ISO 22632

ISO 22632:2021 is an internationally recognized standard developed by ISO/TC 150 for surgical implants — Polymer-based materials. This standard specifically focuses on the requirements and testing methods for polyetheretherketone (PEEK) polymers, which are widely used in the manufacturing of implantable medical devices due to their biocompatibility and mechanical performance.

As a certification body, Quality Asia Certification provides ISO 22632:2021 certification to manufacturers seeking to validate the quality, consistency, and compliance of their polymer materials used in surgical implants. By obtaining this certification, businesses demonstrate a strong commitment to patient safety, product reliability, and regulatory compliance on a global scale.

65% Cost Reduction

60% Sustainability

80%

Customer Attraction

60%

Increase Your Competitive Edge

What is ISO 22632?

ISO 22632:2021 – Implants for Surgery – Polymer Materials Based on Polyetheretherketone (PEEK)

This standard outlines the testing procedures, physical and chemical property requirements, and documentation protocols for polymers intended for long-term use in human body implants. It ensures that PEEK-based materials meet the stringent demands of the healthcare industry, especially for use in load-bearing and high-performance implantable devices.

The certification validates that the manufacturer adheres to best practices in material selection, product safety, biocompatibility, and traceability — all critical aspects in the medical device industry.

Why is ISO 22632 important?

With the increasing global demand for biocompatible and high-strength medical polymers, PEEK has emerged as a preferred material for orthopedic, spinal, and dental implants. However, not all PEEK materials meet international safety benchmarks.

ISO 22632:2021 certification is crucial for any organization that manufactures or supplies PEEK-based surgical implants. It builds trust with healthcare professionals and patients by ensuring that the product is tested for biological safety, chemical stability, and mechanical reliability.

Moreover, obtaining ISO 22632 certification enhances market acceptability, especially in regions where compliance with international standards is a prerequisite for product approval.

What are the benefits of ISO 22632?

  1. Material Validation: Ensures that PEEK polymers used in implants meet strict international safety and performance requirements.
  2. Product Traceability: Establishes strong documentation and traceability from raw material to final implantable product.
  3. Risk Reduction: Minimizes the risk of implant failure due to substandard material properties.
  4. Enhanced Brand Trust: Increases confidence among regulators, healthcare institutions, and end-users.
  5. Global Market Access: Facilitates smoother entry into regulated markets such as the EU, US, and Japan.

What kind of businesses can benefit from ISO 22632?

Achieving ISO 22632:2021 certification with Quality Asia Certification offers measurable value to businesses in the medical device sector:

Builds Reputation: Demonstrates adherence to international quality and safety standards.

Increases Market Reach: Opens access to regulated markets demanding certified products.

Boosts Client Confidence: Provides assurance to buyers and hospitals about the product’s quality and safety.

Improves Product Development: Encourages better design, material selection, and innovation through standardized testing.

Regulatory Compliance: Helps meet FDA, CE, and MDR requirements with globally aligned certification.


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