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To provide storage and retention times and safe disposal guidance for all documents and records of the
laboratory department.
Scope:
All Documents and Records of the Laboratory Quality Management System
Responsibility:
Laboratory Director / Quality Manager
All Laboratory staff are responsible for the retention of all laboratory documents and records as per this
procedure. The retention period of each type of document and record is defined by the Laboratory
Director
Clause & Interface:
Clause:
Clause Number
4.13 Control of Records
Standard Name
ISO 15189:2012
Document name
Documents and Records Table of Contents
Record Maintenance Archival and Retrieval Process
Record Identification Collection and Indexing Procedure
Record Review Access Retrieval and Amendment Procedure
Document code
QDRECLTOC
QDRECL03000
QDRECL03001
QDRECL03002
Procedure:
Storage
All records are stored in secured pre-determined locations in cabinets or cupboards.
o Paper copy records (hard copy) are stored in the designated storage area
o Soft copy records are stored in computer hard disk / CD disk
All records are stored for a predetermined period as per individual record requirements documented in
respective departmental procedures.
Paper Records and Electronic records need to be kept safe from damage, deterioration, loss and
unauthorized access.
All the details of records or original observations, derived data, graphs in various departments are in
the form of work sheets, machine print outs, batch slips. They are stored as up to the predetermined
retention period to establish sufficient information for proof.
Storage of records is done in a manner to prevent loss, damage or deterioration of any kind and also for
easy retrieval
Quality documents in the form of thermal faxes are photocopied.
Records stored for more than 6 months are inspected for deterioration by the concerned user and
suitable action is taken whenever required.
Regular backups of relevant technical data related to test results, where manual records are not
available, are taken by IT Department.
Information in damaged or deteriorated records is transferred to new records or suitable repair is
carried out.
Quality System Essential Section : Documents and Records
Prepared By : Quality Manager
Issue No: 1
Retention
All records and work sheets pertaining to quality management system are retained in their respective
departments till the end of retention period specified in the DOCUMENTS AND RECORDS
RETENTION TIMES chart below.
The retention period is determined by the Laboratory Director following the national (DHA & DAC)
and international (ISO) regulations.
The laboratory maintains a record system to suit its particular circumstances and comply with any
existing regulations. All original observations, calculations and derived data, analyte calibration
records and test report data are retained for a minimum retention period].
Keep all documents and records for the duration as listed on the DOCUMENTS AND RECORDS
RETENTION TIMES chart below.
DOCUMENTS AND RECORDS RETENTION TIMES
Record Type
Storage Time
Archived Quality Documents
2 years minimum for
QSM Manual
Hard Copy
QSP Manual
5 years minimum for
Soft Copy
Main Bench Manuals Technical
SOPs
Storage Area
Hard Copy in
Laboratory Directors
Office
Electronic copy in
Document Control
Software
Hard Copy in
Laboratory Directors
Office
Electronic copy in
Document Control
Software
2 years minimum
Original Requisitions
2 years minimum *
*10 years for donor testing
2 years minimum*
*10 years for donor testing
2 years minimum
Record Type
Storage Time
2 years minimum
Referred-out Logs
Referred-out report (including PHL)
2 years minimum
2 years minimum
2 years minimum
Hard Copies-5 years minimum
Electronic-5 years minimum
Instrument QC Printouts
Instrument Maintenance log
2 years minimum
Life of instrument while in
service
Life of instrument while in
service
2 years minimum
Assay QC Data
Payroll Sheets
Storage Area
hard drive
Stored in BacT/Alert
computer hard drive
Microbiology Store Room
Microbiology Store Room
Microbiology Store Room
Electronic copies in the LIS.
Hard copies <2 years Lab
Manual Shelf. Hard copies
>2years in the Microbiology
Store Room
Hard copies <2 years Lab
Manual Shelf. Hard copies
>2years in the Microbiology
Store Room
Microbiology Store Room
Lab Manual Shelf.
Lab Manual Shelf.
Microbiology Store Room
Record Type
Storage Area
years in Viral Load Lab. Hard
Copies >2 years stored at Iron
Mountain.
Electronic Copies Maintained
by the PHL
Hard Copes-Viral Load Lab
Electronic-On Analyzer
Microbiology Charges Office
Virology Lab Manual Shelf
Storage Time
Disposal of Records
Each December dispose outdated (post specified retention time) documents and records stored
manually and electronically as per Laboratory Confidentiality Policy
The Lab Director / Quality Manager decide the method for the disposal of records.