What You Should Know Before Implementing an ISO 9001 Quality Management System

Successfully implementing an ISO 9001 Quality Management System depends on developing a clear understanding of seven aspects of the program, including:

1. The purpose of a quality management system

The principles of quality management are:

Quality is achieved through conformance to defined specifications in terms of performance, price, and delivery and is not just limited to how a product or service looks or performs.

Customer satisfaction is achieved by understanding the customer requirements and using methods to ensure that these requirements are consistently met.

Controlling and improving processes are achieved through the use of documented policies, procedures, and continual improvement activities.

The ISO 9001 Quality Management System is a business system designed to make it easier for companies to comply with these principles.

The system establishes both the rules for identifying the customer requirements and the policies and procedures for providing organizations with the means for delivering products and services that comply with these requirements. It also creates a means for ensuring consistency, stability, and the continual improvement of the processes used in running a business. It's based on documentation and demands effective information management, operational discipline, and accountability.

The ISO 9001 Quality Management System was developed and is managed by an internationally recognized organization. The system was originally implemented in 1987, subsequently revised in 2000, and is currently used in over 130 different countries by over 350,000 companies.

2. The benefits of a system

An ISO9001 Quality Management System has the potential of providing several significant benefits, including:

Improved Profitability ? Profit improvement results from more productive employees, better organization, better suppliers, better infrastructure, and systematic continual improvement programs.

Employees are more productive because the system establishes standards for hiring and training, requires employee involvement, and demands accountability.

Documented procedures create better organization, which promotes consistency and reduces the number of mistakes.

Qualification criteria, auditing procedures, and the use of performance measurements improves supplier performance.

Controls and policies placed on the management of the infrastructure including the buildings, machinery, tooling, software and hardware, and the general working conditions result in more reliable and better working conditions.

Corrective and preventive action programs and other continual improvement processes provide a mechanism for preventing problems from reoccurring, finding and fixing problems before they occur, and developing new and better ways of doing things.

If effectively implemented a quality management system can eliminate duplication and process variability, lower cycle times and inventories, and reduce both in-house and field failures.

Improved Customer Satisfaction ? Customers benefit because:

Policies and procedures for managing process information, measuring instruments, and the verification and validation requirements result in better products.

Procedural changes and improvements in supplier performance result in better deliveries.

Changes in the way customer communication and product development are managed result in better customer relations.

Increased Sales ? ISO 9001 certification is an internationally recognized accomplishment. It?s a bragging right but more importantly it?s a promotional opportunity. It opens doors to prospects that treat certification as a tipping point or a supplier requirement, and it's a means of letting your customers know that you comply with a set of internationally recognized management standards.

Improved Job Satisfaction ? Job satisfaction improves because:

The system includes change processes that provide all employees with an opportunity to make a difference in how a company is managed.

There's comfort in knowing what you're responsible for doing, and

There?s security in knowing that the system creates a more competitive position.

The instructions bridge interrelated responsibilities, which eliminates confusion and reduces conflict.

The key word to remember is ?potential.? The benefits don?t come automatically and won't happen without a genuine commitment starting at the top, a system that is well composed and managed, and a long-term commitment.

3. The components of the implementation process

The three components of the implementation process are: 1) documentation, 2) information management, and 3) operational changes.

Documentation ? On the surface it may seem that developing the ISO 9000 documentation shouldn?t be that difficult. You must have a manual that includes a policy, objectives, scope, and the interaction of the processes; and you must have written instructions for:

1. Managing the quality system documents
2. Managing the quality system records
3. Conducting internal audits
4. Controlling nonconforming product
5. Implementing corrective action
6. Implementing preventive action

The standard also hints at the need for additional instructions, e. g. referring to the work instructions, section 7.1 states ?shall determine the following, as appropriate,? but technically, aside from the manual and these six instructions, anything more is optional.

The reality, however, is that in order to get the most out of a quality management system a great deal of additional documentation is required. A primary function of the system is to establish consistency and eliminate misunderstandings, which is best facilitated with clear and unambiguous written instructions. Policies, which are a pervasive part of any system, have absolutely no value if they're not in writing, and enforcing accountability is extremely difficult if the responsibilities are not spelled out.

Information Management ? Extensive information management is another integral part of the implementation process. Just keeping track of all of the records associated with the quality system is in itself a daunting challenge. Then there are training records, records of all of the customer complaints, warranty claims, and past due shipments. There's also sales and purchasing records, traceability documentation, product development records, verification and validation records, incoming inspection records, and internal and external non-conformance records.

