Assessment forms and checklist for clinical testing lab based on ISO 15189.docx

1、Assessment forms and checklist for clinical testing lab based on ISO 15189NABLNATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIESNABL 217 ASSESSMENT FORMSand CHECKLIST (Based on ISO 15189: 2007) ISSUE NO : 03 AMENDMENT NO :02ISSUE DATE: 27.06.2012AMENDMENT DATE: 16.10.2012AMENDMENT

2、 SHEETSlPage No.Clause No.Date of AmendmentAmendment MadeReasonsSignature QOSignature Director1.3/836/83-NAF122.08.2012Laboratory locations Internal audit finding 2.16/834.1.5(i)16.10.2012Note: Designated Quality Manager shall .according to ISO 15189:2007APLAC findings3.4.5.6.7.8.9.10.ContentsSl. No

3、. TitlePage No.1.Amendment Sheet 12.Contents23.Guide to use the NAFs & Checklists and Compilation of the Assessment Report34.NAF 1 Assessment Schedule65.NAF1A Attendance Sheet (Opening/ closing meeting) 76.NAF 2 Assessors Observation87.NAF 3 Test(s) witnessed by the Assessment Team98.NAF 3A Details

4、of Re-Testing witnessed during Assessment109.NAF 4 Summary on Non-Conformities 1110.NAF 5 Consolidated Non-Conformities 1211.NAF 6 Summary of Assessment 1312.Checklist 1 By Lead Assessor1413.Checklist 2 Test (s) Witness - By Technical Assessor5014.Checklist 3 For Medical Laboratory Collection Centre

5、s7815.Form 71 Recommended Authorised Signatories8116.Form 72 Recommended Scope of Accreditation 8217.Form 74 Declaration of Impartiality & Confidentiality 83Guide to use the NABL Assessment Forms, Checklists & other Forms based on ISO 15189: 2007 and Compilation of the Assessment ReportIt is presume

6、d that the Assessors who have been nominated by the NABL Secretariat, are fully aware of the NABL Accreditation process, its objectives and the on-site Assessment procedure. This document contains Assessment forms NAF 1 to 6, Checklists 1 and 2 and Forms 71 to 74, which will form a part of the Asses

7、sment Report. The document shall guide the Lead Assessor and the Technical Assessor(s) in completing various forms & checklists and compile the assessment report. Role of Lead AssessorBefore the start of Assessment the Lead Assessor should prepare an Assessment schedule in NAF 1 which should include

8、 the laboratory locations /departments/ sections/ areas/ activities to be assessed and assignment to various Assessors based on their expertise. The Observer (Potential Assessor) should also be guided about the conduct of assessment. The Lead Assessor must review the Laboratorys documented Managemen

9、t System to verify compliance with the requirements of ISO 15189: 2007. He should assess that the documented Management System is indeed implemented & effective, as described and record observations in NAF 2. He should also complete Checklist 1 and record conclusion / comments related to the require

10、ments of respective clause number. All Non-Conformities must be identified and reported, separately on each sheet in NAF 4. No non conformity shall be closed during the assessment. Laboratory shall evaluate the root cause of the non conformity and propose correction and corrective action. The maximu

11、m time period given for a laboratory to close the Nonconformity is two months from the date of assessment.As a leader of the Assessment team, he would collect the reports and documents from all Technical Assessors including his own report and compile it. A consolidated statement of Non-Conformities

12、raised during the Assessment shall be listed in NAF 5. If, during Surveillance or Re-assessment, a case of total system failure and gross negligence in technical aspects is noticed, the Lead Assessor will at the earliest inform NABL and elaborately bring it out in the Assessment summary (NAF-6) of a

13、ssessment report. He would finally summarise the conduct of Assessment and record the recommendations in NAF 6. He must get an endorsement from the laboratory on NAF 6 and hand over a photocopy of the forms NAF 4, 5, and 6 to the Laboratory to enable them to take corrective actions. Copy of recommen

14、ded scope, authorised signatories shall also be given to the laboratory. The Lead Assessor is also required to monitor the performance of Technical Assessor(s) and the Observer. He shall recommend whether the Observer is capable to perform the role of a Technical Assessor in his next visit. His comm

15、ents/ rating for each Technical Assessor shall be enclosed with the report in Form 45.Role of Technical AssessorThe Technical Assessor should clearly understand the areas/ activities to be assessed by him. He must review the Laboratorys documented system to verify compliance with the requirements of

