ISO 13485 is a standard that sets out the requirements for a quality management system specific to the medical devices industry. It is intended to help organizations demonstrate their ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements throughout the life cycle of the product. ISO 13485 is based on the ISO 9001 quality management system standard, but with additional requirements and adaptations for the medical devices sector.

ISO 13485 was first published in 1996 and revised in 2003 and 2016. The latest version, ISO 13485:2016, reflects the changes in technology, regulatory expectations, and best practices in the medical devices industry. Some of the main improvements in ISO 13485:2016 include:

– A greater emphasis on risk management and risk-based decision making throughout the quality management system

– A stronger alignment with the regulatory requirements for organizations in the supply chain

– A clarification of the requirements for validation, verification, design transfer, and control of outsourced processes

– A harmonization of the terminology and definitions with other relevant standards and regulations

ISO 13485 can be used by organizations of any size and type that are involved in one or more stages of the medical device life cycle, such as design and development, production, storage and distribution, installation, servicing, or technical support. It can also be used by suppliers or external parties that provide products or services to medical device organizations. ISO 13485 can be applied to any type of medical device, from simple bandages to complex implants or software.

ISO 13485 is not a requirement of the standard itself, but it can be a voluntary choice or a contractual obligation for organizations that want to demonstrate their compliance with the quality management system requirements. ISO 13485 can also facilitate the access to global markets, as it is recognized by many regulators and certification bodies around the world. However, ISO 13485 does not replace or override the legal or regulatory obligations of the organization or its products. It is the responsibility of the organization to ensure that it meets all the applicable laws and regulations in each country where it operates.

ISO 13485 is developed and maintained by ISO Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices, in collaboration with other relevant stakeholders. The standard is reviewed every five years to ensure that it remains relevant and up to date.

Why is ISO 13485 important?

ISO 13485 is important for several reasons:

  • It helps organizations to ensure the safety and quality of their medical devices and related services, which can improve customer satisfaction and patient outcomes.
  • It helps organizations to comply with the applicable regulatory requirements in different markets, such as the European Union, Canada, Japan, Australia, and others. Some regulators require or recognize ISO 13485 certification as a condition for market access or approval.
  • It helps organizations to demonstrate their commitment to continuous improvement and best practices in the medical devices industry, which can enhance their reputation and competitiveness.
  • It helps organizations to manage risks and opportunities throughout the life-cycle of their medical devices, from design and development to post-market surveillance and feedback.

Implementing a QMS according to ISO 13485 can bring many benefits to your organization, such as:


  • Improving customer satisfaction by meeting their needs and expectations
  • Enhancing your reputation and credibility in the medical devices industry
  • Reducing risks and costs associated with errors, defects, recalls, or nonconformities
  • Increasing efficiency and effectiveness of your processes and operations
  • Fostering a culture of continuous improvement and innovation
  • Facilitating market access and trade by demonstrating compliance with regulatory requirements
  • Global Recognition
  • Improved legal and regulatory or contractual requirements compliance
  • Assistance in monitoring supply chain effectiveness
  • Increased profit margins
  • Improved product safety
  • Increased Efficiency
  • Proactive error detection and prevention
  • Cost Savings
  • More Effective Risk Management
  • Increased likelihood of meeting Customer Requirements
ISO 13485

Benefits of ISO 13485 Certification to your customers

  • Quality ensured medical devices
  • Safe and effective medical devices
  • Lower skepticism and increased confidence for end-customer
How to get certified to ISO 13485?

Certification to ISO 13485 is not mandatory, but it can be a valuable way to demonstrate your commitment to quality and regulatory compliance. Certification is performed by an independent third-party organization, called a certification body, that audits your QMS against the requirements of ISO 13485.


To get certified to ISO 13485, you need to follow these steps:


– Establish your QMS by documenting your policies, procedures, objectives, and records

– Implement your QMS by training your staff, conducting internal audits, and monitoring your performance

– Review your QMS by evaluating your results, identifying opportunities for improvement, and taking corrective actions

– Apply for certification by selecting a reputable certification body and submitting your application

– Prepare for the audit by reviewing your QMS documentation and ensuring readiness

– Undergo the audit by cooperating with the auditors and providing evidence of compliance

– Receive the certificate by resolving any nonconformities and accepting the audit report


How can organizations implement and get certified in ISO 13485?

If you are interested in implementing and getting certified in ISO 13485, here are some steps you can follow:

  1. Understand the standard and its benefits. ISO 13485 provides a framework for managing the processes and activities that affect the quality of medical devices, from design and development to production and distribution. It also helps you comply with the applicable laws and regulations in your market. By adopting ISO 13485, you can demonstrate your commitment to quality, improve your customer satisfaction, reduce your risks and costs, and gain a competitive edge.
  2. Conduct a gap analysis. A gap analysis is an assessment of your current QMS against the requirements of ISO 13485. It helps you identify the strengths and weaknesses of your system, as well as the areas that need improvement or change. You can use a checklist or a tool to perform a gap analysis, or hire a consultant to assist you.
  3. Develop an implementation plan. Based on the results of your gap analysis, you can create a plan that outlines the objectives, actions, responsibilities, resources, and timelines for implementing ISO 13485. You should also define the scope and boundaries of your QMS, such as the products, processes, sites, and functions that are covered by the standard.


  1. Provide training and awareness. To ensure the success of your implementation, you need to train and educate your staff on the requirements and benefits of ISO 13485. You should also communicate the changes and expectations to your stakeholders, such as customers, suppliers, regulators, and partners.


  1. Implement the changes and monitor the results. You should document and update your policies, procedures, records, and controls according to ISO 13485. You should also perform internal audits and management reviews to verify the effectiveness of your QMS and identify opportunities for improvement. You should monitor and measure your performance indicators and customer feedback to evaluate your progress and achievements.


  1. Seek certification from an accredited body. Once you are ready, you can apply for certification from an independent third-party organization that is accredited to audit and certify QMSs based on ISO 13485. The certification process typically involves an initial audit, a certification decision, and periodic surveillance audits to maintain your certification.


Implementing and getting certified in ISO 13485 can be a challenging but rewarding journey for any organization that produces or provides medical devices. It can help you enhance your quality, compliance, reputation, and profitability in the global market.

How to get certified to ISO 13485?

ISO 13485 is a standard that defines the requirements for a quality management system for organizations involved in the medical devices industry. It helps organizations ensure quality and regulatory compliance throughout the life-cycle of a medical device. Certification to ISO 13485 can provide many benefits for your organization, such as improving customer satisfaction, enhancing reputation, reducing risks and costs, increasing efficiency and effectiveness, fostering improvement and innovation, and facilitating market access and trade. The latest version of ISO 13485 was published in 2016 and introduced some significant changes that reflect the current best practices and expectations in the medical devices industry.

If you are interested in implementing ISO 13485 in your organization, you can contact us for more information. We are a certified ISO 13485 consultant that can help you design, develop, implement, audit, and improve your QUALITY management system. We have the expertise, experience, and tools to help you achieve your goals.