FINAS has defined the following phases for the adoption of the new standard, see here
The assessments according to the new standard will be done as part of the normal assessment visits. The laboratory may inform of the use of the new standard version in the material request form. FINAS is ready to start the assessments based on the new version from 1.8.2018. To be able to finalize all the assessment before the end of the transition period, all assessment will be done based on the new standard version after 1.8.2019.
New clients may apply accreditation based on the new standard version after 1.8.2018. The application forms are found here
All accredited testing and calibration laboratories must meet the requirements of the new standard so that the accreditation decisions based on the new standard can be made within the transition period before 30.11.2020.
Self-assessment of the changes
The laboratory shall make a comparison between standard versions and decide the actions to fulfill the requirements of the new standard. In the material request FINAS will ask about the results of the self-assessment and information about the changes made to the management system.
The main changes in the standard
The structure of the standard follows the structure of the 17000 standard family. As a new requirement the risk assessment of the laboratory's activities shall be made. The risk-based thinking applied has enabled some reduction in prescriptive requirements and their replacement by performance based requirements. The impartiality of the laboratory's activities has been highlighted.
Management system requirements: Options A and B
In Option A the management system requirements have been described in the standard. By showing the fulfilment of these requirements, the laboratory fulfils the management system requirements. The requirements takes into account the main requirements of the ISO 9001 standard and thus the laboratory fulfils at least the intent of the standard ISO 9001.
In option B the laboratory has established and maintains a management system, in accordance with the requirements of ISO 9001. The management system shall, however, ensure and demonstrate that the technical requirements of ISO/IEC 17025 standard are fulfilled. The fulfilment of the requirements of ISO 9001 alone does not demonstrate the laboratory's competence to produce technically competent results.
Regardless of which option the laboratory follows, FINAS ensures during the assessments that the management system fulfils the requirements of the standard. The management system shall support the laboratory's competent and reliable technical activities.
As a minimum the management system of the laboratory shall address the following; management system documentation, control of management system documents, control of records, actions to address risks and opportunities, improvement, corrective actions, internal audits and management reviews.
The standard is available from SFS
The standard is available from The Finnish Standards Association SFS. An English version of the standard has been published. SFS is responsible for the translation of the standard to Finnish and it will be published in the autumn 2018. More information is available from SFS (www.sfs.fi). The Swedish version of the standard is available from SIS (www.sis.se).
More information: Jenni Harjuoja (jenni.harjuoja(a)finas.fi)