ISO 20776

ISO 20776 is a globally recognized standard that specifies essential guidelines for antimicrobial susceptibility testing (AST) of infectious organisms. Developed by the International Organization for Standardization (ISO), the latest version is ISO 20776-1:2019 and ISO 20776-2:2021, which together form a comprehensive framework for testing antimicrobial agents against bacterial pathogens. At Quality Asia Certification, we offer expert certification services to laboratories and institutions adhering to this standard, ensuring global credibility and operational excellence in microbiological testing.

With rising concerns over antimicrobial resistance (AMR), obtaining ISO 20776 certification signals your organization's commitment to high-quality, standardized testing procedures — a critical component in modern healthcare and pharmaceutical research.

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What is ISO 20776?

ISO 20776 Certification involves the assessment and validation of your laboratory’s capability to perform reliable antimicrobial susceptibility tests. The standard is divided into two parts:

  1. ISO 20776-1:2019 – Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases.
  2. ISO 20776-2:2021 – Part 2: Evaluation of performance of antimicrobial susceptibility test devices.

Our ISO 20776 certification services evaluate your adherence to these protocols and support your lab in achieving international compliance with test accuracy, repeatability, and result consistency.

Why is ISO 20776 important?

Antimicrobial resistance is one of the biggest threats to global public health. Incorrect or non-standardized antimicrobial testing can lead to:

  1. Misdiagnosis
  2. Inaccurate treatment
  3. Increased resistance development
  4. Global data inconsistency

By implementing ISO 20776-compliant systems, laboratories can improve the reliability of their antimicrobial test results, support global healthcare efforts against AMR, and build trust with pharmaceutical companies, hospitals, and research institutions.

ISO 20776 certification is especially important for:

  1. Diagnostic labs
  2. Research laboratories
  3. Pharmaceutical manufacturers
  4. Medical device manufacturers


What are the benefits of ISO 20776?

Choosing ISO 20776 certification from Quality Asia Certification brings numerous advantages:

✔️ Validates laboratory capability for accurate antimicrobial testing

✔️ Enhances test device reliability and method standardization

✔️ Facilitates compliance with WHO and CDC recommendations

✔️ Improves research integrity and data comparability across institutions

✔️ Increases confidence among clients, regulators, and global partners

✔️ Demonstrates commitment to fighting antimicrobial resistance (AMR)

✔️ Supports accreditation requirements for advanced laboratory operations

✔️ Opens doors for collaboration with global healthcare organizations


What kind of businesses can benefit from ISO 20776?

ISO 20776 certification helps your business in multiple ways:

1.Strengthens Brand Reputation

Earn international recognition as a compliant and quality-focused testing facility.

2.Access to Global Markets

Meet the eligibility criteria for international research collaborations and clinical trials.

3.Competitive Advantage

Distinguish your lab from uncertified competitors in tenders and client evaluations.

4.Enhanced Risk Management

Reduce the chances of testing errors and regulatory issues.

5.Increased Client Confidence

Provide stakeholders with assurance of reliable and validated test results.

6.Supports Regulatory Compliance

Align with national and global microbiology testing guidelines from ISO, FDA, and WHO.

7.Streamlined Operations

Improve internal test accuracy and consistency, saving time and reducing rework.


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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