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Welcome
to the Elsmar Cove!
ISO
9000 - QS-9000 Information Exchange
The following document is provided as a service to those seeking
to achieve and/or maintain ISO and/or QS 9000 compliance.
The following was e-mailed to me some time ago (circa 1996) - its source was not cited.
The content that follows would appear to be identical to content that *used* to be found at http://www.ileaf.com/isoguide.html although that link no longer works, and Interleaf do not have a search capability on their site, so I can't find where they put it. I originaly found the Interleaf material through a link on http://www.exit109.com/~leebee/isorefs.htm
The only difference that I can see is that the ileaf page also had a section on Interleaf's ISO9000 strategy (using their RDM product), and that their ToC was numbered as well as bulleted, and was hyperlinked to the content.
A German company wins a huge contract to sell components to a factory in North Carolina.
A Swiss firm becomes the leading supplier of power line filters in the U.S.
A Japanese electronics conglomerate outbids several European manufacturers for a project in South America.
These are not isolated events, but rather an indication that we have entered a new age in commerce.
Today, more and more business and industry leaders realize that in order to thrive, or even survive, in the new global economy, their companies must become truly world-class.
And that means quality.
Quality in your products and services. Quality in your practices and procedures. Quality you maintain and you can prove - because it is documented.
Quality as a competitive weapon.
And that is the reason for the growing move to ISO 9000 certification.
The best companies are starting to insist on it. Your competitors may already be pursuing it. And if you plan to do business in Europe or Japan, it is absolutely essential.
The U.K. British Standards Institute, estimates that 47% of the companies who fail to achieve certification do so because of documentation deficiencies. Most of these deficiencies occur in compliance with the ISO 9000 section called "Document Control."
And the remaining 53% of failures are in-part related to documentation in areas such as policies and procedures for process, inspection, testing and measurement.
Based on our experience, we believe that ISO 9000 certification will become increasingly important, particularly if companies are to remain competitive in the global economy.
We've written this guide to give senior executives an overview of the ISO 9000 standards and the process for achieving and maintaining certification. It is by no means a definitive text, but will provide a good place to start.
ISO 9000 is a set of international standards for both quality management and quality assurance that has been adopted by over 90 countries worldwide.
The ISO 9000 standards apply to all types of organizations, large and small, and in many industries.
The standards require:
The ISO 9000 series classifies products into generic product categories: hardware, software, processed materials and services.
The standards are published in a series of five booklets, each covering a specific area:
ISO 9000 and ISO 9004 are guidance standards. They describe what is necessary to accomplish the requirements outlined in standards 9001, 9002 or 9003.
Organizations choose the standards they want to register based on their structure, their products or services, and their specific function. Selecting the appropriate standard is an important decision and will be covered later on in this guide.
Documentation is at the core of ISO 9000 conformance. In fact, the standards have been described as this:
"Say what you do. Do what you say. Write it down."
Simply stated, the ISO 9000 standards define "quality" in ways that have been recognized and accepted worldwide.
The ISO 9000 standards are broad enough to cover many different kinds of quality in many different industries. Yet they can be used to achieve some very specific definitions.
The ISO 9000 series was developed for contractual business relationships when a supplier and its customer are based in different countries. The goal is to increase customer confidence in the quality system used by their suppliers. The standards are designed to:
The International Standards Organization (ISO), in Geneva, Switzerland, was founded in 1946 to develop a common set of standards in manufacturing, trade and communications.
It is composed of the national standards institutes and organizations of 97 countries worldwide, including the American National Standards Institute (ANSI).
The ISO publishes thousands of standards, but the ISO 9000 series is having a major impact on international trade.
First published in 1987, the standards have been rapidly adopted by organizations in Europe, Asia and North America. In addition, there is a movement by several industries in the EEC where ISO certification is now a prerequisite to product certification. And that trend is growing.
The standards have been endorsed by the American Society of Quality Control, the European Standards Institutes, and by the Japanese Industrial Standards Committee.
A 1992 poll* of 500 U.S. purchasers of electronics revealed that two-thirds of them will call for ISO 9000 conformance by 1995.
The same is true in industry after industry and many government agencies as well.
