9.1 Quality Management System
157
that there is confirmation that it is performing in accordance with the requirements
of that document.
Standards from ISO 9000 series state the management rules and the general rules
of quality management; however, they do not refer in detail to specific technical
areas. That lack of trade reference has resulted in the need to develop requirements
tailored to certain technical sectors. Because the ISO 9001 standard does not contain
in its scope the technical aspects related to the performance of the test and calibration
laboratories, a document was drafted, designed especially for the needs of evaluating
the technical activity of test and calibration laboratories: the ISO/IEC 17025 standard
General Requirements for the Competence of Testing and Calibration Laboratories.
It is worth noting that the first edition comes from 1999—that is, before the ISO
9001:2000 standard was issued. The ISO/IEC 17025 standard replaced two previously used documents, ISO/IEC Guide 25 and EN 450010, and at the same time, it
referred to the ISO 9001 and ISO 9002 standards issued in 1994. The next, updated
edition of the ISO 9001:2001 standard (replacing the two mentioned above) has led to
the need to update the ISO/IEC 17025 accordingly. The second issue of the ISO/IEC
17025:2005 was valid until the end of 2017, when the ISO/IEC 17025:2017 was
approved.
The withdrawn ISO/IEC 17025:2005 standard comprises five chapters, out of
which the most important are Chaps. 4 and 5. Chapter 4 includes the requirements
regarding the management of the laboratory, and Chap. 5 includes the requirements
regarding the technical performance, including proper equipment for laboratories,
the development of measuring procedures, ensuring proper environmental conditions
(e.g., temperature, humidity), and so on.
The current edition of ISO/IEC 17024:2017 supersedes the previous version. A
new structure has been adopted to align the standard with the other existing ISO/IEC
conformity assessment standards such as the ISO/IEC 17000 series on conformity
assessment. It also covers technical changes, vocabulary and developments in IT.
It should be highlighted that the major requirements for the competence of testing
and calibration laboratories has stayed as it was; however, the scope was extended
to also cover sampling associated with subsequent calibration and testing. The new
expectation is a focus on the process approach, which also matches ISO 9001 (quality
management), ISO 15189 (quality of medical laboratories) and ISO/IEC 17021-1
(requirements for audit and certification bodies). Moreover, the requirements related
to risks and opportunities are added. Finally, the new edition focuses on information
technologies and incorporates the use of computer systems, electronic records and
the production of electronic results and reports.
All revised standards put the emphasis on the processes instead of the detailed
description of its tasks and steps. As already mentioned, the updated standard focuses
on information technologies and incorporates the use of computer systems, electronic
records and the production of electronic results and reports. The concept of riskbased evaluation of the laboratory activities is newly introduced. Last but not least,
the terminology has been updated to be more in accordance with other standards and
technical documents.
157
that there is confirmation that it is performing in accordance with the requirements
of that document.
Standards from ISO 9000 series state the management rules and the general rules
of quality management; however, they do not refer in detail to specific technical
areas. That lack of trade reference has resulted in the need to develop requirements
tailored to certain technical sectors. Because the ISO 9001 standard does not contain
in its scope the technical aspects related to the performance of the test and calibration
laboratories, a document was drafted, designed especially for the needs of evaluating
the technical activity of test and calibration laboratories: the ISO/IEC 17025 standard
General Requirements for the Competence of Testing and Calibration Laboratories.
It is worth noting that the first edition comes from 1999—that is, before the ISO
9001:2000 standard was issued. The ISO/IEC 17025 standard replaced two previously used documents, ISO/IEC Guide 25 and EN 450010, and at the same time, it
referred to the ISO 9001 and ISO 9002 standards issued in 1994. The next, updated
edition of the ISO 9001:2001 standard (replacing the two mentioned above) has led to
the need to update the ISO/IEC 17025 accordingly. The second issue of the ISO/IEC
17025:2005 was valid until the end of 2017, when the ISO/IEC 17025:2017 was
approved.
The withdrawn ISO/IEC 17025:2005 standard comprises five chapters, out of
which the most important are Chaps. 4 and 5. Chapter 4 includes the requirements
regarding the management of the laboratory, and Chap. 5 includes the requirements
regarding the technical performance, including proper equipment for laboratories,
the development of measuring procedures, ensuring proper environmental conditions
(e.g., temperature, humidity), and so on.
The current edition of ISO/IEC 17024:2017 supersedes the previous version. A
new structure has been adopted to align the standard with the other existing ISO/IEC
conformity assessment standards such as the ISO/IEC 17000 series on conformity
assessment. It also covers technical changes, vocabulary and developments in IT.
It should be highlighted that the major requirements for the competence of testing
and calibration laboratories has stayed as it was; however, the scope was extended
to also cover sampling associated with subsequent calibration and testing. The new
expectation is a focus on the process approach, which also matches ISO 9001 (quality
management), ISO 15189 (quality of medical laboratories) and ISO/IEC 17021-1
(requirements for audit and certification bodies). Moreover, the requirements related
to risks and opportunities are added. Finally, the new edition focuses on information
technologies and incorporates the use of computer systems, electronic records and
the production of electronic results and reports.
All revised standards put the emphasis on the processes instead of the detailed
description of its tasks and steps. As already mentioned, the updated standard focuses
on information technologies and incorporates the use of computer systems, electronic
records and the production of electronic results and reports. The concept of riskbased evaluation of the laboratory activities is newly introduced. Last but not least,
the terminology has been updated to be more in accordance with other standards and
technical documents.