Section 149.37. Quality manual.

 

(1)   Purpose and general provisions. The laboratory's quality system shall be defined in a quality manual, however named. All policies and procedures governing the laboratory's quality system shall be documented or referenced in the quality manual. All laboratory personnel shall follow the policies and procedures established by the quality manual.

(2)   Format. The quality manual shall have a format, however conceived, that addresses the content elements specified in this section. Content elements may be presented in narrative, tabular, schematic or graphical form. The manual shall be a document in hard copy or electronic format traceable to the laboratory.

(3)   Content. The quality manual shall include, address or refer to, at a minimum, the following elements:

(a) Organization and management structure of the laboratory.

(b) Procedures for retention, control and maintenance of documents used in or associated with analyses.

(c) Procedures for achieving traceability of standards, reagents and reference materials used to derive any results or measurements.

(d) Procedures for handling samples.

(e) Lists of major analytical instruments and support equipment.

(f) Procedures for calibration, verification and maintenance of major analytical instruments and support equipment.

(g) Procedures for evaluating quality control samples, including, but not limited to, method blanks, laboratory control samples, matrix fortified samples and replicates.

(h) Procedures for initiating, following up on and documenting corrective action addressing quality assurance and quality control failures, discrepancies or nonconformance.

(i) Procedures for reviewing analytical data and reporting analytical results.

(4)   Revisions. The quality manual shall be kept current by the responsible party, however named, for maintaining the laboratory's quality system. All editions or versions of the quality manual shall indicate the dates in which they were issued or revised.

(5)   Laboratories analyzing drinking water samples. Laboratories performing tests in drinking water shall ensure, in addition to the requirements in this section, that the content elements specified in Chapter III of the "Manual for the Certification of Laboratories Analyzing Drinking Water", EPA 815-R-05-004, fifth edition, EPA, Office of Groundwater and Drinking Water, January 2005, are addressed, included, or referenced in their quality manuals.

History: CR 06-005 : cr. Register April 2008 No. 628 , eff. 9-1-08.

Note

Although this section does not require a specific format for quality manuals, the format suggested by the following is acceptable to the department: "Manual for the Certification of Laboratories Analyzing Drinking Water", EPA 815-R-05-004, fifth edition, EPA, Office of Groundwater and Drinking Water, January 2005. This document is available at: http://www.epa.gov/safewater/labcert/labindex.html . Microsoft Windows NT 6.1.7601 Service Pack 1 This document is available at: http://www.epa.gov/safewater/labcert/labindex.html . Microsoft Windows NT 6.1.7601 Service Pack 1