For the first time, there is one internationally accepted standard of quality. There is a way to determine and measure that quality. There is even a way to prove it.
The time has passed to take a "wait and see" attitude for most industries. The chances are good and increasing that your company, or your competition, will be seeking ISO 9000 certification in the next three to five years. ISO 9000 is fast becoming the de facto across industries throughout the world.
With the onset of the ISO 9000 quality standards, manufacturers are gearing up for conformance to remain competitive and to distinguish themselves from competing suppliers.
As international trade and the attention to quality issues has increased, the need for an international quality standard became critical. Some companies are driven to become compliant because of internal operational efficiencies that can lead to dramatic productivity increases and reduced costs.
Many companies implement ISO 9000 programs as a foundation for Total Quality Management (TQM) programs or in pursuit of the Malcolm Baldrige Quality Award in the U.S.
It would be difficult to name an industry that will not be affected.
Virtually every manufacturing company should be aware of the ISO 9000 standards that will affect the companies they sell to, their suppliers and their internal quality practices.
And any industry that is regulated can expect to have to conform to ISO 9000 standards within the near future. The EEC (European Economic Community) is continuing to identify certain sectors of manufactured goods that will be regulated to conform to ISO 9000.
Some commodities are already under the EEC requirement to conform to ISO 9000 standards. These include:
This means manufacturers of these commodities must be compliant in order to sell these commodities into the EEC.
The following list includes industries where companies have achieved, or are applying for, ISO certification.
(It is by no means a complete list.)
Advanced technology
Aerospace
Aircraft
Chemical manufacturing and testing
Civil engineering projects
Computer equipment
Control equipment
Distributors of electrical and electronic products
Electrical equipment manufacturers
Electrical appliance manufacturers
Electronic and microelectronics
Fabricated metal products
Food and drink producers
Food packagers, distributors
Industrial machinery
Information technology
Petrochemical equipment
Printing
Publishing
Raw materials suppliers
Refractory and industrial ceramics manufacturers
Rubber and plastic products
Tableware
Test laboratories
Textiles
Transportation equipment
Wood and paper industry
Instrument manufacturers
Lighting equipment
Manufacturers of bathroom products
Mechanical products manufacturers
Medical equipment
Metallurgy
Nuclear power plants and safety
And to this list, add:
Allen-Bradley, a Rockwell International Company
Allied-Signal, Inc.
Amoco Chemical Company
AT&T
Caterpillar, Inc.
Digital Equipment Corporation
Dow Chemical Company
Eastman Kodak Company
E.I. duPont de Nemours & Company, Inc.
Exxon Chemical Company
Fisher Controls International
The Foxboro Company
GE Industries and Power Systems
GE Medical Systems
GE Plastics
Hoechst Celanese Corporation
IBM
Johnson & Johnson Medical
Northern Telecom
Minnesota Mining & Manufacturing Company, Inc.
Motorola UDS
Solar Turbines, Inc.
Sun Microsystems
Tektronix, Inc.
Texas Instruments
Westinghouse Electric Corp.
Weyerhaeuser Paper Company
Xerox Corporation
Xerox Canada Ltd.
These are some of the companies that have already achieved ISO 9000, many more are in the process of certification.
Companies worldwide are using ISO 9000 registration as a means to differentiate quality companies with those who have elected not to pursue or have postponed the registration process.
According to one quality expert, "If you don't have it, you simply won't be able to play."
Registration* is the assessment of a company's quality system by a third party - a quality system registrar.
An on-site audit by a team from the registrar is required to become registered. The purpose of the visit is to evaluate the facility's compliance with the ISO 9000 series standard.
If the organization's quality system conforms to the registrar's interpretation of the standard, the company is then registered or certified to any one of the ISO 9000 standards, depending on the type and scope of its business.
An organization chooses the standard based on its operational and business practices. For example, ISO 9001 is selected by organizations that have design, manufacturing and testing functions located in one facility. ISO 9002 is chosen by a facility that manufactures, tests and distributes a product, but the design function is provided by outside organizations.
It is the quality system used to produce the organization's product, not the product itself, that is registered. And interpretation of what is required to conform to the standards varies from registrar to registrar.
