Basic Training 4th Annual ICP Conference

17.12 Method Validation

ISO Guide 34:2000

ISO Guide 34:2000

ISO Guide 34:2000 assures: § The chemical and physical stability of the product must be determined before assigning expira@on dates § The Cer@ficate of Analysis must meet ISO Guide 31 requirements § The Cer@fied Value must be traceable to a cer@fied Na@onal Standard (IV uses NIST SRMs).

ISO / IEC 17025

ISO 9001:2000

17.13 Method Validation

Every ISO Guide 34 Registered Organiza7on Must use the following ISO Guides (These Guides define the boundaries, in how one operates under ISO Guide 34)

ISO Guide 34:2000

• ISO Guide 30 - Terms & Definitions Used in Connection with Reference Materials • ISO Guide 31 - Contents of Certificates of Analysis • ISO Guide 32 - Calibration in Analytical Chemistry and Use of Certified Reference Materials • ISO Guide 33 - Uses of Certified Reference Materials • ISO Guide 35 - Certification of Reference Materials - General and Statistical Principles

ISO / IEC 17025

ISO 9001:2000