Compliance testing is often done on one or a small numbers of samples or even prototypes of the final product, so called type-testing. It is however required that compliance is maintained during mass production. Manufacturers and others involved in the supply chain shall take measures to verify that every produced product is compliant. Factories need a quality management system. Importers need to monitor the performance of such system.
Manufacturers shall ensure that procedures are in place for (series) production to remain in conformity.
This obligation means manufacturers shall:
Actually everybody is involved because the compliance of a product can be at risk from the first design to the last item shipped. Quality management procedures shall be in place for design, engineering, purchasing, supply management, production, warehousing, packaging, transport, delivery, sales, customer service of course under governance of the quality department and management.
Quality system - What a factory should do
The quality system of a factory (supplier) shall include procedures on assurance of the compliance of the manufactured products. The factory shall document quality programmes, plans, manuals and records.
Typical quality management elements of product compliance monitoring are:
Suppliers may have a certified quality system and that could reduce the need for inspections. ISO 9001 provides a good basis for quality assurance systems.
There are also specific standards for quality systems: ISO 13485 for medical devices, IATF (ISO/TS) 16949 for the automotive industry, ISO/IEC 25000 for quality of software and ISO 22000 for the Food Supply chain. In the case of Food Contact Materials a certified quality system - Good Manufacturing Practice - is even mandatory since 2006!
And for some products, typically with a higher risk, mandatory involvement of Notified Bodies may be required also for the conformity of production.
Importers shall, to protect the health and safety of consumers, carry out sample testing of marketed products, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and shall keep distributors informed of such monitoring.
This obligation is obviously more important when the risks presented by a product are high.
Even with a quality minded or certified supplier you may want to monitor the compliance of the purchased products. As an importer you are placing products on the (EU) market and as such you need to regularly monitor the quality of your products from the promises of the factory to the satisfaction of your customers.
Audits and inspections, examinations of products before they are shipped are the instruments that you have, such as:
Other elements may be in-store testing, consumer panels, fitness-for-use and performance testing, etc.
Preventive and corrective actions. Customer complaints, including those on social media, must also be monitored. They could be an indication that despite all the efforts something still has gone wrong.