All of this involves gathering, managing, and analyzing information, which is an unavoidable requirement of the ISO 9001 standard.

Operational Changes ? The final component of the implementation process is the operational changes, which are the changes needed in order to meet the procedural requirements of your system. These include such things as training, instrument calibration, housekeeping, product traceability, product preservation, managing nonconforming materials, auditing, and the implementation of the corrective and preventive action activities. It's not good enough to say what you're going to do, you actually have to do it.

System documentation and information management are the paperwork part of the system. The operational changes are the action part and represent the part of the implementation process that makes the system work.

4. The system content

An ISO 9001 quality management system is not limited to just the processes and procedures required by the ISO 9001 Standard.

Section 0.3 in the Introduction of the International Standard states: ISO 9004 is recommended as a guide for organizations whose top management wish to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance.

Section 0.4 states:
This International Standard does not include guidance specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial management, or risk management. However, this International Standard enables an organization to align or integrate its own quality management system(s) in order to establish a quality management system that follows the guidelines of this International Standard.

The implications are: 1) you?re encouraged to use the ideas in the 9004 standard and therefore not limited to building your quality management system exclusively around the requirements in the ISO 9001 standard, and 2) you?re free to combine processes and instructions from other systems.

What makes this significant is the fact that the ISO 9001 requirements are far from inclusive. There's nothing, for instance, in the standard to address inventory control, yet this is a major concern for most companies and a logical addition to a quality management system. The same can be said for product costing. It?s difficult to develop the cost of quality if you?re not costing your products. Nor is there anything in the standard to regulate environmental, safety, business planning, or financial concerns, all of which have a significant impact on the way most people run their business.

The objective is to create a system that effectively manages the important activities of your business, which means that if something is not included in the standard but nevertheless important to your operation, not only can it be included it should be included.

5. The system structure

The authors of the standard have also made it clear that the outline of the standard is not meant as an outline for the quality system documentation.

Section 0.1 of the Introduction states:
It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.

It is also noted that every system is:
[i]nfluenced by varying needs, particular objectives, the products provided, the processes employed, and the size and structure of the organization.

The message is that you're responsible for structuring your own system. There is no process list and no procedure list anywhere to be found in the standard, and nowhere in the standard is it suggested that you should use the outline of the standard as a basis for identifying your processes or developing your procedures.

To the contrary, a persuasive argument can be made that to do so is a mistake. It limits the scope of the system because it removes the need for thinking about the processes that are unique to your operation, and it bogs down the implementation process because it causes you to design procedures around requirements rather than developing procedures to meet your needs, which can be like pushing a square peg into a round hole.

6. The ?process approach?

While the ?process approach? is one of the eight quality management principles listed in section 4.3 of the ISO 9004 standards, and the use of the ?process approach? is recommended as a means for structuring your ISO 9001 system (refer to section 0.2 of the standard), neither standard provides a clear explanation of what a process approach is.

The ISO 9004 standard defines the process approach principle as:
A desired result is achieved more efficiently when activities and related resources are managed as a process.

The ISO 9001 standard defines a process as:
An activity using resources, and managed in order to enable the transformation of inputs into outputs.

Our way of interpreting the meaning of a ?process? is to group related activities based on defining inputs and outputs. For example, the inputs and outputs of the human resource process may be defined as:

Input = Rules for making sure employees are informed and capable of performing the assigned responsibilities

Output = Capable, competent, trusted, and motivated employees

A process that defines the management of the infrastructure of an organization may be described by:

Input = Rules and policies for managing the tangible assets used to support the business

Output =Fewer disruptions, a better working environment resulting in fewer mistakes, better efficiency, better throughput, and more satisfied customers

Policies and procedures that affect such things as hiring, training, and performance management would be part of the human resource process. Housekeeping, machinery maintenance, network maintenance, and the maintenance of measuring devices would be part of the infrastructure process.

The authors of the 9001 standard explain the ?process approach? as: The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management.

Our way of interpreting the meaning of ?process approach? is to think in terms of a common objective for a set of different processes. An objective might be the continual improvement of the management system, which is what is used in the illustration shown in the standard; or an objective might be the growth and profitability of the organization, which is what we use in our 9000 Advisers system model. It?s the objective that binds the processes together and determines how the processes interact. It is also an explanation that fits the model illustrated in the ISO 9001 Standard.

