What Causes a Bad ISO 9001 Implementation?

What Causes a Bad ISO 9001 Implementation?

Author Peter Hargittay

To achieve ISO 9001 certification success, avoid these common pitfalls

The path to a successful ISO 9001 implementation can be challenging. The process requires careful upfront planning, an adequate commitment of resources, and help from experienced people who have been through the process before. The effort is absolutely worthwhile, but not every organization reaps the full benefits of that investment. There are a number of pitfalls that can stand in the way of a good ISO 9001 implementation. Here are some of the most common ones:

Lack of Planning

The first step to any successful ISO 9001 implementation is thorough planning. Everyone involved in the process must fully understand the role they will be playing as well as the overall timeline and key dependencies. Stakeholders throughout your organization should be prepared for the impact that certification will have on their jobs. That includes an awareness of what the project entails, what their responsibilities will be throughout the implementation process, and how it will benefit them and the rest of the organization over the long term.

A business that attempts to implement ISO 9001 without having a comprehensive plan in place is setting themselves up for failure. The standard requires organizations to establish and roll out documented processes for various aspects of their operations. That takes time, and it consumes a lot of bandwidth from the team members who are directly involved. As we’ll discuss in the next section, – that means engaging a broad spectrum of employees and gaining their commitment to achieving a successful outcome. Having a solid project plan in place will help to build confidence from the outset.

Poor Employee Engagement

We have written a great deal on the Intellect blog about the importance of cultivating a culture of quality excellence. As you are planning your ISO 9001 implementation, it’s critically important to keep this in mind. Successful ISO certification projects begin with getting everyone on the same page. Quality leaders should explain the process, articulate the benefits, and answer any questions that might arise.

A key factor in that conversation is driven by project leaders’ ability to articulate the connection between ISO certification and certain real-world improvements that will result. It’s also important to respond to stakeholder expectations, explain the strategic benefits, risks, and opportunities.

A lack of engagement may be caused by a number of factors. Most people are naturally apprehensive about change, particularly if it will affect their everyday activities at work. If employees don’t fully understand what ISO 9001 is or why it’s important, they are likely to limit their participation and cooperate at a bare-minimum level.

By proactively communicating with all members of your team, you can increase the chances that employees will understand the why of ISO 9001 certification, rather than just going through the motions. By answering their questions, you’ll give them an opportunity to be heard. In many cases, employee input will benefit the project by generating ideas and feedback that lead to further improvement, but which might not otherwise come to light.

Inaccurate or Incomplete Current State Assessment

The current state self-assessment is a detailed analysis of the current operation of a business. It typically exposes issues relating to processes, people, and environment that may need improvement in order to meet the requirements of ISO 9001.

This requires a willingness to take an honest look at the organization’s current shortcomings. A good ISO 9001 certification consultant can help to ensure that this process is open and honest, and that it reflects the current reality within the company. Many organizations conduct the current state assessment without outside help, which often leads to a skewed perspective. If the company begins with a self-assessment that isn’t fully honest, then their ISO 9001 implementation isn’t likely to address all of the issues that need attention.

Reliance on Manual Systems

Companies that rely heavily on manual, paper-based systems may find it especially challenging to keep up with the management of all of the documentation and data required for ISO 9001 compliance. An effective QMS program isn’t just about documenting processes, – it’s also about capturing data and making it available for analysis, feeding the process of continuous improvement that ultimately benefits the organization, its customers, and other stakeholders.

Because ISO 9001 is so heavily driven by documentation, it’s important to have tools in place that ease the burden while ensuring accuracy and timeliness. Manual processes often lead to delays caused by inaccurate or complete information, slow approval processes, or challenges in maintaining multiple versions of important documents. The best QMS software makes it easier to collect data, eliminates the need to re-key information from paper forms, automates workflows, and handles document versioning as a matter of routine.

On the other hand, a company that adopts a rigid QMS technology platform is also likely to experience challenges. ISO 9001 is a set of guidelines, – not a one-size-fits-all straitjacket. In other words, it’s intended to be adapted to fit your business. Software that imposes pre-defined processes and templates may not be sufficiently flexible to address the unique needs of your organization. The best QMS software offers a high level adaptability, – preferably via configuration options that don’t require extensive technical expertise.

Thinking About ISO 9001 Certification? Think Long Term.

Achieving ISO 9001 certification is an important milestone, but it’s not a silver bullet. Certification won’t miraculously transform your organization; it takes time, effort, and ongoing commitment to yield benefits and achieve sustained results. Businesses that view the certification as a one-off event may be disappointed when they don’t see dramatic results instantly. It’s important, therefore, to set clear expectations about what certification really means and how it can benefit the company in the long run.

Although ISO 9001 certification requires a significant commitment, it can indeed be incredibly rewarding. Don’t be surprised if the implementation process feels overwhelming at times. When that happens, take a step back and reflect on the bigger picture. Ultimately, ISO 9001 is intended to provide your company with a framework for continuous improvement. That framework has been proven at thousands of companies. If you put in the work and have patience throughout the rough spots, it will ultimately pay off.

If your organization could benefit from working with a company that offers both technology and quality management expertise, Intellect can help. Contact us today to have a conversation about your goals and objectives.