Laboratories play a critical role in various sectors, including healthcare, pharmaceuticals, environmental science, and research. Ensuring the accuracy, reliability, and compliance of laboratory operations is essential for producing valid results and maintaining trust. At QMet, we help laboratories achieve and maintain compliance with industry-specific standards and frameworks, enhancing their operational excellence and credibility.
The laboratory sector is governed by various standards and frameworks designed to ensure quality, accuracy, and regulatory compliance. Key standards and frameworks include:
Medical Laboratories - Requirements for Quality and Competence. Specifies requirements for quality and competence in medical laboratories.
General Requirements for the Competence of Testing and Calibration Laboratories. Specifies requirements for the competence, impartiality, and consistent operation of laboratories.
Conformity Assessment - Requirements for the Operation of Various Types of Bodies Performing Inspection. Establishes general requirements for the competence of bodies performing inspection.
US federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States.
Provides accreditation and proficiency testing for clinical laboratories.
A set of principles intended to ensure the quality and integrity of non-clinical laboratory studies.
Regulations that require manufacturers, processors, and packagers of drugs, medical devices, and certain food products to take proactive steps to ensure that their products are safe, pure, and effective. .
Standards and Interoperability Framework for laboratory information exchange[1].
A set of detailed practices for IT service management (ITSM) that focuses on aligning IT services with the needs of laboratories.
Provides guidelines for improving the cybersecurity of laboratory information systems.
At QMet, we offer a range of services to help educational organizations achieve compliance with relevant standards and frameworks. Our expertise includes:
Our consultancy services are designed to help you navigate the complexities of educational standards and frameworks. We provide:
Quality Management System Development
We offer comprehensive training programs to ensure your team is well-versed in the latest standards and best practices. Our training services include:
Educating staff on the importance of quality, accuracy, and compliance in laboratory operations.
Providing in-depth training on specific standards and frameworks, such as ISO 15189 and GLP.
Preparing your team for certification exams to demonstrate their expertise in laboratory standards.
Our assessment and auditing services help you maintain compliance and identify areas for improvement. We offer:
Trust QMet to be your partner in achieving and maintaining compliance in the laboratory sector. Enhance your operational excellence, ensure quality and accuracy, and let QMet help you navigate the complexities of industry standards and frameworks.