Process requirements

Method selection and validation

Using appropriate methods and, when non-standard, documenting their validation before use.

Sampling

A sampling plan based on appropriate statistical methods when the laboratory performs the sampling.

Handling of test or calibration items

A unique identification and traceability system for every item, from receipt through to final disposal.

What an auditor usually asks for

• Documented validation for non-standard methods
• A sampling plan where the lab samples
• Unique identification for every test item
• A handling log from receipt through to disposal

How to cover process in Kimobox

1. 1Manage method validation as a controlled document linked to the process.
2. 2Log each item's unique identification in the system from receipt onward.
3. 3Document the sampling plan whenever the lab carries it out.

Where each figure comes from

References to the official text in force. If a standard is revised, this page is updated and the review date says so.

1. ISO/IEC 17025:2017 — General requirements for the competence of testing and calibration laboratories ISO/IEC · November 2017
2. Entidad Nacional de Acreditacion ENAC · Official portal
3. ISO/IEC 17000:2020 — Conformity assessment. Vocabulary ISO/IEC · 2020 ed.