By Commenter Larry
The Structure of ISO 17025
There are two main groups of requirements under ISO/IEC 17025 - Management Requirements and Technical Requirements. Management Requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory. Technical Requirements address the competence of staff, methodology and test/calibration equipment, but also address issues critical to lab testing, such as method validation, traceability and sampling. See http://en.wikipedia.org/wiki/ISO_17025. In order to understand how ISO 17025 regulates lab testing, we’ll need to look at both the Management Requirements and the Technical Requirements.
There are fifteen Management Requirement and ten Technical Requirements under ISO 17025. The Management Requirements are:
4.1 Organization and management
4.2 Quality system
4.3 Document control
4.4 Request, tender and contract review
4.5 Sub-contracting of tests and calibrations
4.6 Purchasing services and supplies
4.7 Service to the client
4.9 Control of nonconforming testing and/or calibration work
4.11 Corrective action
4.12 Preventive action
4.14 Internal audits
4.15 Management reviews
The Technical Requirements are:
5.3 Accommodation and environmental conditions
5.4 Test and calibration methods including sampling
5.6 Measurement traceability
5.8 Handling of test and calibration items
5.9 Assuring the quality of test and calibration results
5.10 Reporting the results
In this article, we’re interested only in those ISO 17025 rules (as supplemented by the ISL) that deal with lab testing, and that might serve as the grounds for an “ISL departure” under the WADA rules. So we’re not interested in a number of the ISO 17025 requirements, such as how the lab does its contracting or how the lab hires its personnel. Also, you’ll probably note that the ISO 17025 requirements are not laid out in a logical order for reviewing how a lab performs its tests. Some of the steps we’d expect the lab to perform at the end of the testing process, such as corrective action, are listed before steps that the lab would need to take at the beginning of the testing process, such as test validation and sampling.
So for our purposes, I’d like to reorganize the ISO 17025 Requirements in a different way, so that we can focus just on those requirements dealing with lab testing, and so that we can consider those requirements in a more logical order. The order I propose to use is a sort of “chronological” order, with steps listed in the order that the lab must perform them in order to reach a valid result.
I propose to look at the ISO 17025 and ISL rules in the following order:
Rules governing test method development and validation (ISO Rule 5.4; ISL Rule 5.4.4)
Rules governing “quality control” (ISO Rule 5.9)
Rules governing sampling and other steps taken prior to actual testing (ISO Rules 5.7 and 5.8)
Rules governing how a lab must perform its tests
Rules governing how a lab must interpret the tests it performs
Rules governing the lab’s internal review of its work product (ISO Rules 4.9 and 4.11)
As should be apparent, we’re looking at only a handful of ISO Rules. Nevertheless, the task ahead of us is steep. The analysis of these six categories of rules will take us through a number of difficult and complex topics. We’ll only be able to examine the first of these six categories in this article.
Up to the Introduction; Back to part 3; On to part 5.