| 4.1 Impartiality |
QSP No.02, Annexure IV |
Impartiality and confidentiality agreement. |
QRF/KLELAB/TRG/04 |
Confidentiality Agreement |
Permanent till staff leaves |
HR |
soft copy |
|
| 4.3 Requirement regarding patients & 7.2.2 Laboratory information for patients and users
|
Directory of services & sample collection manual (KLELAB/PSM/04) |
Directory of services |
KLELAB/DOS |
DOS KLE |
Permanent |
Quality Manager |
soft copy/Hard copy |
|
| 5.1 Legal Identity |
Quality manual |
Legal Documents File |
KLELAB/Legal doc |
KLE Legal identity |
Permanent |
Quality Manager |
soft copy |
|
| 5.2.1 Lab Director competence. 5.2.2 Lab Director responsibilities |
Quality Manual, Annexure III |
Laboratory Director Personal file |
KLELAB/HR/01/DEPT/Employee name. 1. Lab director appointment. 2. Lab director competency
assessment. 3.
Laboratory Director Job Description document |
Evaluation of Laboratory Director |
Permanent till ammended |
Quality Manager |
File |
|
| 5.3.2 conformance with requirements |
Quality Manual |
Quality Manual |
KLELAB/QMSM/01 |
QMS KLE |
Permanent till ammended |
Quality Manager |
soft copy/Hard copy |
|
| 5.4 Structure and authority |
Quality Manual |
Organogram |
QMSM Annexure-II |
Organogram |
Permanent till ammended |
Quality Manger |
soft copy |
|
| 5.4.2 Quality Management |
Quality Manual, Annexure III |
Quality Manager Personal file |
KLELAB/HR/01/DEPT/Employee name. 1. Quality manager appointment. 2. Quality manager
competency assessment. 3.
Quality manager Job Description document |
Evaluation of Quality Manager |
Permanent till ammended |
Quality Manger |
File |
|
| 5.5 Objectives and Policy |
Quality Manual, Annexure I |
Policy statement and display |
Annexure I |
Quality Policy |
Permanent till ammended |
Quality Manger |
soft copy/Hard copy |
|
| 6.2.4 continual education |
QSP no. 15 |
Personal files (CME Certificate) |
KLELAB/HR/01/DEPT/Employee name. |
|
Permanent till staff leaves |
Quality Manger |
File |
PDF |
| 6.2.5 Personal files |
|
Personal file |
KLELAB/HR/01/DEPT/Employee name. |
|
Permanent till staff leaves |
|
File |
PDF |
|
|
Primary Sample collection manual |
|
|
Permanent till ammended |
Quality Manager |
soft copy/Hard copy |
PDF |
|
|
Directory of services |
|
DOS KLE |
Permanent till ammended |
Quality Manager |
soft copy/Hard copy |
|
|
|
Referral laboratory Directory of services |
|
Referral lab DOS |
Till the contract |
Quality Manager |
soft copy |
|
|
|
List of NABL accredited tests ( scope) |
|
Scope |
Tll the next assessment |
Quality Manager |
soft copy |
|
| 6.4.3 Equipment acceptance procedure |
|
Instrument IQ/OQ/PQ document |
KLELAB/EQPT/01/ Dept name/name of the instrument |
|
Permanent |
Biomedical Department |
File |
PDF |
|
|
Instrument Manual |
|
|
|
|
File |
PDF |
|
|
Instrument short information charts/cards |
KLELAB/QRG/Department/instrument name |
|
|
|
File |
PDF |
| 6.5.2 Equipment calibration |
|
Instrument metrological traceability certificate |
KLELAB/EQPT/05/name of instrument |
|
|
Biomedical Department |
File |
PDF |
|
|
Instrument calibration certificate |
KLELAB/EQPT/05/name of instrument |
|
1 year |
Biomedical Department |
File |
PDF |
|
|
Equipment SOP |
KLELAB/EPM/Departmet name |
|
Permanent till ammended |
Quality Manager |
soft copy/Hard copy |
PDF |
| 6.6.5 Reagents and consumables — Instructions for use & 7.3.6 |
|
"Kit literature file ( signed for read and understood) |
" |
KLELAB/RGT/KL/name of Department |
|
Permanent till ammended |
Dept In-charge |
|
| 6.7.1 Agreements with laboratory users |
QSP No.04 |
Agreements/ MOU ( Hospital/clinics/labs/organisations) |
QRF/KLELAB/TRF/dept name, |
|
Permanent till ammended |
|
File |
PDF |
| 6.8.2 Referral laboratories and consultants |
QSP No. 05 |
list of Referral laboratories and MOU |
QRF/KLELAB/RLL, QRF/KLELAB/SAM/05/Name of referral lab |
Ref lab list |
Permanent till ammended |
Quality Manager |
File |
|
| 7.2.3.2 Oral requests. |
|
Primary sample collection Manual |
KLELAB/PSM/04 |
PSM KLE |
Permanent till ammended |
Quality Manager |
soft copy/Hard copy |
|
| 7.3.6 Documentation of examination procedures |
|
Test SOP |
KLELAB/SOP/Department |
Test SOP |
Permanent till ammended |
Quality Manager |
soft copy/Hard copy |
|
|
|
Kit inserts ( Signed for read and understood) |
QRF/KLELAB/RGT/KL |
|
Permanent till ammended |
Dept In-charge |
File |
PDF |
| 7.3.7.2 Internal quality control (IQC) |
QSP No.18 |
IQC raw data |
KLELAB/QC/IQC/Department |
|
3 months |
Dept In-charge |
File |
PDF |
| 7.3.7.3 External quality assessment (EQA) |
QSP No.18 |
EQA raw data |
KLELAB/QC/EQAS/Department |
|
3 months |
Dept In-charge |
File |
PDF |
| 7.3.7.4 Comparability of examination results |
QSP No.27 |
Instrument comparison/Harmonisation study Records( biannually) |
KLELAB/MV/department name |
|
1 year |
Dept In-charge |
File |
PDF |
| 7.6 Control of data and information management |
QSP NO. 28 |
|
QSP NO. 28 |
|
Permanent till ammended |
IT Dept |
Soft copy |
PDF |
| 7.6.3 Information systems management |
QSP No.28 |
LIS Validation document |
LIS validation |
LIS validation |
Permanent till ammended |
IT Dept |
soft copy |
|
| 7.6.3 Information systems management |
|
LIS verification records |
KLELAB/LIS/Validation and Verification |
|
1 year |
IT Dept |
soft copy |
PDF |
| 8.2 Management system documentation |
|
Quality Manual |
KLELAB/QMSM/01 |
QMS KLE |
Permanent till ammended |
Quality Manager |
soft copy |
|
|
|
Organisation Information |
KLELAB/HR/02 |
Organisation information |
Permanent till ammended |
Quality Manager |
File |
|