Regulation 45

the qualifications and competencies (including training and competency assessments) of each personnel, that are relevant to the provision of the applicable service;

the quality management activities and measures taken by the licensee in connection with the provision of the applicable service (called in this regulation a quality record);

every programme, policy, system, measure, protocol or process that the licensee is required to implement under these Regulations, and every activity undertaken under that programme, policy, system, measure, protocol or process.

information relating to the quality management system mentioned in regulation 11;

a master list of the initials and signatures of each personnel;

the job descriptions, training and competency assessments for each personnel;

all information and documents related to the review of policies and processes implemented under regulation 11, and documentation of changes made to different versions of those documents;

details regarding the maintenance and calibration of each piece of equipment and instrument used in the provision of the applicable service;

quality control measures for each test, piece of equipment and instrument used in the provision of the applicable service; and

for a clinical laboratory service licensee —

validation of every test method used in the provision of the clinical laboratory service; and

proficiency testing and external quality assurance programme performance.