You are required to demonstrate internal processes that cover the safety and quality aspects of the products being manufactured. This can be in the form of any certification, audit or standard operating procedure. Your factory should have these as standard and can be an ISO, GMP, SGS audit or other formal audit company.
Please Note: The document needs to be valid for the entire period of the service, or will be rejected
If you are a reseller or products are made independently and outside a factory, you will still have the internal processes the regulation requires, but they will be in a different format.
We can help you create these documents if there is no formal certification or audit document available.
What we will need to create is a step by step document to show the quality control checks you carry out on the products once you receive them and check that products are made to the correct standards - to allow us to do this, we will require you to list a few bullet points on what checks you carry out on the products before placing them on the market.
A specification is a detailed list of ingredients, levels and any specific parameters the product should meet whilst being manufactured
A certificate of analysis is evidence that the product being manufactured are tested and match the requirements set out in the specification
These are also required for full traceability and need to be sent with every shipment
A Declaration of Conformity can and is often named in a few different ways. Fundamentaly it is the same document and still accepted. This document details any applicable standards and is a formal way of demonstrating the safety of the product. This document can be self created but some categories require external testing to be carried out
Any product bearing the CE mark will require a Declaration of Conformity
Electronic devices can be self certified
Toys must have EN71 testing before this document can issued
Medical Devices can be self certified for Class I non sterile, Class II and above must have notified body testing
Therefore, the CE mark applies and can be used in both the EU and UK
Accepted levels of Bis Phenol A in food contact material is now zero. This test is required to be carried out on any product, packaging, container that comes into contact with food
EN71 testing is specific for toys and is required before a CE mark can be placed on a product. This looks at flammability and metals in toys
You must be able to demonstrate the source of any leather or wood based products. There are due diligence checks listed in the regulation for timber products and they products must not be sourced from illegally farmed materials.