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Choosing Quality Management Software for ISO 9000

By spending time up front defining your company's needs, you will solve your organization's actual problems.

by Carrie K. Cabak

Now that the business world has come to terms with ISO 9000, total quality management and the Baldrige Award, many companies are simplifying their operational processes to spend more time innovating and responding to customer demands. Often, quality management professionals rely on computer programs to achieve this simplification. Software solutions currently on the market range from statistical process control programs, such as SAS Institute's JMP, to tools that address every ISO 9000 concern, such as DPI Services' QMX. Overwhelmed with this plethora of quality management software, many organizations discover that making the best purchase decision requires a disproportionate amount of time and energy.

For companies formalizing and improving their processes to ISO 9000 requirements, this article provides a method for evaluating and choosing a quality- or business-related software solution. Figure 1 shows a summary of the process discussed; the article will expand on each step and provide specific guidance where helpful. If this process seems reasonable for your company in evaluating, qualifying and choosing a vendor, you may wish to adapt this article as a working instruction addressing Clause 4.6 of ISO 9001/9002, concerning purchasing.


Define your objectives

Quality management professionals typically look at new software for two reasons: to solve recurring incidental problems and/or to improve existing systems and processes. Clearly   understanding the reasons motivating your purchase will help you define the specific objectives you want your software to address. It will also help to clarify your objectives to the point where you can approach the general marketplace (e.g., a  trade show) and weed out products that won't work for your organization.

You can define your objectives in many ways, but the most effective incorporate ideas from people who will use the software. Advanced brainstorming can help, or if this is your first software purchase, rely on traditional brainstorming or create affinity diagrams on the company walls.

From an ISO 9000 perspective, you probably are concerned with problems or improvements in one of the following areas:

 Managing documents and data (Element 4.5) 

 Resolving and following up on corrective actions (Element 4.14)

 Planning, reporting and closing internal audits (Element 4.17)

 Specific problems many organizations face during their ISO 9000 registration cycle include:

 Preventing unauthorized documents from circulating.

 Ensuring that corrective actions are closed following their approval.

 Ensuring that records needed for an upcoming audit are readily retrievable.

 Reducing paperwork associated with ISO 9000 registration.

 Reducing the time required to circulate information.

 Obtaining timely responses from reviewers and approvers.

 Ensuring follow-through from people who approve documents.


By spending time up front defining your company's key problems and opportunities, not only will you make a more informed software selection, you will ultimately solve your organization's actual problems rather than ones created by highly effective salespeople.

After developing a list of objectives for the new software, create a related list of product challenges, or scenarios, that typically would occur while using the program. Present these challenges to several vendors to obtain comparable evaluation of the different products. Keep the scenarios as realistic as possible; hypothetical problems occur infrequently. Product challenges should reflect the tasks you expect the software to accomplish and might include one of the following:

Create a work instruction and show how it will be reviewed and approved. Show what happens when a reviewer fails to respond in the allotted time frame.

 Create a meeting agenda and show how the software will distribute it to everyone attending the meeting. Demonstrate how attendance notification will return to the agenda creator.

 Demonstrate how to use this software to address a customer complaint about a product arriving late.

After listing objectives and product challenges, consider the limitations on the purchase. These constraints identify the maximum amount available to spend, functional requirements and the required software features, such as operating system and maximum number of users.

Identify the constraints

Two categories of constraints will require attention: internal constraints posed by company needs and external constraintscommonly called selection criteriaassociated with product and vendor selection.

Internal constraintsThe primary internal constraint affecting a company purchase decision invariably is budget. In some companies, equally important is which department's budget will pay for the purchase. While addressing these concerns, keep in mind that you usually get what you pay for. Although a savvy salesperson may argue that you can get a Rolls-Royce for the price of a Volkswagen, other costs often creep up after the initial purchase, resulting in a larger overall cost. Weigh the total cost of ownership of the tool, which includes installation, customization, maintenance and support, against the benefits obtained through its use.

Also recognize that some vendors might try to sell you more than you need. They'll encourage you to anticipate upgrades before your company needs them. Carefully consider this strategy because, as you grow, your requirements will change. A certain software solution won't necessarily predict or adequately address future problems. You should assess, as an important selection criterion, the vendor's willingness to keep pace with changes in your organization.

Another key internal constraint is the anticipated number of users. Many vendors require a minimum number of "seats," or simultaneous users, to get started, but most suppliers will negotiate on price as that number increases. In addition to number, you should also understand how users will apply the software. For example, if you need a program to manage the creation, review, approval and distribution of documents, you must consider how many users will be creating, how many will be reviewing and soforth. This might affect the purchase price and certainly will affect the software's installation process in your organization.

Consider, too, whether you need the software to communicate with all users. Building on the preceding example of managing documents, if your organization requires electronic review and approval, your software must provide the mechanism to do that. The terminology typically associated with this type of automated electronic communication is "workflow" or "groupware."

You'll also want to review your company's computing environment. For example, if your company operates in a Windows 95 environment, you'll likely find it easier to obtain company buy-in if the selected software also runs on Windows 95. If your organization uses multiple operating systems, the new software should be able to run on different operating systems. During the decision-making process, enlist the assistance of your in-house information systems staff to define your company's software and hardware platforms. If you don't have in-house resources, you may want to contact various employees to determine the type of computing environment they use.

Selection criteriaExternal constraints are usually called selection criteria, i.e., parameters against which you evaluate and select a product. Selection criteria must consider the software's vendor or supplier as well as its functionality. You can effectively glean this information with an evaluation checklist identifying the criteria most important to your organization. Similar to a product qualification checklist, an evaluation checklist should include specific items addressing the constraints you identified earlier in this process.

