Impact of Implementation of ISO 17025 in Chemical laboratories- Case Study of Sudanese Standards & Metrology Organization- 2016

Abstract

This descriptive study was carried out in Sudanese Standards and Metrology Organization (SSMO), during the period from December 2015 to May 2016, to detect the impact of implementation of ISO 17025 on chemical laboratories of Sudandards standers and metrology organization, which contain two groups: management requirements and technical requirement laboratories. Questionnaires was distributed to the six head departments of the laboratories that apply ISO 17025 and then collected and analyzed using SPSS program ,frequencies and percentages were calculated. The study revealed the following results, in technical requirements which include the laboratories design before implementing of ISO was divided between good (67.7%) and fair (33.3%) but after implementation were improved to excellence (100%). Environment condition inside laboratories before very good (16.7%), good (33.3%) and fair (50%) but after implementing of ISO improved to very good (83.3%) and excellence (16.7%). Continuous improvement of devices before ISO were give good (83.3%), fair (16.7%) but after implementation were improved to very good (83.3%), good (16.7%). The efficiency of individual inside laboratory before implementing of ISO was good (66.7%), fair (33.3%) but after implementation was improved to excellence (33.3%), very good(66.7%) .The responsibilities and powers of the members of the laboratory to avoid inconsistencies before implementing ISO no (66.7%), sometime (33.3%) but after yes (100%). Accreditation system that includes description of all operation before implementing ISO no (66.7%), sometime (33.3%), but after implementation yes (100%). The setting of non matching process before implementation no (66.7%), sometime (33.3%) but after implementation yes (100%). The definition of responsibilities for dealing with non conforming work before yes (83.3%), sometime (16.7%), but after the implementation yes (100%).The records of members with competence before yes (83.3%), no (16.7%), but after yes (100%). Using of modern calibration in the laboratory the frequency before implement was no (83.3%), sometime (16.7%), but after yes (100%). Monitor of non matching process with possibility of providing opportunities for improvement before sometimes (50%), yes (33.3%) and no (16.7%), but after implementation yes (100%). Specific laboratory method to validate test methods before implementing ISO no (83.3%), sometime (16.7%), but after yes (100%). The system to practice the process of withdrawal and sample processing before yes(100%) and after also yes by (100%). Specific way to insure the validity of the test results before no (100%) but after yes (100%). In management requirement there are also improvement as we can see from the results the legal status of lab established in quality manual before implementing ISO 17025 no (100%) but after implementation yes (100%). Purchase orders are available before implementation (66.7%) said that it is available by 30% but after implementation (83.3%) said available by 70%. Control and archiving of documents in laboratory before the frequency fair (83.3%) but after very good (100%). Illustrative description of the organizational structure before implementation no (100%) but after implementing yes (100%). Policies and objectives of the laboratory match in terms of quality with what stated in quality manual yes (66.7%) but after yes (100%). The list of all the laboratory methods used system before no (66.7%) but after implementing yes (66.7%).The internal and external documents alike which must be submitted for verification before no (66.7%) but after yes (100%). Involving of senior management in the review of the laboratory the frequency before no (66.7%) but after yes (100%). Agreement on the procedures carried out according to the time period specified before no (50%) but after yes (100%). Stop working to inform the client if necessary before implementing yes (83.3%) but after yes (100%). Taking immediate action if necessary before yes (100%) and also after implementation yes (100%). Corrective and preventive actions carried out and be verified before no (83.3%) but after implement yes (83.3%). Subcontracting and deal only with accredited laboratories before implement no (100%) but after implementing yes (33.3%). Description of quality manual laboratory to the formation and system documentation before no (100%) but after yes (100%). The system applied in laboratory allows the implementation of internal audits whenever necessary before no (100%) but after yes (100%). Follow up of the laboratory to customer survey procedures before no (100%) but after implementation yes (100%). The study concludes that great and clear improvement in laboratories that implemented ISO and got accreditation certificate.