The Philosophy Behind the ISO 9001 Standard

The ISO 9001:2000 standard was designed to provide general guidance on the development of a successful quality system that will deliver quality services and products. Every company is different and the standard is applicable to every one from service organizations and trucking companies to design houses and manufacturers. Therefore, the guidelines must be flexible so they can be applied in a variety of business models. In general, the ISO 9001 standard promotes improvments in quality by promoting a consistent, controlled process that continuously improvements. If a process is focused (on the customer requirements) from the top management, controlled consistently and is improving, it will eventually product high quality results. The standard does not say when the process will start producing high quality. That depends on many factors.

The standard contains 8 management principles, which provide the foundation for the ISO 9000 series of standards. The 8 management principals that are the basis for the ISO standard are:

Focus On The Customer Provide Quality Leadership Get Involvement Of People Maintain A Process Approach Use the System Approach To Management Continuous Improvement (CI) Decisions Should Be Based On Facts Maintain Mutually Beneficial Supplier Relationships

These principles are not elements against which the organization can be directly assessed. They are what the International Standards Organization believes these eight principals to be the key philosophies of a successful quality-minded organization. These are the underlying philosophy of the ISO 9001: 2000 and should be considered by any organization wishing to comply fully with the intent of the standard, as well as the content of ISO 9000.

ISO 9001 Quality Management System

After helping thousands of small and medium size company with Free ISO 9001 Quality Management System information, we decided to offer a really inexpensive option for companies with small budgets that want to give thier quality system a jump start. By offering a full set of procedures with a database and quality manual, companies can save hundred of hours cutting and pasting information to build all the documentation required for an ISO 9000 quality management system. Our package includes all the origian documents in word, excel and access formats so they can be easily modified. After an order is placed, each set of documentation is customized to include key information about the company. The documentation set includes a general quality statement design to meet the requirements of the standard and designed to help drive your company. You also get a set of sample quality objectives and a sample organization chart. These documents are key to a successful ISO 9001 quality management system. In addition to procedure for all the key areas, the package also includes:

Guide to designing a simple and effective quality management system Sample training presentation including ISO awareness and a "How to be Audited" sample Sample training records and a summary for your training notebook Sample presentation of the management review

The Microsoft Access Database is designed to keep track of 3 areas where there are usually significant number of records that must be maintained and may require complex searching and tracking. The Engineering change system is design to make quick changes for simple errors but still allow significant changes to be handled properly. The calibration and maintenence records require calculations for when each piece of equipment requires calibration and maintenence. The database includes standard reports showing which equipment needs attention. The nonconforming material portion of the database allows for statistical process control based on tacking of defective or non-conforming materials. The output from these systems can also be used as input for management reviews showing many of the key factor for continuous improvment. Our ISO 9000 Quality Management System package is similar quality to the information on this site so you know what your are getting.

Why Focus on Quality?

This article is targeting CEO, entrepreneurs, and other top managers at companies that are NOT growing. If

your company has sustained growing in both sales and profits , you already know what I am about to tell you because company can not sustain growth without a good quality system. Other articles on this site have hinted at the fact that there is more to building a quality product than just getting the ISO 9001:2000 certification. ISO 9000 is only one element to building a quality product, the real key a growing company is to continuous improvement your products and services.

A quality product will cost less to manufacture in the long run. If you have a quality product, the company can spend less on sales and marketing because they will get repeat business and not have to keep finding new customer that have not been burned yet. This reduction in sales and marketing should more than offset the additional cost of maintaining a manufacturing engineering staff that can improve the quality of the products. Most small companies do not understand this point, and thus they stay small companies. As an example, two companies started making industrial flow meters in the same small warehouse in Boulder, Colorado in the early 1970s. One company focused on making limited number of products but making them very high quality, the second company focusing of making every technology of meter with a minimum emphasis on quality. The second company found some niches where there was no competition so their customer had no other good option. After about 30 years the first company (known for their high quality) grew to about 10 times the size of the other company (know for high failure rates). So CEOs, if you want to have sustainable growth, put your money in manufacturing engineering. Manufacturing Engineering can use continuous improvement to make a great product that people will come back for. This can be done with or without ISO 9000. ISO 9000 will try to push the company into changing their culture to be quality oriented and continuous improvement but there is cost associated with maintaining a certification. Don't think short term and spend all your money on marketing, trying to find new customers so you can ship them a bad product and never see them again. If you want to know why some companies don't grow that look at your quality plan. Why Focus on Quality? - Growth (sales and profits)!!!!!