Developing such a checklist requires two steps: deciding what criteria you will assess and deciding how you will determine performance against these criteria. Checklist items might include:

 Maximum number of simultaneous users

 Ease of installation

 Intuitiveness of the fields

 Amount of training needed to use software


To ensure the greatest return on your dollar, your selection criteria should assess the vendor's commitment to upgrading and improving their product continuously. Improvements may result from recognizing new marketplace needs, from your company's specific input or from regulatory requirements.

Figures 2 and 3 show criteria every company should consider when evaluating software for ISO 9000-related applications. To rate products against the criteria, use a rating scale from one to five or a yes/no option. You might want to prioritize the criteria and assign weights based on those priorities. By calculating the results, you can easily quantify your selection. Remember to define specifically how a product warrants a one vs. a five. Philosophies vary about rating scales and other assessment measures, but the most important point is to keep the scale simple and relevant to your specific organization and application.

Evaluate the alternatives

Once you have defined the problems you wish to solve and prioritized the constraints affecting your decision, hit the road and begin evaluating products and vendors. This step, generally regarded as the most fun, can become tedious due to the number of solutions on the market today.

Because a product vendor probably won't provide you with references of customers who weren't satisfied, meet with your key customers or suppliers to see if they use software that addresses your problems. This will give you honest and realistic feedback regarding the software's capabilities, ease of use and installation.

Additional resources include other ISO 9000-registered firms listed in the Registered Firm Directory available from any accredited ISO 9000 registrar or in Quality Digest Online's registered companies database at www.qualitydigest.com. Many registered firms, excited about their registration, will share information about the tools they use to manage their system.

If you use the Internet to search for quality management software, be warned: you will probably get several thousand responses. Because so many software tools focus on quality, you might want to use the Internet for in-depth research on specific products and vendors. Trade publications also can offer worthwhile information. In addition to including advertisements, these publications often publish objective product comparisons and evaluations. Finally, trade shows provide product demonstrations as well as convenient venues to discuss product features and benefits.

From these resources, identify and focus on software that meets your specific requirements. If your continuous improvement efforts require implementing several of the ISO 9000 series standards, you will find software that addresses them all in one package. Though you also could purchase several software packages or create one in-house, both of these options could cost more in the long run.

Demonstrate the products

Once you narrow the field to a few alternatives, ask the local sales representative from each vendor to present a more comprehensive demonstration of the product's capabilities. Before meeting with the sales representative, review your product challenges list and verify that these challenges continue to reflect real problems at your company. If you listed vendor responsiveness among your selection criteria, and the vendor called you before you called them, be sure to note this on your evaluation checklist.

While watching a quality management software demonstration, pay particular attention to the features that will achieve your specific objectives. Too often, sales reps will show you all the bells and whistles, hoping to dazzle you with the product's capabilities. Remember to focus on your objectives. If you have factored in company growth and potential changes, include these issues on the product challenges list and evaluation checklist.

Make your decision

By now, you will have reduced the number of alternatives to three or four. Evaluate the leading candidates with your evaluation checklist. Ask vendors to address areas where you rated them low. Look for differentiating features, such as vendors who will tailor the installation process, often by revising the software,  to meet your specific needs. Some vendors will call this "customization" and charge you for the work. Others will treat it as ongoing product improvement. If you choose to pay for product customization, consider asking the vendor to personalize forms or fields that might take internal resources much longer to do.

In some companies, management must approve the purchase if the total cost of the software exceeds established limits. In these cases, ask the vendor to participate in a management-oriented software demonstration. Before the meeting, allow the vendor to incorporate a few specific examples from your company. This will give you an additional opportunity to test the product. Stress to the vendor the significance of this meeting to inspire the sales reps to adequately prepare.

Stick to a simple and effective selection process to purchase any product that significantly impacts your organization. Using product challenges and the evaluation checklist will help reduce the chances of selecting a product that looked good during the sales pitch but didn't work for your real problems. By following this process, you will reduce time and uncertainty while evaluating alternatives, and you will choose the best software tool for your organization.


Vendor Criteria

Customer service

How responsive is the vendor to your requests? Were service personnel knowledgeable and helpful? Did they return your phone calls promptly? If they didn't know the answer to your question, did they offer to find it and call you back? Were they courteous?

Product-development process

Does the vendor implement recognized software configuration tools throughout all product-development phases?

Technical support

Does the vendor offer accessible ongoing support? Does the company have a 24-hour line? A fax? Internet? E-mail? What does one year's support cost? Are support personnel aware of new product upgrades, bugs, etc.? What assistance is offered during setup?


How many years has this company provided this product? How long has it worked in its core competencies? How well does it know customers' problems?


How financially stable is this company? Can you count on it to provide service in three to five years? Which companies have purchased their products?

How many resources are available to solve customers' problems? How does the vendor ensure the product will keep pace with your organization's changes?


Product Criteria


Will the software work in your computing environment? Will you receive the latest upgrade? When was it upgraded? Does the software make good use of the Internet/intranet? How does this product interact with existing e-mail programs? How does it use existing software tools? Is this product easy to use? Will it install easily? Can you change it easily once installed? Does it support ISO 9001/9002?


To what extent does this product ensure the integrity of information? What type of customization can you expect, based on inherent management roles or electronic signatures?


How easy to use is the documentation? How helpful are the Help files? Can you annotate them for unique company requirements?


How competitive is the price? How does the price compare with the perceived value of the product? What does the price include?


About the author

Carrie K. Cabak is an independent quality-management systems analyst and RAB lead quality systems auditor. She can be reached at CommonCents Solutions/Organizational Learning Center, 10 S. 3rd St., Suite 300, San Jose, CA 95113, telephone (408) 993-1314, e-mail carriec@ commoncents.com


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