ISO 21363

ISO 21363:2020 is an international standard that outlines the requirements and guidelines for nano-object characterization using electron microscopy techniques. It plays a critical role in the nanotechnology and material science industries by ensuring standardized, reproducible, and validated imaging and analysis methods for nano-scale materials. At Quality Asia Certification, we help businesses demonstrate compliance with ISO 21363:2020, thereby ensuring the integrity and quality of their nano-scale characterization processes.

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What is ISO 21363?

ISO 21363:2020 — Nanotechnologies — Measurements of particle size and shape distributions by transmission electron microscopy (TEM) — defines the protocols for measuring and evaluating particle size and shape distributions of nano-objects using Transmission Electron Microscopy (TEM).

The standard ensures:

  1. Reliable size and shape measurements
  2. Standardized image acquisition
  3. Data analysis and reporting consistency

It is applicable to nanoparticles, nanorods, nanoplates, and other nano-objects, and supports industries engaged in nanomaterial manufacturing, research labs, and regulatory compliance bodies.

Why is ISO 21363 important?

Nanotechnology is a rapidly advancing field, and accuracy in particle measurement is non-negotiable. ISO 21363:2020 enables companies to:

  1. Maintain international credibility
  2. Meet regulatory expectations for product consistency and safety
  3. Improve customer trust through validated characterization techniques
  4. Enable comparative studies and data sharing across laboratories worldwide

Getting certified to ISO 21363:2020 through Quality Asia Certification demonstrates your commitment to scientific precision, data integrity, and international best practices.

What are the benefits of ISO 21363?

  1. Standardized Methodology: Provides globally accepted methods for measuring particle size and shape via TEM, ensuring consistency in results.
  2. Scientific Accuracy: Enhances data reproducibility and reliability in research and quality control.
  3. Regulatory Compliance: Helps organizations meet international regulatory requirements in nanotech applications.
  4. Product Quality Assurance: Supports robust validation of material properties used in high-precision applications like electronics, pharmaceuticals, and coatings.
  5. Competitive Advantage: Certification increases stakeholder confidence and positions your brand as a leader in nano innovation.

What kind of businesses can benefit from ISO 21363?

✅ Enhances Technical Credibility: Showcases your commitment to using validated and standardized characterization methods.

✅ Builds Trust with Clients and Partners: Demonstrates transparency and scientific rigor in nano-object evaluation.

✅ Opens Global Market Access: Ensures compliance with international standards required for exporting or scaling operations.

✅ Improves Research Validity: Increases the acceptance of your results in academic, industrial, and regulatory environments.

✅ Supports Innovation & R&D: Reliable data helps in the development of new nano-enabled products with predictable performance.

✅ Ensures Consistency Across Batches: Minimizes variability in nanomaterial production, leading to high product quality.

✅ Facilitates ISO Integration: Complements other ISO standards such as ISO 9001 and ISO 17025 for holistic quality management.


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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