Purpose:

To provide instruction for the review, access, retrieval and amendment of laboratory department records
Scope:
All Records of the Laboratory Quality Management System
Responsibility:
Laboratory Director / Quality manager
All Laboratory staff are responsible for the review and retrieval of laboratory records as per this
procedure.
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
Document and Record Storage Retention and Disposal Procedure

Document code
QDRECLTOC
QDRECL03000
QDRECL03001
QDRECL03003

Procedure:
1. Access to records is given only to authorized persons.
2. Access to records is allowed to third parties /customers / doctors, if specified in the contract.
3. Copies of records are made only with the approval of the Laboratory Director.
4. All personnel in the department concerned have access to all records in their section/department.
5. Access to electronically stored technical records is through a personal password to all the staff.
6. All quality records are reviewed for completeness by the Lab Director before submission.
7. For records requiring review, retrieve the archived document or record from the storage area
outlined in Document and Record Storage Retention and Disposal Procedure QDRECL03003
table.
8. After review, for records not requiring any amendment/action return and file the document or
record to the appropriate storage area.
9. Amendments of records are done as Corrective Action by Quality Manger and reported to Laboratory
Director
10. Record stored electronically is also amended when necessary with approval from Laboratory Director
Consult the Laboratory Director / Quality Manager if you encounter any difficulty in the retrieval
process.

Quality System Essential Section : Documents and Records

Prepared By : Quality Manager
Issue No: 1