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Elexes Team 
ISO 15189:2022 | Medical Device Laboratories
ISO 15189:2022 is an internationally recognized standard specifying quality and competence requirements for medical laboratories. It emphasizes the development of a robust Quality Management System (QMS) to ensure reliable and competent lab practices.
The revised version, published in December 2022, introduced key updates to the 2012 standard, refining and clarifying various requirements. For labs new to ISO 15189, it is important to note its specific focus on medical laboratories, setting it apart from:
⦿ ISO 9001: General QMS for any organization.
⦿ ISO/IEC 17025: Requirements for testing and calibration laboratories (not exclusively medical).
ISO 15189 accreditation enhances the credibility, competence, and quality assurance of medical laboratories, solidifying trust with customers and business partners globally. If you're transitioning to or adopting ISO 15189 for the first time, Elexes can guide you through the process seamlessly.
Is ISO 15189 a Requirement for Medical Laboratories?
ISO 15189 certification is not mandatory but is highly recommended for medical laboratories. The question is less about whether it’s required and more about whether you can afford not to be ISO 15189 accredited.
Without this globally recognized standard:
⦿ Labs risk losing preferred supplier status.
⦿ They may fail to meet stringent tender requirements.
⦿ They could lag in aligning with global efforts for standardized practices and data sharing.
Accreditation offers far-reaching benefits, enhancing credibility, reliability, and quality while enabling participation in international collaborations. For medical laboratories, achieving ISO 15189 is an essential step toward sustained excellence and competitive advantage.
We, at Elexes understand the importance of having ISO 15189 certification, which is why we have a team of experts who guide you through the entire process of certification.
Our Expertise
Our experts will help you identify insufficiencies, determine inspection readiness, and evaluate risks, smoothing the inspection process and providing a greater chance of successful inspection. We will conduct periodic internal audits to ensure compliance with all the applicable ISO standards, cGMPs and internal regulations. Be it short targeted internal audits or more sustainable assessments across the quality management system (QMS), we have experts who can conduct a thorough audit and come up with any compliance gap that needs to be worked on.
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Why do you need ISO 15189 Accreditation?
Achieving ISO 15189 accreditation offers numerous advantages for medical laboratories:
⦿ Legal Compliance: Meeting sector-specific legal requirements.
⦿ International Recognition: Boosting credibility with global institutions, including endorsement by the International Laboratory Accreditation Cooperation (ILAC).
⦿ Tender Readiness: Meeting strict prerequisites for tender applications.
⦿ Global Data Consistency: Meeting the growing demand for standardized, globally consistent data.
⦿ Enhanced Reputation: Strengthening your lab's reputation in the global community.
⦿ Preferred Supplier Status: Increasing chances of securing preferred status with customers.
⦿ Competitive Edge: Gaining an advantage over competitors without ISO 15189 certification.
⦿ Operational Efficiency: Saving money and time by implementing efficient practices and automating tasks.
⦿ Risk Management: Proactively addressing risks to equipment, services, and public health.
⦿ Centralized Information: Maintaining a single source of truth across your lab(s).
⦿ Data Protection Commitment: Demonstrating dedication to safeguarding data.
⦿ Continual Improvement: Establishing a system for ongoing improvement through the Plan-Do-Check-Act (PDCA) model.
⦿ Quality Management Software: Streamlining administrative tasks and enhancing compliance with a reliable QMS solution
ISO 15189 accreditation ensures your lab delivers accurate diagnoses, enhances patient care, and minimizes risks, driving continuous improvements in performance and service quality.
ISO 15189 Accreditation Process
We at Elexes have experts who will assist you through every step of getting ISO 15189 accreditation.
Step 01
Ensure your QMS meets the ISO 15189 requirements.
Step 2
Submit an online application to the accreditation body in your country (e.g., UKAS in the UK, IAS or CAP in the USA).
Step 2
The accrediting body conducts a pre-assessment to identify any significant issues or gaps that need addressing.
Step 2
If necessary, update or modernize your QMS, potentially using advanced QMS software.
Step 01
A technical audit is carried out by experts in your field, assessing your lab’s compliance with ISO 15189 criteria.
Step 01
After the audit, address any remaining issues, then receive your ISO 15189 certification.
Step 01
The entire process usually takes 3 to 6 months, depending on the state of your QMS and any issues identified during the assessments.
Our Services
Our Compliance Assessment Process
Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.
Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.
We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.
Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.
Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.
Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.
A Trusted Team of Consultants
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Local Language
Auditor
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Why Choose Elexes?
Expertise
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
Local Regulatory Certification
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
Confidentiality
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
Looking for assistance with your ISO 13485 certification?
If yes, our experts have years of experience to offer support for certification
Our New Product Approval Service Corner
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
Associated Regulatory Authorities.
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MD Blackrock Pharma, England
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CEO Radformation, New York
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