Let the System Drive Your ISO 9000 Effort

by John M. Murphy

Quality management software can help you reach
ISO 9000 certification and much more.


The pressure is on-you've been told that you have to become ISO 9000 certified because your customers demand it, your competitors do it, and you're likely to lose business if you don't do something about it. But what changes will ISO 9000 demand of your business? And where do you start? More importantly, is there a way to get something back for all the effort? Can you meet the ISO 9000 standard and actually make money from this accomplishment? Many manufacturers are finding that they can, by implementing software systems that automate and integrate critical quality and business functions.

How to view ISO 9000

ISO 9000 provides a set of criteria against which to measure the management principles and procedures employed by a company to assure quality performance. However, unlike other quality standards, ISO 9000 is broader. In addition to quality control and record keeping, ISO 9000 also incorporates quality planning, contract review, design, purchasing, training and servicing.

The ISO 9000 standards don't tell you how to run your company. They only provide a framework for evaluating what a company does or should do. For example, a raw material producer faced with formulating a compound to meet an automotive specification would choose a mix of ingredients to meet the specification and allow the company to earn a reasonable profit. Meeting the ISO 9000 standard should be approached from the same perspective.

ISO 9000 should be used as a framework against which to evaluate your present business systems. The standards present a unique guide for managers to learn what the marketplace is demanding and what sets of quality criteria customers and suppliers are using. With this guide, management teams can pinpoint the strengths, gaps and weaknesses in the existing systems and develop plans to make improvements.

Some jump right in and start filling in the present gaps, adding manual systems to meet specific needs or a standalone PC software package to cover different areas of the standard. After all these gaps have been filled, they spend countless hours documenting in detail what each component does. The end result is a set of complex systems and procedures that are devoid of any integration, leaving islands of operational procedures that become difficult to manage and control. This approach fails to recognize the companywide desire to integrate the various requirements and systems into one workable solution that satisfies ISO 9000 and the operational business objectives as well.

Traditional manufacturing software

Most manufacturers today use a traditional materials requirements planning system to manage and streamline the business functions associated with inventory control, purchasing, production scheduling and materials planning. Many of these systems also include financial and shipping functions. These systems can be used to satisfy ISO 9000 requirements for procedures that cover contract review and acceptance, capacity planning and purchasing. They can also be used to show that the customer requirements are adequately defined and that the company can deliver what is required. In order to satisfy ISO 9000, it would be necessary to document how this system is used every day to coordinate these various ISO 9000 required activities.

Managers must remember that companies evaluate and purchase an MRP system because it meets their unique requirements. Once they implement the system, few companies would consider operating without it. These systems are justified because they automate tasks, reduce paperwork and, more importantly, communicate information throughout the entire company. These systems recognize that the company has unique departments and users who each have different needs for the information.

For example, the purchasing department needs to ensure that sufficient raw materials are on hand to produce an order, scheduling needs to know when the order is due, accounting needs to know the correct selling price at which to invoice and whether credit has been extended, shipping needs to know what truck carrier to use, etc. These systems are critical for the tasks and processes that they control and necessary for the efficiency and productivity of the company.

Quality management software

While an MRP system can provide some of the functions required by ISO 9000, you must bear in mind that it is primarily a quality standard. In addition to the administrative functions handled by MRP systems, ISO 9000 requires many of the elements normally associated with traditional quality management methods. For example, you must be able to:
Verify the processes used to manufacture products.
Inspect and test incoming supplies and outgoing product.
Retain necessary quality records and documentation.
Control inspection and measuring test equipment.
Document corrective actions.
Perform statistical techniques in order to verify process capability.

A quality system is strategic. And while ISO 9000 may be used as the catalyst to implement more effective quality systems and controls, these systems can bring enormous benefit. Today, for example, statistical process control is used to reduce process variation and anticipate out-of-control trends before they occur. SPC helps to analyze the relationships between key process variables. And it contributes to a better understanding of the manufacturing process-providing process engineers and quality personnel with the feedback required to make effective and timely decisions.

The fact is, you have to perform various quality tasks. They may include data collection, record keeping, SPC, Pareto analysis, receiving inspection, gage calibration, test certificates and more. When you examine the building blocks of an effective quality system, you are left with three components: product specifications, process data (measurements or notes) and reports. These components form the heart of any quality system. The functions associated with manually maintaining the specifications, recording the data and summarizing the information in a variety of reporting formats can be time-consuming. Software is ideally suited to automating these tasks. It is faster, more accurate and more cost-effective than manual systems, which are difficult to manage and prone to mistakes.

Today, most companies would not dream of drawing a complicated part design by hand. Rather, they employ computer-aided design software to accurately define each component and, in many cases, transfer this information directly to machining centers that will produce the part. The same argument applies to your quality functions. Why record measurements manually on log sheets that are filed and later retrieved and typed into a word processor to produce a certificate of analysis that must accompany a shipment?

Computer automation of these tasks will save enormous amounts of time collecting and processing data. It allows companies to automate the repetitive tasks, electronically file records, eliminate miscalculations and typos of critical customer paperwork, and enable people to satisfy customer requests for reports and data. Furthermore, it should provide companywide access to the data in real-time for process engineers, quality personnel, lab technicians, production operators, sales personnel and others. The increased productivity associated with software automation will produce substantial cost savings.

Companywide integrated quality systems

Like all software, the fundamental criteria for selecting and evaluating a quality system should be, "Does it fit our business objectives?" However, an often overlooked criteria is the level of integration that the quality software package offers. Remember that the ISO 9000 standards require documentation of procedures for a wide range of quality activities, including inspection data on incoming and outgoing product, gage calibration, statistical analysis and corrective actions. The true measure of a software product's value is its ability to integrate the various business-required functions into one multiuser system.

