iso 15189 - clause 5.0, 3rd apri 2010 tmh 3

ISO 15189

ISO 17025 & ISO 9001

ISO 15189 : 2003

(First edition)

ISO 15189, Clause 5.0 - An overview

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Contents 4.0 Management

requirements&

5.0 Technical requirements(5.1 to 5.8)


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ISO 15189

NABL 112


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Specific criteria

NABL 112


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Contents 4.0 Management

requirements&

5.0 Technical requirements(5.1 to 5.8)


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NABL 112Contents

4.0 Management requirements

&5.0 Technical requirements(5.1 to 5.8)

5.1 Personnel5.1.1 Organizational plan, personnel policies, job description

5.1.2 Educational qualification, experience & health records

5.1.3 Supervision and competency

5.1.4 Responsibility of the laboratory director


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5.1 Personnel5.1.5 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 judgments

5.1.13 Confidentiality of information regarding patients


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NABL 112

Authorized signatory


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NABL 112



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NABL 112


Qualification norms for technical staff


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5.2 Accommodation and environmental conditions5.2.1 Adequacy and suitability of the lab space

5.2.2 Risk of injury and protection from hazards

5.2.3 Accommodation for sample collection

5.2.4 Laboratory design to meet tasks

5.2.5 Control and record of environmental conditions

5.2.6 Separation of incompatible activities

5.2.7 Access control

5.2.8 Adequate communication system

5.2.9 Storage of samples and documents assuring integrity

5.2.10 House keeping


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5.3 Laboratory equipment5.3.1 Availability of adequate equipment

5.3.2 Compatibility with performance specifications - Calibration

5.3.3 Unique identification

5.3.4 Records


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5.3 Laboratory equipment5.3.5 Instruction for use, maintenance and safe handling

5.3.6 Maintenance in safe working conditions

5.3.7 Defective equipment

5.3.8 Measures to reduce contamination

5.3.9 Calibration status labeling

5.3.10 Check after repair

5.3.11 Computer requirements, validation, procedures, maintenance, protection of programs and data

5.3.12 Procedures for safe handling, transport, storage and use

5.3.13 Use of correction factors

5.3.14 Safeguarding from adjustments


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NABL 112

Calibration requirements


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NABL 112

Calibration requirements


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5.4 Pre-examination procedures5.4.1 Information on request forms

5.4.2 Specific instructions for proper collection & handling of primary samples

5.4.3 Sample collection manual-content


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5.4 Pre-examination procedures5.4.4 SCM and document control

5.4.5 Identification and traceability of primary samples

5.4.6 Monitoring of sample transport


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5.4 Pre-examination procedures5.4.7 Sample receipt

5.4.8 Acceptance and rejection criteria

5.4.9 Periodical review of sample volume

5.4.10 Request review

5.4.11 Procedures for receipt, labeling, processing and reporting of urgent samples

5.4.12 Traceability of sample portions

5.4.13 Policy concerning verbal requests

5.4.14 Preliminary and temporary storage


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5.5 Examination procedures

5.5.1 Sample selection for examination

5.5.2 Validation

5.5.3 Documentation and availability of procedures, instructions


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5.5 Examination procedures5.5.4 Performance specifications


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5.5 Examination procedures5.5.5 Periodical review of reference intervals

5.5.6 List of current examinations

5.5.7 Information to users when examination procedures are changed


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5.6 Assuring quality of examination procedures5.6.1 Internal quality control (IQC) system

5.6.2 Appropriate Uncertainty of results

5.6.3 Program for calibration and verification of trueness

5.6.4 External quality assessment (EQA)- interlaboratory comparisons


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5.6 Assuring quality of examination procedures5.6.5 Non availability of EQA

5.6.6 Comparability of results by using different procedures/equipment for the same examination and/or at different sites

5.6.7 Action taken on -Comparability of results by using different procedures/equipment for the same examination and/or at different sites


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5.7 Post-examination procedures5.7.1 Clinical validation

5.7.2 Storage of primary samples

5.7.3 Disposal of primary samples


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5.8 Reporting of results5.8.1 Format of reports (electronic or paper)

5.8.2 Reporting within an agreed-upon time interval

5.8.3 Content of report


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5.8 Reporting of results5.8.4 Vocabulary, syntax and nomenclature in report

5.8.5 Reporting of sample suitability

5.8.6 Retention and retrieval of reported data


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5.8 Reporting of results5.8.7 Procedures for emergency reporting

5.8.8 Alert/critical intervals

5.8.9 Interim reports

5.8.10 Records of actions taken in response to results in critical intervals

5.8.11 Appropriate turn around time (TAT)

5.8.12 Results from referral labs

5.8.13 Procedures for release of examination results

5.8.14 Procedures for verbal reporting or reporting by electronic means

5.8.15 Policies and procedures regarding the alternation of reports

5.8.16 Cumulative reports


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Summary – 5.0 Technical requirements


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Summary – 5.0 Technical requirements5.1 Personnel (5.1.1 to 5.1.13) 13

5.2 Accommodation and environmental conditions (5.2.1 to 5.2.10) 10

5.3 Laboratory equipment (5.3.1 to 5.3.14) 14

5.4 Pre-examination procedures (5.4.1 to 5.4.14) 14

5.5 Examination procedures (5.5.1 to 5.5.7) 7

5.6 Assuring quality of examination procedures (5.6.1 to 5.6.7) 7

5.7 Post-examination procedures (5.7.1 to 5.7.3) 3

5.8 Reporting of results (5.8.1 to 5.8.16) 16

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iso 15189 - clause 5.0, 3rd apri 2010 tmh 3

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