Quality Manual Template
Example
SECTION 2 - TABLE OF CONTENTS
Note: This is the automatically-generated Table of Contents. Tables of Contents (TOC) can be tricky to create and maintain in Word. If the automated TOC makes you break out in hives, delete it and use the manually created TOC (found directly preceding this one). To automate this TOC, you need to use the correct “styles” for section headings throughout the document, and you need to find and use the “Update TOC” button in the View/Toolbars/Outlining toolbar when you add or delete text so that the referenced pages get renumbered. See the instructions document that accompanies this template for more details.
SECTION 3 – INTRODUCTION AND SCOPE
3.1 Scope of Testing
3.2 Table of Contents, References and Appendices
3.3 Glossary and Acronyms Used
SECTION 4 – ORGANIZATIONAL ROLES AND RESPONSIBILITIES
4.1 Laboratory Organizational Structure
4.2 Responsibility and Authority
SECTION 5 – QUALITY SYSTEMS
5.1 Quality Policy
5.2 Quality Manual
SECTION 6 – DOCUMENT MANAGEMENT
6.1 Controlled Documents
6.1.1 Document Changes to Controlled Documents
6.2 Obsolete Documents
6.3 Standard Operating Procedures
6.3.1 Test Method SOPs
SECTION 7 – REVIEW OF REQUESTS, TENDERS AND CONTRACTS
7.1 Procedure for the Review of Work Requests
7.2 Documentation of Review
SECTION 8 – SUBCONTRACTING OF TESTS
SECTION 9 – PURCHASING SERVICES AND SUPPLIES
SECTION 10 – SERVICE TO THE CLIENT
10.1 Client Confidentiality
SECTION 11 – COMPLAINTS
SECTION 12 – CONTROL OF NON-CONFORMING WORK
SECTION 13 – CORRECTIVE ACTION
13.1 Selection and Implementation of Corrective Actions
13.2 Monitoring of Corrective Action
13.3 Technical Corrective Action
13.4 Policy for Exceptionally Permitting Departures from Documented Policies and Procedures
SECTION 14 – PREVENTIVE ACTION
SECTION 15 – CONTROL OF RECORDS
15.1 Records Management and Storage
15.2 Legal Chain of Custody Records
SECTION 16 – AUDITS AND MANAGEMENT REVIEW
16.1 Internal Audits
16.2 External Audits
16.3 Performance Audits
16.4 System Audits and Management Reviews
SECTION 17 – PERSONNEL, TRAINING, AND DATA INTEGRITY
17.1 Job Descriptions
17.1.1 Laboratory Director
17.1.2 Technical Director(s)
17.1.3 Quality Manager
17.2 Data Integrity and Ethics
17.3 Data Integrity and Ethics Training
17.4 General Training
SECTION 18 – ACCOMMODATIONS & ENVIRONMENTAL CONDITIONS
SECTION 19 – TEST METHODS AND METHOD VALIDATION
19.1 Demonstration of Capability (DOC)
19.2 On-Going (or Continued) Proficiency
19.3 Initial Test Method Evaluation
19.3.1 Limit of Detection (LOD)
19.3.2 Limit of Quantitation
19.3.3 Precision and Bias
19.3.4 Selectivity
19.4 Estimation of Uncertainty
19.5 Laboratory-Developed or Non-Standard Method Validation
19.6 Control of Data
SECTION 20 – EQUIPMENT
20.1 General Equipment Requirements
20.2 Support Equipment
20.2.1 Support Equipment Maintenance
20.2.2 Support Equipment Calibration
20.3 Analytical Equipment
20.3.1 Maintenance for Analytical Equipment
20.3.2 Initial Instrument Calibration
20.3.3 Continuing Instrument Calibration
20.3.4 Unacceptable Continuing Instrument Calibration Verifications
SECTION 21 – MEASUREMENT TRACEABILITY
21.1 Reference Standards
21.2 Reference Materials
21.3 Transport and Storage of Reference Standards and Materials
21.4 Labeling of Reference Standards, Reagents, and Materials
SECTION 22 – SAMPLE MANAGEMENT
22.1 Sample Receipt
22.2 Sample Acceptance
22.3 Sample Identification
22.4 Sample Storage
22.5 Sample Disposal
22.6 Sample Transport
22.7 Sampling Records
SECTION 23 – QUALITY OF TEST RESULTS
23.1 Essential Quality Control Procedures
23.2 Internal Quality Control Practices
23.3 Method Blanks
23.4 Laboratory Control Samples
23.5 Matrix Spikes and Matrix Spike Duplicates
23.6 Surrogate Spikes
23.7 Proficiency Test Samples or Interlaboratory Comparisons
23.8 Data Review
SECTION 24 – REPORTING OF RESULTS
24.1 Test Reports
24.2 Supplemental Test Report Information
24.3 Environmental Testing Obtained from Subcontractors
24.4 Electronic Transmission of Results
24.5 Amendments to Test Reports
SECTION 25 – APPENDICES
