FDA Home Page
|
Compliance
|
Federal-State
|
Inspection
|
Import Program
|
Science Ref
|
ORA Search
ORA Laboratory Manual
Introduction
Volume I ORA Laboratory Manual of Quality Policies
Volume II ISO 17025 ORA Laboratory Procedures
Volume III Laboratory Operations, Applicatins and Programs
Volume IV Laboratory Training
Change History
Contact
Search
Science References
ORA Laboratory Manual
Document TOC
Volume 2 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
Page Top
Document TOC