What Does ISO Certification Mean for Us, Our Partners and Customers?

Why ISO Certification Matters: Safety & Quality You Can Trust

ISO certification is more than a technical requirement - it’s a benchmark of global trust, product safety and consistent quality.

In healthcare and sports performance, quality isn’t optional. Clinicians, retailers and distributors need to know that every product they prescribe or sell is safe, reliable and produced under stringent controls. Patients need the reassurance that the orthotics they depend on are manufactured using processes that meet international expectations.

This is why Formthotics’ commitment to quality includes achieving ISO certification, specifically ISO 13485 and ISO 9001 - two of the highest global standards for medical device manufacturing and quality management.

Summary

• Formthotics is certified under BSI ISO 13485 (medical device quality management) and ISO 9001 (quality management excellence).

• These certifications apply globally and are externally audited by the British Standards Institution (BSI).

• ISO ensures safety, traceability, consistent product quality, risk management and regulatory compliance.

• Clinicians benefit from reliable medical devices that support high-quality patient care.

• Retailers gain confidence in selling evidence-supported, rigorously manufactured orthotics.

• Distributors operate with streamlined regulatory acceptance and global quality assurance.

What ISO Certification Actually Means

ISO 13485 – Medical Device Quality Management

ISO 13485 is internationally recognised as the gold standard for organisations involved in designing, manufacturing or distributing medical devices. Orthotics fall under this medical device category in many jurisdictions.

This certification ensures:

• risk management systems across product life cycles

• documentation and traceability of materials and processes

• controls for product safety and performance

• manufacturing consistency across all batches

• regulatory compliance with global medical device requirements

As an ISO 13485–certified company, Formthotics follows strict processes that safeguard patients and support clinicians.

ISO 9001 – Quality Management Systems

ISO 9001 is the world’s most widely recognised quality standard. It ensures organisations:

• operate efficient, well-monitored internal systems

• minimise errors and variation

• focus on customer satisfaction

• continuously improve processes and outcomes

This certification supports our global distributors and retail partners, reinforcing that Formthotics maintains consistent quality in every market.

What ISO Means for Clinicians

For clinicians, ISO certification provides assurance that:

• the orthotics they prescribe are produced under validated, audited systems

• every pair of Formthotics meets consistent performance standards

• materials are controlled, traceable and verified

• quality and safety controls are not optional, but mandatory

• the product aligns with global medical device expectations

This gives clinicians confidence that Formthotics supports effective, evidence-based patient care.

What ISO Means for Sports Retailers

Sports retailers operate in a fast-moving consumer environment where product reliability matters. ISO certification ensures:

• consistency across inventory — no unpredictable variation between units

• clear documentation for customer reassurance

• product reliability, reducing returns or fit issues

• globally recognised quality signals that strengthen retail reputation

For customers comparing footwear solutions or seeking shoe inserts that offer support, ISO certification reinforces trust.

What ISO Means for Distributors

For global distributors, ISO certification is crucial because it:

• streamlines regulatory approvals in multiple regions

• ensures documentation required for import/export compliance

• supports competitive tender applications

• reduces risk across supply chains

• aligns with international medical device oversight

Distributors benefit from working with a manufacturer whose processes are globally validated and consistently audited.

How Formthotics Compare to Other Orthotic Brands With or Without ISO Certification

Patients and clinicians want orthotics they can trust - products that genuinely improve comfort and movement, not ones that make bold claims without evidence. When people invest in foot health, they expect real results, clinical credibility and long-term value.

Here’s how ISO certification strengthens that confidence:

What ISO-Certified Manufacturers Deliver

• medical-grade process controls

• validated, audited manufacturing systems

• documented risk and safety protocols

• consistent quality from batch to batch

What Non-ISO Manufacturers May Not Guarantee

• consistent product quality

• traceable, verified materials

• formal safety and compliance systems

 For Formthotics, ISO certification is only part of the story. We combine these global standards with:

• 40+ years of clinical research

• proprietary Formax™ Foam engineered for support and comfort

• in-clinic heat-moulding for a personalised fit

• evidence showing improvements in comfort, pressure distribution, mobility and pain

Together, these factors set Formthotics apart as a trusted, clinically supported orthotic system that delivers reliable outcomes for every patient.

Conclusion

ISO certification is not a marketing claim — it is proof of our commitment to clinical excellence, product consistency and patient safety. It reinforces the trust our global partners place in us and ensures that every Formthotics orthotic meets the same high standard, whether it’s fitted in Christchurch, Copenhagen or Chicago.

At Formthotics, our products come with a 30-day satisfaction guarantee.
Specific warranty terms vary by distributor or retailer, so we encourage partners and patients to check local details — but our confidence in product quality is the same worldwide.

With ISO-certified systems and four decades of foot science, Formthotics continues to set the standard in safe, effective, reliable orthotic solutions.

References:

1. International Organization for Standardization. ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes. Available at: https://www.iso.org/standard/59752.html

2. International Organization for Standardization. ISO 9001 Quality management systems — Requirements. Available at: https://www.iso.org/standard/62085.html

3. British Standards Institution (BSI). ISO 13485 Certification. https://www.bsigroup.com/en-NZ/

4. British Standards Institution (BSI). ISO 9001 Certification. https://www.bsigroup.com/en-NZ/