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ISO 15189 Certification

ISO 15189 Standards and its Certification

What is ISO 15189 standard?

ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to laboratories. The revised version was published in the year 2012 which cancels and replaces the older version which was released on 2007.

The standard was developed by ISO’s technical committee- ISO/TC 212. They assigned working group ISO 15189 to prepare the standard based on the details of ISO/IEC 17025:1999 (General requirements for the competence of testing and Calibration laboratories)

The standard establishes a stringent set of quality management requirements specifically for laboratories at every level of the health care system. Some of the standard’s objectives for lab operations include ensuring the quality and traceability of patients’ information, maintaining the safety and integrity of lab materials, monitoring the facility’s environmental conditions, and supporting public health decision-making.

This International Standard ISO 15189 is the gold standard for certifying medical laboratories as it covers both management and technical requirements needed for assessing the competence of the personnel.

Hence the ISO 15189 certification is an assurance that the laboratory has been assessed against internationally recognized standard which aims to improve the existence of a quality system, technical competence, and that the personnel is actually capable to generate technically valid results and suitable information for the intended use of each test.

ISO 15189:2012 Certification

Adapting to the certification of ISO 15189:2012 assist the medical laboratories in developing their quality management system and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by regulating authorities, laboratory customers and accreditation bodies.

This certification differs from the ISO 17025 –laboratory Accreditation, and ISO 15189 Certification is more preferred as this gives more importance to the patient well being. It also addresses pre-analytical and post-analytical activities, where as ISO 17025 only addresses the general requirements for testing laboratories.

Coverage of ISO 15189 Certification in Malaysia:

IAS is one of the most well-known ISO Certification Bodies in Malaysia who provides the service of ISO certification Audits in Malaysia for various International standards. Apart from certification we also delivers ISO Lead Auditor Training , ISO Internal Auditor Training, and ISO Awareness/Foundation Training in Malaysia. All these certification and Training services by IAS for the country is managed from its office in Malaysia and  provides services including the local cities of Malaysia like Kualalumpur, Selangor, Penang, johor Bahru, Melaka & Ipoh.

To know more about ISO 15189 – Medical Laboratory Requirement and its certification, click here.

Process to obtain an ISO Certification

  • Contact IAS by sending the Application Form and call us for a discussion and we are here to guide you in getting ISO 15189:2012 certification.
  • Make your Organization ready for certification by implementing and practice the standard, monitored and continually improved.
  • Majorly, the process of ISO certification includes 2 stages

                        Stage 1Audit : Readiness Audit

                        Stage 2 Audit : Verifying the effectiveness of the System

  • The organization applying for ISO certification will be audited based on an extensive sample of its sites, services, process, products & functions.
  • Any deviation is observed during the audit, deviation report will be submitted along with the detailed audit report. According to the grading of the deviations IAS determines the time required for its closure including the correction and corrective actions which has to be approved by IAS. After the effective closure of Non conformity, the Certificate is issued limiting to the scope that was audited.
Click here, For more information on application and audit procedure

Why IAS?

  • Having two decades of ISO Certification audit experience helps to attain the certification faster.
  • The Auditors and trainers in IAS are highly experienced, innovative, simple and practical in implementation process which helps to strengthen the business operations of an Organization.
  • IAS is an authorized ISO certification body for providing ISO 15189:2012 certificates with accreditation.
  • The Knowledge, skills gained through experience and the global presence of IAS has created a history of executing successful large-scale, complex international projects. Our auditors understand the culture and nature of the local market and perform internationally in an effective and consistent manner.
  • IAS conducts the audits in more sensible and value added manner to benefit the clients of small, medium and large organization. Our flexible procedure is simple to understand and the services are timely and cost effective.
  • Our presence is in India, Singapore, Malaysia, Indonesia, Oman, Saudi Arabia, UAE, Qatar, Kuwait, Philippines countries with more than 6000 clients
  • We have successfully addressed almost all the sectors broadly diversified in Automobile industry, Consumer electronics, Chemical Industry, Steel production, Industrial equipment, FMCG industry, Aerospace manufacturing, Healthcare Industry, Food industry, Textile industry, Oil and Gas, Energy, Telecommunication, IT Industry, Hospitality industry.
  • We have more than 300 experienced empanelled auditors to effectively asses an organization’s conformance to Business Continuity Management System unleashing a true potential for Improvement.

Benefits of ISO 15189 Certification

  1. Promotes a strong degree of consistency in conformance to medical laboratory laws and legislation both from an international and national perspective.
  2. ISO 15189:2012 certification promotes the laboratory efficiency and responsibility for better results and service delivery.
  3. Promoting modern laboratory practices that include professionalism and expertise in conduction of medical activities in the labs
  4. Promotes the development of an international reputable image for your organization through Quality Assurance and Management Systems.
  5. Enhances the consumer confidence through Problem Solving and Continual Improvement
  6. Prevent the unnecessary duplication of information gathering on performance often required by regulatory bodies.
  7. Ultimately promoted the growth of customer satisfaction in organizations involved in medical laboratory testing.

What an Organization should do to achieve certification?

  • Call IAS for conducting ISO 15189 audit and discuss the audit procedure specific to your organization.
  • Understand the requirement of ISO 15189:2012 and Implement in your organization before going for certification. E.g. Documenting, training the staffs, practicing the system etc
  • Conduct one internal Audit program through trained 15189 Internal Auditors.
  • Compile the collected data and complete the analysis.
  • Conduct a Management review with the help of analyzed data and effect some decision to improve the Organization performance towards company objectives & goals.
  • Complete the audit successfully. (Stage 1 and Stage 2)
  • Closure of Non conformance, if any.
  • Collect and maintain the ISO 15189 certificate.
  • Comply with the surveillance audit yearly.
To know more about the audit details. Kindly click here.
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