DD ISO/TS 21098:2005

Foreword
Introduction
1 Scope
2 DNA-based analysis
3 Multi-laboratory studies
4 Description of information to be supplied about a
  method submitted to be annexed to ISO 21569, ISO 21570
  and ISO 21571
5 Validation of methods
  5.1 General
  5.2 Validation of quantitative methods
  5.3 Validation of qualitative methods
6 Process for adding, amending and retaining methods
  (as annexes)
  6.1 Expert group for consideration of the methods
  6.2 Addition of methods to the standards
  6.3 Amending of methods in the standards
  6.4 Retention of methods in the standards
Annex A (normative) Template for supplying the required
        information about a method to be annexed to ISO
        21569
Annex B (normative) Template for supplying the required
        information about a method to be annexed to ISO
        21570
Annex C (normative) Template for supplying the required
        information about a method to be annexed to ISO
        21571
Bibliography

Outlines the principles and specifies the nature of the information to be supplied for acceptance of a method as an annex to ISO 21569, ISO 21570 or ISO 21571. Specifies the process for adding, amending and retaining methods annexed to these standards.

This Technical Specification defines the principles and specifies the nature of the information to be supplied for acceptance of a method as an annex to ISO21569, ISO21570 or ISO21571. It also specifies the process for adding, amending and retaining methods annexed to these standards. This Technical Specification is necessary in order to attain consistency in methods that are to be employed as part of the standards. It does not cover the specifics of the development of a method or laboratory set-up. The operation of laboratories is covered in ISO/IEC17025.

Method validation is instrumental in assessing the reliability of a test method. Its central role is to establish numerical values for the performance criteria that are to be established. ISO24276 includes details on method validation, taking into consideration specific technical issues related to the detection of genetically modified organisms and derived products. Given the attention to, and widespread use of deoxyribonucleic acid-based tests or protein-based tests, and the implications to trade of any discrepancies in test results, a single-laboratory validation is most likely not warranted in this case and a multi-centre method validation could be performed according to the international guidelines.