Implementing an ISO 9001 Quality Management System can be one of the most beneficial decisions you make, but it’s crucial to ensure your implementation is done right or you could be setting yourself up for failure. Below are seven common mistakes that can lead to a bad ISO 9001 implementation, along with helpful advice on how to avoid them.
1) Not Knowing your Audience
Even if you meet all of your project objectives, if your audience doesn’t understand what you’re trying to say, then there’s a problem. This is particularly important when it comes to something as complex as an ISO 9001 implementation, which has specific terminology that may not be well understood by even experienced managers.
So before starting an implementation, take time upfront to understand who will be receiving your documentation and work with them to clarify goals and any technical terms used. Then take special care in how you present information so that they can easily understand it—avoid using dense language or complicated diagrams, for example. If someone finds your documents difficult to understand, they may question your competence or even stop taking them seriously altogether.
2) Trying to Do Too Much at Once
Bad implementation of an ISO 9001 system can occur when management is trying to do too much at once. A lot of companies decide they want their company’s quality process in order and so they go about implementing an entire quality program in one fell swoop. While it may seem like a good idea at first if you don’t take time to implement your system effectively and efficiently then you may end up with a very bad implementation that can cause more problems than it solves.
3) Not Building Governance From the Start
If you want your program to last longer than a few months, governance is crucial. Don’t let a bad implementation be at risk of failing due to lack of an effective governing body. Without it, you’ll struggle with team members misinterpreting objectives and coming up with their own interpretation of those objectives. In other words, no plan survives first contact with those who have not planned for it. You can combat that by having clear rules as part of your governance plan so everyone knows what is expected from them and how they should work together as a team toward common goals.
4) Lacking Strong Leadership
Bad ISO 9001 audit is often caused by either poor management or lack of management. Managers who are new to ISO (or any quality initiative, for that matter) may be confused about their roles and responsibilities in an ISO-based environment. They may not understand what is expected of them during each stage of implementation—for example, how they can support their staff with training and certification; how they can assist IT with manual/documentation updates; or how they can help align their team members’ performance goals with those of the company as a whole. Lacking strong leadership across an organization is one of many mistakes leading to bad ISO implementation.
5) Failing to Communicate Across Your Organization
Failing to plan for an IS implementation project can be disastrous. An IS implementation goes well only when employees across your organization are aware of what’s happening and feel that they have a voice in how it impacts them.
If you fail to communicate, or worse yet, if you don’t even try, chances are good that people will feel as though their concerns aren’t being heard—and your business could pay for it. In fact, according to some sources, over 70 percent of all IT projects fail because of poor management . It’s up to each manager and supervisor across your company—which is why it’s essential that everyone at every level is involved in planning from start to finish.
6) Failing To Recognize That Every Individual is Part of Quality Management System
Having information about operational quality and performance is only helpful if you look at it. And, if you don’t have an established process or system for collecting and analyzing data, there’s no reason to expect that you’ll be able to improve your processes and operations based on what you learn.
While it’s not complicated or costly to put together an effective data collection and analysis program, making sure that happens consistently requires leadership attention. That means someone at every level needs buy-in on both processes as well as metrics so they can actually take action based on what they see in their reports. For most companies with quality management systems—particularly mature ones with several years of operation—this probably isn’t news.
7) Overlooking Operational Excellence Data Collection and Analysis
This may seem obvious, but one of your primary responsibilities in any QMS is ensuring you have a good handle on what’s going on in your day-to-day operations. A great pre-shipment inspection service provider will be sure to ask about how much time you’ve spent looking at processes and their results, and if you haven’t been collecting data long enough or in sufficient detail, you’ll be facing a strong audit team pushback.
Before launching an audit, take some time to think about how you would collect and analyze your operational excellence data. You don’t need much—some Excel spreadsheets or even pen and paper will do—but it’s important that whatever approach you take covers all of your business process areas. If it doesn’t, now is a good time to get started.