GUIDELINES FOR THE ACCREDITATION OF
ENVIRONMENTAL TESTING LABORATORIES
LIGNES DIRECTRICES RÉGISSANT L’ACCRÉDITATION
DES LABORATOIRES D’ANALYSE ENVIRONNEMENTALE
CAN-P-1598
January 2003
PROGRAM SPECIALTY AREA - ENVIRONMENTAL TESTING
(PSA-ET)
Copyright © Standards Council of Canada, 2003
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form
or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior written permission of the
publisher:
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Table of Contents
FORWARD…………………………………………………………………………
ii
PREFACE…………………………………………………………………………..
iii
INTRODUCTION………………………………………………………………….
v
GENERAL AND ADDITIONAL REQUIREMENTS
1.0 Scope……………..………………………………………………………….
1
2.0 Normative References……………………………………………………...
1
3.0 Terms and Definitions…………………………………………………......
4
4.0 Management Requirements…………………………………………….....
12
5.0 Technical Requirements…………………………………………………...
12
ANNEXES
A Environmental Working Group…………………………………………....
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i
FOREWORD
The Standards Council of Canada ("the Council") is a crown corporation established by an Act of
Parliament in 1970 to foster and promote voluntary standardization in Canada. It is independent of
government in its policies and operations, although it is financed partially by Parliamentary
appropriation. The Council consists of members from government and the private sector.
The mandate of the Council is to promote the participation of Canadians in voluntary standards
activities, promote public-private sector cooperation in relation to voluntary standardization in
Canada, coordinate and oversee the efforts of the persons and organizations involved in the
National Standards System, foster quality, performance and technological innovation in Canadian
goods and services through standards-related activities, and develop standards-related strategies
and long-term objectives.
In essence, the Council promotes efficient and effective voluntary standardization in Canada in
order to advance the national economy, support sustainable development, benefit the health, safety
and welfare of workers and the public, assist and protect consumers, facilitate domestic and
international trade and further international cooperation in relation to standardization.
In addition, the Council serves as the government's focal point for voluntary standardization,
represents Canada in international standardization activities, sets out policies and procedures for
the development of National Standards of Canada, and for the accreditation of standards
development organizations, of certification organizations, of calibration and testing laboratories,
of quality management systems registration organizations, and of environmental management
systems registration organizations. In addition, the Council promotes and supports the principle of
recognition of accreditation or equivalent systems as a means of decreasing the number of multiple
assessments and audits, both in Canada and with Canada's trading partners.
This document is one of several issued by the Standards Council of Canada to define the policies,
plans, and procedures established by the Council to help achieve its mandate.
Requests for clarification and recommendations for amendment of this document, or requests for
additional copies, should be addressed to the publisher /directly or by accessing the SCC internet
website at http://www.scc.ca/.
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PREFACE
The Standards Council of Canada operates the Program for Accreditation of Laboratories - Canada
(PALCAN) which provides formal recognition of the competence of a calibration or testing
laboratory to manage and perform specific tests or types of tests listed in the scope of accreditation
approved by the Council. Accreditation is available for all types of tests, measurements and
observations and is currently offered in the following fields of testing: Acoustics & Vibration,
Biological, Chemical, Electrical/Electronic, Ionizing Radiation, Mechanical, Nondestructive
Evaluation, Optics & Optical Radiation, Physical, and Thermal & Fire.
Environmental Testing, a PALCAN Program Specialty Area (PSA), includes the measurement of
biological, chemical, physical, or toxicological characteristics of either the receiving environment
or discharges to the receiving environment, and includes as appropriate, biological, chemical and
physical fields of testing.
In June 1994, the Standards Council of Canada (SCC) and the Canadian Association for
Environmental Analytical Laboratories (CAEAL) entered into an Accreditation Partnership
Agreement for the accreditation of environmental laboratories. Under the terms of the
SCC/CAEAL Accreditation Partnership Agreement, CAEAL carries out site assessments and
operates a proficiency testing program. The granting and maintenance of accreditation is under the
authority of the SCC on the recommendation of CAEAL. Reference to the SCC/CAEAL
Accreditation Program within this document is made in this context.
The specific requirements for Environmental Testing Laboratories and these guidelines were
developed through the Environmental Working Group. The members of this working group (see
Annex A) developed the following document as a framework for accreditation of environmental
testing laboratories. The technical basis is drawn from published principles, practices and
procedures used or promoted by national and international organizations. The Environmental
Working Group reports to the Task Group Laboratories (TG Labs), which is constituted by and
reports to the Advisory Committee on Conformity Assessment (ACCA).
This document was designed to meet ISO/IEC 17025 requirements. Rather than serving as a "stand
alone" document, it was designed to harmonize and complement CAN-P-4D (ISO/IEC 17025),
"General Requirements for the Accreditation of Calibration and Testing Laboratories".
Accreditation is based on satisfactory participation in the site assessment program plus satisfactory
participation in proficiency testing, where such testing is offered as part of the accreditation. For
more information on the CAEAL Proficiency Testing Program, refer to the Program Description
for the SCC/CAEAL Laboratory Accreditation Program for Environmental Laboratories. Where
CAEAL does not offer proficiency testing for a test, laboratories are encouraged to seek out other
Proficiency Testing programs. In the case of environmental laboratories, accreditation is the formal
recognition by the SCC of the competence of the laboratory to manage and perform testing of
environmental materials.