Alternatively, some companies purchase many individual and independent standalone software packages, each representing a distinct task that was needed. While improved system efficiency and meeting ISO 9000 requirements may have been the goal, this approach yields islands of automation that control individual tasks but don't tie the elements together into an integrated, companywide system. Let's examine a fictitious company, The ABC Co., to demonstrate the value of software functionality and integration as it relates to quality requirements and the ISO 9000 standards.

When The ABC Co. produces a particular lot of material, various quality audits are performed. Their integrated quality management system allows lab or production operators to input the results of testing into the computer, which stores the information by lot number. Some of these test parameters are taken from lab instruments that are directly cabled into the computer, which controls the uploading and filing of the result. The operator need not key in these values.

When ABC's shipping department prepares to fill an order for customer XYZ, they realize that this customer requires a pH value that is higher than many of ABC's other customers who purchase the same product. The shipping department uses the quality software to hook into the MRP warehouse inventory and list the lot numbers currently held in inventory. The quality software retrieves the quality audits for each lot and compares them to the specifications it stores for customer XYZ. The software informs them that three lots meet customer XYZ's requirements.

Customer XYZ also requires a certificate of analysis to be sent that documents ABC's compliance to the specifications. This data must be specific to the lot number to be shipped. From the quality software, ABC's shipping department types in the lot number and the software prints a certificate of analysis that shows the requirement for each attribute as well as the results obtained through testing on this lot of material. It even incorporates the proper pH value. The acceptable lot is then shipped to customer XYZ.

Whenever quality data has been entered into the system, ABC's engineers are able to produce statistical reports that examine trends over time or comply with customer XYZ's quarterly reporting requirement. The software also keeps track of the number of hours the lab instrument has been in service and will notify the operator when a gage must be calibrated. ABC can even enter the results of incoming materials inspection into the software and generate statistical reports on vendor performance. For traceability, they can track which lots of vendor material go into producing the finished ABC lot of material shipped to customer XYZ.

The true value of ABC's quality management system is that it integrates their various quality requirements into one system. Other companies may have different requirements. For example, a company may want to use bar code readers for accurate and consistent data entry. The user may need to link into their MRP system to print the customer's order number and shipping address on the certificate of analysis. The company may want to be able to add corrective actions or notes directly into the software and associate them with a particular lot number or point in time.

The objective of a companywide quality system is to integrate all these tasks-SPC, data collection, reporting, gaging, receiving inspection, etc.-into a cohesive system, where departments and individual users can quickly access the information they need to be effective. An integrated system streamlines all your data processing so that duplication is eliminated and repetition is automated. This means that data can be collected faster and more efficiently, with less chance of error. And it automates the time spent collecting, filing, distributing and analyzing the data. In addition, integrated systems will decrease training and implementation time by providing common interfaces, terminology and training tools.

A word about software validation

While nothing in the ISO 9001 standard specifically refers to software programs, most auditors investigate the control and validation of software used to validate process capability or verify design. The auditor will be concerned with control of versions and revisions, master software copies, documentation and validation. While most auditors may not expect in-house validation, it should be noted that a software product will produce the proper results. Some vendors may furnish a validation certificate or include a validation statement in their manual.

If a validation report or a user manual is not available, the auditor will issue a noncompliance. This should especially be kept in mind for in-house-developed software. The validation report can simply list the types of tests that were performed, the expected results and the actual results. Some companies have found that a written certification can substitute for a validation report if the software has been in use for some period of time prior to ISO 9000 implementation. The certification would state that the program had performed satisfactorily in the past and was considered proven for use.

However, this grandfathering approach will not eliminate the need for a procedure to validate new software and future revisions to older software. For reference, see ISO 9000-3 Part 3: Guidelines for the application of ISO 9001 to the development, supply and maintenance of software.

Satisfied customers and
empowered workers


ISO 9000, then, can be used to accomplish strategic business objectives, provided that it is used as a guide to improvement. The objective is to create a quality system that fits each business, integrates companywide operations and makes money. A specialized quality software system can help do just that.

The benefits of implementing such a system are clear. They go beyond ISO 9000 certification and extend throughout the entire company. They come in the form of improved worker productivity, increased process efficiency, reduced manual errors, time saved, access to real-time information for decision making, positive customer surveys and empowered workers.

The worker empowerment comes from the ability of employees to make a difference in the processes they manage. An integrated quality system provides workers with the tools to analyze, organize, understand and use large amounts of data to make important decisions that impact the bottom line. Because the software collects and maintains a centralized database, users always have access to the most up-to-date information, and they can share it in real-time. When there's a problem, they have immediate feedback so they can begin troubleshooting on the line, before the situation goes out of control. That's the power of information.

A business system

Business success is based on the degree to which managers know their business. Similarly, quality starts with knowledge about the product. And this knowledge comes from the data collected from processes. Data is a fundamental aspect of any business. Management should build a quality system that collects and protects that data, making it available to the organization's biggest asset, its employees.

Look for software that best fits your needs. Use ISO 9000 as a roadmap to guide you. Select the software that integrates the tools you need to reach those goals. Good software will enable you to build accuracy, efficiency and productivity into your quality system from the start. And it will have the flexibility and features to serve your needs in the future. In the end, you'll have an integrated, companywide quality system that not only provides the marketing effects of ISO 9000 certification but fits your vision of what your business should be.

About the author

John M. Murphy is vice president of sales and marketing for Murphy Software. Since 1987, Murphy Software has helped many Fortune 500 manufacturers implement companywide SPC and quality management software systems. These manufacturers have used Murphy Software's integrated quality system to help them achieve ISO 9000 certification.

© 1995 Murphy Software. All rights reserved.