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International Organization for Standardization/International Electrotechnical Commission is an international standard use for testing and calibration of laboratories to check the quality system of laboratories, to meet the order demonstrated to customers and regulators that they operate a sound management system which produce full control of their processes and are competent to generate technically valid results. Major accreditation bodies use this standard as their basis for their accreditation. One of the goals of this standard is to minimize the number of tests carried out in an international and national laboratory. It is applicable to all organizations performing tests and/or calibrations. These include all section (for example first, second and third party laboratories) that takes part in the laboratory where testing and calibration is carried out as part of product certification and inspection. The first edition of the "International Standard General Requirements for the Competence of Testing and Calibration Laboratories" was produced as a result of the massive experience in carrying out ISO/IEC Guide 25 and EN 45001 and was replaced by ISO/IEC 17025:1999. The second and current edition is the ISO/IEC 17025:2005.
The ISO/IEC 17025:2005 is divided into two main parts (clauses) which are Management Requirements and Technical Requirements. Management requirements are concern with the working and efficiency of the quality management system within the laboratory and this has similar requirements to ISO 9001 and 9002. Technical requirements deal with the capability of staff, testing methods, equipment and quality and reporting of test and calibration results. Most of the technical requirement comes from ISO guide 25.
TECHNICAL REQUIREMENTS OF ISO/IEC 17025
The technical requirements of ISO/IEC 17025 include:
General Information: This section gives the reader the awareness that the correct and reliable test and calibration results are ascertain by various factors which have an impact on the result like sampling, equipment, test methods, and environmental conditions. It also gives the extent to which the factors contribute to measurement uncertainty.
Personnel: This section has the highest impact on the quality of the test and calibration result. The competence of the personnel performing the test and calibration is paramount and these also include both part time and full time employee and even the management. The task, job description and the required skill should be define and carried out by the management. Most importantly, a training program should be created and implemented for each employee and the effectiveness should be evaluated. Specific task should be assign to personnel and date of authorisation should be recorded and the task should be carried out effectively on the date of authorisation.
Accommodation and Environmental conditions: This section ensures that the calibration and test environment will not negatively affect the accuracy of the measurement. The environmental condition of the laboratory should be monitor, control and recorded and areas that are not compatible with the standard should not be use. Test and calibration areas should be restricted to authorized persons.
Test and Calibration methods including sampling: This section deal with the method (this include standard methods and method validation), measurement of uncertainty (this include identification, sources, and method of estimation of uncertainty) and control of data (this include the calculation, computer software, modification used on the data).
Equipment: This section is concern with the capacity and quality of the equipment. Equipment software, calibration and maintenance should be recorded and up to date and the repair status of each piece of apparatus to be monitored.
Measurement traceability: This section shows the calibration of equipment traceable to the SI units and laboratory standards traceable to SI unit. This involves the use of certified reference standard and a generally accepted standards or methods.
Sampling: This section ensures that the sample is a representative of the either samples are taken (statistically) and details of the sample and the sampling procedure, location and the person who took the sample should be written down and preserved.
Handling of test and calibration: It ensures that the integrity of the sample is conserved at all stages and proper documentation is done during transportation, receipt, handling, protection, retention, storage and/or disposal. It also ensures that samples are discarded properly and safely.
Assuring quality of test and calibration result: It ensures that laboratory adheres to all stated quality assurance and control requirements in the methods used and also check the validity of the result.
Reporting the results: This section shows how the result (test and calibration) should be reported to easy comparison with test performed by different laboratories.
The use of first choice quality standard (ISO/IEC 17025:2005) methods of analysis in analytical measurement is one major ways of achieving a valid, comparative and fit for purpose measurement results. Especially in, organic analysis agrochemicals, food analysis, and other analytical areas where variable samples are analysed, the use of quality standard is often recommended by legislation.Â
Comparability of measurement results is based on the value of a standard whereby it can be related to stated references, which permits the comparison of results irrespective of the analyst, place, time, and procedure used. Comparability of measurement is an important factor of first choice quality standard and is a necessity for easy trade at the national, regional, and international level. It has also been identified that first choice quality standard like recovery determinations in analytical measurement has a dual role for deriving recovery values and quality control purposes.
Another important factor of quality standard is that shows the fitness for purpose of the analytical measurement. Every analytical measurement made in the laboratory are required to fulfil a specific purpose, so producing a result that is not fit for the purpose is a waste of time. Applying quality standards helps to produce a result fit for purpose.
During analytical measurements, there is always some level of inaccuracy. To reduce the level of inaccuracy as much as possible by using given the quality standard is always helpful. Results produce in Laboratories are mainly used in public and clinical health settings, and the outcomes depend on the accuracy of the testing and reporting. Inaccurate results bring about various consequences which are very significant:
Unnecessary treatment and treatment complications
Failure to provide the proper treatment
Delay in correct diagnosis.
Raise the cost of a particular thing.
Additional and unnecessary diagnostic testing.
Lead to inappropriate interventions,
Adversely affect the credibility of the laboratory.
May also invite legal action.
These consequences result in increased cost in time, personnel effort, and often in poor patient outcomes. It is essential to perform all procedures and processes in the laboratory in the best possible way. The complexity of the system requires that many procedures and processes be performed properly. Therefore, the first choice quality standard for laboratories is a standard which looks at the entire system in the laboratory and is very important for achieving good analytical measurement.
Generally, quality standards are strategic tools and guidelines that help laboratories resolve some of the most persistent test of the quality of products. They ensure that laboratory operations are as effective as possible, increase the yield and maintaining quality of the results.
to ensure the viability of the method before the costly exercise of a formal collaborative trial;
ï‚· to provide evidence of the reliability of analytical methods if collaborative trial data are not available or where the conduct of a formal collaborative trial is not practicable;
ï‚· to ensure that "off-the-shelf" validated methods are being used correctly.
Fitness for purpose is the extent to which the performance of a method matches the criteria, agreed between the analyst and the end-user of the data, which describe the end-user's needs.