Structuring systems based on this interpretation of the ?process approach? result in systems that are more personal, flexible, and easier to develop. You?re not handcuffed by the outline of the ISO

Standard, and you're not limited by the requirements of the standard. You establish processes that represent the particular needs of your operation and develop the policies and procedures that bring about the desired output of these processes. Then you make sure these policies and procedures accommodate all of the requirements of the ISO 9001 Standard.

7. The basic compliance requirements

Under certain circumstances it is possible to request an ?exclusion? if for some reason you find it impossible to comply with certain requirements within the standard. The requirement must be part of clause 7 of the standard, you must provide an explanation and the justification for the request in the Quality System Manual, and your alternative solution must not affect the ability ?to provide product that meets customer and applicable regulatory requirements.? (Refer to sections 1.2 and 4.2.2 of the standard.)

Procedures that are added to your system as a result of ideas taken from the ISO 9004 Standard, or from other systems, or simply because they are an important part of the way you run your business are not subject to the compliance audit for ISO 9001 certification. Only the requirements specified in the ISO 9001 standard are audited, but unless you have been granted an exclusion you must comply with all of these requirements.

Mr. John Orthaber, BS Metallurgical Engineering, MBA

For the last ten years John has worked as independent consultant specializing in quality systems and product costing. He owns Success Resources and the subsidiary The 9000 Advisers, which specializes in assisting companies implement ISO 9001 Quality Management Systems.

Implementing ISO 9000

You may be in a position where your customers are demanding you implement an ISO 9000 quality system or you would like to do it for the benefits it can provide your organization. You may not have the resources to hire a consultant to help you. Can you achieve this task on your own, without the help of a consultant? Yes. You do not need a consultant to implement an ISO 9000 quality management system. You can do it with the resources you have.

Will a consultant provide you a better quality system than you can implement yourself? No. I say that not as a disrespect to consultants but because quality systems are ever evolving and developing. It's not where you start that is important it's where you end up in a year or two down the road. A consultant can expedite the process and save you a great deal of time. What takes you a day to do and figure out, a consultant can do in an hour or two. Based on this, why would anybody hire a consultant? The same reason some people hire someone to mow their yard and do their landscaping, that time is more valuable to be spent somewhere else.

You may be a position where ISO 9000 implementation is required but the necessary resources are not available to hire a consultant, what do you do? The first thing is to gain information. You need to become educated in the ISO 9000 standards and what they mean and their intent. Whether you hire a consultant or are choosing to implement a quality system on your own you need to purchase the following list of standards:

ISO 9000:2005 Quality management systems - Fundamentals and vocabulary

ISO 9001:2000 Quality management systems - Requirements

ISO 9004:2000 Quality management systems - Guidelines for performance improvements

ISO 19011:2002 Guidelines for quality and/or environmental management systems auditing

ISO 10014:2006 Quality management - Guidelines for realizing financial and economic benefits

You can obtain these standards from the International Organization of Standardization (ISO), American Society of Quality (ASQ) and the American National Standards Institute (ANSI).

The most important piece of advice I can give you, once you have purchased these standards, READ THEM. Find yourself a quiet place and read them. Read them several times. The reading is dull and the wording is somewhat confusing, it's alright, read them. These are international standards, not a John Grisham novel. You are not going to be riveted to the reading and hardly waiting to get back to it. You may find yourself more confused after reading them, that is fine, keep reading. After a several readings, it will begin to make sense to you. You will gain a new understanding of what the standards are saying and begin to realize what needs to be done and how to do it.

At this point, you understand the standard and what needs to be done. If you ever question anything or are not quite sure, refer to the standard. Go back and read it again. The first thing you need to do is provide an overview for your top management. If cost constraints prevent you from hiring someone to train top management, then provide the training yourself. Chances are, your top management knows significantly less about ISO 9000 than you do. That makes you an expert and should you travel greater than 50 miles, you can begin to charge consultant fees.

Your training to top management should answer the following questions, what is ISO?, what is it going to do for us? why are we implementing it? how much is this going to cost us and how long will it take? how are we going to do it? what role does top management have?

What is ISO? ISO 9000 is an internationally recognized quality management systems standard. It's premise is based on knowing customer requirements and continually enhancing customer satisfaction. This is achieved by developing key business processes, monitoring them with metrics against objectives to ensure effectiveness and putting forth effort to continually improve those processes.

