1. Purpose
To define a system in the laboratory to identify the documents by providing a unique identification no. as well as to control the documents as per ISO/IEC 17025:2008
2. Scope
This procedure covers all documents affecting to Laboratory Management System.
3. Responsibility
The quality Assurance Officer is responsible to control the document and to ensure that the document control system is being properly implemented in the organization.
4. Procedure
Various QMS documents are identified and numbered in the following way
i) Quality Manual : PTL/QM/01
ii) Quality System procedures : PTL /QSP/xx
xx means procedure no. i.e. 01, 02 etc.
The Quality Manual and Quality Procedures are the apex documents of the organization, on top right corner of every page, Doc. No., page no, issue No. , Issue date, Rev. No. and Rev. date are given. Every new document will have revision no.00 and Issue No. 01, whenever these documents will be revised the new rev. no. will be escalated by 01. After 20 revisions, Issue no. will be revised.
iii) Formats : PTL/XX/F.xx
XX means Department Abbreviations like Purchase for PUR, Personnel for HR, F stands for the format, and xx means nos. 1,2, 3, etc.
iv) Other documents like work instructions, Approved Supplier, etc. are identified as follows:
Work Instructions : PTL/WI/xx
Approved Supplier : PTL/PUR/F.xx
Records : PTL/TR/xx
xx means nos. 01,02, 03 etc.
a) All documents are reviewed and approved for adequacy prior to the issue by the concerned authorities
b) Whenever required, the documents are reviewed, updated, and re-approved. For example, in case of continual improvement, taking corrective actions nonconformities, etc., documents may be revised/changed. To change a document, a document change request is initiated by the key user and after consultation/discussion with the other key users, the approving authority changes the document, such changes are incorporated in all controlled copies and key users are informed accordingly.
c) Master Copy of the document is being maintained by the Technical Manager, Stamp of ‘MASTER COPY’ is being put at the back side of the page. Controlled copies are identified by the stamp of ‘CONTROLLED COPY’ to prevent mixing with obsolete copy documents.
d) The current revision status of the documents is identified on the top right corner of the page with the date, and the change text is written in italic in case of an amendment.
e) A Master List and a distribution list with the current revision status are maintained by the Technical Manager to ensure that the relevant versions of applicable documents are available at the point of use.
f) Most of the documents are printed by laser/jet printer for proper legibility, and handwritten records/ documents are also legible, No handwritten changes are being done in controlled copies of documents. File nos. are provided to every file, list of files has been pasted onto the racks/almirahs to ensure that the documents are readily identifiable.
g) Documents of external standards/customer specifications are identified through the list of External standard and Codes, and the distribution of such documents are identified through the distribution list. Ensure that manufacturing personnel are using the latest version of the customer
specifications, old copies of the documents are withdrawn prior to the issue of the new one, as per the distribution list.
h) Each obsolete document is identified by the stamp of “OBSOLETE COPY”, all controlled copies of obsolete documents are destroyed and only one Master Copy of the document is retained.
The responsibility for preparing, reviewing, and approving the documents is defined in the footer of the document. In case of changes in documents, the same authorities prepare, review and approve the revised documents.
The master copy of the obsolete document is retained forever.
5. References:
a) Master List of Documents: DTL /xx/ML
xx Document abbreviation
END OF THE DOCUMENT
3. PTL /QSP/03 Procedure for Purchasing, Services, and Supplies
4. PTL /QSP/04 Procedure for Service to the Customer
5. PTL /QSP/05 Procedure for Customer Complaints
6. PTL QSP/06 Procedure for Control of Non-Conforming Testing.
7. PTL /QSP/07 Procedure for Improvement
8. PTL /QSP/08 Procedure for Corrective Action
9. PTL /QSP/09 Procedure for Preventive Action
10. PTL /QSP/10 Procedure for Control of Records
11. PTL /QSP/11 Procedure for Internal Audit
12. PTL /QSP/12 Procedure for Management Review
13. PTL /QSP/13 Procedure for Training
14. PTL /QSP/14 Procedure for Housekeeping
15. PTL /QSP/15 Procedure for Estimation of Uncertainty of measurement
16. PTL /QSP/16 Procedure for Equipment
17. PTL /QSP/17 Procedure for Measurement Traceability and Calibration
18. PTL /QSP/18 Procedure for Sampling
19. PTL /QSP/19 Procedure for Handling of Test and Calibration Items
20. PTL /QSP/20 Procedure for Assuring the Quality of Test
21. PTL /QSP/21 Procedure for Reporting of Results
22. PTL/QSP/22 Procedure for use of NABL Symbol
Note: Replace DTL with PTL for Drug Testing Laboratory.
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