The scope of these guidelines will be evaluated periodically to respond to client, laboratory and
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accreditation requirements, as well as improvements in the available science and technology or
regulatory changes.
This Preface is not an integral part of this document.
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INTRODUCTION
The general requirements for the competence of testing and calibration laboratories are described
in CAN-P-4D (ISO/IEC 17025). These requirements are designed to apply to all types of
calibration and objective testing and therefore need to be interpreted with respect to the type of
calibration and testing concerned and the techniques involved. CAN-P-1510D (Assessment Rating
Guide) and the CAEAL Rating Guide Appendix are tools used to assess conformance to
requirements in CAN-P-4D.
This document provides an amplification of those requirements in CAN-P-4D that are needed to
provide guidance for laboratories involved in performing environmental analysis. The program is
designed to create a network of testing laboratories that meet minimum quality and reliability
standards and to ensure a demonstrated uniform level of proficiency among these testing
laboratories.
This document does not re-state all the provisions of CAN-P-4D and laboratories are reminded of
the need to comply with all of the relevant criteria detailed in CAN-P-4D. The main clause
numbers in this document generally follow those of CAN-P-4D but since not all clauses require
interpretation, the numbering of clauses may not be continuous.
Accreditation under the specific requirements of the PSA Environmental Testing (PSA-ET)
program is the formal recognition by SCC of the competence of an environmental testing
laboratory to manage and perform this type of activity. It is not a guarantee that test results will
conform to standards or agreements between a testing laboratory and its clients. Business
transactions between an accredited testing laboratory and its clients are legal matters between the
two parties.
Laboratories are also reminded of the need to comply with any relevant statutory or legislative
requirements applicable to the jurisdiction in which they operate. With respect to health and safety
legislation, this normally requires the establishment of a health and safety committee, or if the
laboratory is small, an employee with responsibility for overall safety, as per Section 1.5 of
CAN-P-4D.
This document has been approved by the Environmental Working Group, the CAEAL Board of
Directors, and by the TG Laboratories of SCC.
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GENERAL AND ADDITIONAL REQUIREMENTS
Laboratories accredited through the PALCAN program must meet all requirements in the
international standard CAN-P-4D (ISO/IEC 17025) "General Requirements for the Competence of
Testing and Calibration Laboratories", these Guidelines and applicable Appendices to these
Guidelines. The requirements of CAN-P-15 ("Accreditation Programs: Requirements and
Procedures for Suspension and Withdrawal, Complaints, Appeals and Hearings") also apply to all
SCC-accredited laboratories. For information on application and terms and conditions of
accreditation, refer to the SCC/CAEAL Program Description and SCC/CAEAL Application. If an
accredited testing laboratory cannot maintain these requirements, it must cease any publicity
referring to the accredited status for the analysis of environmental materials, and inform the SCC
in writing within five days (details of the procedure are provided in CAN-P-15).
1.0
SCOPE
The accreditation program for environmental laboratories applies to all tests associated with the
measurement of chemical, radio-chemical, biological, microbiological, toxicological and related
physical characteristics of environmental samples (i.e., waste materials, air, water, soil, biological
tissue, etc.).
2.0
NORMATIVE REFERENCES
The following is a list of recommended references:
Application Form – SCC/CAEAL Laboratory Accreditation Program for Environmental
Laboratories, Nov 2001. Canadian Association for the Environmental Analytical Laboratories and
the Standards Council of Canada.
ASTM E178-80. Standard Practice for Dealing with Outlying Observations.
CAN-P-4D (ISO/IEC 17025), March 2000. General Requirements for the Competence of Testing
and Calibration Laboratories, Standards Council of Canada.
CAN-P-15, March 2000. Accreditation Programs: Requirements and Procedures for Suspension
and Withdrawal, Complaints, Appeals and Hearings. Standards Council of Canada.
CAN-P-1510D, May 2001. Assessment Rating Guide. Standards Council of Canada.
CAN-P-1593, January 2001. Guidelines for the Recognition of Proficiency Testing Schemes.
Program Specialty Area-Proficiency Testing (PSA-PT). Standards Council of Canada, Ottawa,
Ontario, Canada.
CITAC, 2000. Traceability in Chemical Measurement. (www.vtt.fi/ket/citac).
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CITAC (Guide 1), English Edition 1.0, December 1995. International Guide to Quality in
Analytical Chemistry: An Aid to Accreditation.
D92.5, November 2001. PALCAN Interpretation for Conducting Assessments of Testing and
Calibration Laboratories, Standards Council of Canada.
EURACHEM/CITAC (Guide 2), English Edition 1.0, October 1998. Quality Assurance for
Research and Development and Non-routine Analysis. (CAN-P-1595 July 2001).
EURACHEM/CITAC (Guide 3), Second Edition, 2000 (QUAM:2000.P1). Quantifying
Uncertainty in Analytical Measurement. (www.vtt.fi/ket/citac or www.eurachem.bam.de).
