The Open University of Hong Kong (OUHK) organized the seminar named "Challenges in Implementation of Laboratory Management according to ISO/IEC 17025:2017 " on 25th July 2019. Dr. Eric Tung-Po Sze was the speaker and he introduced the different between ISO/IEC 17025:2017 and ISO/IEC 17025:2005 version. The main changes stated in the new version were risk-based thinking, greater flexibility and definition of laboratory. Firstly, Dr. Eric Sze mentioned the use of information technology (e.g. LIMS) and new definition of Laboratory that laboratory activities included testing, calibration and “sampling, associate with subsequent testing or calibration”.
Then Dr. Sze stated the verbal forms used in the new version from strong level to weak level term and they were “Shall” > “Should” > “May” > “Can”.
And then he introduced the new version standard structure. The old one mainly separated into clause 4 – Management requirements and clause 5- Technical requirements. The new one separated into clause 4 – General requirements, clause 5 – Structural requirements, clause 6 – Resource requirements, clause 7 – Process requirements and clause 8 – Management requirements.
Dr. Sze use a common flow to explain the processes of laboratory. However, some participants discussed the sequence of review of request and sampling. “It is depended on what type of testing you performed.” Dr. Sze replied.
After that he mentioned the alignment with ISO 9001 in management requirement and introduced the Option A (defined in ISO/IEC 17025) and Option B (in accordance with ISO 9001).
In according to ISO 9001, your system followed the Plan-Do-Check-Act cycle and defined the policy and objectives. They should address Competence, Impartiality and Consistent Operation (e.g. intra-lab test).
Risk-based Thinking was new requirement. We needed to plan action to address these risks and opportunities. Dr. Sze said we could made reference with ISO 31000 and he gave some example for risk (e.g. manpower, safety) and opportunity (e.g. new standard and requirement).
And then he discussed the internal audit requirement between new and old version. We needed to compile ISO/IEC 17025:2017 requirement and laboratory’s own requirements, as well as, consider the effectively implementation (e.g. how effect of checklist use and do we had monitored it regularly?).
The impartiality could be referred to organization structure and the confidentiality should consider the terms and condition (in contract) to be legally enforceable commitment. He employed an example about Disney ordered factory to produce some toy and contracted testing to independent laboratory.
After that Dr. Sze briefed the definition of equipment in 2005 version and he explained that equipment definition extended in 2017 including but not limited to measuring instruments, software, measurement standards, reference materials, reference data, reagents, consumables or auxiliary apparatus, etc.
In order to reduce the confusion among supplies, services providers and subcontractors, the new standard used external providers.
One important item about decision rule in clause 7.4.3 – When the customer requires the item to be tested or calibrated acknowledging a deviation from specified conditions, the laboratory shall include a disclaimer in the report.
Finally, Dr. Sze briefed the different between verification and validation. If you followed standard method to run the test straightly, it performed verification using CRM / Reference Standard. If you used the modified standard method or extended its usage, it performed validation using CRM / Reference Standard.
Lastly, Dr. Sze also discussed the complaints which needed a documented process and a description of the handling process. At the end, Dr. Sze introduced Hong Kong Institution of Certified Auditors (HKICA).
OUHK – Testing and Certification: http://tc.ouhk.edu.hk/about_testing_and_certification/
HKSQ Certification Scheme “Certified Laboratory Quality Specialist (CLabQS)”: http://www.hksq.org/cert_hksq_clabqs.htm .
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