We audit the factory but not the product compliance

Factory audits usually answer other questions. Social audits look at working conditions, and management-system audits look at how the company is run. EU product law asks something narrower: is each product that reaches the market safe and in line with its technical documentation? Under the General Product Safety Regulation (EU) 2023/988, manufacturers design and manufacture products in accordance with the general safety requirement, draw up technical documentation and ensure that procedures are in place for products produced in series to remain in conformity (Article 9(1), (2) and (4)).^[1]

For CE products, the conformity assessment module describes what the factory must do. Under the Low Voltage Directive 2014/35/EU, the manufacturer's technical documentation covers design, manufacture and operation, including drawings of components, the standards applied and test reports (Annex III, point 2), and the manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure compliance with that documentation (Annex III, point 3). Changes in design or characteristics, and changes in the standards, must be taken into account (Article 6(4)). These are the points a product-focused audit can look at.^[2]

Some acts make a factory quality system part of the legal route. Decision No 768/2008/EC sets out Module D, conformity to type based on quality assurance of the production process: the manufacturer operates a quality system for production, final product inspection and testing, approved and surveilled by a notified body. It applies only where a sector act provides for it. A voluntary audit, however thorough, is not the same thing.^[4]

The duties sit with the companies in the chain, whatever the audit says. The GPSR requires every economic operator to have internal processes for product safety that allow it to comply with the Regulation (Article 14), and an importer must ensure, before placing a product, that it complies and that the manufacturer has drawn up the technical documentation (Article 11(1)). For CE products the sector act sets the importer duties instead, because the GPSR's Chapter III, Section 1 does not apply to them (Article 2(1), third subparagraph, point (b)). Authorities can require documents and data on compliance from any economic operator (Regulation (EU) 2019/1020, Article 14(4)(a)).^[1][3]