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

  • This Standard requires the laboratory to plan and implement actions to address risks and opportunities.
  • Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the management system.
  • Achieving improved results.
  • Preventing negative effects.

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

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