While accreditation and certification are often used interchangeably, they represent distinct concepts. However, both certification and accreditation can apply to the same field and complement each other.
Certification and Accreditation: What’s the Difference?
ISO defines certification as the provision by an independent body of written assurance (a certificate) that the product, service, or system in question meets specific requirements. On the other hand, ISO defines accreditation as the formal recognition by an independent body, generally known as an accreditation body, that a certification body operates according to international standards.
In practice, accreditation applies to the entire organization, such as a testing laboratory or certification body, whereas certification pertains to specific areas within the organization (e.g., a specific medical device or service).
ISO 13485 Certification: Medical Devices and Quality Management Systems
ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes is the international standard that focuses on quality management systems for medical devices. This standard ensures that the product conforms to the specific requirements that could be required under, for example, the US FDA. Being verified to this standard helps the manufacturers of medical devices meet either specifications set by customers or regulatory bodies. Examples of what could be included within an ISO 13485 certification are devices for wound care, monitoring devices, and devices for imaging.
ISO 15189 Accreditation: Medical Laboratories — Quality and Competence for LDTs
ISO 15189: Medical laboratories — Requirements for quality and competence is the international standard that focuses on ensuring that medical laboratories meet the necessary quality and competence requirements for conducting clinical testing and analysis. This includes laboratory-developed tests (LDTs), which are tests created, validated, and used by the laboratory without the involvement of commercial manufacturers. This standard is targeted towards healthcare service providers and medical laboratories. Examples of what may fall under an ISO 15189 scope of accreditation are Next Generation Sequencing (NGS), PCR testing, and Microscopic Examination. Organizations that have obtained ISO 15189 accreditation show that the lab’s whole system has the competence and capability to conduct the specific testing as noted within their scope.
For LDTs, ISO 15189 accreditation is crucial as it ensures that the laboratory has the appropriate systems, processes, personnel, and equipment to perform high-quality testing. This standard addresses the management of testing processes, including personnel qualifications, testing protocols, and quality control measures. Laboratories that offer LDTs must demonstrate competence in developing, validating, and interpreting tests to ensure their results are accurate, reliable, and compliant with regulatory standards.
Key Differences Between ISO 13845 and ISO 15189
While both ISO 13485 and ISO 15189 relate to quality, they have different focuses when it comes to laboratory-developed testing:
- ISO 13485: Focuses on quality management for the development and lifecycle of medical devices for effectiveness. For labs offering LDTs for devices, this standard ensures the devices are compliant and effective.
- ISO 15189: Focuses on the overall quality and competence of a medical laboratory, including the specific tests the lab develops and performs, like LDTs. This includes the lab’s management systems, testing, personnel, equipment, etc.
While ISO 13485 focuses on ensuring medical devices are safe, effective, and regulatory-compliant, ISO 15189 ensures that laboratories developing and performing LDTs have the capability and systems in place to produce reliable, accurate test results.
Accreditation and Certification Working Together in LDTs
Though accreditation and certification differ in focus, they often work together to ensure compliance. An accreditation body can accredit the certification body to ISO 17021: Conformity assessment — Requirements for bodies providing audit and certification of management systems which then allows them to register a product, service, or system to ISO 13485. ISO 17011 accreditation can provide an accrediting body with the ability to perform assessments to a variety of ISO accreditation standards such as ISO/IEC 17025, ISO 15189, and ISO 17021. ISO 17021 accredited organizations can then grant certifications such as ISO 13485. The certification body would obtain the accreditation prior to issuing certifications.
For LDTs, laboratories may choose to get ISO 13485 certification for the systems they use to manage and test devices and ISO 15189 accreditation for the specific testing services they provide. Both can work in tandem to demonstrate that a lab has met high-quality standards in developing, validating, and performing laboratory-developed tests.
Conclusion
Laboratory Developed Tests (LDTs) are an essential part of the diagnostic and healthcare landscape. Achieving ISO 15189 accreditation for laboratories ensures that the testing processes, including those for LDTs, meet rigorous international standards of quality and competence. For laboratories developing LDTs related to medical devices, achieving ISO 13485 certification ensures that the devices and their associated processes meet regulatory requirements for safety, efficacy, and compliance.
While neither standard is a regulatory requirement in the United States, both ISO 15189 and ISO 13485 offer international recognition and can help reassure clients and patients that the laboratory’s testing and medical device development processes are conducted to the highest standards of quality and competence.
Want to learn more about ISO 15189 accreditation? Read more about A2LA’s Clinical Testing Laboratories Accreditation Program here. If you’re ready to take the next step toward improving the quality of your laboratory’s test results, request a quote today.