Eurochem Guide, English Edition 1.0, December 1998. The Fitness for Purpose of Analytical
Methods. A Laboratory Guide to Method Validation and Related Topics. ISBN 0-948926-12-0.
Guide to the Expression of Uncertainty in Measurement. ISO First edition, 1993 (revised by
ISO/IEC 1995), ISBN 92-67-10188-9.
ISO 3534-1:1993(E/F). Statistics - Vocabulary and Symbols Part 1: Probability and General
Statistical Terms.
ISO 5725-1:1994(E). Accuracy (trueness and precision) of Measurement Methods and
Results-Part 1: General Principles and Definitions.
ISO 5725-2:1994(E). Accuracy (trueness and precision) of Measurement Methods and
Results-Part 2: Basic Method for the Determination of Repeatability and Reproducibility of a
Standard Measurement Method.
ISO 5725-3:1994(E). Accuracy (trueness and precision) of Measurement Methods and
Results-Part 3: Intermediate Measures of the Precision of a Standard Measurement Method.
ISO 5725-4:1994(E). Accuracy (trueness and precision) of Measurement Methods and
Results-Part 4: Basic Methods for the Determination of the Trueness of a Standard Measurement
Method.
ISO 5725-5:1994(E). Accuracy (trueness and precision) of Measurement Methods and
Results-Part 5: Alternative Methods for Determination of the Precision of a Standard
Measurement Method.
ISO 5725-6:1994(E). Accuracy (trueness and precision) of Measurement Methods and
Results-Part 6: Use in Practice of Accuracy Values.
ISO 7870:1993. Control Charts – General Guide and Introduction.
ISO 7873:1993. Control Charts for Arithmetic Average with Warming Limits.
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ISO 9000:2000. Quality Management Systems - Fundamentals and Vocabulary.
ISO 13528:2001 draft. Statistical Methods for use in Proficiency Testing by Inter-laboratory
Comparisons.
ISO Guide 30:1992. Terms and definitions used in connections with reference materials.
ISO Guide 33:1989. Uses of Certified Reference Materials.
ISO/IEC Guide 2:1996. General terms and their definitions concerning standardization and related
activities.
ISO/IEC Guide 43-1:1997(E). Proficiency Testing by Interlaboratory Comparisons - Part 1:
Development and Operation of Proficiency Testing Schemes.
ISO/IEC Guide 43-2:1997(E). Proficiency Testing by Interlaboratory Comparisons - Part 2:
Selection and Use of Proficiency Testing Schemes by Laboratory Accreditation Bodies.
ISO/IEC Standard 17025:1999. General Requirements for the Competence of Calibration and
Testing Laboratories. International Organization for Standardization, Geneva, Switzerland.
ISO/REMCO n271 Draft 2.1, February 28, 1994, protocol by the IUPAC/ISO/AOAC working
party. Harmonised Guidelines for Internal Quality Control in Analytical Chemistry Laboratories
(Quality Control of Analytical Data Produced in Chemical Laboratories).
IUPAC approved 1975. Spectrochim. Acta B 33B, 1978, p.241-245. Nomenclature, symbols, units
and their useage in spectrochemical analysis - II. Data Interpretation.
ILAC Committee 3, Working Group 6, 1994. Guideline for validating test methods (2nd draft).
John Keenan Taylor, 1987. Quality Assurance of Chemical Measurements. Lewis Publishers, p85.
Journal of AOAC International, 76, No. 4, 1993, pp.926-940. (ISO/REMCO N280, August 1993,
Protocol from the IUPAC/ISO/AOAC working party). The International Harmonised Protocol for
the Proficiency Testing of (Chemical) Analytical Laboratories.
NAMAS NIS 23 edition 3, March 1991. Documented In-house Methods for Chemical Analysis.
NIST Special Publication 260-100:1993. Standard Reference Materials Handbook for SRM Users.
John K. Taylor.
Program Description – SCC/CAEAL Laboratory Accreditation Program for Environmental
Laboratories, November 2001. Canadian Association for the Environmental Analytical
Laboratories and the Standards Council of Canada.
Rating Guide Appendix, February 2002. Canadian Association for Environmental Analytical
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Laboratories.
The National Physical Laboratory (UK), March 2001. Measurement Good Practice Guide No.
11(Issue 2): A Beginner’s Guide to Uncertainty of Measurement.
UKAS Publication LAB12, Edition 1, October 2000. The Expression of Uncertainty in Testing.
(www.ukas.com/pdfs/LAB12.PDF).
(VIM) 2nd ed.:1993, Issued by ISO. International Vocabulary of Basis and General Terms in
Metrology. (ISBN 92-67-10175-1).
3.0
TERMS AND DEFINITIONS
All definitions in CAN-P-4D, ISO 3534, ISO 5725, VIM 2nd ed. [eg. laboratory, testing laboratory,
calibration laboratory, calibration, test, calibration method, test method, verification, quality
system, quality manual, reference standard, reference material, certified reference material,
traceability, proficiency testing, (accreditation) requirements] and those applicable from Guide
43-1, ISO 9000 [e.g. quality assurance, quality control] apply, and some of them are reproduced for
convenience in this document.