The registrar also cannot tell the organization how to set up systems to conform, or even what systems are needed. It is ultimately a decision made by members of the ISO 9000 team within the organization to decide how they should best approach the ISO 9000 standards.
In a word, customers.
More than just a quality standard, ISO 9000 has become a competitive advantage.
In many countries, ISO 9000 compliance is a must for organizations that sell to buyers of industrial products. In the U.S. and Canada, it is becoming increasing important to manufacturers across all industries.
Companies who have achieved ISO 9000 certification enjoy a significant advantage in satisfying their customers and gaining new ones. It also helps maintain approved vendor status, as the trend is to reduce the number of suppliers.
In fact, a recent study* of certified companies revealed that ISO 9000 certification had also brought unexpected benefits, such as greater operational efficiency, increased profitability, savings in administrative costs, and improvements in marketing and sales activity.
ISO 9000 standards specify that "it is the quality system used to produce a product, not the product itself, that is registered."
Individual product lines can be separately registered, or a single site, or even a division with multiple sites. If these sites all conform to the ISO 9000 standards, and they can be audited simultaneously, they may be covered under one registration.
And there's no need to register it all at once. By registering logical groupings individually, an organization can learn from each audit process, and transfer that knowledge and experience base to each subsequent grouping.
ISO 9000 standards don't tell you how to run your business. They only define the critical documented elements that must be taken into consideration to produce a quality product.
ISO 9001 is the broadest standard and applies to most organizations. It is also the most extensive because it is designed for companies that perform the entire product life cycle - from design to manufacturing, testing, training, to delivery and service.
The ISO 9002 is a subset of the ISO 9001 standard and is selected by organizations that do not perform product design functions. ISO 9003 is the standard with the fewest requirements and relates primarily to distribution and warehousing functions.
Even though you may recognize the important benefits of ISO 9000 registration, it may take some time to achieve them.
The entire process can take several months to two years, depending on the size of the organization and its goals.
We recommend that you take a project management approach to ISO 9000 certification. We have found the following steps essential to those companies who succeed.
2. Put together a winning team.
Choose a strong Project Management Leader, and staff the ISO 9000 planning
team with members from cross-functional groups. Give them the tasks
of selecting a registrar, evaluating document management systems, setting
goals and objectives and weighing the benefits of using consulting services.
Make sure they have the responsibility - and the authority - to make
things happen.
3. Keep it moving.
Make sure the ISO 9000 team has all the tools it needs to manage the
process effectively. Establish open lines of communication between senior
management and the team, to ensure that all potential roadblocks are
avoided and that sufficient resources are allocated. Have formal methods
to keep top management abreast of progress.
Most importantly, you should be aware that no organization ever achieved ISO 9000 certification on its own.
Successful organizations work with their suppliers, develop close ties with their ISO 9000 consultants and registrars, and often, form strategic partnerships with document management experts, such as Cayman Business Systems.
This section of the guide is intended as a general outline of the ISO 9000 registration process. It is by no means a definitive instruction.
There are eight basic steps to every registration process.
Step Two: Application for Registration
Once you have selected the registrar, you must complete the registrar's
application for certification. This involves contractual conditions
between the organization and the registrar, including fees, confidentiality
and liability issues. The application includes the scope, standard selection,
company business description and desired time frame for registration.
Step Three: Initial Document Review
The quality manual is the overview document that is provided to the
registrar early in the process. The quality manual is the mission statement
of the organization's quality system and is usually broken down into
the corresponding ISO 9000 elements of the standard selected.
In many cases, the quality manual can be mailed to the registrar to review, rather than have an on-site review of the material. Other important documents, such as policy manuals, can also be submitted for review at this time.
Step Four: Pre-assessment Audit
This is an optional step. Some organizations perform this internally,
with the assistance of an employee or consultant who has attended the
ISO 10011 Auditor training course.
The purpose of a pre-assessment is to identify the factors that will be involved in the registration audit. A pre-assessment is an effective technique in identifying deficiencies in either the quality system or in the documentation components.
Step Five: Internal Assessment
An assessment conducted internally helps your organization make sure
that you are ready for the registration audit. If the assessment is
performed by employees trained in ISO 9000, this can take the place
of a pre-assessment audit with a registrar.
