Quality control is a vital part of the Vernacare business. Accredited to ISO9001, ISO13485 and ISO14001 standards. Vernacare has established, documented and implemented an effective Quality Management System that ensures product safety performance and compliance in accordance with the applicable customer, regulatory and legal requirements.
Quality certificates and CE marking certification
This page contains electronic Adobe Acrobat PDF files of quality certificates, conformity documentation and instruction for use (IFU) material for our manufactured products.
Please click on one of the tabs below to download the relevant PDF file.ISO 9001:2015 ISO 13485:2016 93/42/EEC Certificate Annex II (Exc Section.4) 93/42 EEC Certificate Annex V MDSAP Certification (Bags for Endoscopic Retrieval of Tissue)’
The following specific quality procedures are consistently adhered to:
Moulded fibre products
Products are independently tested against the PAS029 once per year which allows Vernacare to use the associated Kitemark. All products are inspected for defects ahead of packaging. State of the art automatic vision inspection systems are installed on Vernacare’s key production lines, to ensure consistent product quality. Moulded fibre products are guaranteed leak proof for up to four hours. To support this industry leading performance with a significant margin of comfort, products are sampled every 30 minutes from the production line and tested to ensure leak proof for up to 12 hours. All Vernacare’s moulded fibre products are self certified, CE Marked as a Class I Medical Device as per the Medical Device Directive 93/42/EEC.
Macerator disposal units
Macerator disposal units conform to three EC directives (EC Directive 2004/108/EC, EC Directive 42/2006/EC and EC Directive 2006/95/EC). The disposal units also conform to the Water Regulations.
In addition, the units are audited against the Australian SAI Global Water Mark Standard and meet the EN 1917 European Water regulation. Each unit is fully tested against a set of criteria and the test results retained along with a unique serial number and BOM. A log book records the details of each unit, which ensures the traceability of all manufactured products.
Products are independently tested to comply with the international standards for cosmetic products, the Cosmetic Regulation (EC) no 1223/2009. All batches produced undergo rigorous testing to ensure compliance to the standard before product is released for sale.
Vernacare manufactures and supplies a wide range of Medical Devices from Class I through to Class IIb. Products are manufactured under ISO13485:2016, an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. All Medical Devices are certified by SGS Belgium (CE1639).
Products in the Environmental Cleaning and Disinfection portfolio fall under the Biocidal Products Regulation (BPR, Regulation (EU) 528/2012). This concerns products that have been developed
to protect humans, animals, materials or articles against harmful organisms like pests or bacteria. This regulation aims to improve the functioning of the biocidal products market in the EU, whilst ensuring a high level of protection for humans and the environment.
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