What is it going to do for us? The adoption of an ISO 9000 quality system allows us to consistently provides products and services to our customers that meet there expectations and continually enhance their satisfaction. Why are we implementing ISO 9000? Chances are it's one of two reasons, one is your customers are requesting it or two you are interested in achieving the results in can provide. How much will it cost and how long will it take? If you complete it internally you can plan on it taking about a year (depending on your size and available resources) and it won't cost you anything other than what you are currently paying people. You should plan on spending about $1,100 - $1,300 dollars for one person to go to internal auditor training. That person can then train the rest of your designated internal auditors.

The registration audit will be $5,000 - $6,000 and the surveillance audits run $3,000 per year. Approximately, it amounts to a one time cost of $9,000 and annual cost of $3,000. How are we going to do it? We will perform a gap analysis to determine our deficiencies and develop an implementation team from that. We will track the progress of implementation. What role does top management have in ISO 9000? Top management has the biggest role. That group is responsible for the planning, development, maintenance and improvement of the system. Top management is expected to be actively involved in reviewing the designated process metric data and making decisions based on that data.

After you train top management, you must assess where you are now. There are most likely processes in place that are being done even without documentation. Write down all of your key business processes, accounting, purchasing, human resources, customer service, etc. After you get them written down, now you need to flowchart them out to document how they work. A simple downward flowing flowchart in one column with responsibility in another column and the last column has records.

Once you get them documented, now go through the standard and write down any process, clause or section of the standard that your current process does not address. These are the gaps in your system. They are the areas the standard states needs to be addressed that you are not. Once you have this, put it into a document where you can track the action against who is responsible and time line agreed to. Similar to this:

Action Responsible Date Develop internal audit process Joe F. 11-14-06 Train internal auditors Tom C 12-18-06

After you have transferred the actions needed into the above format, you have developed your implementation plan. Ensure this plan is reviewed and monitored by top management frequently. They must be kept in the loop. At some point of the implementation you will want to train the entire workforce on ISO 9000. Work out a schedule that is flexible. It does not have to be extremely detailed, but provide a good overview of what ISO 9000 is, why it is being implemented and how it will impact them. Good luck, you can do it.

Robert Badner is a freelance writer for Innovations for Quality, LLC. Innovations for Quality provides live, interactive, online training for ISO 9000 and ASQ Certification. You can visit their websites at http://www.asqcertification.org and http://iso9000training.org

History of ISO 9000

ISO 9000 grew out of BS 5750, a standard published by the British Standards Institution (BSI) in 1979. Initially, it was used only in manufacturing industries. ISO 9000 is now employed across a variety of other types of businesses. It is a set of international standards of quality management systems. ISO 9000 has been accepted by more than 100 countries as their national quality assurance standard by the end of 1997.

The history of ISO 9000 dates back to Mil-Q-9858a, the first quality standard for military procurement established in 1959 by the US. By 1962, NASA (National Aeronautics and Space Administration) developed its quality system requirements for suppliers. In 1965, NATO (North Atlantic Treaty Organization) accepted the AQAP (allied quality assurance procedures) specifications for the procurement of equipments.

During the 1970s, BSI published BS 9000 (the first UK standard for quality assurance) and BS 5179 (guidelines for quality assurance) norms. In 1979, it created BS 5750, a series of standards for use by manufacturing companies. They were enforced through assessments and audits. In 1988, ISO (International Standards Organization) adopted the BS 5750 standard without changes and published it globally under the name ISO 9000. The ISO adopted this standard with a view to create an international definition of the necessary characteristics of a quality system for all businesses, regardless of industry. In 1994, the ISO revised the ISO 9000 standard and published it globally.

In the beginning, ISO 9000 was implemented exclusively by large companies. But by mid-1990s, small and mid-sized companies began to increasingly implement these standards. In the United States, the total number of registrations increased from a little more than 2,200 in 1993 to more than 17,000 in 1998. Of these 17,000 registrations, almost 60 percent were held by businesses with annual sales of $100 million or less.

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ISO 9000 Assessments

Establishing standards is critical to the success of every business. That is why numerous companies go for ISO 9000 certification, which is a series of globally identified standards and rules that define an effective quality system. ISO standards themselves do not perform assessments or audits to ensure that they are applied by companies in conformity with the requirements of the standards.

Many testing laboratories and certification bodies conduct independent assessment services to provide evidence that services, goods, or systems match to ISO standards. The assessment of a quality system against the ISO 9000 standard is variously referred to as certification and registration. The certification corroborates that the system is in conformity with all the standard requirements. Agencies that issue ISO 9000 certificates are called certification bodies or registration bodies or registrars.

