ISO 9001:2015 Certified Laboratory in Kollam

As an ISO 9001:2015 certified laboratory, we uphold a world-class Quality Management System (QMS) that ensures accuracy, reliability, and excellence across every aspect of our service.

What is ISO 9001:2015?

ISO 9001:2015 is the globally recognized international standard for establishing, implementing, and continually improving a Quality Management System. Developed by the International Organization for Standardization (ISO), it provides a robust framework ensuring organizations consistently deliver products and services that meet both customer and statutory requirements.

Key Principles of ISO 9001:2015

1. Customer Focus – Prioritizing customer requirements and enhancing satisfaction.
2. Leadership – Demonstrating commitment and guiding the organization’s QMS.
3. Engagement of People – Involving staff at all levels.
4. Process Approach – Viewing activities as interrelated processes.
5. Improvement – Striving for continual enhancement.
6. Evidence-based Decision Making – Basing decisions on systematic analysis.
7. Relationship Management – Managing partnerships for mutual benefit.

The 2015 version updated previous editions by introducing risk-based thinking, strengthening leadership involvement, restructuring documentation, and expanding QMS applicability to services.

Why ISO 9001:2015 Matters to Our Clients

• Consistency & Reliability: Standardized protocols—from sample collection to reporting—guarantee reproducible, dependable results.
• Risk Management: We proactively identify risks and opportunities, minimizing errors and enhancing quality.
• Continuous Improvement: The Plan–Do–Check–Act cycle ensures we regularly review and refine our operations.
• Global Acceptance: Our ISO and NABL accreditations mean our reports are respected nationally and internationally.

Our Quality Management Framework

Context of the Organization

We regularly analyze external trends (e.g., regulatory changes, technological advances, healthcare demands) and internal factors (e.g., infrastructure, staffing, systems) to define the scope of our QMS and address stakeholder needs effectively .

Leadership

Our leadership team champions the QMS, establishes a clear quality policy (aligned with ISO section 5.2), sets measurable objectives, delegates responsibilities, and ensures all staff understand and align with our goals.

Planning

We set SMART quality objectives, conduct risk assessments, and identify improvement and change initiatives. This planning phase is vital to ensure continuity and quality in our laboratory services .

Support

We invest in well-trained, certified professionals, state-of-the-art infrastructure, and comprehensive documentation systems to maintain integrity and accuracy across all QMS processes quickerala.com. Our lab also adheres to NABL (ISO 15189) standards, further reinforcing technical competence.

Operation

All diagnostic processes—test design, validation, execution, result evaluation—follow strict operational guidelines. We control non-conformities, manage external providers, and ensure accurate identification and traceability for samples and reports the9000store.com.

Performance Evaluation

Through internal audits, data analysis, monitoring of customer satisfaction, and leadership reviews, we systematically assess our QMS. This ensures transparency, accountability, and timely corrective actions .

Improvement

Focused on root‑cause analysis, corrective actions, and ongoing enhancements, we embed improvement into our daily operations—fostering efficiency and client satisfaction see Quality policy.

NABL & ILAC-MRA Accreditations

Our NABL (ISO 15189:2012) accreditation attests to our technical capability and precise test methods. Moreover, ILAC‑MRA recognition ensures our results are globally accepted—eliminating the need for repeat testing in international contexts.

What Sets Devi Clinical Laboratory Apart?

Holistic Excellence

• ISO 9001:2015 – A comprehensive management system ensuring consistency, risk governance, and continual improvement.
• NABL ISO 15189 – Affirms our technical accuracy and method competency.
• ILAC-MRA – Ensures our results are trusted worldwide.

This multi-tiered accreditation underlines our unwavering commitment to quality and dependability.

Patient-Centric Approach

From transparent pricing and turnaround times to responsive communication and meticulous reporting, we put patients first in every process.

Advanced Infrastructure & Systems

Our facility features cutting-edge lab equipment, digital workflows, and secure document control, ensuring both efficiency and compliance.

Skilled, Certified Workforce

Our team comprises qualified professionals trained in ISO, NABL, and best laboratory practices—ensuring accuracy and precision in every test.

Accrediting Bodies: Why It Matters

National Accreditation Board for Testing and Calibration Laboratories (NABL)

An autonomous body under the Quality Council of India, NABL accreditation signifies global recognition of technical competence, adherence to rigorous testing protocols, and continuous performance evaluations.

International Laboratory Accreditation Cooperation – Mutual Recognition Arrangement (ILAC-MRA)

Through ILAC‑MRA, our test results are internationally recognized, boosting confidence for patients, clinics, and insurers—even across borders.

ISO 9001:2015 Benefits for You

• Trustworthy Reporting: Rigorous QMS ensures precision and accuracy in every result.
• Global Recognition: Our certifications meet international standards, easing travel and insurance logistics.
• Smoother Processes: Streamlined workflows mean faster sample-to-report turnaround.
• Commitment to Improvement: We evolve constantly—input from clients helps us refine standards to serve you better.

Our Quality Policy

In alignment with Section 5.2 of ISO 9001:2015, our quality policy states:

Committed to providing accurate, timely diagnostic services that meet international standards, ensuring complete client and patient satisfaction. We leverage cutting-edge technology, continuous staff training, and robust risk‑based processes. We uphold integrity and accountability, and pursue improvement in every aspect of our operations.

This policy is communicated across all departments, ensuring unified direction and effort