For the sake of clarity the following definitions specific to this document apply:
Accepted Reference Value. A value that serves as an agreed-upon reference for comparison, and
which is derived as:
a. a theoretical or established value, based on scientific principles;
b. an assigned or certified value, based on experimental work of a national or international
organization;
c. a consensus or certified value, based on collaborative experimental work under the
auspices of a scientific or engineering group;
d. when a), b), and c) are not available, the expectation of the (measurable) quantity, i.e.
the mean of a specified population of measurements. (ISO 3534-1, 3.4).
Acclimation. Physiological adjustment of test organisms to one or more (controlled)
environmental factors such as temperature.
Accreditation. Formal recognition, by the SCC, of the competence of a laboratory to carry out
specific functions.
Accuracy of Measurement: The closeness of the assessment between the result of a
measurement and a true value of the measurand. (VIM :1993 , 3.5 amplified by ISO 5725-1 to 6).
NOTE - The term accuracy when applied to a set of test results, involves a combination of random
components and a common systematic error or bias component.
- “Accuracy” is a qualitative concept. Refer to the definition of trueness.
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- The term precision should not be used for “accuracy”.
- Laboratories are expected to treat accuracy as has been done traditionally. Refer to ISO 5725
assistance.
for
Analyte Spike Recovery. Recovery of analyte spike added to sample prior to sample preparation.
Determination of spike recovery is based on results provided by spiked and unspiked sample. Used
to account for matrix effects and sample preparation losses.
Appendix. A unique matrix - test method combination, used by the SCC/CAEAL program; an
appendix may contain more than one parameter.
Bias. The difference between the expectation of the test results and an accepted reference value.
(ISO 3534-1, 3.13).
NOTE - Bias is the total systematic error as contrasted to random error. There may be one or more
systematic error components contributing to the bias. A larger systematic difference from the
accepted reference value is reflected by a larger bias value.
Calibration Curve. Defines the relation between analyte concentration and analytical response.
Normally at least 3-5, appropriately placed, calibration standards are needed to adequately define
the curve. There must be evidence to show that the analytical response is valid at the lower range
of the calibration curve, particularly if analyte concentration is routinely in the low range.
Analytical response, where appropriate, is zeroed using a reagent blank. Either a linear or other
suitable curve fit, as appropriate, may be used. Standards and samples must have equivalent
reagent backgrounds (e.g., solvent, acid content, etc.).
Certified Reference Material (CRM). Reference material, accompanied by a certificate, one or
more of whose property values are certified by a procedure which establishes its traceability to an
accurate realization of the unit in which the property values are expressed, and for which each
certified value is accompanied by an uncertainty at a stated level of confidence (ISO/IEC Guide
43-1).
Coefficient of Variation. For a non-negative characteristic the ratio of the standard
deviation to the average. (ISO 3534-1, 2.35).
NOTES - The ratio may be expressed as a percentage.
- The term ‘relative standard deviation’ is sometimes used as an alternative to ‘coefficient of
variation’, but this use is not recommended.
Control Sample. A sample used as a basis for comparison with test samples, and which
undergoes sample processing identical to that carried out for test samples. Includes reference
samples, method blanks, control samples (e.g., dilution water as used in toxicological testing) and
control cultures (e.g., samples of known biological composition).
Control Standard. A standard used as a basis for comparison with calibration standards, prepared
independently from the calibration standards, and which undergoes sample processing identical to
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that carried out for the calibration standards. Includes reagent blanks.
Cross Sensitivity. A quantitative measure of the response for an undesired constituent or
interferent as compared to that for a constituent of interest. (NIST 260-100).
Culture and/or Holding Conditions. Includes loading density, temperature, illumination, water
quality and associated variables such as water flow, aeration, filtration, re-circulation and renewal.
Environmental Laboratory. A laboratory engaged in the measurement of biological, chemical,
physical, or toxicological characteristics of either the receiving environment or discharges to the
receiving environment.
Holding Time. Elapsed time between sample collection and either sample preparation or analysis,
as appropriate.
Internal Standard. Has chemical characteristics similar to those of the analyte. Provides
analytical response which is distinct from the analyte and not subject to interference. Added to the
sample for the purpose of determining analyte concentration. Internal standards may be added to
the sample just prior to sample analysis (Type I) or just prior to sample preparation (Type II).
Internal Standard Method. Determination of analyte concentration by using an internal standard
analyte (and internal standard) response referenced to Relative Response Factor used to correct for
matrix effects.
Limit of Detection: The limit of detection, expressed as a concentration (or amount), is derived
from the smallest measure that can be detected by a single measurement with reasonable certainty
for a given analytical procedure. [IUPAC 1975]
NOTES - This can also be called detection limit. It is conventionally determined analytically as an
estimate of the lowest concentration of analyte in a real sample matrix that can be detected using
a specific test method, as compared with known matrix spikes and blanks carried through the
complete method.
- This can also be known as method detection limit. The US EPA has defined MDL as the
minimum concentration of an analyte that can be identified, measured and reported with 99%
confidence that the analyte concentration is greater than zero; it is determined from data
produced by analyzing a sample in a given matrix containing the analyte. Depending on the
matrix, the analyte and the instrumentation, the EPA has outlined several specific procedures for
determining MDL in their “Methods for the Determination of Metals in Environmental Samples
– EPA/600 4-91/010” publication.