The registrars evaluate and validate an organization's management (including quality, environmental, safety) system for conforming to the ISO standards. This verification, confirmation and the concluding validation are commonly known as ISO assessment auditing process. Generally, there are two types of assessment auditing - auditing by an external certification body and auditing by internal employees trained for this process. In the ISO 9000 context, the term accreditation refers to the work of national accreditation bodies. ANAB is a well-known accreditation body in the US, famous for its ethics and integrity.

All ISO 9000 series require measurements and assessments for customer satisfaction and management capabilities. Many private and government organizations carry out reasonably priced conformity assessment services. Most of these organizations have professionals who are experienced in working with very small organizations to multi nationals.

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ISO 9000 Elements

ISO 9000 is a set of standards for quality management systems. Perhaps, it is the most popular generic international standard today. First published in 1987 and modified in 1994, it is the true basis for businesses to develop or improve their quality assurance systems. Today, most international businesses document their quality systems according to the ISO 9001 elements.

There are a total of 20 elements (sections) in the overall ISO 9000 standard. Each section explains what a company has to do in order to show that it is abiding by the ISO 9000 rules. Each of these elements should be clearly and completely documented.

The twenty ISO 9000 elements include management responsibility, quality management system (QMS), contract review, design control, document control, purchasing, purchaser supplied product, process control, inspection and testing, inspection, measuring and test equipment, inspection and test status, control of non-conforming product, corrective action, handling, storage, packaging and delivery, control of quality records, internal quality audits, training, servicing, and statistical techniques and product ID and traceability.

Management responsibility addresses the responsibility of an organization to set up a system that frequently meets consumer requirements and expectations, even in times of managerial change. Quality management system defines general requirements, along with documentation requirements such as quality manual, procedures, work instructions and records.

Design control requires that all phases in the designing of products or services must be managed and conducted by qualified employees. The ISO element document control requires that all documents and data used must be controlled and authorized.

The section of statistical techniques includes data analysis, sampling methods, and SPC (statistical process control). These processes should be based on established procedures and sound statistical techniques.

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ISO 9000 FAQs

ISO 9000 is a set of standards internationally accepted by businesses and consumers. It allows organizations to establish and monitor quality management systems. ISO 9000 standards are considered to be generic standards since they can apply to any business, product or service irrespective of the industry. They have been developed and are maintained by the International Organization for Standardization (ISO).

1. What is the ISO 9000 family?

The ISO 9000 family consists of three quality assurance and quality management standards, namely, ISO 9000: 2000, ISO 9001:2000, and ISO 9004:2000. The ISO 9000:2000 and ISO 9004:2000 present guidelines for performance improvement, while the ISO 9001:2000 presents requirements. These standards are implemented by individual businesses, corporations, and government organizations.

2. What are the benefits of ISO 9000?

Major benefits include increased marketability, reduced operational expenses, better management control, improved internal communication, reduction of product-liability risks, and improved customer service.

3. What are the main phases involved in obtaining ISO 9000 certification?

There are two major phases - documentation and certification. Documentation process is done in-house or by the help of an ISO 9000 consultant. Most businesses seek the services of an experienced consultant to create the quality system. An agency accredited in this regard does the certification. The certification process includes documentation review and compliance audit. Documentation review is done with or without visits to the organization. Compliance audit is generally conducted on the site.

4. Is a consultant must for implementing ISO 9000?

The manuals of standards and certification are written in such a way that most of us can hardly understand what they are saying. Only an experienced consultant can help you understand and effectively administer new and existing quality systems.

5. How much does it cost to become ISO 9000 certified?

Unfortunately, there is no simple answer to this question. The cost depends on a lot of factors such as complexity of operations, number of locations of plants, willingness of owners, and type of standards to be implemented.

6. How long does it take to attain ISO 9000 certification?

Depending upon the commitment of the owner and/or managers, the time taken could be 3 months to a whole year. ISO certification is granted initially for a period of three years.

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ISO 9000 History

ISO 9000 is an important marketing tool and is recognized world wide. Maintained by the ISO (international standards organization), it is a family of ISO standards for quality management systems. ISO 9000 grew out of British standards institution's BS 5750. The ISO 9000 series are managed by several accreditation and certification bodies. Though the standard was first applied to manufacturing industries, it is now employed across a variety of other types of businesses.

Studies show that the history of industrialization has seen lots of standards on quality issues. For instance, during the two world wars, a high percentage of bullets and bombs went off in the factories themselves in the course of manufacturing. In an effort to curb such causalities, UK?s ministry of defense appointed inspectors in the factories to supervise the production process.

