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ISO 15189:2012

What is ISO 15189:2012?

ISO 15189:2012 dictates the requirements for quality, competence and abilities in medical laboratories.

It governs the quality management systems in these medical laboratories. Laboratory customers, regulating authorities and accreditation bodies also use this certification to determine, confirm or recognize the competence of medical laboratories.

ISO 15189:2012 Certification Overview

A country could have specific regulations and requirements that apply to some or all of the professional personnel and their activities in the medical laboratories.

We provide the following benefits with the ISO 15189:2012 certifications:

  • Improvement in the national and global reputation and image of the laboratory.
  • Continually improving data quality and laboratory effectiveness.
  • A predefined basis for all the major quality systems, related to the laboratories, such as Good Laboratory Practices.
  • Mutual Recognition Agreement (MRA) in several different countries where test report is acceptable without repetition of analysis.
  • Customer satisfaction is achieved through the introduction of a Quality Management System which is a part of ISO 15189.

ISO 15189:2012 Requirements for Medical Laboratories

The requirements for ISO 15189:2012 medical laboratory accreditation are divided into two parts, technical requirements and management requirements.

The Medical Laboratories Management Requirements for ISO Certified are:

  • Organization and Management
  • Document Control
  • Examination by Referral Laboratories
  • Advisory Services
  • Identification and Control of Nonconformities
  • Preventive Action
  • Quality and Technical Records
  • Management Review
  • Quality Management System
  • Review of Contracts
  • External Services and Supplies
  • Resolution of Complaints
  • Corrective Action
  • Continual Improvement
  • Internal Audits

The Technical Requirements in Medical Laboratories for ISO certified are:

  • Personnel
  • Lab equipment
  • Examination procedures
  • Post-examination procedures
  • Accommodation and environmental conditions
  • Pre-examination procedures
  • Assuring quality of examination procedures
  • Reporting of results

We work as an ISO certification consultants who specialize in ISO medical laboratories standards to ensure a proper outlining of the requirements during medical laboratories training.

How to get ISO 15189:2012 Certification - Training

Samarth Consultants provides the inspection parameters which include matters of quantity, quality, safety, fitness for purpose, and continued safety compliance of installations or systems in operation.

We offer training to individuals within organizations with the training after which they can properly execute the ISO 15189:2012 audit checklist and provide ISO Certification consulting services.

Our ISO 15189:2012 Certification training covers the following:

Through the whole process, we provide awareness training, gap analysis of existing systems, process mapping and process definition, documentation including manuals, procedures, work instructions, test instructions, checklists, formats etc.

During ISO 15189:2012 Certification training we provide:

  • Awareness training to the laboratory personnel.
  • A gap analysis of the existing systems of the laboratory.
  • Process mapping and process definition.
  • Documentation including manuals, procedures, work instructions, test instructions, checklists, formats etc.
  • Step by step assistance in proficiency testing, inter-laboratory comparison and measurement of uncertainty.
  • Assistance in documentation implementation.
  • Internal auditor training and conduct of internal audit.
  • Pre-assessment audit and pre-certification audit.
  • Assistance during the entire phase of accreditation audit.
  • Post-certification assistance in system maintenance.

ISO 15189:2012 Certification Services:

Our ISO 15189:2012 consultancy service includes helping our clients get the certification for ISO 15189:2012 standard. We cover everything that is required by the accreditation body during training and ensure that our clients get the certification on their initial attempt.

To get consulting services for medical laboratories ISO 15189:2012 Certification, we are here just request us to call back you. We are assist ISO 15189:2012 certification consulting services in India, Europe, Germany and all over the world.