Limit of Linearity. The upper limit of concentration or amount of substance for which
incremental additions produce constant increments of response. (NIST 260-100).
Limit of Quantitation. The lower limit of concentration or amount of substance that must be
present before a method is considered to provide quantitative results. By convention, LOQ = 10 so,
where so is the estimate of the standard deviation at the lowest level of measurement. (NIST
260-100).
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Method Blank. Blank which undergoes sample processing identical to that carried out for the test
samples. Blank results are used to assess contamination and/or provide background correction to
analyte concentrations.
Method of Standard Additions. Determination of analyte concentration by adding analyte spike
to sample. Determination is based on results provided by spiked and unspiked samples. Analytical
response must be linear. Used to correct for matrix effects.
Method Reporting Limit: The lowest concentration that will be reported for a specific method.
Outliers. Observations in a sample, so far separated in value from the remainder as to suggest that
they may be from a different population, or the result of an error in measurement. (ISO 3534-1,
2.64).
NOTE - ISO 5725-2 specifies the statistical tests and the significance level to be used to identify outliers in
trueness and precision experiments.
Precision. The closeness of agreement between independent test results obtained under prescribed
stipulated conditions. (ISO 3534-1, 3.14 amplified by ISO 5725-1 to 6).
NOTES - Precision depends only on the distribution of random errors and does not relate to the true value
or the specified value.
- The measure of precision is usually expressed in terms of imprecision and computed as a standard
deviation of the test results. Less precision is reflected by a larger standard deviation.
- "Independent test results" means results obtained in a manner not influenced by any
previous result on the same or similar test object. Quantitative measures of precision
depend critically on the stipulated conditions. Repeatability and reproducibility
conditions are particular sets of extreme conditions.
Proficiency Testing: Determination of laboratory testing performance by means of interlaboratory
comparisons. (ISO/IEC Guide 2)
NOTE - For the purposes of this Guide 2, the term laboratory proficiency testing is taken in its widest sense
and includes, for example:
a) Qualitative schemes - for example where laboratories are required to identify a component of a test
item.
b) Data transformation exercises - for example where laboratories are furnished with sets of data and are
required to manipulate the data to provide further information.
c) Single item testing - where one item is sent to a number of laboratories sequentially and returned to
the organizer at intervals.
d) One-off exercises - where laboratories are provided with a test item on a single occasion.
e) Continuous schemes - where laboratories are provided with test items at regular intervals on a
continuing basis.
f) Sampling - for example where individuals or organizations are required to take samples for
subsequent analysis.
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Proficiency Testing (PT) Sample. A characterized sample, having designated reference values,
that is used in the evaluation of laboratory performance.
Quality Control Sample. A sample (i.e., test sample or control sample/standard) used either
singly or in replicate, as appropriate, to monitor performance characteristics.
Range: The difference between the largest and the smallest observed value of a quantitative
characteristic. [ISO 3534-1, 2.30]
NOTE - In practical terms this means that the “range” is the concentration values for which the validated
method has acceptable accuracy, precision, repeatability, etc. The analytical range may result from
an analytical curve that is linear or non-linear. The Eurachem Guide “The Fitness for Purpose of
Analytical Methods…” 6.26 states “… it is necessary to determine the range of analyte
concentrations or property values over which the method may be applied.”
Reagent Blank. Blank which undergoes processing identical to that carried out for calibration
standards. Blank results are used to assess contamination and establish the baseline used in the
calibration.
Recommended Actions. Corrective actions specified if the consequences of the observed
nonconformances are not so severe as to affect the laboratory's ability to produce competent results
and take longer than the required amount of time needed to conform to requirements.
Recovery Corrected Calibration. Applies to calibration curve, internal standard method or
method of standard additions when standards and samples undergo similar sample processing.
Recovery Standard. Term applied to a Type I internal standard used with a surrogate.
Reference Material (RM): Material or substance one or more of whose property values are
sufficiently homogeneous and well established to be used for the calibration of an apparatus, the
assessment of a measurement method, or for assigning values to the materials. (ISO/IEC Guide
43-1)
Reference Sample. Reference material whose matrix is equivalent to that of the corresponding
test samples and which undergoes sample processing identical to that carried out for the test
samples. Includes reference toxicants, analyte spikes, surrogate spikes and reference materials
whose assigned values have been determined by design, consensus, comparison or certification.
Reference Value. Value assigned to a PT sample. This value may be based on any appropriate
combination of design value, inter-laboratory consensus value, reference consensus value or direct
comparison value.
Relative Response Factor (RRF). Ratio of slopes provided by calibration curves for analyte and
corresponding internal standard (or surrogate and corresponding internal standard). Calibration
curves may be determined by two precisely determined calibration points. Analytical responses
must be demonstrated to be linear.
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Repeatability. Precision under repeatability conditions. (ISO 3534-1, 3.15).
NOTE - This can also be called replicability.
Repeatability conditions. Conditions where independent test results obtained with the same
method on identical test material in the same laboratory by the same operator using the same
equipment within short intervals of time. (ISO 3534-1, 3.16).
