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The Medpoint Blog

Learn best practices and gain new insights on quality assurance, regulatory strategy, and clinical affairs.

5 Reasons to Seek External Auditors for your QMS

Regular internal audits are a vital part of QMS maintenance and are in many cases a regulatory requirement. By collecting evidence and evaluating it objectively, a company can determine how well its quality management system is performingand support an environment of continuous improvement. 

An effective audit can identify areas of risk and opportunity. Even if the audit doesn't reveal any potential problems, it evaluates whether or not  you have an efficient QMS that is functioning as it should.

While they are called "internal audits," hiring external experts to conduct these audits can offer certain advantages to your company as opposed to delegating the task to quality or regulatory affairs staff. Below are a few reasons why.

1. Technical Gaps Requiring Specialization 

Audits are highly demanding. They require a certain set of skills and different forms of expertise. Suitable candidates should have relevant education, training, experience, and personal attributes to conduct an audit. 

While your in-house team may have a full understanding of how to maintain a quality management system, it could lack the necessary experience or training to effectively perform audits. 

By delegating your internal audits to an external auditor, you gain access to experts with extensive experience and passion for driving quality performance.

2. A Fresh Set of Eyes 

Selecting an internal auditor from your staff can be hard since the majority of it is likely to have taken part in creating and maintaining the QMS. This may cause several issues: 

  • It can be harder for these staff members to identify problems that they may have been partly responsible for creating. 
  • These staff members may miss a problem since they firmly believe that the system they created is working properly. 

An external auditor who isn't involved in the system's development and maintenance can run an attentive, careful, and objective QMS process analysis.

3. Decrease Bandwidth Demands

Even if some members of your staff are excellent candidates for to conduct an internal QMS audit, they simply may not have time for it. A top-notch audit requires full engagement, forcing employees to forgo their core duties for the duration of the process. 

By overloading your team members, you don't just affect the company's profitability but decrease staff satisfaction. According to a recent study, burnout is responsible for up to 50% of workforce turnover. 

When your team is working at its full bandwidth, the only way to ensure the company's efficiency and audit quality is to hire external auditors. 

Instead of making formidable investments into permanent team members who can focus on the audits, it's much simpler to delegate the task to a third party for temporary bandwidth relief.

4. Cost-Effective

If you have different sites across the country or around the world, QMS audits can be costly. To complete a regular audit schedule, you may need to send auditors on long business trips, pulling them from their core competencies. It can be much more cost-effective to hire an external auditor who lives in close proximity to the audit site. 

Training Costs  

Even if your staff members have extensive experience setting up and managing a QMS, they can't always perform an internal audit. To achieve efficient results, potential auditors require appropriate training.  They need to take an Internal Auditor training course, arranged by an accredited ISO consulting firm. 

Besides keeping your employees from focusing on their core competencies, auditor training requires a substantial investment. 

The key to a successful audit is not putting all eggs in one basket. A team of auditors should consist of cross-disciplined staff to ensure objectivity. Covering training expenses for a large team of in-house auditors isn't cost-effective. 

When you delegate your internal audits to an external auditor, you work with a diverse team of experts who have undergone the necessary training and obtained the relevant certifications.

5. Objectivity 

Objectivity is the key to a successful QMS audit. When you delegate the task to an in-house team, you can't guarantee an objective point of view. Since the consequences of QMS problems fall upon your staff members, their objectivity suffers.  Employees may worry about the negative repercussions of them critiquing the work of other departments with whom they work closely on a daily basis 

External auditors aren't encumbered by office politics. Their only goal is to make sure your quality management system is working properly and in compliance with the applicable regulations. These experts are more likely to dig deeper and pay attention to small details in order to reach clear and explicit conclusions based on the collected evidence. 

The Takeaway 

Working with your in-house staff to arrange regular QMS audits may demand excessive time and expenses without guaranteeing efficient and objective results. 

Contracting an external expert to review and remediate any issues with your quality management system can help you achieve the desired results without hurting your budget. External auditors add value to the process that cannot be found when working with internal quality assurance or regulatory affairs staff. 

To learn more about finding the right auditors for your needs, subscribe to our blog.