Where this is found not to be the case, do you have a mechanism for taking corrective action toensure that the situation is remedied and not likely to recur?
Do you use the information from any quality problem to enable you to identify where thequality system can be improved and do you act on this?
Do you have mechanisms to monitor trends in quality performance so that failures can beanticipated and dealt with before they become critical?
Do you have mechanisms in place to scrutinize the quality system for areas where improvementsmight be possible?
Do you review the performance of your quality system to determine whether it is delivering theobjectives which you have identified for it?
Do you have a record of the qualifications and experience of your staff, with objective evidence of their qualifications, for example copies of certificates?
Do you have a clear record with regard to your proposed scope of accreditation of whichmembers of staff are authorized to conduct each test or calibration?
Do you have a documented procedure for training staff in quality issues and technical procedures,including tests?
Do you have a documented procedure for conducting evaluation of the competence of staff after training and before authorizing them for the procedure in which they weretrained?
Do you have a system for recording training, including objective evidence of competence?
Do you have a mechanism for identifying which staff conducted each procedure, test or calibration?
Accommodation and environmental conditions
Have you considered whether there are any environmental factors in your laboratory which might impact on the validity of tests or calibrations?
Are you conducting any tests or calibrations where the published procedure which you claim to follow includes a requirement for the work to be done under specific environmental conditions, for example temperature or humidity?
If there are such factors, do you have procedures in place to control and monitor them?
Do you have any activities which need to be separated to avoid, for example, crosscontamination?
Do you have procedures in place which will create an objective, auditable record that environmental conditions which might affect tests or calibrations are controlled and monitored?
Do you have clear instructions to staff on actions to be taken when conditions move out of specification?
Test and calibration methods, method validation and quality control:
Do you have a set of methods specified as acceptable for use in your laboratory?
Are they documented to the extent necessary to ensure they are applied properly and consistently?
Does your laboratory use standard methods which are published and widely accepted?
If not, have you evidence to show that the methods you are using are fit for the purpose claimed and acceptable to your clients?