Consulting With a Personal Touch|Call Us: 832-326-9796

Disrupt the Disruption with ISO 13485: QMS for Medical Devices

Posted by Victoria Ontiveros in Blog, Home Page, Manufacturing, Medical 15 Apr 2020


Virtually every aspect of our lives is experiencing a disruption due to the coronavirus (COVID-19). From nationwide school closures, to employees being forced to work remotely to major disruptions in the global healthcare supply chain. These organization are rapidly working to disrupt the disruption of COVID-19 with innovation. Teachers are developing innovative methods to engage students in virtual classrooms. Organizations are shifting towards utilizing technology to provide remote services. Businesses are pivoting and expanding their product lines to meet the increased need for daily and critical medical equipment. However, one thing has remained constant: the need for quality. As hospitals and healthcare providers are experiencing a shortage of medical equipment and devices, quality is critical in protecting their staff and patients.

For businesses that are ramping up production to support this public health crisis, implementing an ISO 13485 quality management system is a strategic step for managing medical device quality. ISO 13485, the quality management system for medical devices, helps increase the safety of those who depend on the quality and consistency of medical products.


What is ISO 13485 – Quality Management System for Medical Devices?

ISO 13485:2016 is an internationally recognized quality management system (QMS) published by the International Organization for Standardization (ISO). The ISO 13485 standard has been designed to be used by any organization that plays a role in the life cycle of a medical device. This includes initial conception, production, service, delivery and disposal. Implementing ISO 13485 helps organizations consistently provide safe and effective medical devices that meet customer and regulatory requirements.


In August of 2018, the US Food and Drug Administration (FDA), the government sector that regulates the medical device industry, announced that ISO 13485 would be used as the basis for quality system legislation. This increased the recognition and importance of a global regulatory process for medical devices, and reduced burdens on manufacturers by joining domestic and international requirements.


ISO 13485:2003 was replaced by ISO 13485:2016 on February 28th, 2019. The new ISO 13485 standard reflects the latest quality management system practices, changes in technology and regulatory requirements. The revision includes a greater emphasis on risk management, risk-based thinking and the changes to increasing regulatory requirements in the supply chain. Learn how our certified consultants can make your ISO 13485 transition seamless.



From Bandages to Life Support Devices – Quality is Critical

A medical device is defined as “an instrument, machine, implant, in vitro reagent, or similar article that is intended for use in the diagnosis, prevention and treatment of a disease and other medical conditions” (ISO). Medical devices range from every day, basic tools to complex machines and equipment. Simple tools can include wound bandages and personal protective equipment (PPE), such as gloves, gowns and face masks.

The quality of more durable medical equipment that can be improved by 13485 include hospital beds, wheelchairs and oxygen equipment. Life-supporting devices include respirators and lung ventilators. Advanced software-controlled devices can include CT scanners and MRI machines.


A High Level Overview of ISO 13485:2016

Organizations that are interested in implementing an ISO 13485 QMS should be aware of the key requirements of the standard, including:

  • Medical Device File – Organizations will need to establish and maintain file(s) for each medical device type or family. The files will need to contain or reference documents that include content such as the general description of the medical devices, the intended use and instructions, labeling, product specifications and associated procedures.
  • Management Responsibility – Leadership will need to be a critical part of developing, implementing and maintaining the effectiveness of the QMS. Activities that will help top management demonstrate leadership will include establishing a quality policy and quality objectives.
  • Customer Focus – ISO 13485 emphasizes that top management will be responsible for determining customer and regulatory requirements, and ensuring they are met.
  • Responsibility, Authority and Communication –
  • Management Review – The ISO 13485 QMS will need to be reviewed by top management during documented management review meetings that are conducted at planned intervals. This will ensure the continued suitability, adequacy and effectiveness of the QMS.
  • Human Resources – Personnel that perform activities that affect quality will need to demonstrate competence. Organizations shall provide training and ensure awareness of how their activities contribute to quality.
  • Infrastructure – Organizations will need to ensure appropriate infrastructure is in place for sterile medical devices, and be able to validate sterile barrier properties.
  • Contamination Control – Documented controls will need to be implemented to control and prevent contamination and maintain the required cleanliness of the product, work environment and personnel.
  • Planning of Product Realization – Plans for all phases of product planning, from product requirements to criteria for product acceptance, will need to be established and documented.
  • Design and Development – Organizations that are responsible for the design and development of medical devices will need to establish, implement and maintain design and development processes. This includes determining the required planning, inputs, controls, outputs and how to manage transfers and changes. Design and development files are required for each medical device type or family.
  • Cleanliness of Product – For organizations that provide products where cleanliness is significant in their use, are supplied non-sterile products or where process agents are removed during manufacturing, documented requirements for product cleanliness are needed.
  • Installation Activities – Organizations will need to document the requirements for medical device installation, and as appropriate, acceptance criteria for installation verification.
  • Servicing Activities – For products requiring serving, organizations will need to provide documented servicing procedures and maintain records. This includes reference materials and measurements for performing and verifying servicing activities.
  • Particular Requirements for Sterile Medical Devices – The records of the sterilization processes used for each sterilization batch will need to be maintained. These sterilization records will need to be traceable to each batch of medical devices produced.
  • Particular Requirements for Validation of Processes for Sterilization and Sterile Barrier Systems – Documented procedures and records of the results of the validation processes for sterilization and sterile barriers system will need to be established and maintained.
  • Complaint Handling – Documented procedures are needed to ensure timely complaint handling. The procedures need to include requirements and responsibilities for receiving information, evaluating if the feedback is a compliant, investigation, determining the need to report information to regulatory authorities and the handling and corrective actions of the compliant.
  • Control of Nonconforming Product – Organizations will need to establish, implement and maintain processes to determine and manage product nonconformities. This includes actions in response to nonconformities detected before and after delivery.
  • Corrective and Preventive Action – Implementing corrective and preventive actions to address the root causes of actual and potential nonconformities is vital. Corrective actions need to be taken right away.

What Benefits Will ISO 13485 Bring to Organizations?

Implementing an ISO 13485 can be a daunting task, but stringent requirements are needed for devices that impact public health. Organizations that properly implement, maintain, and achieve ISO 13485 certification experience several benefits, including:


1. Meet compliance to regulatory and legal requirements

2. Produce safe and effective medical devices for market

3. Effectively manage risk throughout the medical device life cycle

4. Gain a competitive advantage

5. Improve company reputation in the medical device industry

6. Improve overall operations and reduce waste

7. Meet customers’ requirements for ISO 13485 certification

How to Become an ISO 13485 Certified Company

Organizations of any size, in any industry, can become ISO 13485 certified. The following are steps organizations can take to start the journey to ISO 13485 certification:


1. Ensure adequate resources are in place to implement ISO 13485, including time and team members.

2. Perform an analysis of your organization’s operations, and identify gaps to ISO 13485 requirements.

3. Write required ISO 13485 management system documentation, including a policy, objectives and required medical devices files. Our ISO 13485:2016 documentation package is a cost-effective solution that can help jumpstart the implementation process.

4. Perform an ISO 13485 internal audit to monitor and measure the effectiveness of the QMS. This may require employees undergoing additional internal auditor training.

5. Successfully undergo a certification body audit. Watch our webinar for key strategies on how to pass your certification body audit, stress-free.


Providing healthcare workers, patients and the public with high quality medical devices and equipment are the foundation to keeping us healthy and safe. Even during COVID-19, businesses can disrupt the disruption by producing critical medical devices. For business shifting their focus to support the fight against the pandemic, implementing ISO 13485 will help them follow best practices in providing safe and effective products and services. There is no room for poor quality in the medical device industry; an ISO 13485 QMS will help ensure you provide quality products with confidence. If you are interested in ISO 13485 certification, our consultants can help. Contact us to speak with an ISO 13485 management system expert.



3 tips for preparing your team to undergo a certification body audit.

Victoria Ontiveros |Marketing Coordinator 

Victoria focuses on creating quality educational content that provides value to current and potential clients. By collaborating with members of leadership and sales, she is able to develop informative articles that answer common questions and connect with current trends.

Victoria earned her Bachelor of Science in Sociology with an emphasis in communications from Texas A&M University.

Contact Us Today

Post a comment

Show Buttons
Hide Buttons