Certifications Quality standards, management systems and exemplary regulatory compliance
Our Certificates
Our quality standards, management systems and exemplary regulatory compliance, all contribute to the global success of the company. Our capabilities have been assessed and certified by the following international governing bodies
ISO 9001 : 2008
Brightway, Laglove, Biopro
Manufacture of Natural (Latex) and Synthetic Latex (Nitrile) Examination, Surgical and Industrial Gloves & Nitrile Sheath
ISO 13485 : 2016
Brightway (Plant 1), Laglove, Biopro
Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination and Sterile Surgical Gloves
Directive 93/42/EEC on Medical Devices, Annex V
Brightway (Plant 1), Laglove, Biopro
Natural (Latex) and Synthetic Latex (Nitrile) Surgical Gloves
CMDCAS
Brightway, Laglove, Biopro
Canadian Medical Devices Conformity Assessment System
NextTech Certificate of Compliance
Brightway
ISO14644 compliance
Regulation (EU)2016/425 (UKAS)
Brightway (Plant 1), Brightway (Plant 2), Laglove, Biopro
Manufacture of Chemical Protective Latex and Nitrile Gloves.
Regulation (EU)2016/425 (FINAS)
Brightway (Plant 1), Brightway (Plant 2), Laglove, Biopro
Manufacture of Chemical Protective Latex and Nitrile Gloves.
Medical Device Act2012(ACT 737) Establishment Licence
Brightway, Laglove, Biopro
ISO14644 compliance
Medical Device Registration Certificate
Brightway
Powder Free Nitrile Examination Glove.