Job Purpose
To establish, implement, maintain, and continually improve the Laboratory Management System (LMS) in accordance with NABL requirements and ISO/IEC 17025:2017 standards, ensuring technical competence, impartiality, and consistent operation of laboratory activities.
Key Responsibilities
1. Management System Implementation
- Develop, implement, and maintain the Quality Management System (QMS) as per ISO/IEC 17025:2017 & NABL criteria.
- Ensure compliance with NABL specific guidelines, policies, and circulars.
- Control and update Quality Manual, SOPs, formats, and records.
- Ensure document and record control as per Clause 8 requirements.
2. Compliance & Accreditation
- Coordinate NABL accreditation process, including application, surveillance, reassessment, and scope extension.
- Act as the primary contact for NABL assessors.
- Ensure closure of Non-Conformities (NCs) within stipulated timelines.
- Monitor compliance with statutory and regulatory requirements.
3. Internal Audits & Management Review
- Plan and conduct internal audits as per ISO 17025 Clause 8.8.
- Prepare audit reports and ensure corrective actions are implemented.
- Organize Management Review Meetings (MRM) and maintain records.
- Track effectiveness of corrective and preventive actions.
4. Risk Management & Continual Improvement
- Implement risk-based thinking as per ISO 17025 Clause 8.5.
- Identify risks and opportunities related to laboratory activities.
- Monitor KPIs and quality objectives.
- Drive continual improvement initiatives.
5. Control of Non-Conforming Work
- Ensure proper handling of non-conforming work (Clause 7.10).
- Root cause analysis and corrective action implementation.
- Maintain records of complaints and feedback (Clause 7.9).
6. Proficiency Testing & Quality Control
- Monitor participation in Proficiency Testing (PT)/Inter-Laboratory Comparisons (ILC).
- Ensure corrective actions for unsatisfactory PT performance.
- Review quality control data for trend analysis.
7. Training & Competence
- Identify training needs for laboratory personnel.
- Ensure competency evaluation and authorization records are maintained.
- Promote awareness of quality policies and procedures.
8. Impartiality & Confidentiality
- Ensure laboratory activities are conducted impartially.
- Monitor conflict of interest declarations.
- Maintain confidentiality of client information.
Authority
- Authority to stop work in case of non-compliance.
- Approve quality documents and amendments.
- Initiate corrective and preventive actions.
- Direct access to top management on quality matters.
Educational Qualification
- Bachelor's/Master's degree in Science / Engineering / relevant technical discipline.
- Training in ISO/IEC 17025:2017 and internal auditing (certified preferred).
Experience
- Minimum 58 years of experience in a testing/calibration laboratory.
- At least 23 years in quality management role.
- Experience in handling NABL assessments.
Key Skills & Competencies
- Strong knowledge of ISO/IEC 17025:2017 & NABL requirements.
- Internal audit and root cause analysis skills.
- Documentation and report writing skills.
- Good communication and leadership abilities.
- Knowledge of measurement uncertainty (desirable).