ISO 20658 Certification Service

ISO 20658:2020 Certification – Medical Laboratories Reporting Requirements

Overview
ISO 20658:2020 is an international standard that specifies requirements and guidelines for the post-examination process in medical laboratories, focusing on the structure and content of medical laboratory reports. It ensures uniformity, clarity, and completeness in the communication of laboratory results to healthcare professionals and patients. The standard supports quality in medical diagnosis by promoting consistent, reliable, and clinically relevant reporting practices.

What is ISO 20658:2020?
ISO 20658:2020, titled Medical laboratories — Requirements for collection, transport, receipt, and handling of samples, sets forth essential criteria for the accurate documentation and communication of sample-related information in clinical testing environments. It addresses various aspects of the reporting chain including sample identification, patient data, reference intervals, measurement units, and interpretation comments. The standard complements ISO 15189 by providing more detailed guidance specifically on reporting processes in medical laboratories.

Why ISO 20658:2020 Certification?
Certification to ISO 20658:2020 helps medical laboratories demonstrate a standardized approach to handling laboratory samples and issuing reports. It builds confidence among stakeholders including healthcare providers, patients, and regulatory authorities by ensuring that laboratory outputs meet global best practices. The certification also aids laboratories in reducing errors related to reporting, ensuring traceability, and enhancing communication of clinically significant results.

Benefits of ISO 20658:2020 Certification

• Promotes consistency and clarity in laboratory reporting.

• Reduces misinterpretation and clinical errors due to poor documentation.

• Ensures compliance with international quality and safety standards.

• Enhances trust among patients and healthcare professionals.

• Strengthens internal processes related to sample handling and report issuance.

• Facilitates audit-readiness and regulatory compliance in medical labs.

Certification Process

1. Application Submission: The laboratory submits an application outlining its scope of work and readiness for ISO 20658:2020 certification.

2. Document Review: Evaluation of internal documentation including reporting formats, SOPs, and quality records related to sample collection and reporting.

3. On-site Audit: An audit team reviews actual reporting processes, report formats, staff competence, and report traceability during sample handling.

4. Compliance Verification: Gaps, if any, are reported, and the laboratory is given time to implement corrective actions.

5. Certification Issuance: Upon successful closure of all non-conformities, the certification is issued.

6. Surveillance Audits: Annual audits are conducted to ensure ongoing compliance with the standard.