10 Records ISO 17025 Requires Your Lab to Keep
Why ISO 17025 Record-Keeping Matters
ISO/IEC 17025:2017 clause 8.4 explicitly requires laboratories to establish and maintain records to demonstrate that processes meet requirements. NATA-T assessors will ask to see these records directly. Missing records can result in a Major Nonconformance that affects accreditation status.
The 10 Records ISO 17025 Requires
1. Calibration Records
Clause 6.4.6 requires calibration records for every piece of equipment: readings, uncertainty, calibration date, due date, reference standard used, and the responsible person's signature.
2. Traceability Records
Clause 6.5 requires a documented chain of traceability back to national or international standards (NMI). Records must show the chain: instrument → reference standard → national standard (NIMT).
3. Personnel Records
Clause 6.2.5 requires records of qualifications, experience, and training for all personnel, including authorisation records for specific tasks.
4. Training Records
Clause 6.2.2 requires training plans and records of training effectiveness, updated when methods or requirements change.
5. Sample / Item Receipt Records
Clause 7.4 requires records of received items: description, condition, identification, and customer agreement. This is the start of the chain of custody.
6. Raw Data / Test Records
Clause 7.5 requires original observations and data used in calculations — not just the summary result. This includes worksheets, readings, formulas used, software version, and the operator.
7. Contract Review Records
Clause 7.1.1 requires documented pre-job review including customer agreements, deviations from scope, and approval from the authorised signatory.
8. OOS / Nonconformity Records
Clause 7.10 requires a process for handling nonconforming work, with records every time OOS occurs: investigation, corrective action, and the decision on how to proceed.
9. CAPA Records
Clause 8.7 requires a CAPA (Corrective and Preventive Action) system with records of root cause analysis, actions taken, and effectiveness monitoring.
10. Internal Audit Records
Clause 8.8 requires at least annual internal audits, with records of all findings, nonconformities, and corrective actions taken.
Record Retention Period
ISO 17025 clause 8.4.2 requires records to be kept "as required by legal or contractual obligations." For Thai calibration labs, 10 years is common practice; some industries (medical, pharma) require 15–25 years.
Digital vs Paper Records
ISO 17025 clause 8.4.1 permits both paper and electronic systems, but electronic systems must provide: tamper evidence, backups, access control, and an audit trail showing who changed what and when.
LabSync covers all 10 of these record types automatically. The hash-chained audit log cannot be edited or deleted. The 14-dimension compliance dashboard shows the status of each record type in real time — so your lab is audit-ready every day, not just before the assessor arrives.