ISO 11607

ISO 11607:2019 is an internationally recognized standard that outlines the requirements for packaging systems used to maintain the sterility of terminally sterilized medical devices. With growing global demand for safe and sterile medical products, this standard plays a critical role in ensuring the integrity and performance of packaging throughout the device’s shelf life. Quality Asia Certification provides ISO 11607 certification services to manufacturers, suppliers, and packaging providers in the healthcare and medical device industry, ensuring they meet global regulatory and customer expectations.

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What is ISO 11607?

ISO 11607:2019 is a two-part standard:

  1. Part 1 specifies the requirements and test methods for materials, sterile barrier systems, and packaging systems.
  2. Part 2 outlines the validation requirements for forming, sealing, and assembly processes of packaging.

The standard ensures that medical device packaging maintains sterility until the point of use and can withstand various physical and environmental conditions during transportation, storage, and handling.

Why is ISO 11607 important?

Compliance with ISO 11607:2019 is essential for any manufacturer or supplier involved in the packaging of medical devices. Regulatory bodies such as the FDA (USA), EU MDR (Europe), and other international health authorities recognize ISO 11607 as a critical benchmark for packaging validation and sterility assurance. Achieving certification not only demonstrates your commitment to quality but also facilitates smooth market entry, enhances product credibility, and builds customer trust across global healthcare markets.

What are the benefits of ISO 11607?

  1. Ensures sterile barrier system effectiveness across the entire supply chain.
  2. Aligns packaging processes with international healthcare regulatory expectations.
  3. Reduces product recalls and contamination risks.
  4. Strengthens brand reputation and customer assurance.
  5. Streamlines validation and documentation processes for packaging systems.
  6. Enhances supply chain confidence and traceability in case of audits.

What kind of businesses can benefit from ISO 11607?

Achieving ISO 11607:2019 Certification through Quality Asia Certification provides your organization with the following key advantages:

  1. ✅ Regulatory Compliance: Supports compliance with FDA, EU MDR, and global medical packaging regulations.
  2. ✅ Market Access Expansion: Facilitates entry into regulated markets and enables participation in global tenders.
  3. ✅ Risk Mitigation: Minimizes the risk of device contamination, regulatory penalties, and recalls.
  4. ✅ Customer Confidence: Builds trust with healthcare professionals, hospitals, and medical procurement bodies.
  5. ✅ Operational Efficiency: Helps standardize packaging processes, reducing rework and waste.
  6. ✅ Competitive Advantage: Sets your organization apart in the crowded medical device industry.
  7. ✅ Improved Product Lifecycle Management: Ensures product sterility throughout handling, distribution, and end-use.


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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