NOTE - Repeatability means same analyst, same instrument, same laboratory and same day.
[Eurachem/CITAC Guide CG2 6.8.5.3]
Repeatability limits, r. The value less than or equal to which the absolute difference between two
test results obtained under repeatability conditions is expected to be with a probability of 95%.
(ISO 3534-1, 3.18).
Reproducibility. Precision under reproducibility conditions. (ISO 3534-1, 3.20).
Reproducibility conditions. Conditions where test results are obtained using the same method on
identical test items in different laboratories with different operators using different equipment.
(ISO 3534-1, 3.21).
NOTE - Reproducibility means different analyst, different instrument, different laboratory and different day.
[Eurachem/CITAC Guide CG2 6.8.5.3]
Reproducibility limits, R . The value less than or equal to which the absolute difference between
two test results obtained under reproducibility conditions is expected to be with a probability of
95%. (ISO 3534-1, 3.23).
Required Actions. Corrective actions specified if the observed nonconformances are deemed to
potentially compromise the integrity of the testing (e.g., absence of necessary documentation,
faulty facilities or equipment, inadequate staff performance, etc.). Must be corrected within 6
months of an initial assessment for accreditation or within 3 months of a re-assessment for
continued accreditation.
Robustness: The degree to which a measurement procedure or method is immune to variations
induced by operational parameters including, but not restricted to, environmental factors, chemical
parameters, electrical/site services and human activity. [Taylor, 1987]
NOTES - This term is also sometimes defined as ruggedness.
- In any analytical procedure performance can be influenced by a number of different variables, such as:
matrix interferences in the samples; reagent concentrations; temperature; etc. Experimental design is
usually used to describe the stages of identifying the different factors that affect the result of an
experiment, designing the experiment so that the effect of these factors is minimised, and using
statistical analysis to separate the effects of the factors involved. For example a ruggedness test will
indicate firstly whether a particular method will stand up to everyday use, and will indicate which parts
of the method are vulnerable to change and need to be subject to quality control. [Eurachem/CITAC
Guide CG2 6.7.3.1]
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- Functional relationships for parameters determine to be sensitive to these factors should be
known and their relative effects on measured values documented. Such data is used to
determine the tolerances within which these parameters must be kept to obtain results within
acceptable limits. Robustness should be tested when developing every method or standard
operating procedure.
- Taylor gives an experimental-statistical procedure to determine robustness.
Sample. For environmental testing laboratories, a sample generally refers to a water sample (grab
sample/composite sample), soil sample, air sample etc…For the purposes of this document, the
term "sample" is synonymous with the term "test item" in CAN-P-4D (ISO/IEC 17025).
Sample Analyses. All procedures carried out on samples (and standards) subsequent to sample
preparation. Includes any chemical or biological alteration to the sample as well as subsequent
measurement of specific sample characteristics.
Sample Collection. All procedures carried out on a sample at the time of sample collection,
including filtration to remove unwanted material from the sample or to isolate the sample.
Sample History Requirements. Includes requirements for sample collection, chemical
preservation, sample container, storage conditions, holding time, and sample pre-treatment.
Sample Preparation. All procedures such as purging, aeration, pH adjustment, extraction,
clean-up, digestion, distillation etc. carried out on samples (or standards) prior to analysis.
Sample Pre-treatment. All pre-treatment procedures carried out on a collected sample prior to
sample preparation or analysis, including removal of unwanted material, removal of moisture,
sub-sampling and homogenization.
Selectivity. The capability of an analytical procedure to reliably discriminate among chemically
or physically related substances.
NOTES - It is sometimes quantified as cross sensitivity.
- It is also sometimes defined as specificity.
Sensitivity. The capability of an analytical procedure to reliably discriminate between samples
having differing concentrations or containing differing amounts of an analyte. (NIST 260-100).
Significant figures. The number of figures required to express a numerical determination such
that only the last figure is uncertain, which is dependent upon a method's precision.
NOTE - To determine the number of significant figures in any value, start from the left most non-zero figure
and count through the last figure, including zeros.
Storage Conditions. Includes sample temperature, exclusion of light, exclusion of air, etc., during
both sample transport and sample storage at the laboratory.
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Surrogate. Has chemical characteristics similar to those of analyte. Provides analytical response
which is distinct from the analyte and not subject to interference. Added to sample prior to sample
preparation. Used to assess recovery of analyte.
Surrogate Spike Recovery. Recovery of surrogate spike added to sample prior to sample
preparation. Used to account for matrix effects and sample preparation losses.
Test. A unique combination of matrix, parameter and test method (e.g., lead in water by ICP).
Test Group. A term used by the SCC/CAEAL Program to describe one or more parameters in a
specific sample matrix that is/are offered as a unique set of Proficiency Testing samples
(designated as C-1A, C-1B, C1C, C-2, C-3, etc.).
Test Organism History Requirements. Includes culture and/or holding conditions, quarantine
requirements, feeding requirements, acclimation requirements, and disease control and treatment.
Traceability. A property of the result of a measurement or the value of a standard whereby it can
be related, with a stated uncertainty, to stated references, usually national or international
standards, through an unbroken chain of comparisons. (ISO Guide 30).
