ISO 20658
ISO 20658:2017 sets out internationally recognized requirements for the proper collection, handling, transportation, and reception of samples intended for medical laboratory examinations. At Quality Asia Certification, we offer end-to-end ISO 20658 certification services to help medical laboratories, hospitals, diagnostic centers, and sample collection agencies align with global best practices. By complying with this standard, organizations reduce the risk of sample rejection or misdiagnosis and enhance diagnostic accuracy, patient safety, and operational efficiency.
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What is ISO 20658?
ISO 20658:2017 is a process-based ISO standard specifically developed for medical laboratories and health institutions involved in sample testing. It provides clear guidelines for pre-examination processes including sample collection, labeling, packaging, documentation, and transportation. The goal is to ensure the integrity of the sample from the point of collection to the time it reaches the laboratory for analysis.
This standard acts as a vital support to ISO 15189 and is highly relevant for any facility aiming to build a reliable quality management system for medical testing and diagnostics
Why is ISO 20658 important?
In the healthcare and diagnostic sector, sample quality directly impacts test accuracy and patient outcomes. Improperly collected or mishandled samples can lead to misdiagnosis, test repetition, and regulatory non-compliance. ISO 20658 bridges this gap by enforcing rigorous sample handling protocols.
Adopting ISO 20658 helps you:
- Minimize sample rejection and reporting delays.
- Meet national and international regulatory standards.
- Strengthen patient trust and improve overall healthcare delivery.
- Gain a competitive edge when applying for tenders and government empanelment.
What are the benefits of ISO 20658?
- Standardized Sample Management: Brings uniformity in sample collection, storage, and transportation procedures.
- Improved Diagnostic Accuracy: Reduces risk of contamination, degradation, and labeling errors.
- Operational Efficiency: Streamlines workflow between collection points and laboratories.
- Audit Readiness: Helps laboratories meet accreditation requirements under ISO 15189 and other healthcare regulatory bodies.
- Documentation Control: Ensures traceability and accountability through proper labeling and documentation practices.
What kind of businesses can benefit from ISO 20658?
Here’s how ISO 20658 certification from Quality Asia Certification benefits your organization:
✅ Improved Patient Safety – Reduces chances of incorrect diagnosis due to mishandled or compromised samples.
✅ Enhanced Reputation – Aligns your operations with global quality benchmarks, building brand trust among patients and partners.
✅ Compliance Assurance – Helps meet requirements of NABL, CAP, and other national/international health authorities.
✅ Tender & Empanelment Readiness – Increases eligibility for private and government healthcare projects.
✅ Training & Awareness – Enables your staff to follow best practices through structured guidelines and documentation.
✅ Error Reduction – Minimizes human error in pre-examination processes with standardized protocols.
✅ Increased Revenue Potential – Boosts customer confidence and attracts quality-focused clients and partners.
Top Tips on making ISO 9001 effective for you.
#1
Top management commitment while practicing and accomplishing the standard is the key to success.
#2
Keeping staff informed about the ongoing practices, a well-communicated plan would increase the motivation and zeal of working in them.
#3
Making sure that the various departments of the organization work as a team for the benefit of the organization and customers as well.
#4
Review systems, policies, processes, and procedures for a smooth working of QMS.
#5
Speaking to customers & suppliers while getting feedback & working on improvements.
#6
Training staff carrying out the internal audits with the opportunity for improvement.
#7
Celebrate your achievement and use the QualityAsia Assurance Mark on your literature, promotional material, and website.
#8
Ensure continuous improvement by regularly reviewing and updating your quality management practices.
#9
Promote a culture of quality by encouraging innovation, accountability, and employee involvement at every level of the organization.
Why QualityAsia?
QualityAsia always vanguard in the auditing and governing of internationally acclaimed standards practices. At QualityAsia, we focus on driving the success of our clients through creating excellence with our trained professional auditors. The content of our service provision, comply with international certification rules defined by the accreditation bodies without burning a hole in your pocket. We will take you through the journey of audits with our best kept audit practices, viz.:
Initial Certification – Stage 1 (Preparatory Phase)
- Thorough documented information review.
- Exchange of information with staff through online or onsite presence.
- Identification of key performances, processes & objectives as per the standard requisites.
- Analysis of facilities, infrastructure, systems and processes in regard with the requested certification scope with a resource allocation review.
Initial Certification – Stage 2 (On-site Audit)
- Measurement, reporting & reviewing the performances against key performances objectives.
- Reviewing the suitability of the system meeting the legal, regulatory & contractual requirements.
- Operational control of processes, internal audits & management reviews while understanding the responsibilities for the policies.
- Conclusion based on prescriptive requirements, policy, performance objectives, staff skill, operations, procedures, internal audits, etc.
Surveillance & Certification Renewal
Drawing out the scrutiny on various aspects of the previously done audits on effectiveness while reviewing the various processes and control of the operations in the QMS and finally going for the recertification.