This step can be valuable in identifying key areas that require more attention before the organization moves forward to prepare for the full ISO 9000 audit.
The pre-assessment audit and the internal audit involve an evaluation of the current quality system and the documentation supporting it. These audits should include review of key documents that involve policies and procedures such new product releases, engineering change process or test and inspection process. In addition, records such as batch production records, work instructions, analysis and test results and even meeting minutes should be examined for compliance.
Step Six: Full Assessment
When an organization determines that it is ready, the on-site assessment
audit is scheduled. Typically, a full assessment for ISO 9001 involves
2 or 3 auditors and takes approximately 2-4 days to complete.
The on-site audit consists of management and team meetings, daily reviews and often a draft report of the findings of the audit team that includes its recommendation on registration. The audit team will require escorts to assist in meeting personnel on all levels and in examining the documentation produced or used.
The team will also determine the compliance-revision level of documentation, examine release level consistency and check the availability of pertinent documents related to the quality system.
In most cases, these reviews will expose inconsistencies that will be included in the final report. Depending on the inconsistency or deficiency, some organizations can take corrective action during the audit visit.
Step Seven: Registration
The assessment will result in approval, conditional approval or disapproval
for the organization.
Approval can occur with only minor deficiencies outlined in the registration report. This means your quality system has been verified to conform to the requirements of the ISO 9000 standard, the registrar will issue you a certificate.
The certification is then listed in a register, which is available to the public. You may also display the registrar's mark in your advertising, stationary, bids and proposals.
Conditional or provisional approval occurs when the organization has systems documented but not yet fully implemented. Or if the organization has insufficient documentation or access and control of documentation. Insufficient, incomplete and lack of appropriate documentation is the most common reason organizations fail a first-time registration audit.
Disapproval occurs when there is lack of an adequate documentation system or when basic elements of the standard (such as document control) have not been addressed. Once corrected, the organization can reapply for registration.
Step Eight: Surveillance
Most registrations are valid for a three-year period. During that time,
the organization must maintain and improve the quality system that was
certified. Organizations usually have a maintenance contract with the
registrar for ongoing surveillance.
A surveillance audit by the registrar is usually done every 6 months, but may vary and may be scheduled or unscheduled. A complete reassessment is usually required at the certification expiration time.
The quality system must be ready to substantiate that processes in place at the time of the original ISO 9000 certification still exist or are surpassed. Your chances of maintaining certification are better with an electronic document management system.
Keeping the lines of communication open and sharing improvements in the document control and distribution system with the registrar will afford a more organized, smoother approach to maintaining the ISO 9000 certification. Modifications to the quality system should be well-documented and provided to the registrar regularly.
A registrar is an independent company whose business is evaluating a supplier's quality system for ISO 9000 conformance.
The first thing to do is to obtain a list of registrars, which is available from the Registrar Accreditation Board (RAB) in the United States. You should know that every registrar is different, with experience in different industries.
Once you have made a short list of registrars to interview, you may want to ask the following questions:
These are just the preliminary questions and by no means a complete list.
It is important to keep in mind that choosing a registrar is just like any other business decision. Remember that your relationship with the registrar will be long term. Make sure you have complete confidence in your choice.
Some registrars also have a consulting organization that advises or "tutors" organizations in achieving ISO 9000 certification. This may involve setting up a quality system or writing up the quality documentation that is being assessed.
The ISO requires strict separation of assessment and registration services and consulting. This means that the company you select as a consultant may not perform the registration audit for ISO 9000 certification.
The fees for registration vary based on the size of the organization, your country and the ISO standard you select.
Costs include the application fee, the registrar's cost for review of documentation, as well as the initial visit and the formal audit.
The time required to achieve ISO 9000 certification can be anywhere from six months to two years, depending on the size and complexity of the organization.
Many buyers of manufactured products have targeted 1995 as the year they will begin calling for ISO 9000 conformance from their suppliers. That means that many companies are starting right now.
As one expert put it, "When the customer demands ISO 9000, gaining management support is easy. But when it's not..."
Every successful ISO 9000 program must have the support and commitment of senior management within an organization.
It must be recognized that obtaining ISO 9000 certification is an investment - one that will pay off over time in new business, increased efficiency and higher quality.
