Iso 17025 Quality Manual
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A prerequisite for a laboratory to become accredited is to have a documented quality management system. The usual contents of the quality manual follow the outline of the ISO 17025 standard [1]. This is as follows:
1.0 Scope
2.0 References
3.0 Terms and Definitions
4.0 Management Requirements
4.1 Organization
4.2 Management System
4.3 Document Control
4.4 Review of Requests, Tenders, and Contracts
4.5 Subcontracting of Tests and Calibrations
4.6 Purchasing Services and Supplies
4.7 Service to the Customer
4.8 Complaints
4.9 Control of Nonconforming Testing and/or Calibration Work
4.10 Improvement
4.11 Corrective Action
4.12 Preventive Action
4.13 Control of Records
4.14 Internal Audits
4.15 Management Reviews
5.0 Technical Requirements
5.1 Technical Requirements - General
5.2 Personnel
5.3 Accommodations and Environmental Conditions
5.4 Test and Calibration Methods and Method Validation
5.5 Equipment
5.6 Measurement Traceability
5.7 Sampling
5.8 Handling and Transportation of Test and/or Calibration Items
5.9 Assuring the Quality of Test and Calibration Results
5.10 Reporting the Results
Section 4.2 Management System outlines the documentation requirements for a laboratory. Specifically stating "The laboratory shall establish, implement and maintain a management system appropriate to the scope of its activities. The laboratory shall document its policies, systems, programmes, procedures and instructions to the extent necessary to assure the quality of the test and/or calibration results." ISO 17025
Subclause 4.2.5 states that "the quality manual shall include or make reference to the supporting procedures including technical procedures. It shall outline the structure of the documentation used in the management system." ISO 17025
Furthermore, ISO 17025 requires a laboratory to document procedures for the following activities: - Document control
- Contract review
- Purchasing
- Client complaints
- Control of non-conforming work
- Corrective action
- Preventive action
- Control of records
- Internal audits
- Management reviews
- Training
- Estimation of uncertainty
- Equipment
- Reference standards / materials
- Sampling
- Handling of test items
[edit] References
- ISO 17025:2005
