ISO 23788

ISO 23788:2022 is an international standard developed by the International Organization for Standardization (ISO) that outlines documentation and data management requirements in medical laboratories. It complements ISO 15189 by providing specific guidance on how to manage technical and quality records to ensure traceability, accuracy, and data integrity. For laboratories seeking global recognition, implementing ISO 23788 is a strategic step toward improving operational transparency, patient safety, and compliance with regulatory expectations.

Quality Asia Certification offers ISO 23788:2022 certification services to help medical and clinical laboratories demonstrate their capability to handle laboratory data and records in a secure, consistent, and compliant manner.

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What is ISO 23788?

ISO 23788:2022 – Medical laboratories — Requirements for collection, transport, receipt, and handling of samples is a process-oriented standard specifically designed for medical laboratories. It defines the structured handling of samples from collection to final analysis and emphasizes the importance of proper documentation, traceability, and risk-based control throughout the entire sample lifecycle.

This standard acts as a supporting framework for ISO 15189 and other related standards by ensuring the seamless flow of information and minimizing errors related to sample management and data documentation.

Why is ISO 23788 important?

Medical laboratory services are critical in modern healthcare, and errors in sample handling or documentation can compromise patient safety and diagnostic accuracy. ISO 23788:2022 certification is essential for laboratories aiming to:

  1. Strengthen the reliability of laboratory results through proper documentation.
  2. Minimize risks associated with sample misidentification, loss, or contamination.
  3. Meet compliance requirements of national and international healthcare regulators.
  4. Enhance integration with quality management systems like ISO 15189 and ISO 9001.
  5. Improve trust among patients, doctors, and partner institutions through standardized data control processes.

Choosing ISO 23788 certification is a proactive move to elevate your laboratory's performance and gain recognition as a compliant and quality-focused organization.

What are the benefits of ISO 23788?

Implementing ISO 23788:2022 offers the following benefits:

  1. Improved Data Integrity: Ensures all laboratory records are accurate, traceable, and safeguarded.
  2. Enhanced Risk Management: Addresses potential errors in sample collection and handling using risk-based approaches.
  3. Streamlined Documentation: Offers standardized protocols for technical and quality documentation.
  4. Support for ISO 15189 Compliance: Complements ISO 15189 by focusing on the critical area of sample and data management.
  5. Faster Accreditation Readiness: Laboratories with ISO 23788 are better prepared for ISO 15189 audits or other regulatory assessments.
  6. Patient Safety Assurance: Reduces diagnostic errors by maintaining traceable and reliable sample records.


What kind of businesses can benefit from ISO 23788?

ISO 23788:2022 certification provides measurable business value for medical laboratories, diagnostic centers, and healthcare institutions:

✅ Increases Customer Confidence: Demonstrates a commitment to high-quality and secure data handling practices.

✅ Enhances Regulatory Compliance: Prepares the business to meet local and global regulatory audits with confidence.

✅ Boosts Operational Efficiency: Standardized procedures reduce errors, save time, and improve workflow.

✅ Promotes International Recognition: Certification signals global compliance and helps expand partnerships across borders.

✅ Reduces Legal and Financial Risks: Helps avoid penalties and liabilities arising from mishandled laboratory samples or data loss.

✅ Strengthens Brand Credibility: Positions your laboratory as a quality-driven and trusted organization in the healthcare sector.


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.

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