How to choose a consultant for ISO 13485 implementation

What is ISO 13485:2016 Certification

One of the medical device industry’s most widely used international standards for quality management, ISO 13485, is evolving with the publication of a new version of the standard by the International Organization for Standardization (ISO).

The ISO 13485:2016 Certification standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 Certification provides a practical foundation for manufacturers to address the Medical Device Directives, regulations, and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

Choose a Consultant

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.

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 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. Check this To learn more about the ISO 13485 Certification.

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 ISO 13485 Certification Body 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.

 

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, the 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 researches, 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 13485 Certification Services. 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.

If you are looking for an ISO 13485 Certification Body to assist you with your certification, you should ensure that the company has the qualification and expertise necessary to offer relevant ISO 13485 Certification Services. While accreditation is not compulsory for ISO certification companies, an accreditation certificate is an indicator of good qualification. ISO 13485 Certification body helps to check out the ISO procedure. Check out these some frequently asked questions.

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