In fact, it is an investment in the organization itself. And as such, it can be the most profitable investment you can make.
Think of how your organization selects a major supplier today.
Often, representatives of key groups - design engineering, manufacturing, purchasing, engineering and quality assurance - must make visits to potential suppliers to assure their quality practices.
This slows down the selection process considerably. Many potential suppliers are rejected. Others are put through a rigorous and time-consuming review.
As a result, your production schedules can be delayed, and the critical time-to-market window for success can be put at risk.
It's also true when your own organization is being considered.
ISO 9000 certification can help reduce this cycle, making it easier for organizations to foster productive business relationships.
When your organization has achieved ISO 9000 certification, it means that you have a documented quality system, which is being followed by personnel and maintained as an integral part of your policies, procedures and practices.
In a world where companies are reducing the number of suppliers they use and demanding higher and higher standards of quality, ISO 9000 has become critical.
The ISO 9000 standards are quite explicit on one point.
Your organization must document what you do.
Why is that so important?
A recent study by The Gartner Group revealed that 75% of all business information is in document form.
Today, more and more senior managers realize that information is their most important asset. And how they manage that information - in the form of documents - is critical to their success.
For ISO 9000, documentation is the medium that the communication about the quality of your organization must take.
And conversely, poor documentation systems is one of the main reasons that companies fail.
Many organizations are still partially paper-based in the creation and distribution of their critical documents.
For example, frequently changing information in a test procedure or assembly instruction needs tight controls, because the quality of your product is at stake.
In this case, managing ongoing changes to these documents can be a labor-intensive, manual, error-prone process. And once changes are approved, it is sometimes difficult to ensure that the right version of the procedure or instruction is actually being used by an operator or engineer.
Because of situations like this, an electronic document management system is essential for ISO 9000 compliance.
Managing documents electronically automates the document change and distribution process, so personnel can focus on improving what they do, not how they document it. And this enables you to change processes and procedures to increase customer responsiveness and to adjust to changing needs in the market.
Would you still be in business?
Chances are, most people will not remain in the same position over the years. They'll be promoted, change jobs, or even leave your organization. But what happens to all the knowledge and on-the-job training they've accumulated?
When every function and process is documented, your organization will increase the likelihood of functioning at the same high level and even have systems in place for continuous improvement.
The document control requirements are fully described in the ISO 9000 standard and cover the breadth of the organization.
It begins with the quality manual and broadens out to the "Three Tier Document Structure" shown on the next page.
The level 1 quality manual document states the organization's philosophy and vision. The quality manual represents the strategic plan for an organization's quality system. This is a relatively short document that addresses each of the ISO elements. For example, an organization seeking ISO 9001 certification, creates a quality manual of about 20 pages - one page per element.
Level 2 documents are procedural documents. These include departmental policy and procedure manuals - the manuals that describe the actions to take place, who is responsible and when they should be carried out.
Examples of level 2 documents are new product development procedures, training policies and test and verification policies.
Level 3 documents are the quality documents that represents how tasks are executed, such as design specifications, operating instructions and assembly instructions.
Quality records, sometimes referred to as level 4 documents, document the results of actions specified in level 3. For example, calibration reports and batch records.
Standardized electronic templates, revision control, active document intelligent authoring, linking of related information
The ISO 9000 standards require two specific kinds of documents: quality documents and quality records.
Quality documents tell "what to do." For example, work instructions would be a quality document. They may include how to assemble, test, package, store or ship a particular product.
They can also be the specifications for a new product design, which list engineering requirements for the design and govern the product development cycle.
A quality record is evidence that your organization has fulfilled the actions described in quality documents. Using the example of product testing, the quality record would describe who did the test and would include the date, time, location, which product, test result and then the actions taken.
The following pages show the relationship between quality documents and quality records and list some additional examples.
The quality manual drives the ISO 9000 quality system implementation. Policies and procedures describe the quality practices - what each department must do. Quality documents describe the process - how procedures are to be done, at an individual level. Quality records report the outcome of processes and support the results.
