Guide to ISO 9001 Implementation

8 April 2024

You've been tasked with the ISO 9001 implementation. But now the question arises: Where do you start? Should you engage a quality system consultant, embark on an in-house initiative, or perhaps consider the use of a certification kit?

The best ISO 9001 implementation approach is contingent upon your specific circumstances. It is imperative to carefully review and compare your options to make an informed decision. In this article, we will explore different ways to implement ISO 9001 and discuss the practical implications of each approach. We'll also show you how to start with an ideal implementation strategy for your organization.

ISO 9001 Consultants or DIY Implementation Approach?

Doing It Alone

Embarking on an in-house implementation, without external assistance, is an initial consideration for many small businesses. This approach is viable if your organization has staff members with the requisite expertise. An internally developed quality system tailored to fit the organization's culture can be an invaluable asset. Additionally, involving numerous staff members in implementing the quality standard fosters broad employee support.

However, it is crucial to acknowledge that this approach demands not only internal expertise but also a substantial amount of time. It can easily necessitate full-time engagement of one or more employees for several months. In addition, this approach presents a heightened risk of costly errors that could further delay your certification and negatively affect the efficiency of your operations. Despite these challenges, relying solely on internal resources may be a suitable option for companies with ample internal expertise, idle human resources, and no immediate urgency for certification.

ISO 9001 Consultant

Engaging a specialized ISO 9001 consultant to oversee the entirety of the implementation process is a swift and convenient approach. Most tasks are handled by the consultant, with your staff executing the remainder under the consultant's guidance. The option of on-site or remote consultancy may also be available.

Engaging a consultant for ISO 9001 implementation offers several advantages. Not only does it expedite the process, but it also brings valuable expertise to improve your operations. Consultants bring a wealth of experience and best practices to the table, contributing to the success of your quality management system. In addition, their authority and credibility can help dispel doubts and fears among your staff, promoting employee buy-in.

However, it is important to consider the potential drawbacks of this approach. One significant aspect is cost. Hiring a consultant can be expensive, and organizations need to weigh the benefits against the financial investment required.

Another consideration is the consultant's understanding of your company's culture. For successful implementation, the consultant needs to comprehend your organization's values, structure, and dynamics. This knowledge enables them to tailor the ISO 9001 system to fit your unique requirements and effectively engage your employees.

Furthermore, the sustainability of your ISO certification depends on the consultant's ability to transfer knowledge and expertise to your staff. It is crucial to ensure that the consultant does not create a dependency on their guidance and micromanage the implementation process. Your organization should strive for independence and build internal capability to maintain the ISO 9001 system in the long run.

Certification Kit

Certification kits are a popular solution, providing the necessary guidance and tools for in-house implementation by staff members without prior ISO experience. These kits significantly alleviate the burden on your staff through pre-written templates, step-by-step instructions, and online or video training.

The Do-It-Yourself Toolkit approach emerges as the most cost-effective option. By utilizing a proven and tested toolkit, the process becomes surprisingly straightforward and expeditious. Furthermore, an internally developed ISO system holds the advantage of aligning well with corporate culture, leading to employee acceptance and support. With the expertise provided by your own staff, knowledge and skills remain in-house, fostering long-term sustainability in certification.

However, it's important to note that even with a reliable certification kit, the DIY approach demands effort and a willingness to learn. Establishing initial momentum can sometimes pose a challenge, making it advisable for a senior individual to spearhead the implementation. Their confidence-inspiring leadership and understanding of the significance of staff training will aid in a smooth and successful journey towards ISO 9001 certification.

Hybrid Approach

The ISO 9001 Hybrid Approach is a tailored and comprehensive solution that considers individual needs and combines the benefits of the Certification Kit with targeted consultancy services. In its basic form, a consultant plays a crucial role in establishing momentum and initiating the ISO 9001 implementation process. By conducting an analysis of your company's processes, the consultant provides a feasible and comprehensive roadmap to certification.

One of the main advantages of the Hybrid Approach is its ability to leverage the best of both worlds. It combines the cost-effectiveness of the DIY approach with the specialized expertise of an external consultant. This allows you to harness the consultant's knowledge and skills precisely where they are most needed. For example, you can engage a consultant to review your documentation for compliance and offer suggestions for improvement. Additionally, outsourcing your internal audit to an expert ensures a smooth certification process. In the case of our service, we not only provide consulting during the audit but also offer the opportunity for your internal auditors to learn auditing techniques by shadowing our lead auditor. To explore the variety of possibilities, refer to our typical implementation scenarios.

Flexibility is another notable benefit of the Hybrid Approach. You have the freedom to add consultancy services as needed, ensuring that you only pay for the expertise required for your specific situation. This approach helps you avoid unnecessary costs for services that may not be necessary in your implementation journey.

While the Hybrid Approach incorporates consultancy services, it is important to recognize that the backbone of this approach remains the Certification Kit. This means that the majority of the ISO implementation work is carried out by your own company staff. This requires effort and a willingness to learn, but it also ensures that the necessary knowledge and skills are retained in-house, leading to long-term sustainability.

How to Choose Your ISO 9001 Implementation Strategy

When it comes to selecting an ISO 9001 implementation approach, several factors come into play, including budget, urgency, and staff availability. Each approach – whether independent, consultant-led, kit-based, or hybrid – has its own advantages and drawbacks. To make an informed decision, it is crucial to carefully weigh the benefits against the costs involved.

Start by considering the benefits that your company can gain from ISO 9001 certification. Think about the operational and marketing advantages that this certification can bring. Additionally, consider the time aspect and how a fast or slow certification can impact your organization and sales volume.

On the cost side, it is relatively straightforward to evaluate the direct costs associated with each implementation approach. Keep in mind to account for the fees for independent assessment and certification by an accredited registrar. In addition, it is essential to also factor in the time your staff will spend on implementation efforts and training.

You can now consider the financial impact and potential benefits of each approach. Ask yourself questions such as: Does the urgency of certification outweigh the cost of hiring a consultant? Will it be more financially rewarding to have your staff focus on regular business operations rather than dedicating time to implementing ISO 9001?

Once you have determined how to best implement your ISO 9001 system, select a provider that maximizes benefits, minimizes costs, and establishes an efficient ISO system aligned with your unique company requirements. Look beyond the upfront cost and consider factors that impact indirect costs, such as reducing the likelihood of mistakes, optimizing the implementation approach for simplicity, ensuring ease of use for your staff, and minimizing time requirements. Remember, the effectiveness of training can also greatly impact the bottom line.


Selecting the right ISO 9001 implementation strategy and provider is crucial for the success of your quality management system. Whether you choose to do it alone, engage a consultant, use a certification kit, or opt for a hybrid approach, each option has its own advantages and drawbacks.

When making an informed decision, consider the benefits, costs, urgency, and staff availability. Assess the direct costs, but also consider the often overlooked cost of maintaining an inefficient ISO 9001 system. Streamline your quality system, prioritize practical benefits, and choose a provider that emphasizes operational advantages, business value, and simplicity. By selecting the most suitable approach and provider, you can establish an efficient ISO system aligned with your company's unique requirements and maximize the benefits while minimizing costs.

Feel free to contact us and have our experts evaluate your situation, guiding you towards a successful ISO 9001 implementation.

Naomi Sato

Naomi Sato

Consultant and Product Manager

Naomi holds dual responsibility as an ISO 9001 consultant and product manager, and is an enthusiastic contributor to our online and print resources.

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