ISO 15189 Certification


What is ISO 15189:2012?

ISO 15189 is developed specifically for the Quality Management System of medical laboratories. The standard fulfills the requirements in medical laboratory quality and competency in providing the test results, sample collection procedures, and emergency handling of laboratory materials effectively. Additionally, the ISO 15189 standard focuses on the effective implementation of medical laboratory management systems in all aspects of operations and ensures continual improvement.

ISO 15189 Certification follows the best practices for the examination of samples, customer’s privacy, storage of samples, handling customer complaints, the release of results, and competency of lab personnel that certainly improves the laboratory work environment. Getting certified to ISO 15189 is a good way to convey the competency of the laboratory and enables standardization of all business processes, continuous monitoring, evaluation, and documentation in an effective manner to avoid any regulatory complaints.

Benefits of ISO 15189 Certification for Businesses

  • Meets statutory and regulatory requirements
  • Develops customer satisfaction and confidence
  • Provides an effective quality management system for medical laboratories
  • Improvement in productivity and quality
  • Global recognition
  • Enhances company reputation and credibility

Who Can Apply for ISO 15189 Certification?

The ISO 15189 standard is designed to address the needs of hospitals and other healthcare institutions that conduct medical laboratory testing. As a result, the standard is primarily aimed at large-scale healthcare institutions with sufficient resources and personnel. Smaller laboratories, such as those in doctors’ offices and clinics, are also covered. As a result, any medical laboratories, regardless of size, type, or location, are eligible for ISO 15189 certification.

Why Choose IAS for ISO 15189 Certification?

Although the International Organization for Standardization (ISO) establishes and publishes the ISO 15189 standards, they do not perform ISO 15189 certification. Therefore, organizations turn to third-party certification bodies to obtain ISO 15189 certification such as IAS. Integrated Assessment Services (IAS) is a leading globally recognized ISO 15189 Certification Body, operating in the United Kingdom, which is accredited by Universal Quality Accreditation Services (UQAS). We provide ISO 15189 certification in the UK and also in various countries across the world. Incorporated in 2006, we have two decades of professional experience in auditing and providing ISO 15189 certification and various product and ISO process certifications.

We are independent experts in auditing and the most trusted ISO 15189 certification body in ensuring the conformity and requirements of international management standards. We effectively support our clients to implement the management system for their growth and development.

Procedure to Obtain ISO 15189 Certification through IAS:

  • Initially, make an inquiry on our global website or contact us directly through mail or telephone, based on your country/region.
  • Download and fill the application form which is available for free on our website.
  • After reviewing the application, IAS will contact you for further certification procedures.
  • Our auditors will form a customized plan to perform the ISO 15189 certification audit.
  • Our ISO 15189 Certification audit includes 2 major stages:
  1. Evaluation of your organization – Readiness Audit
  2. Verifying objective evidence and conformity to the ISO 15189:2012 standard requirements – Implementation Audit
  • IAS will convey the audit findings, any non-conformities, and any necessary observations found during the audit to your organization.
  • The time duration for effective non-conformity closure is between 30 to 60 days.
  • Verification and validation of non-conformity closure and also follow-up visits will be conducted by our IAS team for ISO 15189 certification.
  • Finally, IAS will issue ISO 15189 certification with a validity of three years.
  • IAS also conducts a surveillance audit every 12 months throughout the ISO 15189 certification validity period.
  • IAS will also conduct a re-certification audit after the validity of the initial ISO 15189 certification.

ISO 15189 Certification Cost

IAS provides competitive pricing for ISO 15189 certification. The ISO 15189 Certification cost depends on the size and nature of your organizational structure. ISO 15189 certification cost also depends on your organization’s knowledge and preparedness in implementing an ISO 15189 quality management system. The total cost includes service charges, auditor fees, audit reports, site visits, certification issuance, etc.

IAS offers a free quotation service to help you understand the cost of ISO 15189 Certification and all the associated fees such as consultancy, training, documentation, re-certification audits, etc. Please get in touch with us to get a free quotation!

For more details about ISO 15189 certification, ISO 15189 certification cost, other ISO management standards & product certification, and audit procedures, kindly contact us at [email protected]

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