Question
(a) You were the laboratory management of a newly established 3rd party laboratory. To start up the business, you would like to establish a quality
(a) You were the laboratory management of a newly established 3rd party laboratory. To start up the business, you would like to establish a quality management system and provide only one testing service (The technical details of the testing are not important in this question) according to ISO/IEC 17025. Explain with the aid of relevant clause(s) in ISO/IEC 17025, how a laboratory establishes and implements the management system and providing testing service using "quality management systems approach".
(b) You were the Quality Manager of a 3rd party laboratory, where the laboratory information management system (LIMS) was managed and maintained by a private data centre company. Previously the data centre company was upgraded the laboratory's LIMS system. Under the new system, laboratory after completed all testing will upload all testing data and results to LIMS and LIMS will generate test reports automatically. You noticed a requirement in Clause 7.8.2.1 p), which requires a clear identification for results from external providers in the test reports. You wonder whether such clear identification is required in each report as the LIMS is managed by the data centre company (an external provider). With the aid of ISO/IEC 17025, explain briefly your decision to the above situation.
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