SHREYATESTHOUSE(LAB DIVISION OF SHREYA REALTY PVT. LTD.) STH /MSR/8.8/05ISO 17025:2017 CHECKLIST (INTERNAL AUDIT)
Clause Description Yes No N.ARemarksNo. 4. General Requirements4.1 Impartiality Does the laboratory demonstrate4.1.2 management mitment to impartiality?To considerManagement review Code of conduct Declaration forms relating toconfidentility / impartiality4.1.4 impartiality on an ongoing basis? Does the laboratory identify risks to its- Risk from its relationships Risk from activities- Risk from the relationships of its personnelTo considerRisk assessment Risk matrix4.1.5 Does the laboratory eliminate or minimizethe risks identified?4.2 Confidentiality4.2.1 How is the laboratory responsible for the confidentiality of information obtained orcreated during the performance of laboratory activities and proprietary rightsof its customers?To considerContractual agreement Code of conduct4.2.2 Does the laboratory notify its customers when the laboratory is legally obliged torelease confidential information of its customers?
DOCUMENT NO.:STH/MSR/8.8/05 DOCUMENT NAME:INTERNALAUDIT CHECKLISTISSUE NO.: 01 ISSUE DATE:15.04.2019 AMEND NO.:00 AMEND DATE:00 PAGE: 01 OF 01PREPARED BY: REVIEWED&APPROVEDBY ISSUED BY:
Clause Description Yes No N.ARemarksNo. 4.2.3 Does the laboratory ensure that informationabout its customers received from sources other than the customers are keptconfidential?Does the laboratory ensure that theis not revealed to the customers unless source(s) of information about its customersagreed by the source(s)?4.2.4 How does the laboratory ensure thatpersonnel keep confidential all information obtained or created during the performanceof laboratory activities?5. Structural Requirements5.1 Is the laboratory or the organization legally responsible?To produceCompany registration number Valid ACRA Certificate5.2 Does the laboratory identify management that has overall responsibility for thelaboratory?To consider Job description Organization chart 5.3 Does the laboratory define and document5.4 therange of laboratory activities whichconforms to ISO 17025:2017?Does it cover work carried out in: 0 Permanent facilities?0 Sites away from its permanent0 facilities? Associated temporary facilities?0 Mobile facilities?0 Customer's facilities?Do these activities conform to customer and regulatory requirements?5.5 Does the laboratory:a) structure of the laboratory define the organization and managementb) specify the responsibility authority andinterrelationship of all personnel who
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Clause Description Yes No N.ARemarksNo. manage perform or verify work affectingthe resultsc) Document necessary procedures to ensurethe validity of its results? consistent application of its activities andTo considerand Responsibilities Standard Operating Job description Organization chart RolesProcedures5.6 Does the laboratory have authorized andsufficient personnel to:a) management system? Implement maintain and improve theb) minimize or prevent such deviations? Identify deviations and initiate actions toc) Report to management on the performanceof the management system and any needfor improvements?d) Ensure the effectiveness of laboratory activities?5.7 Does the laboratory municate to staffabout the effectiveness and integrity of themanagement system when changes are made to it?6. Resource Requirements6.1 GeneralDoes the laboratory have sufficient personnel facilities equipment systems and support services necessary to manage and perform its laboratory activities?6.2 Personnel6.2.2 Does the laboratory document thethat may influence the results of laboratory petence requirements for each functionactivities?- Education - QualificationTraining required-Skills -Technical knowledge-ExperienceTo consider
DOCUMENT NO.:STH/MSR/8.8/05 DOCUMENT NAME:INTERNALAUDIT CHECKLISTISSUE NO.: 01 ISSUE DATE:15.04.2019 AMEND NO.:00 AMEND DATE:00 PAGE: 01 OF 01PREPARED BY: REVIEWED&APPROVEDBY ISSUED BY:
No. Training and Competency MatrixJob description Training records. Curriculum vitae6.2.4 Are the duties responsibilities andauthorities of laboratory personnel municated to them?6.2.5 Does the laboratory have procedures and retain records for:a) Determining the petence requirements?b) to f) Selection training supervision authorization and monitoring ofpetence of personnel performing laboratory activities?To produceProcedures of the aboveRecords of the above6.2.6 Does the laboratory authorize personnel to perform laboratory activities pertaining to:a) Development modification verification and validation of methods?b) Analysis of results including statements ofconformity or opinions and interpretations?c) Report review and authorization of results?6.3 Facilities and environmentalconditions6.3.1 6.3.2 Does the laboratory document and ensure control of the facilities and environmentalconditions necessary for the performance of the laboratory activities?To produce c Procedures of the above6.3.3 Does the laboratory monitor control andrecord the environmental conditions?To produceRecords of the above6.3.4 periodically review the measures to control Does the laboratory monitor andfacilities? For example:- Access to and use of laboratory areas?
DOCUMENT NO.: STH/MSR/8.8/05 DOCUMENT NAME:INTERNALAUDIT CHECKLISTISSUE NO.: 01 ISSUE DATE:15.04.2019 AMEND NO.:00 AMEND DATE:00 PAGE: 01 OF 01PREPARED BY: REVIEWED&APPROVED BY ISSUED BY:
No.or other adverse influences? - Prevention of contamination interference- Effective separation between areas withinpatible laboratory activities?6.3.5 Does the laboratory ensure pliance tolaboratory activities are performed at sites Section 6.3 of ISO 17025:2017 whenor facilities outside its permanent control?6.4 Equipment6.4.1 Does the laboratory have access to equipment required for the correctperformance of laboratory activities and which can influence results?6.4.2 Does the laboratory ensure pliance to Section 6.4 of ISO 17025:2017 when usingequipment outside its permanent control?6.4.3 Does the laboratory have a procedure forhanding transport storage use and planned maintenance of equipment?To produceProcedures of the above6.4.4 Does the laboratory verify that equipmentconforms to specified requirements before being placed or returned into service?6.4.5 Does the laboratory ensure that measuring6.4.6 equipment is calibrated and capable ofmeasurement uncertainty required to achieving the measurement accuracy orprovide a valid result?6.4.7 calibration programme and review the Does the laboratory have an establishedsuitability and frequency of calibration?To produceCalibration programme Records of review of calibrationprogrammeTo considerEquipment Master List 6.4.8 Is there a system of labeling coding orcalibration or which has a defined period of identification of all equipment requiring
DOCUMENT NO.:STH/MSR/8.8/05 DOCUMENT NAME:INTERNALAUDIT CHECKLISTISSUE NO.: 01 ISSUE DATE:15.04.2019 AMEND NO.:00 AMEND DATE:00 PAGE: 01 OF 01PREPARED BY: REVIEWED&APPROVED BY ISSUED BY:
