Guidelines for the Accreditation of Environmental Testing Laboratories

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)

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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………………………………………….... / 17

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 publicprivate 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 standardsrelated activities, and develop standardsrelated strategies and longterm 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

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 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.

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.

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).

1.0SCOPE

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.).

2.0NORMATIVE 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. (

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. ( or

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.

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 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. (

(VIM) 2nd ed.:1993, Issued by ISO. International Vocabulary of Basis and General Terms in Metrology. (ISBN 92-67-10175-1).

3.0TERMS 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 theoretical or established value, based on scientific principles;
an assigned or certified value, based on experimental work of a national or international organization;
a consensus or certified value, based on collaborative experimental work under the auspices of a scientific or engineering group;
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.

- The term precision should not be used for “accuracy”.

- Laboratories are expected to treat accuracy as has been done traditionally. Refer to ISO 5725 for assistance.

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).