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U.S. Department of Health and Human Services

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Volume II ISO 17025 ORA Laboratory Procedures


Section 1 - Management Requirements(Templates)


Organization (refer to Vol. I section 4.1; Org. charts) ORA-LAB.4.1

Quality System (refer to Vol. I section 4.2) ORA-LAB.4.2 (ORA LM of Quality Procedures)

Document Control and Management ORA-LAB.4.3

Request, Tenders, Contracts (refer to Vol. I section 4.4) ORA-LAB.4.4 (Review of Requests, Tenders and Contracts)

Subcontracting (not applicable to field labs)

Purchasing and Receipt ORA-LAB.4.6

Client Services (refer to Vol. I section 4.7) ISO 17025 Subclause 4.7

Complaints ORA-LAB.4.8

Control of Non-conforming Work ORA-LAB.4.9

Corrective Action Procedure ORA-LAB.4.11

Preventive Action Procedure ORA-LAB.4.12

Record and Data Management ORA-LAB.4.13

Audits ORA-LAB.4.14

Management Review ORA-LAB4.15


Section 2 - Technical Requirements


General N/A

Personnel: Training Procedure ORA-LAB.5.2

Facilities and Environmental Conditions (linked to Vol. III, sec. 2) ORA-LAB.5.3

Test Methods & Validation

Methods, Method Verification and Validation ORA-LAB.5.4.5

Estimation of Uncertainty of Measurement ORA-LAB.5.4.6

Equipment ORA-LAB.5.5

Instrument and Equipment Documentation and Records ORA-LAB.5.5.1

Measurement Traceability ORA-LAB.5.6

Sampling (not applicable to field labs)

Sample Management ORA-LAB.5.8

Assuring the Quality of Test Results ORA-LAB.5.9

Reporting Laboratory Data ORA-LAB.5.10