NABL Laboratory Quality Management Checklist - India
This checklist supports NABL accreditation preparation against ISO/IEC 17025:2017 and NABL 112 specific criteria for testing and calibration laboratories. Designed for quality managers and technical managers in Indian testing and calibration laboratories.
- Industry: Healthcare
- Frequency: Quarterly
- Estimated Time: 60-90 minutes
- Role: Quality Manager / Technical Manager
- Total Items: 27
- Compliance: ISO/IEC 17025:2017 General Requirements for Testing Laboratories, NABL 112 Specific Criteria for Accreditation, ISO 9001:2015 (reference), NABL 120 Policy on Metrological Traceability
Management Requirements (ISO 17025 Cl. 8)
Quality management system requirements.
- Quality management system documented and implemented?
- Quality policy defined, communicated, and understood by all?
- Document control procedure ensuring current versions in use?
- Risk and opportunity analysis performed (Cl. 8.5)?
- Internal audit programme and records for last 12 months?
Personnel Competence
Personnel qualification, training, and authorisation.
- Technical staff qualifications documented and current?
- Written authorisation for specific test/calibration activities?
- Training records demonstrating competence maintained?
- Personnel under training supervised by competent person?
Equipment and Calibration
Equipment management and metrological traceability.
- Equipment inventory with unique ID, calibration status listed?
- All reference standards and measuring equipment calibrated by NABL-accredited lab?
- All calibration certificates current and within validity?
- Equipment maintenance records available?
- Out-of-service equipment clearly labelled and segregated?
Test Methods and Method Validation
Validation of test and calibration methods.
- Current versions of standard methods / SOPs in use?
- Method validation / verification records for non-standard methods?
- Measurement uncertainty evaluated and reported where required?
- Quality control samples (blanks, standards) run regularly?
Facility and Environmental Conditions
Laboratory environment and facility requirements.
- Environmental conditions (temperature, humidity) monitored and recorded?
- Access to laboratory controlled to prevent contamination?
- Incompatible activities in separate areas?
- Laboratory clean, tidy, and free of contamination risk?
- Non-conformances and observations
Reporting of Results
Test and calibration report compliance.
- Reports contain all mandatory elements per ISO 17025 Cl. 7.8?
- Reports signed / authorised by technically competent personnel?
- Report amendment procedure in place?
- Customer complaints procedure and records maintained?
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Why Use This NABL Laboratory Quality Management Checklist - India?
This nabl laboratory quality management checklist - india helps healthcare teams maintain compliance and operational excellence. Designed for quality manager / technical manager professionals, this checklist covers 27 critical inspection points across 6 sections. Recommended frequency: quarterly.
Ensures compliance with ISO/IEC 17025:2017 General Requirements for Testing Laboratories, NABL 112 Specific Criteria for Accreditation, ISO 9001:2015 (reference), NABL 120 Policy on Metrological Traceability. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the NABL Laboratory Quality Management Checklist - India cover?
This checklist covers 27 inspection items across 6 sections: Management Requirements (ISO 17025 Cl. 8), Personnel Competence, Equipment and Calibration, Test Methods and Method Validation, Facility and Environmental Conditions, Reporting of Results. It is designed for healthcare operations and compliance.
How often should this checklist be completed?
This checklist should be completed quarterly. Each completion takes approximately 60-90 minutes.
Who should use this NABL Laboratory Quality Management Checklist - India?
This checklist is designed for Quality Manager / Technical Manager professionals in the healthcare industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.