Examples of quality documents and records generated from quality processes that require control...(from Section 17.2, ISO Standard 9004)
When you stop to think about it, documents are a unique type of data:
This is obviously the heart of the ISO 9000 standards. And, as we've noted, the reason why many companies fail.
Here's why:
In many companies, important process information does not reside in documents, but rather in management.
"Managers know what to do. They just do it. Why should we keep records for everything we do?"
The answer is that the ISO 9000 standards require you to create and maintain quality records. These quality documents and quality records represent the work instructions and records that instructions have been followed in your organization.
These are the vital elements of any ISO 9000 project. Because these documents are dynamic, the document control is critical to ensure that the right version of these documents are used and maintained.
Documents requiring control include CAD files, routing sheets, product specifications, work orders and virtually every other document that relates to the way you do business.
Information managed includes revision level, change history, who has changed it, the relationship between it and other documents, and its availability to all who need it.
Often organizations have developed partial solutions that may control certain types of documents such as CAD files or ECOs. Information, however, usually crosses the boundaries of all types of documents.
What most organizations require is a system that can manage documents from many different applications on a variety of hardware platforms for different products and projects.
The registration audit can be an organization's single most powerful tool for continuous improvement, as well as a tool to achieve ISO 9000 certification.
Quite simply, it is a structured review of your organization's documented practices as they compare to how your organization actually accomplishes them. Using an electronic document control system you can
The registration audit process can be costly and time-consuming if you are tracking your documents manually. The process is greatly enhanced for organizations with an automated document management systems. For paper-based companies, it can be an expensive nightmare.
And of course, once you achieve ISO 9000 certification, regular surveillance auditing becomes a necessary part of ensuring that you maintain the ISO 9000 standards.
ISO 9000 certification requires that control and verification of your products be your responsibility, from design to delivery.
Section 4.4 of ISO Standard 9001 is specific:
"Your organization shall control and verify the design of its product to assure it meets specified requirements."
You have to start by documenting your design, and then ensure that all plans for the development of your product, including any changes in design and specification, are updated regularly.
This means that you must be able to substantiate that your design process reflects the specification requirements. You must also provide verification that any applicable regulations are being fulfilled.
It is not only the design process that must be documented, but even more important, the design change process. And that is where an advanced document management system can make compliance faster and easier.
As we've said, documentation is at the core of the ISO 9000 standards.
Documentation is absolutely necessary to maintaining and proving quality.
This may sound like an expense. Many organizations, however, view documentation as an excellent investment. The following pages will show how an advanced document management system can lead to substantial benefits for your organization, beyond ISO 9000 registration.
The ISO 9000 standard does not specify how an organization must achieve certification.
Organizations with a paper-based document management system, however, are at a considerable disadvantage.
In fact, some experts believe it is virtually impossible to achieve and maintain ISO 9000 certification without a powerful document management system in place.
The fact is that those companies that use state-of-the-art document management technology to create, manage and distribute policy, product and procedure information are best positioned for success.
And because certification is an ongoing commitment, an electronic compliance system will make it easier to maintain.
But there are other benefits to advanced document management software that have little to do with ISO 9000 conformance.
The right document management system can allow your company to reap substantial savings, as well as enhanced productivity.
A large manufacturer of guidance systems will save $2 million over the next five years by electronic documentation for the creation and distribution of manufacturing work instructions.
Before installing an electronic documentation solution, the company used traditional word processing and a manual cut and paste production process. This required a staff of documentation support personnel.
Today, all instructions in the company are created by methods engineers without the additional support costs, and the company has realized a 25% savings. The return on investment in the electronic documentation system was achieved in 10 months.
A large chemical company selected electronic documentation to create and manage an electronic, integrated manufacturing documentation system as part of their CIM implementation and for compliance with ISO 9000 standards.
In the chemicals business, it is critical to have access to information about a batch of products during production. If a batch in production is being manufactured with incorrect specifications, corrective action must be taken immediately, or the results could be disastrous.
With electronic documentation on the factory floor interfacing directly to the manufacturing process, the chemical company achieves a higher level of control and an improved response time, which greatly contributes to profits.
A large medical device manufacturer is subject to strict FDA regulation. That makes their documentation mission-critical.
Electronic documentation provides a totally integrated system to distribute accurate, current documentation to over 300 production workers, engineers and managers.
