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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