Article 5 Quality assurance system
United Kingdom
The business operator shall establish, implement and ensure adherence to an effective and documented quality assurance system. That system shall:
take account of the adequacy of personnel, their knowledge and skills, and the organisation of the premises and equipment such as is necessary to ensure that finished materials and articles comply with the rules applicable to them;
be applied taking into account the size of the business run by the operator, so as not to be an excessive burden on the business.
Starting materials shall be selected and comply with pre-established specifications that shall ensure compliance of the material or article with the rules applicable to it.
The different operations shall be carried out in accordance with pre-established instructions and procedures.