Test Methods


Introduction

The requirement of ISO/IEC 17025 is that the test/calibration method has to be from standard written instructions. However, the standard ( ISO/IEC 17025) allows flexibility in adopting a non-standard test/calibration method , subject to certain conditions and where required subject to validation. It is also flexible in accepting a test/calibration method that has been developed by the laboratory but has been subjected to full validation. It also permits use of Industry standard methods.

It is the responsibility of the laboratory to provide a method which is fit for purpose. This may involve discussions with the customer. In the end the customer can specify the method but under these circumstances the laboratory has the responsibility to inform the customer if the method being insisted upon is not ideally suited to the purpose the customer requires.

The following are the possible situations where the laboratory is required to make its own judgment to select a test method:

  • Client's wants and needs
  • Regulatory requirements
  • Industry acceptance
  • Sampling and sample preparation
  • Environmental requirements
  • Staff capability requirements
  • Repeatability, reproducibility and uncertainty
  • Recovery and matrix effects
  • Safety
  • Cost and time

The introduction of test and calibration methods developed and validated by the laboratory shall be a planned activity and shall be assigned to qualified personnel, equipped with adequate resources. Plans shall be updated as development proceeds and effective communication amongst all is ensured.

Validation is the confirmation by examination, by established techniques, with the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. Each test/calibration method as applied by each specific laboratory has its own precision, bias and uncertainty of measurement and laboratories must determine the values for these parameters delivered by them.

The user of the test methods should be in position to evaluate its performance on the basis of:

  • Matrix effect
  • Linear concentration range, bias and precision.
  • Justification for deviation from standard methods
  • Scientific basis /logic for deviation from standard procedure
  • Identification of key or critical steps
  • In-house quality control
Back to top
Test Methods

Labs shall use appropriate methods and procedures for all tests and / or calibrations within its scope. These include sampling, handling, transport, storage and preparation of items to be tested and / or calibrated. The laboratory shall have instructions on the use and operation of all relevant equipment and on the handling and preparation of items for testing or calibration or both where the absence of such instructions could jeopardize the results of tests or calibration. Deviation from test and calibration methods shall occur only if the deviation is documented, technically justified, authorized and accepted by the customer.

A. Selection of test methods

B. Laboratory developed methods

C. Non standard methods

D. Sources of methods

A. Selection of test methods.
The laboratory shall use test and calibration methods including methods for sampling which meet the needs of the customer and which are appropriate for the tests or calibrations it undertakes. Methods published in international, regional or national standards shall be preferably used. The laboratory shall ensure that it uses the latest valid edition of a standard unless it is not appropriate or possible to do so. When necessary, the standard shall be supplemented with additional details to ensure consistent application. When the customer does not specify the method to be used, the laboratory shall select appropriate methods that have been published either in international , regional or national standards, or by reputable technical organizations, or in relevant scientific text or journals or as specified by the manufacturer of the equipment. Laboratory developed methods or methods adopted by the laboratory may also be used if they are appropriate for intended use and if they are validated. The customer shall be informed as to the method chosen. The laboratory shall confirm that it can properly operate standard methods before introducing the tests or calibrations. If the standard method changes, the confirmation shall be repeated.

Back to top

B. Laboratory developed methods.
The introduction of test and calibration methods developed by the laboratory for its own use shall be a planned activity and shall be assigned to qualified personnel equipped with adequate resources.

Back to top

C. Non standard methods.
When it is necessary to use methods not covered by standard methods, these shall be subject to agreement with the customer and shall include a clear specification of the customer's requirement and the purpose of the test or calibration. The method developed shall have been validated to establish their performance characteristics and fitness for the intended purpose before use.

Back to top

D. Sources of methods.
Test methods are specific for the intended use. Several countries have published their National methods. Some times methods of international origin have been adopted as their National methods. In general, product-wise test methods can be obtained from:

1.Test methods on water
a) U.S.Environmental Protection Agency
1. http://www.epa.gov/waterscience/methods/
http://www.epa.gov/waterscience/pc/

b)American Public health association:
http://www.apha.org

2.Solid waste management :National technical information service

Paid site
http://www.ntis.gov/products/families/environmental_test_methods.asp?loc=4-3-2

3.Foods and allied Products:
a)AOAC
http://www.aoac.org

b)CODEX Alimentarius
http://www.codexalimentarius.net/web/standard_list.do

c)US FDA
http://www.cfsan.fda.gov

4.Drugs and Pharmaceutical products
a)US Pharmacopoeia
http://www.usp.org/USPNF/

b)British Pharmacopoeia
http://www.pharmacopoeia.co.uk/

c)Indian Pharmacopoeia
http://www.mohfw.nic.in/kk/95/ia/95ia0e01.htm

e)Japanese Pharmacopoeia
http://jpdb.nihs.go.jp/jp14e/

5.Chemicals and other Products
American Society for Testing and Materials Standards.
http://www.astm.com

6.International Organization for Standardization:
http://www.iso.org/cate/cat.html

7.American Society of Materials
http://www.asminternational.org

 

Shop Shop Software

Shop Borland Software shop

http://www.prosoftwarestore.com/

Shop Autodesk Software

Microsoft Software Symantec shop Windows Software MAC Software Adobe Software VMware Software Software Store