The benefits of ISO 9001 certification are clear. Certified companies have a more robust Quality Management System (QMS), higher employee engagement and customer satisfaction, and are more profitable. In fact, 69% of non-certified companies reported losing bids to ISO 9001-certified companies at least once. So, if you want to avoid this scenario, exploring common pitfalls in ISO 9001 implementation will be worth your time. 

 Today, we will explore the common challenges and mistakes organizations face in the ISO 9001 certification process. Plus, we will offer practical tips so you can avoid these mistakes. So, let’s dive right in! 

Mistake 1: Pursuing ISO 9001 Certification for the Wrong Reasons 

It’s absolutely true that certified organizations get a number of external benefits. But letting external pressure drive your ISO 9001 implementation is not the right way to go. If you fall into this trap, you will see the certification process as a checkbox exercise to get to your end goal. And you may not get there. 

 

Rather, you should focus on continuous improvement and building a powerful quality management system. Then, all the benefits will come in due time. Higher productivity and efficiency, paired with some marketing efforts, will help you achieve your end goal. 

 

So, what are some of the “wrong” reasons to pursue ISO certification? 

• ISO 9001 certification for marketing purposes. Getting certified in ISO 9001:2015 can help your marketing. But emphasizing marketing strategies over process improvement can be a costly mistake. First of all, you will not be noticing high-impact operational benefits. Keeping your mindset on marketing will take focus off processes that improve product quality and customer satisfaction. 

• Getting ISO 9001 certificate to win contracts. Again, this quality management systems standard can help you penetrate new markets. Governments, non-profit organizations, and many others prefer to work with certified companies. However, checking the boxes to win contracts will not bring long-term benefits. Let’s say you accelerate your certification process. You will formally achieve certification. But, without focusing on improving your operations, you risk failing on contractual obligations. Superficial ISO 9001 compliance will leave you with dissatisfied customers and severe reputational damage. There may even be financial and other penalties. 

• Pursuing certification because you have ISO-certified competitors. You may feel pressured to get certified if your main competitors comply with ISO 9001. But it’s important to adopt the mindset of quality management first. You need to improve your processes and products to deliver the best option to customers. You also need to consider all the financial challenges and risks. You may not have the same resources for implementation or certification. Then, you can damage your bottom line by investing in certification rather than improving your products. 

 

ISO 9001:2015 certification is a worthy goal. But the decision to pursue it needs to be deeply internal. Without a sincere commitment to quality management and customer focus, you may get superficial compliance. And it may help you win some contracts initially. But, if your QMS fails because you didn’t address the key points, such as customer requirements, risk management, and continual improvement, the consequences can be severe. 

 

So, begin by defining your reasons for seeking ISO 9001 certification. But make sure they’re the right reasons that will help your company meet and exceed expectations in the long term. Certification is not a sprint but a marathon, and you need to invest in the future of your organization. 

Mistake 2: Lack of management commitment 

Lack of management commitment in the certification process leads to a variety of problems: 

• Communication issues, 

• Lack of resources, 

• Insufficient expertise. 

Communication issues 

Senior leaders must take a leading role in the ISO 9001 implementation process. Without their guidance, support, and oversight, it’s difficult to achieve certification. First of all, leaders who don’t communicate the benefits of ISO 9001 to the organization won’t get employee participation. And without having the entire workforce on board, it’s difficult to establish a culture of quality. Employees may see this as excessive and unnecessary bureaucracy and resist change. 

Lack of resources 

Secondly, if the leaders aren’t on board, they may not allocate enough time and resources to implement an ISO 9001-based QMS. Certification can take six months or more to complete, and there will be costs associated with it. Other than the cost of certification audits, there can be process improvement costs. Employees may need additional training or support. Machinery may need updating. Documentation practices may need to change. If the implementation team can’t have the resources for all of this, it’s almost impossible to get certified. 

Insufficient expertise 

Leaders should also recognize the need for additional expertise in ISO implementation. If nobody within the organization is familiar with the process, the management team will have to act. Whether it’s sending employees for ISO-based training, educating themselves, or hiring outside help, top managers must provide the means to bridge this gap. 

