documentation Updating Declarations: Change Triggers and Version Discipline A declaration describes a specification; everything that moves the specification moves the declaration. The trigger list - materials, suppliers, standards, grades, labels - and the assessment of when a change is a re-issue and when it is a note. Conformity and documentation Writing the EU Declaration of Conformity: Fields, Signatory, Languages The declaration's required content, who may sign it, in which languages it travels, and how it is made available. Includes the version discipline that keeps declarations and specifications in step.