NABL accreditation is a formal recognition of the technical competence of a medical testing laboratory

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2 NABL accreditation is a formal recognition of the technical competence of a medical testing laboratory Third party assessment NABL has Mutual Recognition Arrangement with APLAC and ILAC

3 NABL accredited labs are all member of global family of accredited labs NABL provides efficient and transparent mechanism to the labs Labs prove technical competence by participation in proficiency test NABL is an autonomous body under DST

4 Management defines project owner Project owner studies details of standard ISO15189:2007 Understands carefully all 15 clauses under the management requirement

5 Understands carefully all 8 clauses under the technical requirement Defines scope of accreditation Performs a gap analysis Estimates the cost of accreditation and presents to management

6 Management decides to proceed with accreditation Project owner leads implementation steps Conduct atleast one internal audit followed by Management Review Meeting

7 Sampling as per the plan All samples to be uniquely identified Monitor quality of test results % CV, LJ Charts

8 Maintain proper records Validate all procedures Calibration of equipment Document all non conformance

9 Monitor environmental conditions Prepare documentation as per standard Follow up all complaints from the clients A formal program to manage suppliers

10 4.1 Organization and Management Legal Identification Needs of patients and clinical personnel Requirements of the standard

11 4.1.4 Personnel responsible for primary sample examination Design, implementation maintenance and improvements of quality management system Communication in the lab

12 4.2 Quality Management System Policies and Procedure ILC, IQC Quality Policy Quality Manual Calibration of instruments

13 4.3 Document Control Documented procedures Review, Approval and Control Unique identification

14 4.4 Review of Contacts Procedure for review of contacts Records of review Referrals Information on deviations to customers

15 4.4.5 Amendments 4.5 Examination by Referral Laboratories Documented procedure for evaluation and selection Review the arrangements Maintain a register of all referral labs

16 4.5.4 Examination results to the request 4.6 External services and supplies Documented procedure for selection and evaluation Verification of purchased material Inventory control Critical reagents suppliers

17 4.7 Advisory Services 4.8 Resolution of Complaints 4.9 Identification and Control of Non Conformities Documented procedure for non conformities

18 4.9.2 Route analysis of non conforming examinations Release of results in case of non conformities 4.10 Corrective Action Causes of problem

19 Changes in the operational procedures Monitor the results of CA Investigations causing doubts

20 4.11 Preventive Action Develop action plan for PA Procedure for preventive action

21 4.12 Continual Improvement Review of procedures at regular intervals Review of effectiveness of the CA Implementation of actions Monitoring of quality indicators

22 4.12 Continual Improvement Training opportunities to laboratory personnel

23 4.13 Quality and Technical Records Index, storage, maintenance and save disposal of quality records Easy retrieval of records Retention period of records

24 4.14 Internal Audit Internal quality audit at refined intervals Planning, implementation and documentation of the audits Results of audits to the management

25 4.15 Management Review MRM once in a year Input for MRM Laboratorys contribution to patient care, monitoring and evaluation Record of findings and actions of MRM

26 5.1 Personnel 5.2 Accommodation and Environmental Conditions 5.3 Examination Procedures 5.4 Laboratory Equipments

27 5.5 Examination Procedures 5.6 Assuring the Quality of Examination Procedures 5.7 Pre-Examination Procedures 5.8 Reporting of Results

28 Quality System Manual adequacy study by NABL lead Assessor Pre-assessment visit by the Lead Assessor Final Assessment by the NABL team Report to NABL by Lead Assessor

29 Report review by NABL Technical Committee Communication to laboratory about accreditation status Periodic surveillance with annual fees

30 Quality Policy Statement Quality Manual Lab Safety Manual Waste Management Manual Control of Documents

31 Selection and Evaluation of Supplier Client Complaints Control of Non-Conformities Corrective and Preventive action Control of Records

32 Internal Quality Audit Management Review External Quality Assessment Scheme (EQUAS) Standard Operating Procedures of each lab Calibration Procedures

33 Having access to more contracts for testing Potential increase in business Improved national and global reputation and image of the laboratory Time and money saving due to reduction in re-testing

34 Continually improving quality data and laboratory effectiveness Having a basis for most other quality systems related to laboratories, such as Good Manufacturing Practices and Good Laboratory Practices

35 Standard has been developed by health care experts and tested Ensure a safe and efficient work environment that contributes to staff satisfaction

36 Establish collaborative leadership that strives for excellence in quality Understand how to continuously improve diagnostic processes and outcomes

37 Poor Quality Management Poor Sample Control Poor Results Verification Quality Control and assessment

38 Non Validated Tests Time pressures Poor workload Management Understaffed Inadequate Attention to Detail ILC and EQAS

39 THANK YOU

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