ISO 13485 auditor certification online | What are the career options?

The ISO 13485 is a quality management system standard for the medical device production industry. Since the market is increasingly competitive in the United States, this standard has become a mandatory requirement lately. The certification process involves several crucial analyses and assessments and one of them is an audit. Two types of the ISO 13485 audit take place during the certification procedure. One is the internal audit before registering the quality system for third-party evaluation. The second one is the external or third-party audit, which is done to inform the certification provider about the compliance maintained by the system. Based on that, accreditation is provided.

With the increasing demand for certification, it is not difficult to assume the prospect of becoming a certified audit specialist. Pursuing the ISO 13485 auditor certification online is therefore a relevant choice. One can choose to become an internal or an external auditor. Career opportunities are high as thousands of companies prefer to keep in-house audit specialists in the US.

There are two categories as mentioned above. Based on that individual online classes are arranged for:

  • Internal audit – Management systems auditing
  • Lead audit – Leading management system audit

The following blog will discuss career opportunities and the process to become a certified auditor for the ISO 13485.

What are the career opportunities for pursuing the ISO 13485 auditor certification online?

Based on necessity and individual convenience, the following categories of audit services are popular in the country.

  • Part-time audit specialists – Their job role is to assist a company in attaining the clauses of the ISO 13485 before registering the system for third-party analysis. This job role is also in high demand for external audit assessment as well. Companies often hire part-time executives based on project demands. These part-time jobs target less experienced and recently qualified candidates.
  • Lead/senior auditor – Lead auditor is the second most popular role in high demand. Their responsibilities include leading an audit group and performing the major assessments. Major companies hire for in-house purposes. However, there are audit agencies, which search for experienced and certified auditors as well. To get the
  • Audit lead manager – This position is the same as the previously discussed one. The role is to manage a team of auditors, giving them training, and including them in varied assessments. For a lead management role, one must have experience and wide exposure. Working for both part-time and full-time jobs for assorted sizes of medical device production and selling companies are mandatory. This role is also in demand for both internal and external audits.

How To Become an ISO 13485 Auditor in the US?`

  • The first step is picking a CQI IRCA ATP Institute for admission. This is most important as the institute and faculty play a significant role.
  • The second step is attending classes regularly. The fundamental learning objectives to become an ISO 13485 audit specialist are: interpreting requirements, understanding the difference between the ISO 9001 and the ISO 13485. Conduct a practical audit exercise, learning to design a checklist, asking questions, and streamlining an auditing system based on the audit requirements.
  • The third step is completing all the necessary exams. This includes short-term mock tests where the candidates must perform an audit assessment all by themselves.
  • The next step is gaining expertise and applying for the IRCA grade membership. Once membership is earned, one can successfully apply for part-time as well as full-time jobs.

Today, online courses make it easy for aspirants to complete every phase without any difficulties. Online courses are beneficial for countless reasons. It saves time, allows students to save expenses, and gives exams and practice mock-test as per their convenience. Choosing the right institute and completing all the learning objectives are crucial to becoming a successful auditor. Since career prospects are high, too many applicants apply for the same institute. It is often difficult to get a chance to go to reputable institutions.

Contact us at Compliancehelp Consulting LLC to know more about the ISO 13485 auditor certification online. We are the United States more premier firm for achieving any ISO certification. Our bespoke solutions for the ISO 13485 accreditationare ready to guide you through the exhausting process of certification without any difficulties. Get help choosing the right assessment.