ISO 15189:2012 | Medical Laboratory Services
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ISO 15189:2012 | Medical Laboratory Services
What is ISO 15189:2012?
ISO 15189:2012 is an international standard that defines the quality management system requirements specifically for medical laboratories. It sets out criteria to ensure the laboratory’s competence in delivering accurate and reliable test results. The standard focuses on quality management throughout all phases of testing—pre-analytical, analytical, and post-analytical—ensuring that laboratories operate efficiently and in compliance with regulatory and accreditation requirements.
Benefits of ISO 15189:2012
- Improved Test Quality: Guarantees the accuracy and reliability of test results, which are vital for proper patient diagnosis and treatment.
- Patient Safety: Promotes safety by ensuring consistent and dependable laboratory services.
- Increased Credibility: Enhances the laboratory’s reputation and credibility within the healthcare industry.
- Regulatory Compliance: Supports laboratories in meeting local and international regulatory requirements and standards.
- Operational Efficiency: Encourages effective management practices that lead to improved laboratory operations and reduced errors.
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Frequently Asked Questions
We’ve compiled answers to some of the most common questions about certification.
ISO (International Organization for Standardization) is an independent, non-governmental international body that develops and publishes standards to ensure quality, safety, and efficiency across various industries and sectors. These standards help organizations deliver consistent, high-quality products and services.
Compliance certification is the process through which an organization verifies that it adheres to specific regulations, standards, or guidelines. Achieving certification demonstrates that the organization meets industry norms, ensuring credibility and compliance with legal or regulatory requirements.
A standard is an established set of guidelines, rules, or criteria that an organization or industry follows to ensure quality, safety, and consistency. Standards can be created for various aspects, including processes, products, services, and management systems, to maintain uniformity and meet customer expectations.
ISO 9001:2015 is an internationally recognized standard for quality management systems (QMS). It provides a framework for organizations to ensure their products and services meet customer requirements consistently, while also enhancing operational efficiency, continuous improvement, and customer satisfaction.
When choosing a certification body, it's crucial to select one that is reputable, accredited, and has expertise in your industry. Look for a body with a proven track record, experienced auditors, and a commitment to delivering high-quality services. Ensure they offer the specific certifications relevant to your business and meet global standards.
The cost of certification varies depending on the type of certification, the size of your organization, and the complexity of the processes involved. Certification bodies typically offer pricing based on these factors, which may include audit fees, training, and ongoing maintenance. Contact your chosen certification body for a customized quote based on your requirements.