ISO 21856:2022
ISO 21856:2022 is the latest international standard that defines general requirements for assistive products for persons with disability. Developed by ISO/TC 173/SC 1, this standard ensures that assistive products are designed and manufactured with high quality, safety, and usability in mind. As the global need for accessible and inclusive products grows, ISO 21856 plays a crucial role in ensuring that such products meet uniform standards that protect users and improve their quality of life.
This certification demonstrates an organization’s adherence to globally accepted requirements for assistive products, helping companies enhance product safety, reliability, and functional performance.
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What is ISO 21856:2022?
ISO 21856:2022 – Assistive Products – General Requirements is a comprehensive international standard that outlines performance, safety, usability, and risk management criteria for assistive products used by individuals with disabilities. These include mobility aids, communication devices, and other tools that support daily living and independence.
The standard covers all aspects from design to manufacturing, emphasizing product durability, usability across diverse environments, and the ability to meet user needs consistently. ISO 21856 is applicable to all manufacturers of assistive products, including both standalone items and complex systems.
Why is ISO 21856:2022 important?
With the global rise in aging populations and increased awareness of disability inclusion, assistive technology is becoming more central to public health and social care. ISO 21856:2022 ensures that products are:
- Safe for daily use in real-world environments
- Designed with user feedback and ergonomics in mind
- Aligned with international legal and quality expectations
- Adaptable for different markets and demographics
Choosing ISO 21856 compliance shows a manufacturer's commitment to quality and inclusivity, which is critical in gaining trust from end-users, healthcare providers, and regulators.
What are the benefits of ISO 21856:2022?
ISO 21856:2022 enhances the integrity and user confidence in assistive products. Key benefits include:
- Improved User Safety: Ensures assistive devices do not pose risk to users, minimizing the chance of malfunction or injury.
- International Market Access: Facilitates easier product acceptance in global markets by meeting international conformity requirements.
- Product Standardization: Promotes consistency across product lines, reducing design and manufacturing errors.
- Better User Experience: Focus on ergonomics and usability leads to increased user satisfaction and trust.
- Regulatory Compliance: Helps align with medical and accessibility regulations applicable in many countries.
- Supports Inclusive Design: Drives innovation towards universal design that benefits a wider population, including elderly users.
What kind of businesses can benefit from ISO 21856:2022?
Implementing ISO 21856:2022 offers strategic advantages to businesses that manufacture assistive products:
-Enhanced Brand Reputation
Demonstrates a proactive approach to quality, safety, and accessibility, elevating the company's standing in the industry.
-Global Competitiveness
Compliance with ISO 21856 positions your products for easier acceptance in international markets and tenders.
-Reduced Risk of Legal Issues
Meeting recognized safety and usability standards decreases liability and product recall risks.
-Streamlined Product Development
Standardized requirements reduce ambiguities in product design and improve development timelines.
-Increased Customer Trust & Retention
Certification reflects reliability, leading to higher customer loyalty and positive word-of-mouth.
-Eligibility for Public and Institutional Procurement
Many government and healthcare institutions prefer or require certified products for procurement.
-Operational Efficiency
Encourages consistent manufacturing processes, quality control, and cost-effective production.
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.
