Table of Contents
Transisition to the new version ISO/IEC 170:2017
- presentation of the main changes in apporoach (PDF, 531.77 KB)
Frequently asked questions
In case of nonconformities related exclusively to new or significantly different requirements introduced by the 2017 version of standard ISO/IEC 17025, the general provisions described in the document BELAC 3-11 for the resolution of nonconformities in the context of an initial assessment apply (paragraph 126.96.36.199.). Even if the transition assessment to the new version of the standard is a surveillance or extension assessment, the time-frames for resolving the nonconformities referred to above are not applicable and the laboratory therefore has a longer time period to resolve them.
The “new or significantly different” requirements are those highlighted in red in the document BELAC 6-101 that has been prepared as a support for transition assessments.
It is therefore important that the assessor mentions clearly in the E module the nonconformities for which the laboratory has a longer time-frame to resolve them.
- if the nonconformities linked to the transition cannot be closed within the normal time limits, the assessment phase must be subject to a decision so that the accreditation according to the 2005 version of the standard can at least be confirmed. The report (and consequently the E modules) will be completed when all corrective actions have been taken and an additional decision has to be taken to make the transition to the 2017 version of the standard. In order to allow sufficient time for all this, the corrective action will have to be taken at the latest on 1 September 2020.
- On 1st December 2020 all certificates (and technical annexes) referring to the conformity with the standard ISO/IEC 17025:2005 must be converted into accreditation certificates referring to conformity with the standard EN ISO/IEC 17025:2017. The bodies that fail to adapt themselves to the new standard at the end of the transition period will lose their certificate.
Can the concept “laboratory activities” be interpreted as referring only to “technical” activities? What about “associated” activities such as communication, the internal audit, the management review, the administration of the broader management system, the assessment of suppliers, the administrative support activities that have no direct impact on the test result?
The aim of the standard is to ensure the reliability of the test results issued by the lab through the support of an adequate management system.
The term “laboratory activities” therefore refers not only to the technical activities of performing tests but also to all closely related “technical” activities (such as calibrations or facilities management) or “organizational” activities linked to the management system that support the actual test process.
The concept “laboratory activities” should be understood in a global sense.
The accreditation of laboratory activities that are systematically outsourced is in fact forbidden. This requirement aims to guarantee that the laboratory’s competence can be demonstrated for any accredited activity.
This principle-based approach was already adopted by BELAC but case-by-case derogations remained possible (see document BELAC 1-03). The document BELAC 1-03 has been reviewed and only the systematic outsourcing of parts of testing is still possible, under strict conditions and involving a case-by-case derogation to be issued by the Accreditation Office BELAC.
Obviously, outside the accreditation, laboratories are still authorized to accept testing requests that will be systematically outsourced.
The new version of the standard is indeed less prescriptive on a number of points and the laboratory has a greater degree of freedom in establishing its policies and procedures. Thus, a quality policy declaration is no longer required.
A laboratory that wants to maintain a quality policy declaration - as well as a quality manual – as documentation tools for its policies and objectives is obviously free to do so; equivalent tools are nevertheless accepted if they can demonstrate the commitment of the laboratory to develop and implement a management system compliant with the requirements of the standard and to ensure its effectiveness from the perspective of continuous improvement.
IIn the new version of the standard, there are no more formal requirements:
- independence of the auditor with regard to the activities to be audited (no self auditing)
- competence of the internal auditor regarding the requirements of the standard ISO/IEC 17025 : 2017
- the content or frequency of the internal audits.
How does the laboratory therefore have to define its policy for internal audits?
The new version of the standard is indeed less prescriptive on a number of points and the laboratory has a wider margin of freedom for establishing its policies and procedures.
Nevertheless he laboratory must still be able to demonstrate the effectiveness of the internal audits that it puts in place as a tool to confirm that the announced technical performance level is met, that the test results are reliable and that the operation of the laboratory meets all accreditation requirements. The assessment of the internal audits by the accreditation assessors is therefore of crucial importance. The identification during a BELAC assessment of nonconformities not recorded during the internal audits can lead the BELAC assessor (but also the laboratory) to question the internal audit policy defined by the laboratory and its implementation (for instance in terms of the internal auditors’ competence, audit content and frequency).