What Is the Total ISO 13485 Certification Cost?

The medical device production and supply industry is rapidly growing. The increasing necessity for technological intervention in medical recovery has made this industry more competitive today, than in other previous point in time. Undoubtedly, maintaining the quality of your devices is a pivotal parameter for customer satisfaction and revenue generation. The support provided with the ISO 13485 certification enables companies to maintain quality assurance, along with setting standards, policies and procedures for quality improvement. Accreditation is required when it comes competing against your competition and maintaining a solid customer base.

However, small and medium companies are often skeptical when they are asked to implement this accreditation. Most confusion is centered around the ISO 13485 certification cost. They think these charges are high or outside their budget. The cost of obtaining the ISO 13485 certification can vary significantly depending on various factors, including the size and complexity of your organization, the scope of the certification process, the level of existing quality management system (QMS) maturity, and the chosen certification body.

The following blog will focus on factors which determine the ultimate certification cost and common charges of a stage 1, and 2 audits and the issues of certification.

Eight Major Factors That Effect ISO 13485 Certification Cost

1.The size of the company

• The size of the company refers to the number of employees a company maintains.

• It also emphasizes the type of procedures the management team must follow. If the process is complex even with a small number of employees, the certification charges will increase.

2.Scope of the certification

It refers to the products and activities relevant to the organization and are covered under this standard. If the scope is broad, then the number of resources and amount of investment will be higher as well.

3.Professional ISO consultancy services

• If your company is unable to conduct significant assessments with the help of their internal team, then the management team must hire an external team of consultants.

• The cost of consultancy services can vary based on the expertise, reputation and the consulting firm.

• However, most consultancy agencies offer personalized help, so that their solution packages are affordable.

4.Implementation of the quality management system

Implementing the necessary processes and documentation in order to meet the ISO 13485 requirements involves all costs related to staff training, consultancy services, and documentation development. It is often regarded as the most crucial aspect of the project.

5.Costs for competency

• The implementation of this certification depends highly on the competency of its workers.

• To ensure they are proactive, efficient, conduct seminars, and organize training and awareness campaigns.

• Training costs may include the development of training materials, trainer fees, and employee time.

6.Fee of the certification body

The fee of hiring a certification body for a stage 1 and 2 audit and issuance of the certification is mandatory. A company cannot be given this grant without appointing a proper authorization council. The following table will help you to understand the general costs.

Process by the Certification bodyNon-accreditedAccredited
Stage 1 Audit$500$1000
Stage 2 Audit$1000$3000
Issue of the certification$500$1000

7.Internal audits

• Before an external audit, companies need to conduct internal audits that help the management team better identify areas that require further improvement.

• The audit will assess current compliance to the ISO 13485 before the certification audit happens along with the costs related to training internal auditors and dedicating resources to an internal audit process.

8.Costs for continual improvement

The last clause of the ISO 13485 is continuous improvement. To ensure that your system adheres to all quality clauses for regulatory compliance, companies need to implement new strategies and mobilize resources from time-to-time to monitor and assessments its current state. In order to hire professional support to meet the requirements of your information security management system, all standards must be met including conducting an internal audit. Therefore, contact us at Compliancehelp Consulting LLC. We are a premium site for achieving any ISO certification in the US. Our customized solutions for ISO and other global certifications are ready to make the seemingly exhausting process of accreditation, comfortable and seamless. From basic consultation to audit and analysis, we will cover everything. Get help to better understand all concepts regarding the clauses of any management system standard you require.