Common Challenges During ISO 9001 Certification and How to Mitigate Them

We recently wrote our Introduction to ISO 9001 article which covered the basics of ISO 9001, what it is, what it’s not together with some tips around certification.

In this companion article, we’ll talk about some of the challenges around 9001 and how you might approach them.

We’ll be covering:

  • What is ISO 9001
  • Why challenges exist with 9001 and why it isn’t a bad thing
  • Key challenges
    • Leadership support
    • Resources
    • Resistance to Change
    • Lack of documentation
    • Non-Conformities
    • Insufficient Training and Awareness
    • Overcomplication of Processes
    • Lack of Continuous Improvement
    • Failure to measure and monitor performance

What is ISO 9001

So we’re not going to cover this in too much detail (if you want that, then please check out our Introduction to ISO 9001)

In summary, ISO 9001 is a widely recognized standard for quality management. This standard offers significant benefits for organizations of all sizes and industries as it helps to enhance their overall performance, meet customer expectations and exhibit their dedication to quality. The requirements of this standard lay out the guidelines for establishing, implementing, maintaining, and continuously improving a quality management system (QMS).

It’s globally recognized, and its implementation demonstrates a company’s commitment to its quality management system (QMS). It really is rather good; you should check it out;-)

With that over. It shouldn’t surprise you that implementing it requires effort, and while this shouldn’t represent too higher mountain to climb for most, there are some common challenges that many businesses face, which we’ll cover here. Now these aren’t show stoppers but they do require some thought around your approach.  

Ok let’s get to it.

1. Lack of Leadership Support

Now this isn’t specific to ISO and its equally true for any change program or major initiative. If you don’t get adequate leadership support (that might include backing, resources, alignment of priorities etc) then you’ll struggle.

Indeed, one of the most common reasons for failure when first embedding ISO 9001 is the lack of leadership support. 

Without a visible commitment from senior leadership, employees may not take the QMS seriously, leading to resistance and, ultimately, certification failure.

All too often this stems from a lack of understanding of what ISO is and getting leadership onside is as much about communicating what it is and it’s benefits than making the assumption that people automatically understand it.

Mitigation Strategy:  So what do you do in this case? Firstly, senior management should understand the importance and benefits of ISO 9001 certification and actively participate in the process.  

Leaders should understand not only the goal but also the road map to getting there. Communicate the benefits of certification and what help you need to get there (and how long it might take). Discuss resources, ongoing support to the QMS implementation team, leadership communications to the organization, etc. Fundamentally, ensure that you engage your leadership in your journey and have them participate.

2. Inadequate Resources

Implementing ISO 9001 requires time, money, and people. Insufficient allocation of resources can hinder the implementation process, leading to delays and compromised effectiveness.

Unfortunately, all too often, this stems from poor upfront planning (understanding what you’re going to do and how you’re going to do it). Many businesses think the magic ISO tree will deliver 9001 with little to no effort. This is not the case, and many businesses find after they’ve started the journey that certification will take work and people to do it.  

All of a sudden, there is the issue of balancing priorities, and things get tricky.

Mitigation Strategy:   Like any change program, conduct a thorough resource assessment before embarking on the certification journey. Allocate sufficient budget, manpower, and time to each phase of the implementation process. Prioritize tasks and ensure clear communication of resource requirements across the organization. Also check how you’re doing along the journey so that you can tweak plans accordingly if you need too.

3. Resistance to Change

Implementing ISO 9001 often requires changes in processes, procedures, and organizational culture. Resistance to change from employees who are comfortable with the status quo can impede progress and undermine the success of the QMS.

Mitigation Strategy:   Foster a culture of openness and transparency by involving employees in the QMS implementation process from the outset. Provide training and support to help employees adapt to new processes and technologies. Address concerns and objections promptly and transparently to build trust and commitment. The final point here is to communicate, communicate, communicate! Make sure the business knows what’s going on and why it’s important.

4. Lack of Documentation:  

Effective documentation is a cornerstone of ISO 9001 compliance. Inadequate or poorly maintained documentation can result in non-conformities during audits and certification assessments. Remember, this doesn’t have to be war and peace, and documentation needs to be appropriate (and can be simple) but does need to be there (check out for further info).   

Mitigation Strategy: When developing your certification roadmap it’s best to plan your documentation route upfront, what do you have already, what gaps do you have, how will these be addressed (and who will do it).

