ISO 15189:2012 is the international standard specifically developed for medical laboratories, outlining the requirements for quality and competence. It combines elements of ISO/IEC 17025 and ISO 9001, tailored to the unique needs of medical testing environments.
Certification under ISO 15189:2012 is essential for laboratories that want to demonstrate reliable results, technical competence, and adherence to best practices in patient care. It is widely recognized by healthcare authorities and accrediting bodies worldwide.
Purpose of ISO 15189:2012 Certification
- Ensure accurate, consistent, and timely diagnostic results
- Promote quality management in medical laboratories
- Enhance patient safety and clinical decision-making
- Meet regulatory and accreditation requirements
- Boost trust among patients, physicians, and stakeholders
- Establish a framework for continual improvement
Our ISO 15189:2012 Certification Process
We follow a step-by-step certification process to ensure clarity, objectivity, and transparency:
1. Application Submission
The organization submits a completed Certification Request Form including:
- Company profile
- Number of employees
- Locations of operations
- Scope of certification
2. Application Review & Quotation
We review the details to:
- Verify audit feasibility
- Define the certification scope
- Provide a formal quotation
3. Audit Planning
Once confirmed, we plan the certification audit including:
- Audit team assignment
- Timeline and logistics
- Client coordination
4. Stage 1 Audit – Documentation Review
Assessment of the organization’s QMS documentation for:
- Conformance with ISO 9001:2015
- Readiness for on-site audit
- Identification of potential gaps
5. Stage 2 Audit – On-site Assessment
Comprehensive audit of the implemented QMS:
- Process evaluation
- Staff interviews
- Objective evidence verification
- Identification of nonconformities (if any)
6. Audit Report & Certification Decision
- Audit team submits findings and recommendations
- Independent decision-maker reviews the report
- Certification granted if requirements are met
7. Certification Issuance
- Valid for 3 years
- Certificate includes scope, standard, issue/expiry dates
8. Surveillance Audits (Year 1 & 2)
- Annual on-site surveillance audits
- Verification of continued conformity and improvements
9. Recertification Audit (Year 3)
- Full system reassessment before certificate renewal
Key Features
- ✅ Independent & Impartial Laboratory Audits
- ✅ Assessments by Medical Testing Experts
- ✅ Emphasis on Patient-Centric Quality Systems
- ✅ Detailed Audit Reports and Actionable Feedback
- ✅ Full Compliance with ISO/IEC 17021-1 and ISO 15189 Guidelines
About Quality HUB India
Quality HUB India(QHI) is a NABCB, IAF accredited third-party certification body (CB) offering independent and impartial certification services for a range of ISO management systems. Quality HUB India(QHI) is a trusted name in the field of quality, management system training, and certification support. With a strong focus on empowering organizations to achieve operational excellence. We specialize in ISO 9001:2015 (Quality Management), ISO 14001:2015 (Environmental Management), and ISO 45001:2018 (Occupational Health & Safety Management) certifications.
We follow globally accepted auditing practices in strict compliance with ISO/IEC 17021-1, ensuring fair, transparent, and unbiased assessments across diverse industries and sectors.
How to Get Started
Step 1: Submit the ISO Certification Request Form
Step 2: Our team will contact you for review and audit scheduling.
📞 Contact Us: +91- 7073111630
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