Extraordinary Surveillance Assessment Meeting under ISO 20387:2018 Standards
Held at Innovate Biotech Co., Ltd. on 20 January 2025
Meeting Participants
- Assoc. Prof. Dr. Nattawat Onlamoon – Lead Assessor
- Ms. Nattakarn Laiddee – Senior Medical Technologist
- Mr. Anapat Pakdeesuk-anan – General Manager
- Dr. Natakarn Nimsanor, MT – Lab Manager, Quality Manager
- Dr. Patcharapa Tragoonlugkana, MT – Assistant Lab Manager, LSO, DCC
- Ms. Oraya Lersprajak – Laboratory Officer
- Ms. Jiranan Buthongjan – Document Control Officer
Surveillance Findings
The following areas were reviewed during the extraordinary assessment:
Human Research Ethics Certification (Clause 7.2.3.4)
It was found that the laboratory had not yet completed human research ethics certification to support biological sample storage operations.
However, the approval application has now been submitted, and the organization is currently in the process of implementing a new system-wide sample collection procedure.
Biological Sample Usage Agreement (Clause 7.3.3.2)
It was identified that no formal agreement had yet been established regarding the use of biological samples.
The meeting resolved that such agreements must be developed in compliance with personal data protection policies and relevant documentation, including:
- QM-001
- F-001-QP-13
- F-002-QP-013
Withdrawal of Data and Sample Retention (Clause 7.7.8)
It was found that clear procedures for withdrawal of data and biological sample retention had not yet been formally established.
The meeting therefore resolved that comprehensive procedures and associated forms must be developed, referencing:
- QM-001
- QP-010
- F-001-QP-010
- F-002-QP-010
Validation and Verification Processes (Clause 7.9.2)
Validation and verification activities had been conducted, and related reports were available.
However, acceptance criteria and clear conclusions were not explicitly documented within the forms.
The meeting resolved that all related documentation must be revised and completed, referencing:
- WI-003-QP-017
- WI-004-QP-017
- Relevant supporting forms
