4.2 Management system
4.2.1 General
The PTL has established, implemented and maintained a management system appropriate to the scope of its activities and in accordance with ISO/IEC 17025:2017 and NABL documents. The laboratory has documented its policies, systems, program, procedures, and instructions.
System Documentation of the laboratory is communicated to, understood by, available with, and implemented by the personnel responsible for maintaining the quality of test results.
Information is communicated through:
- paper or electronic documents, such as manuals, procedures, instructions, specifications, quality records, reports, required reading, etc.;
- e-mails, letters, and meetings
- training and awareness programs.
4.2.2 Quality Policy
The laboratory's management system policies related to quality, including a quality policy statement (Annexure 3), has been defined in a quality manual. The quality policy statement has been issued under the authority of the Chairman. It includes the following;
a) the laboratory management's commitment in relation to the quality of its testing services and to provide customers at all times with service compliance with the recognized standards of practice
b) the management's statement of the laboratory's standard of services given to its customers;
c) the purpose of the management system related to quality;
d) a requirement that all personnel concerned with testing activities within the laboratory familiarize themselves with the quality documentation and implement the policies and procedures in their work; and
e) the laboratory management's commitment to comply with ISO/IEC 17025:2017 and continually improve the effectiveness of the management system.
4.2.3 Top management has provided adequate resources like competent and sufficient manpower, the latest testing equipment, and infrastructure for the development and implementation of the management system and continually improving its effectiveness.
4.2.4 Top management has communicated to the organization the importance of meeting customer requirements as well as statutory and regulatory requirements through email, meetings, etc.
4.2.5 The quality manual includes reference to the supporting procedures including technical procedures. It outlines the structure of the documentation used in the management system.
The quality system is structured in four tiers of documentation and is being maintained as follows-
a) Level A- Quality Manual
b) Level B- Quality System Procedures
c) Level C – Standard operating / test procedures
The quality manual makes reference to supporting procedure which is quality system procedure which in turn makes reference to all technical procedures and records. All the above documents are being distributed and maintained in the form of controlled documents.
4.2.6 The roles and responsibilities of technical management and the quality manager, including their responsibility for ensuring compliance with this International Standard, have been defined in the quality manual (Annexure 1).
4.2.7 Top management ensures that the integrity of the management system is maintained when changes to the management system are planned and implemented. In case of any changes in infrastructure and resources, top management ensures that newly appointed personnel are competent as per system requirement and that changed equipment and infrastructure is also in accordance with the NABL guidelines. The changes can be verified through the quality of test results i.e. ILC and PT program etc.
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2. PTL /QSP/02 Procedure for Document & Data Control
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
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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