Blog

Accreditation & Certification for Global Central Labs
(CAP, ISO 17025)

Obtaining international certification for a central lab is crucial as it ensures adherence to recognized standards, establishes credibility, and enhances global recognition. Certification also signifies regulatory compliance, provides a competitive edge, and fosters trust among stakeholders, contributing to overall quality assurance and facilitating international collaborations. Today, we are looking for accreditations & certifcations that central labs need to prepare.

What is the difference between Accreditation & Certifcations?

Both of them look similar, but there is a big gap.

Accreditation is a formal recognition granted to an organization or institution that has demonstrated competence, compliance with standards, and the ability to meet specified criteria. It often involves an in-depth evaluation of various aspects, such as governance, management, facilities, processes, and performance. Accreditation is typically provided by external accrediting bodies and is common in sectors like education, healthcare, laboratories, and certification bodies themselves.

Certification is a formal attestation or declaration by a certification body that a product, service, system, or individual meets specific requirements or standards. The certification process involves an assessment against predetermined criteria, and once successfully completed, a certificate is issued as evidence of compliance.

Which accreditation or certification is required for global central labs?

There are so many global standard for laboratory or analytical agency, but 3 types of accreditation & certifcation is generally required.

• CAP
• ISO 17025
• ISO 15189

ISO 17025 sets international standards for technical competence and quality management systems in laboratories. ISO 15189 focuses on quality and safety in medical laboratories, while CAP is a quality certification body with a focus on pathology labs. Adhering to these standards ensures a high level of quality and safety in global central labs.

All of these certificate system serve as essential tools to guarantee quality assurance, international credibility, patient safety, scientific standardization, and regulatory compliance for global central labs.

Difference bewteen ISO 17025 VS ISO 15189

ISO 17025 could replace ISO 15189 when the laboratory could not achieve ISO 15189 as the laboratory does not obtain medical professionals. Therefore, some people are wondering the difference bewteen two ISO certifcation.

The main difference is that ISO 15189 is intended for testing request from medical professionals. A laboratory with patience care will get advantage from ISO 15189, but ISO 17025 would be more profitable option for the laboratory only focusing on testing or calibration.

Due to the difference of intended purpose, ISO 15189 require more preparation regarding patient care or medical things. ISO 15189 defines specific terms and definitions relevant to testing and medical laboratories. ISO 15189 specifies that internal audits need to emphasize areas critically important to patient care, but ISO 17025 does not require it. Accroding to section 5.2(Accommodation and environmental conditions), ISO 15189 include further additions, such as laboratory design to minimise the risk of injury and occupational illness, patient, and visitor safety, protecting humans from hazards. The consideration of the patient’s disabilities, comfort and privacy, and the optimization of collection conditions are only emphasized in ISO 15189.

To summerize these difference, the table would be as below.

How to achieve CAP or ISO 17025 or ISO 15189?

Achieving certification or accreditation may involve navigating through challenges and putting in consideration effort. However, it's worth the patience. The cost of achievement depends on the area that company would like to achieve and the number of employee. You can check the process of achieving CAP, ISO 17025, and ISO 15189.

What about Huscience?

To provide the best quality clinical support & analysis service, we have prepared achieving accrediation & certifcation since 2023. Consequently, we predict that we could achieve ISO 17025 until 2024 2Q. CAP accreditation would be ready on early 2025.

If you are willing to start the conversation with the validatied global central lab, Let's continue the conversation.

Reference

[1]https://www.ukas.com/accreditation/about/accreditation-vs-certification/

[2]https://www.imsm.com/gb/blogs/what-is-the-difference-between-iso-17025-and-iso-15189/

[3]https://3billion.io/blog/what-cap-accreditation-means-for-diagnostic-testing