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Purpose:

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

Interfaced Related Documents:

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

2 years minimum for


Hard Copy
5 years minimum for
Soft Copy

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

Meeting / Committee Minutes


MRM, Education, QA, QI, Safety,
Operations etc
Local Regulatory Compliance Files
Dubai Municipality File
Electronic work cards

2 years minimum

Original Requisitions

2 years minimum *
*10 years for donor testing

Assay Work lists/Day lists/printouts

2 years minimum*
*10 years for donor testing

VITEK computer record

2 years minimum

Quality System Essential Section : Documents and Records


Prepared By : Quality Manager
Issue No: 1

Reside in LIS live


environment for 2 years and
then moved to archive
environment by SCC.
Microbiology Store Room for
3 months, Iron Mountain for
the rest of the 2 years and 10
years
Microbiology Store Room for
3 months, Iron Mountain for
the rest of the 2 years and 10
years
Stored in VITEK computer

Record Type

Storage Time

BacT/Alert computer record

2 years minimum

Referred-out Logs
Referred-out report (including PHL)

2 years minimum
2 years minimum

Statistics: LCDC reports


Proficiency testing results (QMPLS,
CAP, etc)

2 years minimum
Hard Copies-5 years minimum
Electronic-5 years minimum

Proficiency testing reports (QMPLS,


CAP, etc)

Hard Copies-10 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

Instrument Service Record


Temperature controlled equipment QC
Study and Research Documents
Method Evaluation
Incident Report

As defined by study protocol


Duration of method
2 years minimum*
*10 years for donor testing

Assay QC Data

Electronic-2 years minimum*


Hard copies-2 years minimum*
*10 years for donor testing

Quality Control records

Electronic-2 years minimum


Hard copies-2 years minimum

Schedule Sheets/Bench Rotation

Payroll Sheets

Hard Copies-7 years minimum


Electronic Summaries of Bench
rotations and Christmas list-10
years minimum
Hard Copies-2 years minimum

Viral Load Requisitions

Hard Copies-10 years minimum

Quality System Essential Section : Documents and Records


Prepared By : Quality Manager
Issue No: 1

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

Lab Manual Shelf


Iron Mountain for donor
testing
Electronic copies in the LIS.
Hard copies in Microbiology
Store Room for 2years
Iron Mountain for 10 years for
donor testing
Electronic copies in the LIS.
Hard copies in the
Microbiology Store Room
Hard Copies in Charges
Office
Hard copies in the
Microbiology Store Room.
Hard Copies of the current 2

Record Type

Viral Load Patient Results

Electronic-10 years minimum

Viral Load Run Results

Hard Copies-10 years minimum


Electronic-10 years minimum
Hard Copies-Duration of
employment

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

Hard Copies-10 years minimum

Hard Copies in Mycology

Bench Training Checklists


Fungal Isolates-Important Isolate
Binders

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.

Quality System Essential Section : Documents and Records


Prepared By : Quality Manager
Issue No: 1