Malaysian deadlines set by Standards Malaysia
1 January 2018

All new applications

New applications submitted after 1 January 2018 will be assessed using ISO/IEC 17025:2017

All accredited laboratories

Accredited laboratories may request in writing for assessment transitioning to ISO/IEC 17025:2017

1 July 2018

All existing applicants and accredited laboratories

All existing applicants and accredited laboratories to submit Transition Plan to Standards Malaysia

1 January 2019

All existing applicants and accredited laboratories

Existing applicants (before 1 January 2018) and accredited laboratories shall be assessed to ISO/IEC 17025:2017

30 November 2020

All laboratories

End of transition period
New Revision ISO 17025:2017
Clauses of ISO/IEC 17025 that require revision:

The clauses of ISO/IEC 17025 where there is consensus amongst the IILAC AIC that revision is needed include:

5.4 Calibration, Measurement Uncertainty & Validation/Verification
5.5 Equipment (possibly)
5.6 Traceability*
5.7 Sampling
5.9 Quality Assurance including Proficiency Testing
5.10 Reporting Results (opinions/interpretation)
Other areas that should be considered in the revision include, not listed in order of importance:

The terminology used in the current standard is outdated and causes confusion in today’s world, e.g. changes to VIM terminology and the fact that hard copy is now rarely used for manuals, records and reports;
The scope requires revision and updating to cover new areas;
ISO/IEC 17025 takes a prescriptive approach and is out of step with the modern standards approaches which are performance-based or process-based. The formatting should also be matched to newer standards such as ISO 9001, ISO 15189, ISO/IEC 17020, ISO/IEC 17043, ISO/IEC 17021, ISO/IEC 17065; Bio-security and bio-safety considerations associated with laboratory work should be added;
Impartiality needs to be addressed in a more informed way;
Subcontracting circumstances need to be clarified (reference to how this is handled in ISO/IEC 17043 would be helpful);
Traceability requirements should be expanded/clarified along more informed lines; Sampling and sub-sampling needs to be considered with more recognition that reliable test results are directly related to sampling;
Consider pre- and post- analysis requirements; Reconsider the handling of testing and calibration as separate parts of the standard. The reasons for any different approaches in the standard between these areas should be clarified;
Review ISO/IEC 17000 and its relevance to ISO/IEC 17025;
Incorporate and recognise the use of computer systems, electronic records and report issue, as well as remote issue, of results/reports;
Address software validation to allow for its relevance to testing and result generation, as well as records management;
Clarify further the possible conflict that may exist between ISO/IEC 17025 and national regulations and the need to establish precedence;
Consider the relevance of the product certification standard (ISO/IEC 17065) to ISO/IEC 17025;
Ensure that notes are avoided in the future standard version. There are too many notes included in the current version which make it difficult to use;
Update the Bibliography.
The proposal states that ISO 17025 is not a management system standard (MSS) so it will not have to follow the mandatory clause structure and common text that is now required for all new or revised MSS’s.

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More about ISO 17025:2017
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