Mouthguard Quality Management System

Non-Members - £250.00 inc. VAT
Members - FREE (Please Login)

Description

This system is to be used in conjunction with your laboratories MDD or DAMAS system

The Personal Protective Equipment (PPE) directive is a CE marking directive which is intended to ensure that all PPE meets common standards of quality and performance. It also sets out basic health and safety requirements.

The responsibility for ensuring that the directive is adhered to falls upon the manufacturer. The directive is enforced in the UK by the local authority Trading Standards Service. It is the manufacturer’s responsibility to decide whether a Sports Mouthguard is either ‘simple design’, complex design’ or ‘neither simple nor complex’.

This system has been developed following the ‘simple design’ as conformity to the ‘neither simple nor complex’ design cannot be fully achieved at present as no current International Standard for mouthguard testing exists meaning type testing for ‘category 2’ cannot be achieved.

This system aims to help the laboratory in showing due diligence in meeting its obligations as far as practicable within the current regulations.

Due to the current issues with the PPE regulations for custom made mouthguards this system is for laboratory guidance only and holds no force in law. Please see the attached terms & conditions.

What the system includes:

  • Mouthguard Technical & Quality Manual – this contains procedures that establish what happens in your laboratory.
  • Mouthguard Technical & Quality Disk – this disk includes all files within the system. It is recommended that you copy all files on to your hard drive and therefore keep the disk as a backup.
  • Mouthguard Technical & Quality Checklist – you will need to complete this to help implement the system.
  • DTI Personal Protective Equipment Guidance – this is an overview of the regulations.

This system is to be used in conjunction with your laboratories MDD or DAMAS system. If you do not have these systems already in place then please contact the DLA as one of these systems should be implemented first.