Electronic documentation allows for the creation of documents from a multitude of sources such as CAD systems, scanned drawings, PCs and Macs, enabling the company to leverage its current investment in existing applications, while providing state-of-the-art tools for final document preparation.
The result is that only current documentation will ever be distributed on the shop floor, which is essential to the company's continued success.
Absolutely not. In fact, a significant percentage fail for the reasons shown on the following page.
ISO 9000 certification is like any other function in business.
Some organizations plan for it, develop a strategy for achieving and maintaining it, and then utilize it as a competitive advantage against organizations who do not have the same high level of quality.
Other organizations do not pursue ISO 9000 certification with the same level of commitment.
"Documentation sounds simple, but it's one of the principal things that
must happen with ISO 9000."
- Mark Morrow, Sr. Editor, Quality Systems Update
You will be told the reason for non-conformance, and you will then have the opportunity to correct it.
The auditor's report will include the necessary corrective actions. As soon as you fulfill these, you can reapply for registration, with no penalty.
In many cases, the implementation of an electronic document management system gives companies an edge toward gaining ISO 9000 certification on the first try.
There is substantial evidence that one area of the ISO 9000 standards is responsible for most failures.
And that's poor documentation.
One registrar confirms that 70% of companies fail their first-time audit due primarily to deficiencies in documentation.
The ISO 9000 auditor will pay careful attention to what you say you do and what you actually do.
An electronic system that can integrate information from existing applications such as word-processing, spreadsheet, MRP, CAD, scanning and e-mail systems, means team members can access a cohesive set of tools to help plan, design, implement, control, analyze and maintain an ISO 9000-compliant quality system.
Quality experts believe that there are three major areas that cause organizations to fail to achieve ISO 9000 compliance.
They include one or all of the following problems:
Many organizations do not have a formal, documented process to respond to an RFP (request for proposal) or an invitation to tender.
Yet, this area is a critical part of the ISO 9000 standards.
ISO 9000 specifies a contract review between the purchaser and the supplier. Any changes in the product, the specifications or even the delivery date must be negotiated and put in writing.
This not only ensures ISO 9000 compliance, but also prevents potential disagreements and even lawsuits. In this respect, ISO 9000 represents a better way of doing business.
You regularly test the equipment you use in your manufacturing process. But what assurance do you have that the testing equipment itself is accurate? With ISO 9000, validation is the first item on the test or inspection report.
The work that you have already done in the area of improving quality and quality practices can be used as a baseline to achieve ISO 9000 certification.
For many companies, the process of applying for ISO 9000 certification enables them to document their quality system and ensure that they will continue to maintain the quality they've developed.
Many companies already have level 2 and level 3 documents in different systems - MRP, multiple CAD systems, word processing systems or on paper.
Organizations should work to capitalize on their current systems. An electronic document management system will leverage these systems, contributing to a compliant, controlled system that will help your organization achieve registration.
In a broad sense, they each focus on quality. Not just quality of product or service, but rather quality in the process. But there are also important differences.
The Malcom Baldrige National Quality Award is given by the National Institute of Standards and Quality. It represents a finite point, an award that marks an achievement in a given year. There are only a very small number of winners and many "non-winners."
The Deming Prize is given by the Union of Japanese Scientists and Engineers and is Japan's highest award for quality. (It has only been open to foreign companies since 1986.) There are no firm requirements other than to meet or exceed customer's needs based on Deming's 14 points. They include intangibles such as "Breaking down barriers between departments."
ISO 9000 is not a one-time award. It opens the door to continuous and ongoing improvement. Under the current ISO 9000 guidelines, organizations must be audited every three years and go through the entire certification process upon expiration of certification.
And ISO 9000 registration is based on the documented way your organization achieves and maintains quality. That's one of the reasons that an electronic document management system is so important. Finally, every company that achieves ISO 9000 is a "winner." Unregistered companies are the only "losers" - of customers and new business.
In the final analysis, ISO 9000 standards will have a much greater impact on business than any quality award. You wouldn't limit your suppliers to those companies that have won the Baldrige Award (there have only been 17 to date). But you may have to limit your suppliers to those who are ISO 9000 certified.
