Steps Guide to import KN95 Face Mask to EU Countries
According to the EU PPE regulation requirements, Manufacturer / Importer must have the (Module B) and (Module C2) CE certificate / (Module D) CE certificate issued by the notified body to be sold in the EU.
CE Mark and Face Mask
CE Mark Registration
If the medical device is manufactured outside of EU, the EU Authorized Representative assists the manufacturer to apply.
CASE STUDY | RaisePrint
One big of their Client requested RaisePrint to get FSC Certification and provide FSC Certified printed packaging for coming order. If RaisePrint could not get FSC Certificate, they may lose this client and a certain sales volume. They had no idea about FSC Certification how to comply and apply.
non FSC Certified Company can sell FSC product ?
The reason is that the FSC-certified supplier resells the ownership of the FSC-labeled product to your company. Since your company did not have an FSC certificate at that time, your goods will immediately become non-FSC products. What is FSC Chain-of-Custody
Face Mask and ISO13485
For example: When a mask manufacturer passed an ISO13485 certification audit by UK accredited certification body (such as SGS, BV, Lloyd’s, BSI ..) covering operation and management of a company. The mask manufacturer received a UK Accredited ISO13485 certificate. The ISO13485 certificate states that the operation and management of masks manufacturers meet ISO13485 requirements. However, it cannot be claimed that the mask conforms to ISO13485, because ISO13485 is a certification of the company’s management practices, not a certification of the mask itself.
3 Tips for Implementation of ISO 9001 : 2015
For ISO 9001 risk identification, the company should identify risk from 6 aspects such as Political, Economic, Social, Technology, Environmental and Legal.
Moreover, the company conduct SWOT Analysis through brainstorm meeting. You can identify where the strength, weakness, opportunity and threat are for improvement.
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