Laboratory Management System Requirements of ISO/IEC 17025
How the standard is structured
- Clauses 4–7 are technical/operational and apply to every laboratory regardless of which option is chosen at 8.1.
- Clause 8 is the management system block; 8.1 is the fork between Option A and Option B.
Clause blocks to know in order
- 4 General requirements - 4.1 impartiality, 4.2 confidentiality.
- 5 Structural requirements - legal entity, defined organisation and management, documented range of laboratory activities, adequate premises and equipment, competent personnel with authority, documented procedures to the extent necessary, control of documentation.
- 6 Resource requirements - 6.2 personnel (competence, authorisation, monitoring), 6.3 facilities and environmental conditions, 6.4 equipment, 6.5 metrological traceability, 6.6 externally provided products and services.
- 7 Process requirements - 7.1 review of requests, tenders and contracts; 7.2 selection, verification and validation of methods; 7.3 sampling; 7.4 handling of items; 7.5 technical records; 7.6 evaluation of measurement uncertainty; 7.7 ensuring validity of results; 7.8 reporting of results; 7.9 complaints; 7.10 nonconforming work; 7.11 control of data and information management.
- 8 Management system requirements - 8.2 documentation, 8.3 control of documents, 8.4 control of records, 8.5 risks and opportunities, 8.6 improvement, 8.7 corrective actions, 8.8 internal audits, 8.9 management reviews.
Worked example
An intermediate check on a balance exceeds its tolerance. Under 7.10 the equipment is taken out of service and labelled, the significance of affected results is evaluated, the customer is notified in writing where results are compromised, work is recalled, and resumption is authorised only after verification. The root cause goes through 8.7 corrective action, and all records are retained.
Traps that cost marks
- Mixing 7.9 complaints with 7.10 nonconforming work - one is customer-initiated, the other is lab-detected.
- Assuming standard methods need validation; 7.2 requires verification of standard methods and validation only for non-standard, laboratory-developed, modified or out-of-scope methods.
- Forgetting 7.8.6: a decision rule must be documented and communicated before any statement of conformity.