Questions for Laboratories to be Accredited

Dr. Muayad Koji President of KSQCA Talal Khalid Hassan QC & QM Expert

INTRODUCTION
These questions are designed to assist testing and calibration laboratories set up a quality management

system that conforms to (ISO 17025:2005), the international standard for laboratory quality management systems. Compliance with this standard provides a globally accepted base for laboratory accreditation. The standard specifies the management and technical requirements to be met by testing and calibration laboratories in both their organization and their management of quality. Answering these questions will enable laboratories to identify where their current operations meet the requirements of ISO 17025 as well as the areas where they do not. It will also guide them in develop systems capable of achieving compliance. These questions are put in the a way to cover most requirements of ISO 17025 and classified them to categories that makes compliance easier to achieve:

1. The quality system and its components:

The work was done by a properly qualified person who had been trained in the relevant technical operations and had access to all information necessary to the proper execution of the work? The method used was technically sound and appropriate to the sample and to the requirements of the client? The equipment used was properly maintained and calibrated at the time the data was generated? All appropriate quality control checks were carried out and the results of such controls fell within the specifications? With respect to your management and organization. Are there clearly assigned responsibilities for management of quality? Are procedures in place specifically designed to ensure quality is maintained? Are these procedures documented? Do you have a mechanism for approval of this documentation and for ensuring that all copies issued are kept up to date? Do you monitor the arrangements for managing quality to ensure they are fully implemented and being followed by all? Where quality problems occur do you have a mechanism for taking corrective action which seeks to develop the quality system so that a recurrence of the problem is unlikely? Do you have a mechanism for identifying potential quality problems and taking action to prevent them materializing? Do you have a mechanism for identifying opportunities to improve the effectiveness of your quality system?

2. Monitoring and maintenance of the quality system:

Do you have a mechanism for checking that your arrangements for quality management are being operated on a day-to-day basis by all staff?

 Where this is found not to be the case, do you have a mechanism for taking corrective action to ensure 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 the quality system can be improved and do you act on this? Do you have mechanisms to monitor trends in quality performance so that failures can be anticipated and dealt with before they become critical? Do you have mechanisms in place to scrutinize the quality system for areas where improvements might be possible? Do you review the performance of your quality system to determine whether it is delivering the objectives which you have identified for it?

3. Personnel
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 which members 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 were trained? 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?

4. 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, cross contamination? 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?

5. 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?

 Have you determined the accuracy, precision and, where relevant, the limit of detection of the methods which you use, including standard published methods? Do you run routine quality control samples and evaluate the results before releasing data? Do you monitor trends in quality control results in order to anticipate possible problems? Have you tested your methods and laboratory by use of certified reference methods and/or inter laboratory comparison?

6. Equipment:
Do you have a system for commissioning equipment and verifying its performance and calibration before it is used for test or calibration work? Do you have a plan for periodic calibration and verification of the performance of all equipment which affects the validity of measurements? Do you have records showing that this plan is followed and which enable the status of any equipment to be verified at any point in its history of use? Is equipment subject to regular checks or calibrations labeled so that its status can be seen immediately by users?

7. Traceability of measurement:
Have you identified all the measuring equipment which is involved, directly or indirectly, in measurement or calibration and which, if not properly calibrated, would affect the validity of measurements? Is this equipment calibrated in a manner which provides traceability to the international measurement system? Do you have a management procedure to ensure that the calibration is maintained at all times, i.e. recalibration is conducted as necessary and, where possible, equipment is monitored so that any drift away from calibration will be detected? Do you have records which could be audited to confirm the calibration status of the equipment at any point in the past?

8. Administration of work and sample tracking:

Do you have procedure for logging samples into your laboratory? Are all samples uniquely numbered as soon as practicable after receipt? Does your system ensure that samples are stored securely and in a way that will preserve them against any changes which may affect data generated from them? Do you have a system for ensuring that the procedures required to be carried out on samples are clearly communicated to laboratory staff? Do you have a procedure to ensure reports are checked to make sure they correspond to the raw data?

9. Recording of results and associated data:

Does your system ensure that all observations are recorded at the time when they are made? In this record, is the raw data always preserved so that any problems can be investigated? Do you have a policy on how amendments to entries on laboratory records are to be made? Does the system allow the person making any record to be identified?

10. Computer systems:

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 Do you have control of what software may be loaded onto any of your computers? Are all computer systems, including software, checked to ensure that they record and process data correctly? Is all software secured against unauthorized changes? Do you have records showing when software was updated and that checks were made on its correct functioning after update? Do you have a procedure for regular backup of data held on computers?

11. Reporting requirements:

Do you have a defined report format? Does this comply with the detailed requirements of ISO 17025? Does your system ensure reports always reach only those entitled to receive them? Does the report acknowledge subcontracted work? Do you have a policy on how to deal with situations where it becomes apparent that suspect data has been reported? Do you have a clear identification of staff authorized to approve reports?

12. Purchasing services and supplies:

Do you take steps to control the quality of any purchased goods or services which might affect the validity of your data? Do you have a list of approved suppliers and a policy on their selection ? Do you keep this list under review and remove any suppliers found to be inadequate from a quality perspective? Do you have a system for checking all received materials against the order specifications?

13. Sub-contracting:
Do you evaluate the suitability of any sub-contractors used against a defined set of criteria? Do you have a list of these approved sub-contractors? Do you have a mechanism which ensures that the use of any sub-contractors found unsatisfactory is discontinued? Do you obtain clearance from clients before sub-contracting work?

For more information write to: info@ksqca.com