ISO 13485:2016 -


Introduction to ISO 13485:2016

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. This standard is designed to be used by organizations involved in the design, production, installation, and servicing of medical devices and related services.

What is ISO 13485?

ISO 13485 is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It is designed to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

What are the benefits of ISO 13485?

Adopting ISO 13485 can help your organization to:

  • Demonstrate compliance with regulatory and legal requirements.

  • Manage risk effectively within the manufacturing process of medical devices.

  • Ensure the establishment of effective production and supply chain processes.

  • Achieve global recognition within the medical devices industry.

  • Increase efficiency, cut costs, and monitor supply chain performance.

  • Enhance customer trust and satisfaction by consistently providing products that meet customer and applicable regulatory requirements.

Steps to getting ISO 13485 certification


  • Comprehend the Standard: Gain an understanding of the ISO 13485:2016 requirements.

  • Gap Analysis: Evaluate your current processes in relation to the standard's expectations.

  • Strategic Planning: Formulate a detailed plan for system implementation.

  • Training: Educate your team about the standard and their role in the QMS.

  • Documentation: Develop your QMS documentation in line with ISO 13485 requirements.

  • System Implementation: Deploy your quality management system throughout your operations.

  • Internal Auditing: Perform thorough internal audits to ensure compliance and identify areas for improvement.

  • Choose a Certification Body: Select a credible certification body for external auditing.

  • Certification Audit: Pass the external audit conducted by the chosen certification body.

  • Ongoing Improvement: Continuously improve your QMS based on audit findings and industry advancements.


Why PCONNECT Management Systems?

PConnect Management Systems stands as your expert guide through the intricacies of ISO 13485:2016 certification. Our consultants specialize in the medical devices sector, offering nuanced insights and strategic guidance. We ensure your QMS not only achieves certification but also propels your business towards operational excellence and heightened customer trust.

How can ISO Consultants help your business?

Our dedicated ISO consultants bring a wealth of industry-specific knowledge to your organization. We assist in refining your processes, ensuring compliance, and maintaining the high standards expected in the medical devices industry. With our support, your journey to ISO 13485:2016 certification will be straightforward, ensuring that you meet both customer needs and regulatory demands confidently and competently.


Q: What is the difference between ISO 9001 and ISO 13485?

A: ISO 9001 is a general standard for quality management systems, applicable to any industry, while ISO 13485 is specifically tailored for the medical devices industry, with a particular focus on safety and regulatory compliance.


Q: Can ISO 13485 help with global market access?

A: Absolutely. ISO 13485 certification is often a requirement for regulatory purposes in many markets worldwide, and it can facilitate entry into those markets.


Q: How often is ISO 13485 certification renewed?

A: Similar to ISO 9001, ISO 13485 certification is typically renewed every three years, with surveillance audits recommended annually to maintain the certification's validity.


Q: Is ISO 13485 certification worth it for small to medium-sized enterprises (SMEs)?

A: Yes, ISO 13485 is beneficial for businesses of all sizes. It can enhance the credibility and competitive edge of SMEs in the medical devices market.