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.