Trueness. The closeness of agreement between the average value obtained from a large series of
test results and an accepted reference value. (ISO 3534-1, 3.12).
NOTES - The measure of trueness is usually expressed in terms of bias.
- Trueness has been referred to as “accuracy of the mean”. This usage is not recommended.
Uncertainty. An estimate attached to a test result which characterizes the range of values within
which the true value is asserted to lie. (ISO 3534-1, 3.25).
Uncertainty of Measurement. Parameter, associated with the result of a measurement, that
characterizes the dispersion of the values that could reasonably be attributed to the measurand.
(Expression of Uncertainty, B.2.18; VIM 3.9).
NOTES - The parameter may be, for example, a standard deviation (or a given multiple of it), or the
half-width of an interval having a stated level of confidence.
- Uncertainty of measurement comprises, in general, many components. Some of these components
may be evaluated from the statistical distribution of the results of series of measurements and can
be characterized by experimental standard deviations. The other components, which can also be
characterized by standard deviations, are evaluated from assumed probability distributions based
on experience or other information.
- It is understood that the result of the measurement is the best estimate of the value of the
measurand, and that all components of uncertainty, including those arising from systematic
effects, such as components associated with corrections and reference standards, contribute to the
dispersion.
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4.0
MANAGEMENT REQUIREMENTS
All the requirements in Section 4.0 of CAN-P-4D apply to all accredited laboratories. The intent
of this section is to provide amplification of some clauses of CAN-P-4D for which procedures
specifically applicable to environmental testing will be used. The following section numbers
correspond directly to the clauses in CAN-P-4D. For more general interpretation on some clauses,
also refer to the "PALCAN Interpretation for Conducting Assessments of Testing and Calibration
Laboratories" (D92.5).
4.6
Purchasing Services and Supplies
4.6.2. New reagents and standards should be verified against old ones, and records
maintained.
4.6.4. List and records of investigation of all approved suppliers includes
subcontractors.
4.12
Technical Records
4.12.1. Technical records include reagent preparation logs. Reagent preparation logs must
include, as appropriate: supplier, grade, batch number; dates of preparation or
verification; measurement of weights, volumes, time intervals, temperatures and
related calculations; relevant processes (e.g. pH adjustment, sterilization etc);
verification results; and, discard date.
4.13
Internal Audits
4.13.1. The SCC requires that internal audits be conducted on an annual basis except for
such laboratories that can demonstrate that their systems are mature and stable.
Every part of the system must be audited annually; however, it is not necessary to
audit each person or each testing /measurement procedure, or to audit every aspect
at one time.
4.14
Management Reviews
4.14.1. The SCC requires that management reviews be conducted annually even though the
wording of the standard might appear to allow for a longer periodicity.
Management reviews are often a series of events/meetings that percolate upwards.
5.0
TECHNICAL REQUIREMENTS
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All the requirements in Section 5.0 of CAN-P-4D apply to all accredited laboratories. The intent
of this section is to provide amplification of some clauses of CAN-P-4D for which procedures
specifically applicable to environmental testing will be used. The following section numbers
correspond directly to the clauses in CAN-P-4D. For more general interpretation on some clauses,
also refer to the "PALCAN Interpretation for Conducting Assessments of Testing and Calibration
Laboratories" (D92.5).
5.2
Personnel
5.2.1. Qualifications generally required in an environmental laboratory are as follows:
 key supervisors: appropriate degree, diploma, or equivalent and at least 3 years
laboratory experience
 analysts: appropriate technical diploma or equivalent and variable years
laboratory experience depending on technical complexity of duties, which is
relevant to the tests being accredited.
5.2.5. Records of competence is analogous to documented evidence of analyst
proficiency.
5.3
Accommodation and Environmental Conditions
5.3.1. Accommodations and environmental conditions will depend on the type and
volume of work being performed, and may include (as required):
 adequate lighting at work areas
 controlled photoperiods of adequate quality and intensity in specific lab areas as
required
 adequate power
 sufficient appropriately grounded outlets which are free of surges and have
voltage regulators in use
 back-up emergency power supply available
 sufficient sinks with hot and cold running water
 suitable reagent water supply
 dilution water supply (marine or fresh water) suitable for use in toxicity testing
and culturing test organisms; incorporate suitable piping with dechlorination
and filtration as required
 air supply free of dust, fumes and oil and suitable for sample aeration and/or
purging
 vacuum source is able to maintain sufficient vacuum
 bench tops are adequate
 adequate bench space
 adequate floor area
 temperature is controlled in specific laboratory areas as required
 humidity control in specific laboratory areas as required
 appropriate air quality in specific laboratory areas as required (e.g. biological
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

sterility); otherwise ensure the laboratory is well ventilated (once through
ventilation, where appropriate) and free of dust and/or fumes
sufficient fume hoods, able to maintain appropriate face velocity
appropriate refrigerated storage, including freezer storage, available for
samples and other materials
5.3.2. The lab must have procedures for monitoring, controlling and recording
environmental conditions where applicable, such as:
 acceptable lighting
 replenishment of consumables used in reagent water and/or dilution water
treatment
 water quality characteristics as required, especially conductivity on a daily or as
used basis and corrective actions taken for nonconformance
 temperature
 humidity
 storage temperatures and corrective actions taken for nonconformance
5.3.5. Procedures must be in place to ensure that the use of materials used in cleaning
and/or pest control do not cause interference with testing.
