v._k._mehta
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� N A B L a c c r e d i t a t i o n i s a f o r m a l
recognition of the technical competence
of a medical testing laboratory
� Third party assessment
� N A B L h a s M u t u a l R e c o g n i t i o n
Arrangement with APLAC and ILAC
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� 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
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� Management defines project owner
� Project owner studies details of
standard ISO15189:2007
� Understands carefully all 15
clauses under the management
requirement
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� 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
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� Management decides to proceed with
accreditation
� Project owner leads implementation
steps
� Conduct atleast one internal audit
followed by Management Review
Meeting
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� Sampling as per the plan
� All samples to be uniquely
identified
� Monitor quality of test results
� % CV, LJ Charts
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� Maintain proper records
� Validate all procedures
� Calibration of equipment
� Document all non conformance
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� Monitor environmental conditions
� Prepare documentation as per standard
� Follow up all complaints from the clients
� A formal program to manage suppliers
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4.1 Organization and Management
4.1.1 Legal Identification
4.1.2 Needs of patients and clinical
personnel
4.1.3 Requirements of the standard
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4.1.4 Personnel responsible for
primary sample examination
4.1.5 Design, implementation
maintenance and improvements
of quality management system
4.1.6 Communication in the lab
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4.2 Quality Management System
4.2.1 Policies and Procedure
4.2.2 ILC, IQC
4.2.3 Quality Policy
4.2.4 Quality Manual
4.2.5 Calibration of instruments
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4.3 Document Control
4.3.1 Documented procedures
4.3.2 Review, Approval and
Control
4.3.3 Unique identification
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4.4 Review of Contacts
4.4.1 Procedure for review of contacts
4.4.2 Records of review
4.4.3 Referrals
4.4.4 Information on deviations to
customers
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4.4.5 Amendments
4.5 Examination by Referral Laboratories
4.5.1 Documented procedure for
evaluation and selection
4.5.2 Review the arrangements
4.5.3 Maintain a register of all referral
labs
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4.5.4 Examination results to the request
4.6 External services and supplies
4.6.1 Documented procedure for selection
and evaluation
4.6.2 Verification of purchased material
4.6.3 Inventory control
4.6.4 Critical reagents suppliers
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4.7 Advisory Services
4.8 Resolution of Complaints
4.9 Identification and Control of Non
Conformities
4.9.1 Documented procedure for non
conformities
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4.9.2 Route analysis of non conforming
examinations
4.9.3 Release of results in case of non
conformities
4.10 Corrective Action
4.10.1 Causes of problem
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4.10.2 Changes in the operational
procedures
4.10.3 Monitor the results of CA
4.10.4 Investigations causing doubts
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4.11 Preventive Action
4.11.1 Develop action plan for PA
4.11.2 Procedure for preventive action
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4.12 Continual Improvement
4.12.1 Review of procedures at regular
intervals
4.12.2 Review of effectiveness of the CA
4.12.3 Implementation of actions
4.12.4 Monitoring of quality indicators
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4.12 Continual Improvement
4.12.5 Training opportunities to laboratory
personnel
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4.13 Quality and Technical Records
4.13.1 Index, storage, maintenance
and save disposal of quality records
4.13.2 Easy retrieval of records
4.13.3 Retention period of records
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4.14 Internal Audit
4.14.1 Internal quality audit at refined
intervals
4.14.2 Planning, implementation and
documentation of the audits
4.14.3 Results of audits to the
management
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4.15 Management Review
4.15.1 MRM once in a year
4.15.2 Input for MRM
4.15.3 Laboratory’s contribution to patient
care, monitoring and evaluation
4.15.4 Record of findings and actions of MRM
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5.1 Personnel
5.2 Accommodation and Environmental
Conditions
5.3 Examination Procedures
5.4 Laboratory Equipments
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5.5 Examination Procedures
5.6 Assuring the Quality of
Examination Procedures
5.7 Pre-Examination Procedures
5.8 Reporting of Results
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� 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
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� Report review by NABL Technical
Committee
� Communication to laboratory about
accreditation status
� Periodic surveillance with annual fees
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� Quality Policy Statement
� Quality Manual
� Lab Safety Manual
� Waste Management Manual
� Control of Documents
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� Selection and Evaluation of Supplier
� Client Complaints
� Control of Non-Conformities
� Corrective and Preventive
action
� Control of Records
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� Internal Quality Audit
� Management Review
� External Quality Assessment Scheme
(EQUAS)
� Standard Operating Procedures of each
lab
� Calibration Procedures
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� 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
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� 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
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� Standard has been developed by
health care experts and tested
� Ensure a safe and efficient work
environment that contributes to staff
satisfaction
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� Establish collaborative leadership that
strives for excellence in quality
� Understand how to continuously
improve diagnostic processes and
outcomes
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� Poor Quality Management
� Poor Sample Control
� Poor Results Verification
� Quality Control and assessment
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� Non Validated Tests
� Time pressures
� Poor workload Management
� Understaffed
� Inadequate Attention to Detail
� ILC and EQAS
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THANK YOU