Laboratory Quality Management System
This International Standard has been developed with the objective of promoting confidence in the operation of laboratories. It contains requirements for laboratories to enable them to demonstrate they operate competently, and are able to generate valid results. Laboratories that conform to the requirements of this standard will also operate generally in accordance with the principles of ISO 9001.
Laboratory Quality Management System
Benefits
The laboratory is responsible for deciding which risks and opportunities need to be addressed. The use of this Standard will facilitate cooperation between laboratories and other bodies and assist in the exchange of information and experience, and in the harmonization of standards and procedures. The acceptance of results between countries is facilitated if laboratories conform to the requirements of this standard.
Scope
This standard specifies the general requirements for the competence, impartiality and consistent operation of laboratories. It is applicable to all organizations performing laboratory activities, regardless of the number of personnel. Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use this document in confirming or recognizing the competence of laboratories.
Training Module
2 Days Training Session
Day 1 Schedule
Duration | Subject |
---|---|
9:00 - 9:30AM | Registration |
9:30 - 11:15AM | Introduction to the Course, Laboratory Accreditation International perspective & Basic Terms & Definitions (Clause 3 of ISO/IEC 17025) |
11:15 - 11:30AM | Tea Break |
11:30 - 1:30PM | General Requirements, Structure & Resources (Clause 4, 5 & 6 of ISO/IEC 17025) |
1:30 - 2:30PM | Lunch Break |
2:30 - 3:30PM | Process Requirements (Clause 7 of ISO/IEC 17025) |
3:30 - 3:45PM | Tea Break |
3:45 - 4:30PM | Process Requirements (Contd.) |
4:30 - 6:00PM | Management System Requirements (Clause 8 of ISO/IEC 17025) |
6:00 - 6:30PM | Exercise I |
Day 2 Schedule
Duration | Subject |
---|---|
9:00 - 9:30AM | Review of Day 1 |
9:30 - 10:30AM | Exercise II & III |
10:30 - 11:15AM | Risk Based Approach (Clause 8.5 of ISO/IEC 17025) |
11:15 - 11:30AM | Tea Break |
11:30 - 12:30PM | Internal Audit (Clause 8.8 of ISO/IEC 17025) |
12:30 - 1:30PM | Internal Audit (Contd.) & Exercise IV |
1:30 - 2:30PM | Lunch Break |
2:30 - 3:30PM | Key Changes: ISO/IEC 17025 – 2005 version vs. 2017 version |
3:30 - 3:45PM | Tea Break |
3:45 - 5:15PM | NABL Accreditation Programme/ Route to Accreditation |
5:15 - 5:45PM | Discussion |
5:45 - 6:00PM | Valedictory & Distribution of Certificates |
4 Days Training Session
Day 1 Schedule
Duration | Subject |
---|---|
9:00 - 9:30AM | Registration |
9:30 - 11:15AM | Introduction to the Course, Laboratory Accreditation International perspective & Basic Terms & Definitions (Clause 3 of ISO/IEC 17025) |
11:15 - 11:30AM | Tea Break |
11:30 - 1:30PM | General Requirements, Structure & Resources (Clause 4, 5 & 6 of ISO/IEC 17025) |
1:30 - 2:30PM | Lunch Break |
2:30 - 3:30PM | Process Requirements (Clause 7 of ISO/IEC 17025) |
3:30 - 3:45PM | Tea Break |
3:45 - 5:30PM | Process Requirements (Contd.) |
5:30 - 6:00PM | Exercise I |
Day 2 Schedule
Duration | Subject |
---|---|
9:00 - 9:30AM | Review of Day 1 |
9:30 - 11:15AM | Management System Requirements (Clause 8 of ISO/IEC 17025) |
11:15 - 11:30AM | Tea Break |
11:30 - 1:30PM | Management System Requirements (Contd.) |
1:30 - 2:30PM | Lunch Break |
2:30 - 3:30PM | Management System Requirements (Contd.) |
3:30 - 3:45PM | Tea Break |
3:45 - 4:45PM | Exercise II |
4:45 - 5:30PM | Exercise III |
5:30 - 6:00PM | Discussion on Exercises |
Day 3 Schedule
Duration | Subject |
---|---|
9:00 - 9:30AM | Review of Day 2 |
9:30 - 11:15AM | Risk Based Approach (Clause 8.5 of ISO/IEC 17025) |
11:15 - 11:30AM | Tea Break |
11:30 - 1:30PM | Internal Audit (Clause 8.8 of ISO/IEC 17025) |
1:30 - 2:30PM | Lunch Break |
2:30 - 3:30PM | Exercises – IV (Mock Audit) |
3:30 - 3:45PM | Tea Break |
3:45 - 5:30PM | Exercises – IV (Contd.) |
5:30 - 6:00PM | Discussion on Exercise IV |
Day 4 Schedule
Duration | Subject |
---|---|
9:00 - 9:30AM | Review of Day 3 |
9:30 - 11:15AM | NABL Accreditation Programme/ Route to Accreditation |
11:15 - 11:30AM | Tea Break |
11:30 - 1:30PM | BIS Labs and BIS Lab Recognition Scheme |
1:30 - 2:30PM | Lunch Break |
2:30 - 3:30PM | Exercise - V Evaluation of Elements of ISO/IEC 17025:2017 |
3:30 - 3:45PM | Tea Break |
3:45 - 4:00PM | Feedback |
4:00 - 4:30PM | Valedictory & Distribution of Certificates |