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Transitioning from ISO 9001 to 13485

With the recent updates to ISO 9001: 2015 and ISO 13485: 2016, many companies are now beginning to review which standard is most applicable to their business. ISO 9001 is generally the more applicable standard designed to guide any quality management system regardless of industry or business type. ISO 13485 is specifically targeted towards companies involved in the design, manufacturing, or supply chain processes of medical devices. If the recent changes have you wondering which standard is most applicable to your business, a review of the key similarities and differences may help to guide your decision making.

Key Similarities:

  • Organizational Importance: In both standards, organizational involvement is identified as a key element of a successful quality management system. This leads to requirements for management reviews, trainings, and clear organizational hierarchy and responsibilities.
  • Customer Focus: While ISO 9001 and 13485 have slight differences in how customer satisfaction is measured, both are clear that the end of goal of an effective quality management system is to produce reliable, effective results that meet customer expectations and result in client satisfaction.
  • Risk Management: Risk management is an integral part of both ISO 9001 and ISO 13485. Assessing organizational risk is a critical element of both quality systems and should be a foundational element in any decision-making process.

Key Differences:

  • Focus: An important difference between ISO 9001 and ISO 13485 is their primary focus. Because ISO 9001 is designed to be utilized by a wide variety of industries, it’s focus heavily emphasizes customers and risk-based decisions that minimize customer dissatisfaction. In contrast, ISO 13485 is focused on ensuring that the end medical device product is both safe and effective, leading to an emphasis on activities that most directly influence the final product.
  • Product Realization: While ISO 9001 emphasizes the process required to deliver products, ISO 13485 instead focuses on the design and development of product. This difference is designed to improve a focus on operations rather than documentation in ISO 13485 certified companies.
  • Continual Improvement: Both ISO 9001 and 13485 have a clear focus on continual improvement within an organization; however, they use different approaches to achieve this goal. ISO 13485 focuses on improving activities and effectiveness of the QMS, while ISO 9001 places greater emphasis on improving customer satisfaction and internal processes.

It should be noted that some companies may find it beneficial to maintain certification to both ISO 9001: 2015 and ISO 13485: 2016. But if transitioning from ISO 9001 to ISO 13485 is the right move for your company, Medpoint can help. We have experts ready to help you throughout the conversion process, including helping with:

Gap Assessment: Your starting point will be a thorough gap assessment encompassing all company processes and procedures to determine which already meet ISO 13485: 2016 expectations and what areas will require updates.

SOP Review: Medpoint consultants can assist as your update old procedures and draft new ones to ensure the changes being made are fully aligned with ISO 13485: 2016 expectations.

Training: Your team will need to undergo training to the new standard in order to understand why changes are being made, what the new expectations are, and how each employee affects compliance under the new standard. Medpoint consultants have experience crafting interactive, engaging training programs that will educate your team to the new requirements effectively.

If making the jump from an ISO 9001 compliant QMS to ISO 13485 is right for you, contact us today to see how Medpoint can help make the transition go as smoothly as possible: or 800.200.9292.




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