ISO 15189 Certification

ISO 15189 Certification is a comprehensive standard specifically meant for MEDICAL LABORATORIES. It covers the Management, staff, customers, physical lab, error prevention and management towards achieving laboratory quality. Expert Certifier performs compliance verification and certifies the medical laboratory towards ISO 15189 Certification standards as per the Expert Certifier standard audit procedure.

ISO 15189 certification is a laboratory accreditation standard. IAS coordinates with UCAS to deliver the laboratory accreditation. It is a comprehensive standard specifically meant for MEDICAL LABORATORIES.

ISO 15189 Certification Principles

• Laboratory Management has a responsibility to manage
• The laboratory must know who are its users (customers) and meet their requirement
• The physical laboratory should not interfere with laboratory workers or laboratory samples

The requirements of this standard cover the following aspects:

Management, staff, customers, physical lab, error prevention and management towards achieving laboratory quality.

Management Requirements

• Organization and management responsibility
• Quality management system
• Document control Service agreements
• Examination by referral laboratories
• External services and supplies
• Advisory services
• Resolution of complaints
• Identification and control of nonconformities
• Corrective action Preventive action
• Continual improvement Control of records Evaluation and Audits Management review.

Technical Requirements

• Personnel
• Accommodation and environmental conditions
• Laboratory equipment,
• reagents, and consumables
• Pre-examination processes
• Examination processes
• Ensuring the quality of examination results
• Post-examination processes
• Reporting of results Release of results

What does ISO 15189 Certification mean?

ISO 15189 Certification Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization’s Technical Committee 212 (ISO/TC 212).

Our advice, go for it!

If you are looking or thinking on how to get ISO 15189 certification in India you can reach out to us. You can partner with us on consulting the standard requirement. We help our customers to consult free of cost. You can reach out to us at or write to us on info@gmsintercert.com with your entire certification requirement. Also, you can feel free to visit our official website at www.gmsintercert.com and provide your contact details so that one of our Consulting experts can contact you in order to understand more about your process so that we can perform a free gap analysis. We are available 24/7 for all of our customers.