Audit checklist for fertilising product manufacturers
Last reviewed 5 October 2026. Source: Regulation (EU) 2019/1009, consolidated text of 1 July 2026.
In simple words
Audit-ready means this: every document that an auditor can reasonably ask for exists, is up to date, is in the right language and can be found quickly. This checklist follows Article 6 and Annex IV. It is a working tool. It is not legal advice.
Words in this article
- Technical documentation
- The set of documents that show the product follows the rules. It includes the product description, the materials, the production process, test reports and the label.
- EU declaration of conformity (DoC)
- A signed document in which the manufacturer states that the product follows the rules.
- Quality system
- The written rules, checks and records that a company uses to make products of steady quality.
- Notified body
- An independent organisation that an EU country has approved to check products or quality systems. Some modules need one.
- Competent national authority
- A government body in an EU country that checks if products follow the rules. It is also called a market surveillance authority.
For every module
- The technical documentation is complete and up to date.
- The declaration of conformity is signed, up to date and translated for each EU country where you sell.
- The label or leaflet follows Annex III and uses the right language.
- The packaging shows a type or batch number, the manufacturer's name and one postal address.
- You have procedures that keep series production in line with the rules. They cover changes in the process or the product.
- You have records of corrective actions and, where suitable, of complaints and recalls.
- You keep the documents for 5 years after the product is first sold in the EU.
Extra for Module B followed by C
- The EU-type examination certificate with its annexes.
- Evidence that production follows the approved design.
- Proof that you told the notified body about changes that can affect compliance.
Extra for Module D1
- A written quality system: goals, organisation, production, quality control and tests.
- Quality records: inspection reports, test results, calibration data and training records.
- Internal audit records and corrective actions. The regulation requires a yearly internal audit explicitly for CMC 3, 5, 12, 13, 14 and 15.
- Audit reports and visit reports of the notified body.
- Access for the notified body to production, inspection, testing and storage areas, also for visits without warning.
How does RecyFert help?
RecyFert builds the dossier in the Gilbert FPR software and keeps it ready. As an option, RecyFert joins the notified body audit with you. Read how RecyFert works.