5.4
Test and Calibration Methods and Method Validation
5.4.6. Laboratories shall demonstrate implemented use of adequate procedures for
estimation of the uncertainty of measurement associated with accredited tests.
Guidance on estimation of uncertainty of measurement is available from the SCC
and/or CAEAL.
5.6
Measurement Traceability
5.6.2. and 5.6.3. Items that laboratories need to consider to ensure conformance to
measurement traceability include the following:
 the availability of Class S or Class 1 weights used for balance calibrations only;
laboratories must have traceability for the item in its possession
 the accuracy of volumetric measurements by using Class A glassware, where
appropriate
 the availability of a thermometer, traceable as per SCC policy (see D92.6,
PALCAN Handbook, Appendix F) used for calibrations only; laboratories must
have traceability for the item in its possession
 certificates for certified weights and thermometers maintained on file
 certificates for reference materials or reagents used in preparing reference
materials (e.g., certified reference materials and calibration standards)
maintained on file
5.6.2.2.1. Method calibration procedures need to include, as appropriate: use of a reagent
blank to establish a calibration baseline; use of equivalent standard/sample reagent
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background; use of an adequate number of standards; establishment of linearity and
calculation of slope and/or RRF; use of a control standard to monitor calibration
stability/accuracy; use of control charting; and, identification of calibration
non-conformance.
5.7
Sampling
5.7.1. The laboratory must provide the client, as appropriate, with field supplies (e.g.
sample bottles, filters, preservatives) and maintain appropriate records of field
supplies provided or provide the client with specifications for sampling.
5.8
Handling of Test and Calibration Items
5.8.3. The laboratory must ensure any abnormalities and deficiencies are recorded,
upon receipt of the sample. Abnormalities and deficiencies may include:
 damaged sample
 insufficient sample for analysis
 deficiencies related to field filtration, chemical preservation, sample container,
temperature on arrival, exclusion of air, elapsed time subsequent to sampling
5.8.4. Once the sample is received at the laboratory, the laboratory must have
appropriate facilities and environmental conditions to maintain integrity of the
sample.
5.9
Assuring the Quality of Test and Calibration Results
5.9.1. Appropriate quality control procedures include, but are not limited to:
 appropriate level of quality control effort (i.e., duplicates, reference materials,
analyte/surrogate spikes, method blanks, control cultures, and control samples)
 use of control charting
 identification of non-conformance in method performance
 participation in proficiency testing, where applicable, and/or analysis of
independently prepared check samples
5.10
Reporting the Results
5.10.2. Results shall be reported, usually in a test report, and shall include all the
information requested by the client and necessary for the interpretation of the test
result and all information required by the method used.
(b) The laboratory must be able to track the location at which the test was carried
out, if tests were carried out at different locations. The lab must have the
capability to put this information on the test report at the clients’ request. The
location of subcontractors does not need to be identified.
(e) The laboratory must have the capability to provide the identification of the
method and should have the capability of placing this information on the test
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report should the client require it.
(g) The laboratory must be able to trace the date of analysis and be able to include
it on a test report at the clients' request.
(i) Test reports must contain the test result, with units. Appropriate significant
digits must be used in reported results.
(j) The test report should include at least, the name of the analyst and the name of
the person authorizing the report. The actual signature of the person authorizing
the report need not be on the report, but must be maintained on file. An
electronic signature is sufficient, provided that the laboratory has procedures in
place to guard against improper use of the electronic signature.
5.10.3. Test reports must include information necessary for the interpretation of results,
such as:
 flags when data is reported below the detection limit (or other specified limit)
 flags when a result is qualified due to a nonconformance related to test method
variance, sample history, method performance, interference or data validation
 flags when there is no result due to damaged or insufficient sample
 maximum allowable concentrations or standards
5.10.6. It is necessary to identify tests that were subcontracted but laboratories are not
required to identify the subcontractor.
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ANNEX A ENVIRONMENTAL WORKING GROUP
Members of the Environmental Working Group operating under the Task Group
Laboratories of the Standards Council of Canada are as follows:
Dr. Robert Audette, Audette Consulting
Ms. Colleen Cotter, Canadian Association for Environmental Analytical Laboratories (Convenor)
Mr. Peter Haulena, Accutest Laboratories, representing the Canadian Council of Independent
Laboratories
Ms. Debbie Macey, Canadian Association for Environmental Analytical Laboratories
Dr. William Mills, United Nations University
Mr. Benoît Prémont, Centre d'expertise en analyse environnementale du Québec
Mr. David Schellenberg, New Brunswick Environment
Mr. Michel Simard, Bureau de normalisation du Québec
Dr. J. D. Somers, Standards Council of Canada
Mr. Richard Turle, Environment Canada
Mr. Dave Warry, Environment Canada
Ms. Nancy Maxwell, Maxxam Analytics Inc.
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