ISO 12469

ISO 12469:2022 is the international standard that defines the performance and safety requirements for microbiological safety cabinets (MSCs). It is essential for laboratories working with infectious agents to ensure protection for users, samples, and the environment. At Quality Asia Certification, we provide ISO 12469:2022 certification to manufacturers and laboratories that wish to demonstrate their compliance with global biosafety standards.

With biosafety becoming a global priority, especially post-COVID, having ISO 12469:2022 certification not only demonstrates your commitment to safety but also opens doors to national and international research collaborations, exports, and institutional partnerships.

65% Cost Reduction

60% Sustainability

80%

Customer Attraction

60%

Increase Your Competitive Edge

What is ISO 12469?

ISO 12469:2022 is titled “Biotechnology — Performance criteria for microbiological safety cabinets”. This standard outlines the design, construction, performance testing, and operational protocols for Class I, II, and III biological safety cabinets.

It is relevant for:

  1. Manufacturers of biosafety cabinets
  2. Testing laboratories
  3. Research centers
  4. Pharmaceutical and healthcare laboratories
  5. Diagnostic and biotech companies


Why is ISO 12469 important?

ISO 12469:2022 replaces the earlier 2000 version and incorporates updated safety performance criteria in line with modern laboratory demands. In today's world of advanced biotech research and high-risk pathogen handling, compliance with this standard has become mandatory in many regulated environments.

Choosing ISO 12469 certification helps you:

  1. Meet international import/export regulations
  2. Comply with national biosafety regulations (like ICMR, BSL standards)
  3. Build trust with hospitals, research institutes, and buyers
  4. Ensure product validation and quality consistency


What are the benefits of ISO 12469?

  1. Aligns with the latest biosafety cabinet testing protocols
  2. Recognized in EU, WHO, and national biosafety programs
  3. Ensures minimum operator exposure to harmful aerosols
  4. Supports consistent airflow integrity and HEPA filter performance
  5. Helps demonstrate compliance during audits and inspections

What kind of businesses can benefit from ISO 12469?

✅ Global Market Access: Enables export of microbiological safety cabinets to Europe, North America, and regulated markets.

✅ Brand Credibility: Positions your product as reliable and compliant with WHO & EU norms.

✅ Regulatory Compliance: Supports smooth approvals in pharma and medical device tendering.

✅ Competitive Advantage: Gain an edge over uncertified competitors in B2B supply chains.

✅ Operational Efficiency: Identifies design flaws early through stringent testing, reducing long-term liability.

✅ Client Assurance: Enhances trust from end-users like hospitals, research labs, and bio-pharma clients.

✅ Improved Product Safety: Reduces risk of contamination and cross-infection during research and handling of infectious materials.

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.

Whatsapp