Total Quality Management (TQM) is yet another way of approaching quality processes for your organization and may help support your ISO 9000 certification.
In fact, many of the practices and policies of TQM are comparable to the ISO 9000 model.
Manufacturing experts agree that ISO 9000 certification provides a solid foundation for developing a TQM system. And if undertaken together, relatively little extra effort or expense is needed to achieve both.
TQM, however, can be defined in many different ways, and even two companies who do business with each other may disagree on the standards. ISO 9000 standards are clearly defined and internationally accepted. And that makes ISO 9000 an excellent place to launch your TQM initiative.
Ask yourself, or your top management team, the following questions:
If you answered "yes" to several of these questions, your organization may benefit from ISO 9000 certification.
Unlike many TQM initiatives or general quality improvements, the benefits of ISO 9000 certification have been studied and quantified.
In a September 1991 study for the British government, Survey of Quality Consultancy Scheme Clients 1988-90, researchers (Pera International and Salford University Business Service Ltd.) contacted over 2300 firms. The survey of registered companies found that:
According to leading experts, the ISO 9000 standards result in greater operational efficiency, increased productivity, reduced overtime payments, reduced administrative costs and the elimination of unnecessary procedures.
And while some people think that ISO 9000 benefits are mainly for large organizations, studies have shown that they also produce significant savings for smaller companies, such as sub-contractors.
How would you feel if the companies you buy from had documented proof of higher quality?
Wouldn't you have more confidence in their products?
On its most basic level, the ISO 9000 standard has been written to be attached to a contract between two companies.
In fact, one of its most important functions is to assure that an organization delivers whatever it has agreed to by contract and that it has permanent systems in place to maintain that capability.
ISO 9000 certification can eliminate the need for some audit visits by your customers. This decreases the cost of establishing agreements and doing business between suppliers and customers.
It is an excellent way to ensure quality and confidence.
You can use ISO 9000 certification to gain or maintain approved vendor status, even when companies reduce the number of their suppliers.
You can enter new and lucrative markets that were previously closed to you.
You can successfully compete with virtually any other company in your industry.
In fact, small and medium-sized companies are using ISO 9000 to win business away from much larger organizations.
In Europe, buyers of industrial products are insisting on ISO 9000 compliance and procurement specs from their suppliers. And virtually every industry seeks ISO 9000 certified suppliers.
In the U.S., IBM and Motorola are two of the many companies that are starting to call for ISO 9000 compliance. And regulated industries and government agencies may not be far behind.
Throughout the world, more and more companies are demanding it from their suppliers.
"Are you ISO 9000 certified?" may well become the first question these companies ask.
The answer may surprise you.
Right now, most manufacturers have to accept their customer's definition of quality. And different customers have different requirements.
Many manufacturers even have to undergo customer-driven "quality audits," which can be expensive and time-consuming. ISO 9000 practically eliminates the need for many customer-driven quality programs. ISO 9000 certification is a uniform standard, accepted and recognized internationally. So you save money.
That also means your organization can allocate time and resources toward improving the real quality of your processes and products not measuring up to individual supplier standards.
There are several important ones.
In fact, you begin to accrue benefits even before you achieve ISO 9000 certification.
The preparation for ISO 9000 registration involves a close analysis of your existing quality systems. This is at the heart of the ISO 9000 standards.
It presents you with the perfect opportunity to standardize and document your procedures. (In some organizations, this will be the first time this has been done.) And it enables you to communicate this information to your employees, to increase productivity and profits.
In addition:
Because ISO 9000 standards require you to document the procedures and practices affecting every area of your organization, you will quickly realize which are wasteful and unnecessary.
This can give top management the first clear picture of exactly how the company does business and will reveal ways in which it can improve.
Documents are the major vehicle of communication in every company. And ISO 9000 requires that documents be readily accessible to every employee who needs them.
Once you have documented the best ways to do things, there's no returning to second best.
And with an electronic document management system, you can be sure that everyone will be working with the most up-to-date, accurate information. There are no expensive mistakes.
And that can only improve the quality of your decisions.
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This page last reviewed or edited: Sun, 2007-02-04 16:32 (Coordinated Universal Time [ZULU] -5 hours)