Section 610. Quality manual

A. General.

1. The laboratory shall document its quality system in a quality manual. The quality manual shall reflect all quality assurance and quality control practices and programs used by the laboratory. The required elements of the quality system may be described in more than one document.

2. The quality manual shall be maintained current under the responsibility of the quality assurance officer.

3. The quality manual and any related documents shall be communicated to, understood by, available to, and implemented by all laboratory personnel.

4. The quality manual shall include but not be limited to the elements listed in subsections B and C of this section.

B. The elements of a quality manual shall include but not be limited to:

1. A document title;

2. The laboratory's full name and address;

3. The name, address (if different from above), and telephone number of the responsible official, laboratory manager, and quality assurance officer;

4. The laboratory facility or facilities covered by the quality manual;

5. Signed and dated concurrence, with appropriate titles, of the responsible official, laboratory manager, and quality assurance officer;

6. The effective date of the quality manual;

7. Table of contents and applicable lists of references, glossaries, and appendices; and

8. A quality policy statement, including objectives of the quality system and commitment to ethical laboratory practices and to upholding the requirements of this chapter's standards.

C. The quality manual shall include or reference but not be limited to:

1. The organization and management structure of the laboratory, its place in any parent organization and relevant organizational charts.

2. Job descriptions of key staff and reference to the job descriptions of other staff.

3. Processes or procedures for establishing that personnel have adequate training and experience in the duties they are expected to carry out and are receiving any needed training.

4. Mechanisms for ensuring that the laboratory reviews all new work to ensure that it has the appropriate facilities and resources before commencing such work.

5. Procedures to ensure that all records required by this chapter are retained, as well as procedures for control and maintenance of documentation through a document control system that ensures that all standard operating procedures, manuals, or documents clearly indicate the time period during which the procedure or document was in force.

6. Procedures for dealing with complaints.

7. Procedures for audits and data review.

8. Verification practices that may include inter-laboratory comparisons, proficiency testing programs, use of reference materials and internal quality control schemes.

9. Procedures to be followed for feedback and corrective action whenever testing discrepancies are detected, or departures from documented policies and procedures occur.

10. The laboratory management arrangements for permitting departures from documented policies and procedures or from standard specifications when the departures are planned and controlled.

11. The major equipment and reference measurement standards used as well as the physical facility and environment used by the laboratory in conducting tests.

12. Procedures for calibration, verification and maintenance of equipment.

13. A list of all technology/methods under which the laboratory performs its certified testing.

14. Procedures for achieving traceability of measurements, including standards.

15. Procedures for receiving, handling, storing, and disposing of submitted samples.

16. Procedures for reporting analytical results.

17. Policy addressing the use of unique electronic signatures, where applicable.

D. Review and approval of quality manual.

1. The quality assurance officer shall review the laboratory's quality assurance program, manual and any related documentation whenever there is any change in test methods employed by the laboratory, change in equipment, or any other change in the laboratory that affects the quality assurance program.

2. The quality assurance manual shall be reviewed and approved by the quality assurance officer, the laboratory manager, and the responsible official at least annually.

Historical Notes

Derived from Volume 25, Issue 07, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

Statutory Authority

§ 2.2-1105 of the Code of Virginia.