Quality Manual

The Quality Manual is a living document describing the people, equipment, and processes used by the laboratory to ensure quality. This document should be updated frequently, including the following topics:

Company and Staff Information

The company structure and contact information should be described in this section, as well as a summary of laboratory personnel, including a job description and resume for each. In-house training procedures should be documented, as well as current CTTP (and other) certifications held by each technician.

  1. Cover Page
  2. Table of Contents
  3. Organizational Structure
  4. Technician Job / Position
  5. Technician Certification Chart
  6. Technician Training and Evaluation Record

Equipment

Items of equipment should:

  • Be included on the equipment inventory list,
  • Have a unique equipment description, and
  • Include a calibration / verification procedure, unless calibrated by an outside service

Inventory List

All equipment pertaining to QC/QA test methods included in the certification should be included on an inventory listing. The inventory list should include the name of each piece of equipment, model number, serial number (if applicable), in-service date, and calibration interval. Sieves should be listed individually.

Sample Inventory Listing

Equipment Descriptions

A description of each item should also be provided in the equipment section, including a description of the procedure and any additional items used for the calibration/verification of the equipment. Sample equipment descriptions are available in the Equipment Checklist.

Blank Equipment Description

Calibration / Verification Procedures

Each item of equipment requiring a calibration or verification must have a clearly stated procedure unless the calibration/verification is performed by an outside service. To learn which equipment items require calibration/verification, please see the Equipment Checklist.

Calibration / Verification Records

Calibration records should be maintained for each piece of equipment, as appropriate, showing recorded measurements for calibration items, performed at the prescribed intervals. Refer to the Equipment Checklist for sample calibration/verification worksheets.

Equipment Checklist

Test Records and Reports

Samples of data sheets and submitted test reports should be included in this section, along with a description of any internal procedures used to produce these test reports.

Test Record Procedure

Subcontracting

This section should document all companies and/or individuals that provide services to the laboratory for items such as equipment calibrations, equipment rental, technician testing services, or outsourced training. Equipment sharing between sister companies may also be documented in this section. Note that if testing services, equipment, etc. is shared with another company, a letter of acknowledgment from that company must be included in this section.

Subcontracting Form

Example Quality Manual

Click the link below to access an example Quality Manual. Note that this is an example and may not include all necessary laboratory information.

Example Quality Manual