» Technical Bulletin – ISO/IEC 17025: 2017 Guidance for Accredited and Applicant Laboratories

25 January, 2018

Following the publication of ISO/IEC 17025:2017, this bulletin has been produced to update laboratories and stakeholders on the UKAS transition process and overall timelines for transition of laboratory accreditation to this new version of the standard.

Timeline:

Date

Milestone/Activity

30 November 2017

ISO/IEC 17025: 2017 issued

December 2017 to February 2018

UKAS preparation

1 March 2018

UKAS ready to start assessing to ISO/IEC 17025: 2017

1 March 2018

to 31 Dec 2018

Optional Stage: Labs can choose to be assessed to the 2017 version or remain with the 2005 version. In any case reports may highlight major deviations from the new standard

01 July 2018 onwards

Only applications to ISO/IEC 17025:2017 accepted

1 January 2019 onwards

All initial assessments will be to ISO/IEC 17025: 2017

1 January 2019 onwards

(assessment visits should be completed by 31 May 2020)

Mandatory Stage: All assessments will be to ISO/IEC 17025: 2017

1 December 2020

Accreditations to ISO/IEC 17025: 2005 cease to be valid.     Laboratories that have not transitioned to the 2017 version by this date will no longer be able to claim accreditation for their test or calibration results.

 

UKAS transition process for accredited laboratories:

UKAS will be ready to begin the transition of its accredited laboratories to ISO/IEC 17025:2017 from 1st March 2018. However, assessments to the requirements of ISO/IEC 17025:2017 will not be mandatory until 1st January 2019. Therefore, during the period of March to the end of December 2018 laboratories will be given the option of either delaying their transition until the following year or deciding to bring it forward to 2018. It is proposed that the transition assessments be undertaken with the scheduled annual UKAS visits.

When arrangements are being made for the 2018 assessment, laboratories will need to inform UKAS if they wish the assessment to be conducted to the 2017 version of the standard. There will be no need for a formal application requesting transition to be completed.

If a laboratory does not wish to transition early, its UKAS assessment team, from March 2018 onwards, will continue to assess against the 2005 version, but may highlight any areas that will need to be addressed in order to comply with the revised version – these shall be recorded as recommendations.

From the beginning of 2019, all UKAS assessments of accredited laboratories will be conducted against the requirements of ISO/IEC 17025:2017. These will be combined with the laboratories’ annual assessment visits.

In preparation for the transition assessment, each laboratory will be required to complete an ‘assessment readiness’ gap analysis proforma and return it to UKAS at least 1 month prior to the assessment. This proforma will be provided by UKAS at the time the transition assessment is arranged, although it will also be made available on the UKAS website.

The proforma will identify where changes have been made in ISO/IEC 17025, and it will be the responsibility of the laboratory to consider the extent and impact of these changes, and to complete the form to state what changes (where necessary) it has made in order to meet the revised and new requirements in ISO/IEC 17025:2017.

Additional office time will be required by UKAS to review the changes made by the laboratory, as highlighted in the proforma. Subject to the extent of the changes made by the laboratory, it is not anticipated that additional site time will be required for most laboratories. The additional time required as part of the transition will be chargeable, with a fee to cover the desk assessment, primarily of the assessment readiness questionnaire and submitted evidence. This will vary depending on the size/complexity of the laboratory and hence the expected time to complete the review. This is likely to be ½ day for laboratories with very small scopes of accreditation, to 1 day for larger scopes and possibly more for those that are more complex (e.g. multi-site).

Any additional site visits arranged to specifically assess the transition to ISO/IEC 17025:2017 will need to cover changes to both the management system and technical requirements for laboratory accreditation and, as such, will require input from both UKAS Lead and Technical Assessors. Such visits will be chargeable at the rate in force at the time (see UKAS Terms of Business) and will require more effort (assessment days) than if combined with the annual assessment.

The effectiveness of the changes shall be verified by the assessment team during the site visit. If areas are identified that do not adequately fulfil the requirements then these will be raised as findings. All mandatory findings must be addressed by the laboratory in the normal way before accreditation can be formally transitioned to ISO/IEC 17025:2017.

The deadline for transition to the new version has been internationally agreed as three years from the date of publication, meaning that from 1st December 2020 only accreditation to the 2017 version will be valid. It is therefore imperative that all accredited laboratories are fully transitioned before this date, and the UKAS transition timeline is based around this.

A new certificate and schedule of accreditation referencing ISO/IEC 17025:2017 shall be issued to each laboratory following the successful decision on its transition. Annual visit dates, current year in the accreditation cycle, initial accreditation dates and UKAS reference number will remain unchanged.

The accreditation of laboratories that fail to transition by the deadline of 30 November 2020 will cease to be valid from that date. Their accreditation will be listed as ‘suspended’ for up to six months until such time that they can demonstrate to UKAS that they meet the requirements of ISO/IEC 17025: 2017.

 

UKAS transition process for applicant laboratories:

Laboratories that have already applied to UKAS for accreditation to ISO/IEC 17025:2005 but have not yet had their accreditation granted, may continue with the accreditation process to ISO/IEC 17025: 2005 (following grant of accreditation these laboratories will need to transition to ISO/IEC 17025:2017 before 1st December 2020). However, if the assessment has not been conducted by 1st January 2019 then the applicant will need to change to, and be assessed against, the requirements of ISO/IEC 17025: 2017, with any mandatory findings being satisfactorily address before accreditation can be granted.

Laboratories that are considering applying to UKAS for accreditation should consider developing their systems and processes in accordance with ISO/IEC 17025:2017. Those that have already prepared an application against the 2005 version can still submit it, but should be aware of the dates specified above, and that they will then need to transition to the 2017 version before the deadline.

UKAS will not accept any new applications for accreditation to ISO/IEC 17025: 2005 after 30th June 2018.

 

Further details and contact:

Further details on the transition of ISO/IEC 17025, including obtaining a copy of the new version, can be found in the Customer Area of the UKAS website.

Queries regarding the transition process should be directed to the laboratory’s appointed assessment manager.

Alternatively, please contact trevor.thompson@ukas.com or kevin.belson@ukas.com

 

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