16、 ISO 15189: 2007 and related NABL Specific Criteria. He should assess to verify that the documented SOPs, test methods, records are indeed implemented & effective, as described and record observations in NAF 2. He should also complete Checklist 2 related to the requirements of respective clause numb

17、er and NAF 3 for the Test(s) witnessed by him. Assessors shall interview the Laboratorys Authorised Signatory for their competence, and recommend in Form 71. Assessors shall refer NABL 112 for requirements of authorised signatory.All Non-Conformities must be identified and reported, separately on ea

18、ch sheet in NAF 4. The Scope of Accreditation to be granted to the Laboratory must be checked thoroughly with necessary recommendations on Form 72. Any deletions or alterations in the scope must be clearly brought out and signed by both the Laboratory Representative and the Assessor.The report shoul

19、d be handed over to the Lead Assessor alongwith the TA/ DA form. When the Lead Assessor, also performs the job of a Technical Assessor, he should follow the above procedure. Role of Technical ExpertThe role of Technical Expert is same as of Technical Assessor, except he will seek guidance of Lead As

20、sessor in filling the relevant forms, checklist etc.Role of ObserverThe Observer (Potential Assessor) will be assigned to accompany the Lead Assessor and Technical Assessor(s) as per the schedule provided to him. He shall be guided by the Lead Assessor and the Technical Assessor(s). He is not requir

21、ed to submit any report however his TA/ DA form may be submitted to the Lead Assessor. He is not entitled for payment of any honorarium. Compilation of Assessment Report The Assessment Report should consist of various documents in the order as indicated in NAF 6. Each form or checklist should be car

22、efully filled in. The pages should be serially numbered in the box provided at the right top corner of each page, starting from NAF 6. The assessment report should be submitted to the NABL Secretariat within 10 days from the completion of assessment. The Lead Assessor should return all documents to

23、NABL/ laboratory which have been forwarded to him for conducting the assessment such as Laboratorys Quality Manual, Application form etc. Form 74 Declaration of maintaining impartiality & confidentiality must be filled up by the Lead Assessor, all Technical Assessors & Observer and enclosed with the

24、 assessment report. The TA/ DA forms of the Technical Assessors and his own may also be enclosed alongwith the assessment report. *NAF 1 ASSESSMENT SCHEDULELaboratory:Quality Manager:Date(s) of Visit:Type of Visit: Assessment / 1st Surveillance/ Re-Assessment /Supplementary visit Field : Medical Tes

25、ting Discipline (s):Assessment Standard: Laboratorys Quality Manual, ISO 15189: 2007 and Specific Criteria NABL 112Assessment Timings Opening/Closing Meeting Date/TimeDaily Debriefing Date / Time(at the end of each day)Morning: AM to PMAfternoon: PM to PMOpening Meeting:Closing Meeting:Day 1:Day 2:D

26、ay 3:Name and Expertiseof the AssessorSchedule of Locations /Department/ Section/ Activity to be Assessed (datewise)Day 1Day 2Day 3Morning AfternoonMorningAfternoonMorningAfternoonLead AssessorAssessor 1Assessor 2Assessor 3Assessor 4Assessor 5Assessor 6Assessor 7Observer(only for observation)Signatu

27、re of Lead AssessorNAF 1AATTENDANCE SHEET (OPENING / CLOSING MEETING) Laboratory:Date & Time :Type of Visit: Assessment / 1st Surveillance/ Re-Assessment /Supplementary visitSl.Assessors / Lab Personnel Present Capacity/ Designation Signature NAF 2 ASSESSORS OBSERVATIONS Laboratory:Date:Department:A

28、ctivity Assessed:Auditee:Education:Years of Experience:SLOBSERVATIONREMARKSSignature & Name of Assessor NAF 3 TEST(S) WITNESSED BY THE ASSESSSMENT TEAM(To be filled in by each Technical Assessor)Laboratory:Date(s) of Visit:Assessor: Discipline:Ref. to Obs. in NAF 2Test(s) witnessed Test Method Used or Standard Referred RemarksSignature of AssessorRemarks by Lead Assessor, if anySignature of Lead AssessorNAF 3ADETAILS OF RE-TESTING WITNESSED DURING ASSESSMENT(To