ISO 17025 Self Assessment Compliance

 

SELF–EXAMINATION QUESTIONNAIRE FOR ISO 17025 COMPLIANCE
MEASURABLE ELEMENTS			1	2	3	4
ORGANIZATION
Is the laboratory managed in such a way that it operates independently and is free from external influences?
MANAGEMENT REQUIREMENTS
Is Senior Management committed to quality system, including compliance with ISO 17025, and agreed that resources will be provided to establish and maintain it?
Do staff at all levels recognize that, irrespective of workload and other pressures, the requirements of the quality system must be followed at all times?
Is there a person who is responsible for establishing and monitoring compliance with the quality system on a day-to-day basis?
Is there a documented specification of the quality management system, for example in a quality manual, with clear assignment of authority and responsibility such that the managers who supervise work have authority to ensure the quality of the work which they supervise?
DOCUMENT CONTROL
Are there documents available that give work instructions so that staff have a source of reference to enable them to conduct their work properly and consistently?
Are all documents controlled? Which means can you answer “yes” to the following:
Are all documents giving instructions or used to record data authorized by defined management personnel?
Is a record of the issue of all documents kept and procedures adopted so that when amendments are made, every copy can be retrieved to be updated?
SUBCONTRACTING OF TEST AND CALIBRATIONS
Do you have a list of approved subcontractors?
Do you have a record of the accreditations of the subcontractors?
Where subcontractors are not accredited do you have other evidence that they are competent?
PURCHASING SERVICES AND SUPPLIES
Do you have a list of approved suppliers and a policy for inclusion of a supplier on the list?
Does this policy ensure that purchased materials and services will be good enough to ensure that the quality of your data is not threatened?
SERVICE TO CLIENTS AND COMPLAINTS
Do clients know how to contact you and who to speak to about the progress of their work?
Do you follow up complaints from clients and learn from them so that you can take steps to ensure that the problem does not happen again?
CONTROL OF NON–CONFORMING WORK
Nonconforming work occurs when data or services are detected which do not meet the laboratory’s agreed standard of quality. This may be detected internally or externally.
Do you have a procedure for ensuring that work or release of data, is stopped immediately nonconforming work is identified?
Do you follow up on nonconforming work in order to learn from it and take action to ensure that the problem cannot happen again?
CORRECTIVE ACTION
Where quality problems are identified, do you have a procedure for ensuring that prompt corrective action is taken?
Do you ensure that the corrective action taken addresses the root cause of the problem, i.e., do you think that you normally make it unlikely that the problem will happen again?
Do you follow up to ensure that the corrective action has been effective, for example after a period of settling in?
PREVENTIVE ACTION
Do you track trends so that you can respond to deterioration in quality before it reaches unacceptable levels?
Do you hold regular meetings of senior technical staff to discuss areas of concern about quality and consider proposals for improvement?
Do you track measurable items, for example turnaround times, numbers of re–tests necessary, and respond when performance appears to be deteriorating?
RECORDS
Where documentation requires a procedure to be followed do you have records which show whether it was actually done or not?
Would your records enable you to identify the person who did each piece of work?
Would your records enable you to identify the equipment used?
Would your records enable you to prove that the equipment was properly calibrated and functioning correctly?
INTERNAL AUDITS AND MANAGEMENT REVIEWS
Do you carry out record regular inspections to check that the procedures which you have defined and documented are, in fact, being followed?
Does senior management carry out reviews to determine whether the quality system continues to meet the needs of the organization?
PERSONNEL
Do you have appropriate numbers and types of staff so that work can be carried out without having to rush so much that quality may be compromised?
Do you formally check if all persons performing technical functions possess the required educational/professional qualifications and experience?
Are there clearly defined descriptions set out for each of the persons working in the laboratory?
Do you have a procedure for regular performance evaluation to assess their competence?
Do you have a procedure for training staff in testing and/or calibration?
ACCOMODATION AND ENVIRONMENT CONDITIONS
Does the accommodation provide adequate separation of functions to minimize the possibility of cross contamination? (Give a lab floor plan?)
Are you confident that the conditions and standard of housekeeping in your laboratory are adequate to ensure that the quality of data is not being compromised?
Are there measure to provide uninterrupted services (electricity, gas, water)?
Are there measures to restrict the entry of unwanted materials and persons into the laboratory?
Are there appropriate storage facilities to provide integrity of samples before and after testing?
TEST AND CALIBRATION METHODS, VALIDATION AND QUALITY CONTROL
Do you use only standard, internationally accepted methods for testing?
Are all methods documented to the extent necessary to enable them to be performed properly and consistently?
Do you have validation data which shows the performance characteristics, for example accuracy and precision, of all the methods which you carry out?
Are quality control procedures in place to ensure that the performance characteristics established for the methods continue to be met on a routine basis?
Is the laboratory staff trained in sampling?
Where these are available, does the laboratory make regular measurements on certified reference materials to confirm the accuracy of its measurements?
Where available, does the laboratory participate in interlaboratory comparison exercises, i.e., exchange of samples with other laboratories and comparison of results?
CONTROL OF DATA AND DATA INTEGRITY
Is all raw data recorded at the time of observation and traceable, for examples by being signed, to the person who made the observation?
Are transfers of data between documents, or between documents and computers, subject to checks?
EQUIPMENT, CALIBRATION AND TRACEABILITY
Are operational procedure charts available with each of the equipment?
Where the concept is applicable, has equipment been calibrated to ensure traceability to the SI system of unit through an unbroken and, if necessary, international chain?
Are regular cleaning and maintenance checks performed?
Do you have evidence to show that calibration is carried out often to ensure that drift between calibrations is not so large as to undermine data quality?
Where practicable, is equipment checked between calibration and records kept to confirm that it has not drifted and lost its calibration?
Is all equipment which is subject to regular checks or calibrations labelled to show when the next calibration or check is due?
Is there a record of all equipment and particularly of its cleaning, maintenance and calibration history?
HANDLING OF TEST AND CALIBRATION OF ITEMS
Do you have a system for uniquely labelling and numbering items so that the number remains with all samples and sub–samples as the item moves through the laboratory?
Do you have procedures for identifying samples which requires special storage or preservation and for ensuring that appropriate action is taken?
REPORTING
The basic required contents of a report are as follows:
a.     Name and address of the laboratory
b.     Name and address of client
c.      Unique identifier of certificate or report (such as serial number);
d.     On each sheet of the certificate or report, a unique form of sheet identifier (such as the serial number of the certificate or report, with a unique page number in the form “page – of – pages”
e.     Date of receipt of calibration or test item, and date(s) of performance calibration or test, as appropriate;
f.      Date of issue of certificate or report;
g.     Signature and legible name of approved signatory or signatories taking responsibility for the content of the certificate or report, or equivalent form of technical authorization;
h.     Unambiguous identification of item(s) calibrated or tested (including name of manufacturer of item(s), any model or type designation and any relevant serial numbers, as appropriate);
i.       Any abnormalities or departures from standard conditions;
j.       Reference to calibration or test method and procedure used;
k.     Any standard or other specification relevant to the calibration or test method or procedure, and deviations, additions to or exclusions from the specification concerned;
l.       Where relevant to the validity or application of the calibration or test result(s), details of any sampling, item preparation, or data analysis;
m.   Calibration or test result(s);
n.     Any design or performance specifications met or failed;
o.     Estimated uncertainty of the calibration or test result (this information need only appear in test reports and test certificates where it is relevant to the validity or application of the test result, where a client’s instructions so require, or where uncertainty affects compliance to a specification or limit);
p.     Any other available information requested by a client relevant to the validity or applicability of the calibration or test result.
Total Score
SCORING SYTEM	1	No, we do not meet this requirement at all
	2	We meet some parts of this requirements
	3	We meet most parts of this requirements
	4	We meet these requirements fully