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ISO9001:2015

Quality Management Systems

Who should aim for an ISO9001 certification, what are the benefits & how Rheintec supports you

Who should get ISO9001 certified and why?

An ISO9001 Certification should be considered by organizations that want to ensure the quality of their products and services and which are looking for an organizational mean to continuously improve their processes. 

The ISO9001 Certification is not limited to companies that provide physical goods but also plenty of service providers or even educational institutions like Camebridge International Education have attained an ISO9001 certificate. 

 

 

Benefits of an ISO9001 Certification

The ISO9001:2015 Standard is an internationally recognized standard. There is no legal requirement to fulfill ISO9001 requirements but the certificate provides your business with an independent attestation that your organization is adhering to rigorous quality management requirements & measures, therefore ensuring best practices are implemented when it comes to the quality of their services and products.

The ISO9001 certificate fosters trust in your organization by existing and potential new customers, providing a potential competitive edge and may act as a door opener to attract new business. Many large enterprise organizations in market segments such as pharmaceutical, medical device, automotive and the aviation industry may require ISO9001 certification by their vendors in order to engage in business. 

Furthermore companies can strengthen their overall quality mindset throughout all stages of the business via adhering and consistently executing on the requirements defined and outlined by the ISO9001 Standard. A well established Quality Management System (QMS) provides you with the means for proper reporting to management, therefore enables your organization to address potential negative trends such as increases in customer complaints or defects in a pro-active manner, which significantly contributes to proper prioritization & allocation of resources where it matters. 

Implementing a risk based approach is a key driver in achieving higher efficiency and placing focus to high risk areas rather than wasting resources where only minimal increases in consistent product or service quality can be achieved with high expenses.

 

How Rheintec supports your organization

Rheintec applies an integrated approach when it comes to establishing Quality Management Systems (QMS). With our proven track record we provide hands-on consulting services to support & guide you through the process. 

Our goal is to implement the QMS into your existing business processes therefore increasing adoption of ISO9001 governed practices & requirements by your whole organization and employees

 

Roadmap to ISO9001:2015 Compliance

ISO27001 Certification Roadmap-2

What happens after the QMS is implemented?

After successfully implementing the Quality Management System (QMS), Rheintec recommends conducting an internal audit, as outlined in the roadmap, to review the QMS and overall compliance status. This proactive approach helps prevent unexpected issues or major non-conformities during the certification process.

If the audit confirms that the company's management system has achieved the required maturity level and compliance with ISO9001 standards, the next step is scheduling the official certification audit with a notified body. To streamline the process, it is advisable to contact a certification body 1–2 months in advance.

Various certification bodies are available, including TÜV, SQS, and Cert-X. Rheintec will coordinate with the selected body to schedule the audit and provide guidance throughout the process.

It is important to note that Rheintec does not conduct certification audits directly. This is to avoid conflicts of interest, as a service provider involved in establishing a QMS cannot certify the same system.

 

 

 

Costs of an ISO27001 Certification

The overall costs of an ISO9001:2015 certification may vary based on the following factors:

  • Size of the organization
  • Scope & complexity of the business
  • Current status of the QMS 
  • Available know-how & resources

As a general rule the bigger and more complex the organization the higher the expected costs since more effort is required to implement all the requirements and processes. If for example several business locations are established this will increase the effort required by the notified body (certification body) to perform the stage I & II audits and therefore also drive costs.

Another important factor is the existing know-how in the company and already available processes & documentation. The more processes and associated operating procedures the organization has established the lower the effort to fully implement a functioning QMS. 

For a company of around 20 - 50 employees the costs could be estimated as follows:

  • Gap assessment & consulting for implementation of the QMS - between 10'000 - 20'000.-
  • Initial Certification by the notified body - between 6'000 - 10'000

As the ISO9001:2015 Certificate remains valid for 3 years the notified body will carry out surveillance audits in the following years. The costs for these are lower than for the initial certification but these should as well be considered by the business. These can be estimated as follows:

  • Surveillance Audit - between 4'000 - 6'000.-

Furthermore the organization needs to provide required resources and make these available to continuously maintain the QMS, a rough estimation would be around 20% of a full time equivalent which of course may vary significantly based on the size & scope of the organization.

The herein stated estimates do not represent binding offers and may vary significantly based on the above outlined factors.

 

Why partner with Rheintec for your ISO9001 Certification?

Constraints of other consulting organizations:

  • focus solely on guidance & compliance
  • provide a fixed price e.g. 10'000.- but then only offer templates & a portion of technical writing
  • sell QMS tools but do not provide the hands-on support required to achieve a well established & functioning QMS with it's benefits
  • apply a standardized approach which is not tailored to your organization, creating high costs in gap assessments that are not necessarily needed

Your benefits in partnering with Rheintec:

  • Our focus goes well beyond compliance, an integrated risk based approach & focus on key areas of improvement that matter for the business are integral parts of our principles
  • We custom tailor our approach based on your needs and current QMS status. If organizations are at the starting point of the implementation we suggest to skip the gap assessment and jump right into the establishment of your QMS - this saves costs and speeds up the implementation
  • Hands-on & value driven form further key components of our approach. Achieving a Zero Risk & 100% compliance status is impossible and achieving 99% compliance is extremely resource intense. We focus on core business areas and drive effective improvement to achieve desired maturity and compliance 

 

Interested in establishing a Quality Management System?

Schedule a free meeting with one of our consultants to discover what best fits your business needs.