As you can see, the lack of top management commitment can lead to several certification problems. Hence, it’s pivotal to make the leaders the champions of the ISO 9001 implementation process. Trying to pursue QMS certification without management support is an uphill battle many companies have faced. Don’t make the same mistake. 

Mistake 3: Insufficient understanding of requirements 

Like other ISO standards, ISO 9001:2015 has ten sections. The first three sections offer a general overview of the standard’s scope and intent, as well as key definitions. There are also references to ISO 9000 that you will need to review to grasp the key concepts. Sections 4-10 list out the compliance requirements. However, the ISO standard for quality management systems is generic in nature. That’s why it can be implemented by any organization in any sector. So, here’s the problem. Understanding what those requirements mean in practice can be challenging. 

 

For example, the organization must identify the scope of its quality management system. This includes three main parts: 

1. Internal and external issues, 
2. Requirements of interested parties, 
3. Products and services. 

It’s up to each organization to determine exactly what these elements are for them. And then, to sum it all up in a concise statement. 

Understanding each requirement of ISO 9001 requires a deep dive into definitions and operations. So, having a competent team or an experienced consultant is key. They will help you document and implement each practice according to the international standard. No more, no less. 

Where many organizations fail is, they just jump right into implementation without proper understanding. They don’t know what must be included or excluded from the QMS. They also don’t know how to implement the requirements within their organizational context. 

Mistake 4: Unrealistic expectations 

Setting unrealistic expectations regarding certification is a surefire way to fail implementing ISO 9001. 

The most issues arise around: 

• The speed of implementation/certification, 

• Certification costs, 

• Benefits of certification. 

Speed and cost often go hand in hand. Miscalculating how quickly you can comply with ISO 9001 requirements can result in additional costs. Some organizations may not gauge their current readiness and project they can get certified in a couple of months. Then, they will miscalculate how much employee and management time to allocate to these efforts. Worse yet, as the timeline gets pushed, additional costs will arise. 

 The key to avoiding these mistakes is knowing where you are, where you want to go, and why. What’s the current state of your QMS? What do you want to achieve with ISO certification? What benefit will that bring to your bottom line? 

 Here’s how it can all go very wrong with unrealistic expectations: 

 

Expectation	Obstacle	Result
Certification will take 2,5 months	Obsolete QMS, lack of expertise, not understanding the requirements of ISO	Certification can take six months, depending on the state of QMS, documentation, expertise available, and auditor availability
Certification will cost $3000	Cost calculations include employee and management time, consultant fees, notified body (and auditor) fees, process improvement costs, etc.	Certification costs rise with each additional day and month devoted to improvement efforts, equipment calibration, and auditor hours spent reviewing documentation and interviewing employees
We will win a multimillion-dollar contract with the government	There are ISO-certified competitors with longstanding reputations bidding for the same contract	Organization spends a lot of time and resources chasing the certification and contract, incurring massive costs, and doesn’t get the contract. Operations are disrupted, while employees, management, and stakeholders are bitter and looking to assign blame.

 

Mistake 5: Insufficient training/competencies 

Each employee needs to be qualified to fulfill their role for smooth operations of the QMS. However, many organizations overlook ISO-specific employee training. Another mistake is not updating manuals, procedures, and responsibilities. A better approach is to think about this in advance. That way, you can address potential competency issues as your organization evolves. Training should be continual, and you should encourage and enable employees to access it as needed. 

 

You should also provide appropriate training for managers and leaders. Alternatively, you can hire outside consultants to help with both QMS implementation and training. If you fail to educate your organization, all you will get is a resentful workforce resistant to change. 

Mistake 6: Not choosing the right consultants 

If you opt to hire outside help for your certification efforts, there are a few factors to consider: 

• Pricing, 

• Availability, 

• Expertise and experience, 

• Range of services, 

• Reputation and track record. 

Many companies make mistakes balancing these factors. Ideally, you want to find an expert ISO 9001 consultant that you can also afford. Their services should include, at a minimum: 

• Initial QMS assessment/gap analysis, 

• Action plan, 

• Implementation guidance, 

• ISO 9001 training, 

• Pre-certification assessment, 

• Post-certification support. 

