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Introduction
- Approval Signature Page ( PDF, 48 kb)
Volume I ORA Laboratory Manual of Quality Policies
- ORA Laboratory Manual of Quality Policies ( PDF, 381 kb)
Volume II ISO 17025 ORA Laboratory Procedures
Section 1 – Management Requirements (Templates)
- Organization (refer to Vol. I section 4.1; Org. charts) ( PDF, 381 kb)
ORA-LAB.4.1
- Quality System (refer to Vol. I section 4.2 ( PDF, 381 kb)
ORA-LAB.4.2 (ORA LM of Quality Procedures)
- Document Control and Management ( PDF, 169 kb)
ORA-LAB.4.3
- Request, Tenders, Contracts (refer to Vol. I section 4.4) ( PDF, 381 kb)
ORA-LAB.4.4 (Review of Requests, Tenders and Contracts)
- Subcontracting (not applicable to field labs)
- Purchasing and Receipt ( PDF, 116 kb)
ORA-LAB.4.6
- Client Services (refer to Vol. I section 4.7 ( PDF, 381 kb)
ISO 17025 Subclause 4.7
- Complaints ( PDF, 80 kb)
ORA-LAB.4.8
- Control of Non-conforming Work ( PDF, 64 kb)
ORA-LAB.4.9
- Corrective Action Procedure ( PDF, 223 kb)
ORA-LAB.4.11
- Preventive Action Procedure ( PDF, 74 kb)
ORA-LAB.4.12
- Record and Data Management ( PDF, 115 kb)
ORA-LAB.4.13
- Audits ( PDF, 198 kb)
ORA-LAB.4.14
- Management Review ( PDF, 89 kb)
ORA-LAB4.15
Section 2 – Technical Requirements
- General N/A
- Personnel :Training Procedure ( PDF, 144 kb)
ORA-LAB.5.2
- Facilities and Environmental Conditions (linked to Vol. III, sec. 2) ( PDF, 123 kb)
ORA-LAB.5.3
- Test Methods & Validation
- Methods, Method Verification and Validation ( PDF,
152 kb)
ORA-LAB.5.4.5
- Estimation of Uncertainty of Measurement ( PDF, 90 kb)
ORA-LAB.5.4.6
- Equipment ( PDF, 188 kb)
ORA-LAB.5.5
- Instrument and Equipment Documentation and Records ( PDF, 100 kb)
ORA-LAB.5.5.1
- Measurement Traceability ( PDF, 107 kb)
ORA-LAB.5.6
- Sampling (not applicable to field labs)
- Sample Management ( PDF, 113 kb)
ORA-LAB.5.8
- Assuring the Quality of Test Results ( PDF, 95 kb)
ORA-LAB.5.9
- Reporting Laboratory Data ( PDF, 139 kb)
ORA-LAB.5.10
Volume III Laboratory Operations, Applications and Programs
- Section 1 Environmental Health and Safety ( PDF, 118 kb)
- Section 2 Chain of Custody – Sample Handling ( PDF, 119 kb)
- Section 3 Recording of Results - Analyst’s Worksheet ( PDF, 183 kb)
- Section 4 Basic Statistics and Presentation ( PDF, 346 kb)
- Section 5 Analysts on Inspection ( PDF, 223 kb)
- Section 6 ORA Method Development and Validation Program ( PDF, 92 kb)
- Section 7 Private Laboratory Guidance ( PDF, 183 kb)
- Section 8 Courtroom Testimony ( PDF, 91 kb)
Volume IV Laboratory Training (linked to ORA U)
- Orientation and Training Levels( PDF, 114 kb)
- Section 1 Laboratory Orientation
Answer Key: Laboratory Orientation ( PDF, 276 kb)
- Section 2 Microbiology
Answer Key: Microbiology ( PDF, 471 kb)
- Section 3 Drug Analysis
Answer Key: Drug Analysis ( PDF, 435 kb)
- Section 4 Microanalytical and Filth Analysis ( PDF, 591 kb)
- Section 5 Pesticides Analysis
Answer Key: Pesticides Analysis ( PDF, 124 kb)
- Section 6 Elemental Analysis
Answer Key: Elemental Analysis ( PDF, 92 kb)
- Section 7 Mycotoxin Analysis
Answer Key: Mycotoxin Analysis ( PDF, 152 kb)
- Section 8 Sensory Analysis
Answer Key: Sensory Analysis ( PDF, 94 kb)
- Section 9 Seafood Chemistry
Answer Key: Seafood Chemistry ( PDF, 164 kb)
- Section 10 Food Standards & Additives
Answer Key: Food Standards and Additives ( PDF, 262 kb)
- Section 11 Nutrient Analysis
Answer Key: Nutrient Analysis ( PDF, 820 kb)
- Section 12 Radioactivity
Answer Key: Radioactivity ( PDF, 97 kb)
- Section 13 Engineering ( PDF, 93 kb)
- Section 14 Consumer Complaints/Product Tampering ( PDF, 108 kb)
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The Laboratory Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used as an agency policy for testing consumer products, training of laboratory staff, report writing, safety, research, review of private laboratory reports and court testimony. (Formerly: Laboratory Procedure Manual)
Important disclaimer: The LM Adobe pdf by volumes/sections files provided represent a duplicate of the HARDCOPY LM content. Be aware that the pdf files have not been updated although these files may be updated in the future. The LM html version is the most current version.
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