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Step by Step Procedure For Medical Laboratory Accreditation
Step by Step Procedure For Medical Laboratory Accreditation
Step by Step Procedure For Medical Laboratory Accreditation
By KKV Yasas
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afford to meet the accreditation cost are able to maintain quality requirement are under the supervision of senior consultants are having state of art technology with them are able to get external contracts
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006
not have adequate financial or the manpower Eventually will become part of medium/large labs Get converted in to collection centers Might close down if not accredited
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006
By
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006
NABL-112
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006
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Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006
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Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006
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4.1
4.1 ORGANISATION AND MANAGEMENT 4.1.1 Legal identity : 4.1.2 Laboratory design appropriate to meet the needs : 4.1.3 Conformity with relevant requirements for permanent facilities, Decentralized facilities : 4.1.5a appropriate authority for all personnel, resources to carry out their duties: 4.1.4 Possible conflict of interest, financial or political considerations: 4.1.5b 4.1.5c Confidentiality, impartiality and operational integrity 4.1.5d 4.1.5e Organizational structure, relation with other organizations 4.1.5f Function descriptions and interrelationships 4.1.5g Staff training (to be considered along with NABL-112) 4.1.5h Technical management 4.1.5i Quality manager (authority and responsibilities) 4.1.5j Deputies for all key functions
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006
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4.2
4.2.1
Documentation, communication and implementation 4.2.2 IQC and EQA 4.2.3 Quality policy statement : content and availability 4.2.4 Content of the quality manual 4.2.5 Calibration, monitoring and preventive maintenance of instruments
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 16
4.3
4.3.1
Procedures for document management 4.3.2 4.3.3 Identification of documents 4.3.2 a-d, g Availability, release, review, amendments 4.3.2. h Changes 4.3.2 e-f Archives and removing of invalid documents
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 17
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006
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5.1
5.1.1 Organizational plan, personnel policies, job descriptions 5.1.2 Records of education and qualification 5.1.3 Supervision and competency 5.1.4 Responsibilities of the laboratory director 5.1.5 Adequate staff resources 5.1.6 Training of personnel in quality assurance 5.1.7 Authorization to perform specific tasks 5.1.8 Use of and access to computers 5.1.9 Continuing education program 5.1.10 Training to prevent or contain the effects of adverse incidents 5.1.11 Assessment of competency after training and re-evaluation 5.1.12 Qualification for professional judgements 5.1.13 Confidentiality of information regarding patients
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 20
5.2
5.2 ACCOMMODATION AND ENVIRONMENTAL CONDITIONS 5.2.1 Adequacy and suitability of the lab space (including other sites) 5.2.4 5.2.2 Risk of injury and protection from hazards 5.2.3 Accommodation for sample collection 5.2.4 5.2.5 Control and registration of environmental conditions 5.2.6 Separation of incompatible activities 5.2.7 Access control 5.2.8 Adequate communication system within the facilities 5.2.9 Storage of samples and documents assuring integrity 5.2.10 Housekeeping
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006
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Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006
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NABL - 112
Provides
description and type of laboratory Covers all 23 elements from the angle of local/regional regulatory requirement Annexure I describes routine and special tests under each discipline
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006
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Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006
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Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006
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Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006
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Stage III Final Assessment by the NABL team (two days or more)
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 28
will reach NABL with total knowledge of the laboratory NABL technical committee will review the report and recommendations Will communicate to the laboratory about the accreditation status Accredited labs need to go in for periodic surveillance with annual fee
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 29
Irrespective of Laboratory size, Quality needs to be validated by Third Party Documentation is easy under ISO 15189 NABL guide lines provide local/ regional requirements Laboratory can be accredited by any authorized Third Party Quality Control and PT requirements are the integral components of accreditation Focus should be continual improvement
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006
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