CERTIFICATION IN INDIA

ISO 15189:2012 - MEDICAL LABORATORIES ACCRIDITATION

What is ISO 15189?

ISO 15189 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).

ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories. 

This working group included the provision of advice to medical laboratory users, including specifics on the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency, and the lab’s role in the education and training of health care staff.

While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.

Benefits of ISO 15189:2012

Cost-saving

Continual improvement

Globally recognised

Risk reduction

Legally compliant

Improved team morale

Who can be Certified ISO 15189:2012?

Laboratory testing is incredibly important in the delivery of information-based healthcare outcomes – this is incredibly important in a world where decisions need to be driven by facts, science, and data. Any medical laboratory that wants to deliver clinically relevant results that meet the highest ethical standards should become ISO 15189 accredited.

Shamkris Group

Medical Lab

Shamkris Group

Pathological Lab

Who can issue this Accreditation?

UKAS

GAAS

QASL

IAS

NABCB

RVA

DAR

ANSIRAB

Document required for ISO 15189:2012

The extent of Documented Information differs as per:

Role of Shamkris and Process of ISO 15189:2012

Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain an accreditation body of success in addition to enhanced performance.

The implementation process is described below:

Time Frame

Task

Process

Day 1

GAP Analysis
Cost Estimates
Application to Accreditation Body

Week 1

Developing Documents

Week 4

Implementing Management System

Week 8

Internal Audit
MRM
CAPA

Week 10

Accreditation Body
Audit
N-C Closing

Week 12

Accreditation Body

Year on Year

Yearly Compliance

FAQ

ISO 15189:2012 is a regulatory standard for medical labs. Its criteria help labs develop quality management systems and assess their own competence. The standard is also used by regulators, accreditation bodies and customers to confirm or recognize a lab’s competence.

ISO 15189:2012 is an international standard for medical laboratories. Laboratory accreditation helps labs develop quality management systems, assesses their competence and ensures they are functioning in line with industry and legal standards.

Clause 5.1. 6 of ISO 15189 states “ personnel shall have training specific to quality assurance and quality management for services offered.” … Although ISO 17025 requires the lab to identify the training needs of personnel and provide the relevant training, the emphasis on continuing education is greater in ISO 15189.