ISO 17665

ISO 17665:2006 is an internationally recognized standard focused on the sterilization of healthcare products using moist heat (steam sterilization). It outlines the validation and routine control of moist heat sterilization processes to ensure that products meet the required sterility assurance level (SAL). The standard is critical for manufacturers of medical devices, healthcare facilities, pharmaceutical companies, and any organization involved in sterile product handling or production.

At Quality Asia Certification, we offer trusted ISO 17665:2006 certification services to ensure your processes align with global sterilization and safety benchmarks. Our expert auditors and industry knowledge help your business achieve compliance efficiently.

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What is ISO 17665?

ISO 17665:2006 is a process-based certification standard that specifies the requirements for the development, validation, and routine control of a moist heat sterilization process for medical products. The standard includes:

  1. Guidelines for establishing validated sterilization cycles
  2. Performance qualification and operational controls
  3. Documentation and traceability requirements
  4. Risk-based approaches for ensuring product sterility

This certification is essential for any business where sterilization of reusable or single-use medical devices is a critical process. It supports both regulatory compliance and market entry in global healthcare markets.

Why is ISO 17665 important?

Maintaining sterility in healthcare products is not just a regulatory demand but a critical safety requirement. Sterile failures or non-compliance can result in severe health risks, product recalls, and loss of trust. With increasing regulatory scrutiny, having ISO 17665:2006 certification:

  1. Demonstrates commitment to patient safety
  2. Boosts confidence among hospitals, clinics, and buyers
  3. Helps meet FDA, EU MDR, and WHO requirements
  4. Serves as a key credential in tenders, approvals, and audits

Choosing ISO 17665 certification ensures your organization’s sterilization procedures are globally recognized, safe, and effective.

What are the benefits of ISO 17665?

By obtaining ISO 17665:2006 certification, your organization can achieve the following:

  1. Validated sterilization cycles that ensure consistent results
  2. Improved risk management through documented and tested processes
  3. Better control over critical parameters such as temperature, pressure, and exposure time
  4. Easier compliance with national and international healthcare regulations
  5. Higher customer and patient trust through proven sterilization performance
  6. Foundation for additional certifications like ISO 13485 and ISO 11135


What kind of businesses can benefit from ISO 17665?

Here’s how ISO 17665:2006 certification directly benefits your business:

✅ Ensures Regulatory Compliance

Meet the legal and healthcare regulatory standards required in domestic and international markets.

✅ Enhances Product Safety and Quality

Improves the sterilization process, reducing contamination risks and increasing patient safety.

✅ Boosts Market Access

Open doors to new contracts, especially in Europe, the US, and global healthcare supply chains.

✅ Reduces Operational Risks

Clear protocols and documentation reduce process deviations and human errors.

✅ Increases Client Confidence

Certified sterilization processes build confidence among healthcare providers and patients.

✅ Supports Competitive Advantage

Differentiates your brand with third-party verified credibility and quality assurance.

✅ Aligns with QMS Standards

Complements other standards like ISO 9001 and ISO 13485 for an integrated quality management system.


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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