An Introduction To ISO and Certification

At the root of ISO certiciation, there are really 3 things you must do to maintain an ISO certified or compliant quality system:

You must document how you operate your business. You must create documentation to comply with the standard You must maintain records to allow auditing to the ISO standard.

The ISO 9001 standard is designed to promote quality but the certification process does not set product quality standards. It establishes requirements for a quality system that should eventually produce quality products. At the basic level: maintaining ISO certification = maintaining records to prove that your quality system meets the standard The focus of many ISO programs is the generation and maintenence of records for the purpose of maintaining certification. The secondary effect is that this system will produce quality products (if adequate resources are applied to quality). The samples on this website are designed as the foundation for a compliant quality system. The ISO standard says you shall do specific things. Each procedure or document that you generate says "we do these things" and here is how we do it. You must add the detail of how you want to perform each specific tasks. Then you must generate records that show that you are using your system properly.

An Introduction to ISO 9001:2000

ISO 9001:2000 is a quality systems standard created by the ISO (International Standards Organization) to help standardize the minimum requirements for a quality system. The standard is 9001 and the revision level is 2001. The ISO 9001 standard is widely excepted in the EU (European Union) and somewhat accepted in the US. Because ISO certified company are urged to buy from other ISO companies as part of the requirement for purchasing (section 7.4) portion of the standard, the number of companies getting certified continues to grow at a slow rate.

The requirements for ISO certification from a supplier are still very strong in the process and safety industry.

It can be very difficult to sell into these markets without a certified quality system. Products such as gas chromatographs, flow meters, process temperature and pressure measurement equipment, and other equipment that helps control a dangerous process are great candidate for manufacturing under the ISO 9001:2000 standard. Many of the these product require safety approvals such as FM, UL, CSA, Cenelec, and ATEX. These safety standards are working with ISO to unify the auditing process by bring ISO and the safely audit requirements together. These safety standard regulate the product design and ISO regulates the manufacturing process to ensure that the final product is consistently build to high quality standards. The ISO9001:2000 standard requires:

Customer centered focus for the company Maintaining CONTROLLED documentation of all processes in the company Extensive record keeping for the purpose of maintaining history and providing evidence during audits Maintaining product quality through the use of good purchasing, trained personnel, process control and product testing Application of some of the companies resources (including top management) to the quality system Continuous improvement of the companies processes and quality system Routine audits (both internal and external) to confirm compliance and for feedback into the preventive and corrective actions system.

Another way to look at the standard is: What are the additional requirement that most companies are not already doing? With this perspective, there are 4 areas that may require additional resources.

1 Document how you operate your business This is something that most successful companies do even before they hear about ISO 9001:2000. Documenting your process helps make training/cross-training easier and helps eliminate random errors. If they don't already exist, he company must create procedures on how to build your products, communicate with customers, and monitor your processes. 2 Create and maintain documentation to comply with the standard This includes a some elements like a ISO 9001:2000 quality manual and an all-inclusive document control procedure that the company may not have fully documented. The ISO standard also requires:

Standards for design and development activities A system for maintaining and calibrating equipment A system for corrective and preventive actions

Routine management reviews of the quality system Routine internal audits

Samples of these are available on this web site. 3. Maintain records to allow auditing to the ISO standard. The quality manual and the company procedures will require the generation and maintenance of quality records for each area. This includes design reviews. production instructions, production records, management quality control meetings, personnel training, internal audits. 4. Show continuous Improvement The 2000 revision to the ISO 9001 standard place an increased emphasis on continuous improvement. Once again, most successful companies already have some kind of continuous improvement program. The focus in on improving the products and also improving the process The samples on this web site are designed to fulfill part 2. The ISO standard says you shall do specific things. Each procedure or document that you generate says we do these things and here is how we do it. You must add the detail of how you want to perform the tasks. Then you must generate records that show that you are using your system properly.

The Minimum Six Required Procedures

Because of the way the ISO 9001: 2000 standard is written, some people say there are six "required" procedures.

Document Control (clause 4.2.3) Control of Quality Records (clause 4.2.4) Internal Audit (clause 8.2.2) Control of Nonconformity (clause 8.3) Corrective Action (clause 8.5.2) Preventive Action (clause 8.5.3)

This is bit misleading because I dont think there are any companies that could pass an audit with only 6 procedures. The rest of the procedures are required as needed but they are need at every company as far as I know.