In October 2026, ASEAN released the ASEAN Guideline on Integrating ISO/IEC 17025:2017 — Risk and Opportunity Management in Quality Control and Method Review Processes for Cosmetic Testing (V1 Final). The guideline has been endorsed at the 26th ASEAN Cosmetic Testing Laboratory Committee (ACTLC) Meeting and the 43rd ASEAN Consultative Committee for Standards and Quality (ACC) Meeting.
Intended for cosmetic testing laboratories, the guideline introduces a risk-based approach to the review of in-house validated methods. Relevant cosmetic testing laboratories and enterprises exporting cosmetics to ASEAN should pay attention. CIRS Group has summarized the main contents of the guideline as follows for reference.
Background of the Guideline
ISO/IEC 17025:2017, General Requirements for the Competence of Testing and Calibration Laboratories, allows laboratories flexibility in developing their management systems. Compared with the previous version, the 2017 version is overall more risk-based and less procedure-based, with the key change being the application of risk-based thinking, which reduces prescriptive requirements and replaces them with performance-based requirements.
At the 19th ASEAN Cosmetic Testing Laboratory Committee Meeting, Singapore proposed applying a risk-based approach to the cosmetic quality control and method review processes in accordance with ISO/IEC 17025:2017; subsequently, a technical working group (TWG) comprising Brunei, Thailand, and Singapore was established.
The TWG's terms of reference include collating information from ACTLC members on their current method review processes, reviewing existing approaches, and developing common approaches that meet the method review requirements of ISO/IEC 17025:2017 while preserving quality integrity and remaining compliant with the ISO/IEC 17025 requirements.
Scope
This guideline provides guidance on applying a risk-based approach to the review of in-house validated methods. It is particularly applicable to in-house validated methods in cosmetic testing laboratories and can, where necessary, be extended to other in-house validated methods, but it does not apply to standard or official methods.
The guideline is intended to help ASEAN Member State (AMS) laboratories demonstrate that they operate competently and are able to generate reliable testing results.
Evaluation on Method Review Frequency
The guideline requires that the following aspects be considered during the evaluation process:
Table 1 Aspects Considered in the Method Review Process
| Aspect | Description of information |
| Frequency of use | Frequently, occasionally, or rarely |
| Instrument/facilities replacement | Review to be conducted when the instrument is replaced or moved to different facilities |
| Changes in parameters or matrices | New cosmetic matrix, changes in control forms or Excel spreadsheets |
| Quality control | Outcomes of internal quality control or quality assurance programs, e.g., proficiency testing |
Possible risks associated with this approach include: A. Personnel may need time to re-familiarise with the method due to infrequent use; B. Delay in results delivery to stakeholders; C. Validation challenges; D. Resource constraints; E. Regulatory change; F. Unsatisfactory proficiency testing results.
CIRS Reminder
Although this guideline targets testing laboratories, the quality of testing data underpinning cosmetic safety assessment and filings in ASEAN is directly affected by laboratory method management. Relevant enterprises are advised to pay attention to the following aspects:
(1) Pay attention to the method management of contracted testing institutions: when commissioning testing from ASEAN laboratories, enterprises may check whether the laboratory has established a risk-based method review system, and where necessary request quality control evidence such as method validation, spike recovery, or reference material results, to ensure that the testing data can be used for product safety assessment and filing;
(2) For enterprises with laboratories or in-house testing capabilities in ASEAN: review the frequency of use of each test method, instrument and facility changes, matrix changes, and proficiency testing results against the guideline, and establish a risk-based method review schedule to balance compliance and operational efficiency;
(3) Distinguish method types and follow up on subsequent implementation updates: the management requirements under this guideline do not apply to standard methods and officially designated methods. Confirm the category of test methods adopted with the laboratory prior to commissioning testing, and keep track of the adoption progress and supporting implementation arrangements of this guideline among ASEAN Member States.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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- ASEAN Cosmetics Notification
- ASEAN Cosmetics Formula/Label Review
- ASEAN Cosmetics Regulatory Compliance Consultation
Further Information:
Integrating ISO/IEC 17025:2017 Risk and Opportunity Management in Quality Control and Method Review Processes for Cosmetic Testing