 

At Sternberg Consulting, we go a step further for our clients. We offer all these services and more, and we help companies based in Germany apply for subsidies. 

Mistake 7: Overcomplicating documentation/business processes 

ISO 9001 requires regular internal audits, extensive amounts of documentation, and precise record-keeping. However, some companies take it a step too far. Excessive documentation is an obstacle to optimal organizational performance. Having unnecessary process documents that don’t improve processes or support operations is a common mistake. The problem is that this will crush motivation, employee involvement, and even management support. 

Even those who achieve certification with such complex systems in place find it difficult to keep up with the self-imposed obstacles. To avoid this mistake, ask yourself: 

• Is this document relevant and useful in doing the job it addresses? 

• Is it mandatory to have this document (e.g., are there compliance requirements or regulatory requirements)? 

• Is the content concise and presented in the best format? 

If the answer is negative to any of these questions, consider revising or discarding the document. 

 Word of caution: proper documentation and document control are crucial for ISO 9001. You may face non-conformities without relevant documents. So, to keep things concise and easy to manage, you can use document templates and cloud-based record-keeping systems. 

Mistake 8: Choosing the wrong notified body 

Similar to choosing the wrong consultant, choosing the wrong notified body (registrar) for your external audit can be a costly mistake. It can lead to excessive costs, delays in getting certified, and reputation damage. And in today’s age of opportunity, there are many ways to get scammed. You may encounter organizations that claim to offer ISO 9001 certification services but aren’t accredited by a national or international accreditation body. Unfortunately, this can sink all your efforts and the good steps you’ve taken so far. 

Here’s what you should look for to avoid this trap: 

• Check which certification bodies are available in your area and if they’re accredited, 

• Look into which certification bodies are used within your industry and by your top competitors, 

• Make sure they have industry-specific knowledge within your domain, 

• Check their reputation with customers, 

• Look into the biographies and availability of their auditors, 

• Request a quote in advance to check their pricing and avoid hidden costs. 

Mistake 9: Resistance to change 

Change is hard. Employees can get into a routine and find it difficult to change their ways. Managers may not want new responsibilities. Some workers may have reservations about new technologies. Resistance to change is a high hurdle to overcome in quality management systems. But if you want to implement ISO 9001, you will have to face employee resistance head-on. 

 Firstly, accept that what you’re trying to do will cause some pushback. And that the pushback often comes from misunderstandings. Some stakeholders may not understand the purpose of ISO 9001:2015. Others may not recognize the role they will play in it. Some may fear the unknown and the uncertainty of their position in the organization. Finally, they may not grasp the impact their actions have on the QMS. It is your job to remove doubts through open communication, training, and support. 

 

Mistake 10: Not embracing continual improvement 

The ISO 9001:2015 certification process is the road to continual improvement. This has to be clear at all levels of the organization at all times. Through careful implementation of ISO, you will be forced to change things. You will have to raise risk awareness and risk management to new levels. You will have to evaluate and re-evaluate each element of your QMS. And you will have to take action. 

 

It’s easy to become complacent after achieving certification. This is the main reason for non-conformities in annual audits and failure to keep your certification after the initial 3-year period it’s valid for. Sure, there should be time to celebrate your certification success. And you should give credit to everyone for their participation. But the hard work has just begun. 

 

Don’t let documentation become obsolete. Make sure to update documents and records. Schedule internal audits and management reviews and stick to it. Keep lines of communication open and encourage employees to speak up if they notice problems or have new ideas. 

Summary 

There are many obstacles to ISO 9001 certification. Getting your QMS certified under ISO 9001:2015 requires careful planning, expertise, involvement at all levels, and an organizational culture focused on continual improvement. 

 

Some of the most common pitfalls in the ISO 9001 implementation process are unrealistic expectations, lack of resources, poor communication, and resistance to change. And these traps are far too easy to fall into. One mistake can trigger a cascade of other problems, and avoiding them altogether is your best option. If you want help in navigating the complexities of ISO 9001 and its requirements, we’re here to support you on your ISO journey.