Practical sheet | REF: FIC1432 V1

Documentary traceability obligations and management

Author: Benoît BOUDIER

Publication date: March 10, 2015 | Lire en français

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1. What is the philosophy behind ISO/IEC 1025 regarding documentation?

Documentation is dealt with in ISO/IEC 17025 in three separate paragraphs: 4.3 Control of documentation, 4.13 Control of records and 5.4.7 Control of data. However, there is no requirement for laboratories to deal with them through separate processes.

The aims of the ISO/IEC 17025 requirements are, for the laboratory, to :

  • formalize its activities, i.e. "write down" in a document the way in which the laboratory has chosen to carry out its technical services (analysis, testing, calibration) and its quality-related activities. This is a systematic approach;

  • control the documents it produces, otherwise known as internal documentation or internal provisions;

  • master the external documents (standards, regulations, publications) it uses to provide technical...

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What is the philosophy behind ISO/IEC 1025 regarding documentation?