Develop a robust and appropriate management system that ensures all processes, procedures, and records are accurately and adequately documented and easily accessible. Train employees on documentation requirements and provide templates and tools to facilitate documentation.

5. Non-Conformities

During the certification process, auditors may identify non-conformities—instances where the organization’s practices do not adequately meet ISO 9001 requirements. Failure to address non-conformities promptly and effectively can delay certification or even result in failure.

Mitigation Strategy:   Remember that no one is perfect; NCRs may well happen. What’s important is that you have a system for dealing with them. Develop a systematic approach for addressing non-conformities, including root cause analysis, corrective actions, and preventive tactics. Assign responsibility for resolving non-conformities to specific individuals or teams and establish clear timelines for resolution. Demonstrate to your auditor that despite raising an NCR, you have a systematic approach to managing them and remedying any issues that crop up.

6. Insufficient Training and Awareness

Effective implementation of ISO 9001 requires that all employees understand their roles, responsibilities, and the processes and procedures you are implementing. 

One all too common issue is that many businesses develop their QMS under cover of darkness without realizing they actually need to communicate it to their business.

Insufficient training and awareness can arise and this can lead to non-compliance which then undermines the effectiveness of your QMS.

Mitigation Strategy:  Your QMS is there to be understood and executed. Consider training needs, especially around any new or changed processes and procedures. Take into account any feedback and ensure your leadership is aware. This should all fall into your engagement strategy as you roll out your QMS.

7. Overcomplicated Processes

Repeat after me, “My processes and procedures should be simple to understand and execute”. Do not write reams of documentation that are impenetrable and cannot be understood.  

This will lead to confusion, inefficiencies and, worst of all, your beloved QMS being ignored.

Far too many organizations make the mistake of overcomplicating their QMS taking pride in its complexity. This is a huge mistake and can turn off the whole organization.

Mitigation Strategy:  Keep processes simple, streamlined, and focused on achieving the organization’s objectives. Eliminate unnecessary bureaucracy and paperwork, and encourage continuous improvement and innovation in process design.

8. Lack of Continuous Improvement

ISO 9001 emphasizes the importance of continuous improvement in achieving and maintaining quality standards. Failure to prioritize (or even simply to undertake) continuous improvement can result in stagnation and eventual non-compliance.

Mitigation Strategy:  Embed a culture of continuous improvement throughout the organization by encouraging feedback, fostering innovation, and regularly reviewing and updating QMS processes and procedures. Implement tools and techniques such as performance metrics, benchmarking, and customer feedback to drive improvement initiatives. Consider how PDCA can be integrated into your QMS from the outset.

9. Poor Communication

Effective communication is essential for successful QMS implementation. Poor communication between stakeholders can lead to misunderstandings, errors, and delays.

Does your team know what 9001 is? Do they know why you’re doing it? Do they know your implementation roadmap, do they know about internal/external audits and thier roles in it? As you proceed with developing your QMS do you keep them updated? No? Then don’t expect things to run smoothly.

Mitigation Strategy:  Establish clear channels of communication between all stakeholders involved in the QMS implementation process, including senior management, employees, suppliers, and customers. Use multiple communication methods which may be at your disposal eg: meetings and workshops, emails, newsletters, and intranet portals, to ensure that information is conveyed effectively and consistently.

10. Failure to Monitor and Measure Performance

ISO 9001 requires organizations to monitor, measure, and analyze their processes and performance to ensure ongoing compliance and improvement. Failure to establish appropriate monitoring and measurement mechanisms may result in missed opportunities to capture optimization and improvement.

Far too many organizations think that they simply roll out their QMS and forget about it. NO! Have clear performance measurement techniques and use PDCA to monitor and improve.

Mitigation Strategy:  Develop key performance indicators (KPIs) aligned with the organization’s quality objectives and regularly monitor and analyze performance against these metrics. Implement a system for collecting and analyzing data, use any insights to identify improvement areas taking corrective action as necessary.


Implementing your QMS requires carefull consideration. This article lists some of the common challenges when going for 9001 certification. You might have others that are pertaining to your industry.  

However, don’t let this put you off, million of companies around the world have succesfully obtained ISO 9001 certification and navigated the challenges listed above.  

By anticipating potential hurdles and implementing effective mitigation strategies, organizations can navigate the certification process successfully and reap the rewards of a robust quality management system.

We’d love your feedback, how have you navigated around the issues listed, did you have any that stopped you in your tracks? What did you do? Let us know in the comments.