ISO 13485 Blog

Chany Runnels

How to choose a consultant for ISO 13485 implementation

If your company has decided to implement the ISO 13485 standard, you might be considering bringing in a consultant to assist with the implementation process. The wise selection of an ISO 13485 consultant is one solution that will greatly increase your chance of success and decrease your timeline in accomplishing accreditation. If you decide to implement ISO 13485 under the direction of a consultant, we encourage you to learn about a few factors that will assist you in finding an individual to best meet your needs.

Take a look at this Diagram of ISO 13485:2016 Implementation Process to become more familiar with the standard.

Key steps in selecting an ISO 13485 consultant

Most would assume that it is tricky to decide to hire a consultant for a task when you are not overly familiar with the subject matter. So, what are the key steps to success when hiring an ISO 13485 consultant?

Research and confirm your findings. With networking tools such as LinkedIn, verification of an individual’s skillset may be endorsed and commented on specifically through professional social media platforms. Having potential consultants provide you with professional references should be a part of your evaluation process. Ensure that your conversations with references are both pointed and specific to not only the experience, but also the deliverables and timeline to completion, while working with the consultant in question.



Inform yourself and your team on the standard. In your consideration of a consultant, be sure that your organization has a foundation in the standard to be implemented. Make an investment to educate your organization on the ISO 13485 standard and invest in an ISO compliance software. This will give your organization a baseline of knowledge when your consultant comes online and begins communicating requirements to achieve compliance with the standard. To learn more about the ISO 13485 requirements, check out the article ISO 13485 structure and requirements.

Recognize credentials. In the evaluation of a potential consultant’s CV or resume, you want to verify the source of their ISO 13485 knowledge. Any training certificates should be from reputable and recognizable organizations. Evaluation of on-the-job training should be well understood to ensure that an individual has solid experience either leading, maintaining, or complying with the standard over a number of years. Evaluate the version of the standard that your potential consultant is familiar with; ISO standards undergo regular reviews and new iterations are released periodically.

Verify that the consultant is familiar with the applicable version of the standard; this will encourage an implementation that is in accordance with the version that is valid at the time you need it.

Tips to choose an ISO 13485 consultant

Check out this free Checklist of ISO 13485 implementation and certification steps to inform yourself about the steps needed for the implementation according to the latest version of the standard.

The key is risk aversion

Understanding the risk level of your organization will assist in your selection of an ISO 13485 consultant.  The cost of a consultant may vary based upon experience level. The determining factor in your organization’s criteria for choosing the right person should be in alignment with the organization’s pre-determined risk level. Even if your organization is risk tolerant, use of a consultant will ultimately influence policy, procedures, and daily activities.

The selection of an ISO 13485 consultant will result in a change management-oriented position within your organization. Every organization should veer towards wise and timely hiring of consultants.  However, the key is to avoid the risk of exposing your organization’s key activities without proper legal agreements. Confidentiality by the consultant should be evaluated and expectations clearly identified during the hiring process. On the other side, as an organization, you must avoid the risk of exposing yourself to incorrect guidance. Do your research, verify the potential consultant, and ensure that their temperament is in alignment with the culture of your organization.

The end goal

The goal of hiring a consultant is to find a source of residential expertise in whichever market you are exploring. A consultant can add significant value when implementing a Quality Management System based on ISO 13485. If your company does not have an internal source of information that is familiar with the standard, (e.g., understanding the expectations on fulfilling the standard and knowledge of enduring an audit to obtain accreditation), then why not search for help? But before you decide whether to hire a consultant, think hard as to whether you really need one. Be sure to research and verify, educate yourself, and recognize the value of a potential hire’s credentials.

For a detailed comparison between using a consultant and implementing ISO 13485 yourself, see this free white paper: Implementing ISO 13485:2016 with a consultant vs. the DIY approach.


About the author:

Chany Runnels has a BS in Biology and an MBA with a concentration in Organizational Management. She has consulted in healthcare, industry, and government, providing roadmaps for the implementation of Quality Management Systems. She has successfully led laboratories in the manufacturing verification of medical devices, which were distributed domestically and internationally. These devices were compliant with FDA cGMP and modeled in accordance with ISO 13485. Previously serving as a Forensic Biology SME, she has been qualified as an auditor for ISO 17025/Forensic Testing Agencies and FBI’s QAS.

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