NELAC Quality Manual Template

Preface to the Quality Manual

This document has been prepared to facilitate preparation of a Quality Manual based on the July, 1999 NELAC standards.   This Example Manual is intended to serve as a tool for the production of individual laboratory manuals as required by Chapter 5 of the NELAC standards.

The Example Manual is based on a relatively focused laboratory operation involving typical areas of chemical analyses-wet chemistry, metals, and organics. The example used to develop this document in no manner addresses all required information for all types of laboratories. The example is limited to the collection of soil and/or water samples to undergo chemical laboratory analysis. The specific analytical requirements for a given laboratory may involve a far wider variety of sample matrices and analytical methods.  The appendices provide additional information which may be useful.

It is critical to realize that this example is not a stand-alone document, but rather must be used in conjunction with laboratory SOPs.

The example is organized generally according to a 16 Element approach for an EPA Quality Assurance Project Plan (QAPP), incorporating more recent EPA guidance.

The following formatting conventions are used.
•	Explanatory information is provided in [bold text] within square brackets.
•	Laboratory-specific information necessary to complete a subsection is noted in  <BOLD UPPERCASE TEXT> and generally contained within less than/greater than symbols as shown.
•	Short checklists, quoting directly from the NELAC standards, designed to determine if all critical information has been provided, follow each section, and are shown in italicized blue font.
•	Unless otherwise stated, a reference to a section number is to the 1998 NELAC standards.

DOs AND DON'Ts TO FACILITATE PREPARATION

1.  DO NOT use the example verbatim. Use the example as a guide for your own laboratory. DO append or otherwise incorporate laboratory specific information to address your operations. DO review your laboratory operations to ensure that the requirements in the Manual are consistent with your operation and are being performed!

2. DO NOT include photocopied pages from EPA methods as laboratory Standard Operating Procedures (SOPs). Specific references to EPA methods may be made, as in specifying which methods were used as a guideline in preparing the SOPs.  DO prepare laboratory-specific SOPs.  

3.  DO NOT assume this manual will reflect your laboratory operation as defined within NELAC.  DO thoroughly familiarize yourself with this document and the NELAC standards, especially Chapter 5.

Required Elements for a Quality Manual (Section 5.5.2)

a)	a quality policy statement, including objectives and commitments, by top management;
b)	the organization and management structure of the laboratory, its place in any parent organization and relevant organizational charts;
c)	the relationship between management, technical operations, support services and the quality system;
d)	procedures to ensure that all records required under this Chapter are retained, as well as procedures for control and maintenance of documentation through a document control system which ensures that all standard operating procedures, manuals, or documents clearly indicate the time period during which the procedure or document was in force; 
e)	job descriptions of key staff and reference to the job descriptions of other staff;
f)	identification of the laboratory's approved signatories; at a minimum, the title page of the Quality Manual must have the signed concurrence, (with appropriate titles) of all responsible parties including the QA officer, technical director, and the agent who is in charge of all laboratory activities such as the laboratory director or laboratory manager;
g)	the laboratory's procedures for achieving traceability of measurements;
h)	a list of all test methods under which the laboratory performs its accredited testing;
i)	mechanisms for ensuring that the laboratory reviews all new work to ensure that it has the appropriate facilities and resources before commencing such work;
j)	reference to the calibration and/or verification test procedures used;
k)	procedures for handling submitted samples;
l)	reference to the major equipment and reference measurement standards used as well as the facilities and services used by the laboratory in conducting tests;
m)	reference to procedures for calibration, verification and maintenance of equipment;
n)	reference to verification practices including interlaboratory comparisons, proficiency testing programs, use of reference materials and internal quality control schemes; 
o)	procedures to be followed for feedback and corrective action whenever testing discrepancies are detected, or departures from documented policies and procedures occur;
p)	the laboratory management arrangements for exceptionally permitting departures from documented policies and procedures or from standard specifications;
q)	procedures for dealing with complaints;
r)	procedures for protecting confidentiality (including national security concerns) and proprietary rights;
s)	procedures for audits and data review;
t)	processes/procedures for establishing that personnel are adequately experienced in the duties they are expected to carry out and/or receive any needed training;
u)	reference to procedures for reporting analytical results; and
v)	a Table of Contents, and applicable lists of references and glossaries, and appendices.

[Note that while the above elements are specifically addressed, many other sections of the NELAC standards, especially elsewhere in Chapter 5, require additional activities. In the Template, a reference is provided to one of the above elements, or elsewhere within Chapter 5.]

A Typical Page from the Template

1.0 POLICY STATEMENT

[The policy statement outlines the overall scope of the manual and its basis. Note the statement indicating that this is a summary document.  This approach allows you to have a basic Quality Manual which is seldom revised, with details (e.g. QC limits) in supporting documents which are easier to change. However, there should be regularly scheduled reviews (e.g., annually in conjunction with the annual internal audit) to ensure that the Manual reflects current laboratory practice]

This Quality Manual summarizes the policies and operational procedures associated with <FACILITY NAME> in <FACILITY LOCATION>.  Specific protocols for sample handling and storage, chain-of-custody, and laboratory analyses, data reduction, corrective action, and reporting are described. All policies and procedures have been structured in accordance with the NELAC standards adopted in July 1999 (current as of the date of this publication) and applicable EPA requirements, regulations, guidance, and technical standards. This manual has been prepared in accordance with the guidance documents listed in Section 15.  Further details on these policies and procedures are contained in SOPs and related documents. This Quality Manual, SOPs, and related documentation describe the quality system for <FACILITY NAME>. 

<FACILITY NAME> performs chemical analyses for inorganic and organic constituents in water and soil. <FACILITY NAME>’s goal is to produce data that is scientifically valid, defensible, and of known and documented quality in accordance with standards developed by the National Environmental Laboratory Accreditation Conference (NELAC) and any applicable state or EPA regulations or requirements. A Certification Statement (see Appendix A) has been recorded to this effect.  [This certification statement is required.  See 4.1.9.]

[The NELAC standards define the following types of laboratories relative to personnel qualifications (See Chapter 4)
•	chemical analysis ,
•	inorganic chemical analysis, other than metals analysis, 
•	microbiological or biological analysis, 
•	microbiological analysis limited to fecal coliform, total coliform and standard plate count,
•	radiological analysis, 
•	microscopic examination of asbestos and/or airborne fibers, and
•	radon in air 
Although it is not required to summarize the scope of your laboratory services, a statement to this effect at the beginning will assist those reading your Manual.]