In 1959, the United States introduced Mil-Q-9858a, the first quality standard for military procurement. By 1962, NASA developed its quality system requirements for suppliers. Six years later, NATO accepted the AQAP (allied quality assurance procedures) specifications for the procurement of equipments. In 1969, UK and Canada introduced suppliers? quality assurance standards.

During the 1970s, British standards institution (BSI) published BS 9000 (the first UK standard for quality assurance) and BS 5179 (guidelines for quality assurance) norms. During the period, the BSI held meetings with industry to set a common standard. Consequently, in 1979, the institution developed BS 5750, a series of standards for use by manufacturing companies. They were enforced through assessments and audits.

In 1987, the BSI revised the standard to take in service providers and manufacturing industries also. In 1988, ISO adopted the BS 5750 standard without changes and published it globally under the name, ISO 9000.

In 1994, ISO revised the standard. In December 2000, the standard was again reorganized. The new ISO 9000 standard has many resemblances to its predecessors.

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ISO 9000 Implementation

Businesses face lots of challenges in the international market. Implementing an ISO 9000 initiative is an action-oriented program that refers to obtaining ISO 9000 registration and working with its standards. The ISO certification process starts with pre-assessment audits and passes through on-going maintenance. The process of implementing ISO 9000 includes identifying, collecting and organizing the information required for certification.

ISO 9000 is a generic standard. It can be applied to any organization that intends to set up a quality management system, whether the organization is small or large, for-profit or governmental, whatever the service or product. The certification is now implemented by thousands of companies around the world. Many countries have taken it as their national standard.

Application of ISO standards generally refers to the process of implementing the collective intent of ISO 9000 family. The family includes four standards on quality management and quality assurance, namely, ISO 9000: 2000 (presenting fundamentals and vocabulary), ISO 9001: 2000 (presenting quality requirements), ISO 9004: 2000 (providing guidelines for performance improvement), and ISO 19011 (which is the auditing quality and environmental management systems).

Implementing quality management and quality assurance, as well as using the principles and guidelines contained in this family help the organization ensure complete customer satisfaction. ISO 9000 implementation also helps organizations design and manage their processes effectively to attain corporate aims, choose the right things to perform based on an objective analysis of the environment, and create an environment in which people will be motivated.

Many ISO services offer ISO implementation assistance for organizations. Their service includes professional implementation or upgrading of the appropriate standard in the organization through consulting (i.e., planning, procedures developing, system audits, etc), training, continuous improvement support, and risk analysis programs. The training programs instruct project managers how to implement ISO 9000 in their organization. ISO 9000 self implementation manual kits are also available in the market.

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ISO 9000 Procedures

The basic ISO 9000 procedures include document control procedure, records procedure, internal audit procedure, control of non-conformance procedure, corrective action procedure, and preventive action procedure. Documentation is a basis upon which an ISO-compliant quality system is constructed. An unauthorized change in any information makes problems. Your mandatory document control procedure must define how you approve documents, update and re-approve amended documents, prevent the inadvertent use of obsolete documents, and ensure that documents are available where they are needed.

A mandatory records procedure is needed to specify which records are kept, by whom, for how long and how they are disposed of. These records include the records of sales activities, internal audit results and follow-up actions, results of corrective action, records of design and development reviews and any related actions, records to demonstrate the validation of special processes, and records of the product nonconformities and any subsequent actions.

An internal audit procedure requires resources such as criteria, scope, program frequency, method, report results, and keep records. The non-conformance procedure has to address how you deal any problems.

In a corrective action procedure, you should see how you decide the cause of the problem, review non-conformance and customer complaints, and decide an appropriate course of action to stop the recurring problem. With preventive action procedure, you take steps that should see how you decide the potential cause of the problem, review potential problems, and decide an appropriate course of action to stop the problem occurring.

The process of achieving ISO 9000 certification can be intimidating because it requires several procedures to follow. The instructions regarding standards and certification are written in such a way that most of us can hardly recognize what they are saying. Luckily, there are several specialists available to assist in the process.

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ISO 9000 Production

Many industries and governments depend on ISO 9000 production standards these days. ISO 9000 production standards guarantee that all products are of a consistently high quality.

Although the ISO production standards are still voluntary, lots of companies are using them as a standard when targeting foreign markets which require environmentally-safe products. The ISO 9000 production departments assure the quality of all equipment shipped.

ISO 9000 production standards basically have three requirements. First, the business should document the quality system and business process in detail. Second, the business should make sure that each employee understands and follows the guidelines stated by the documentation. Third, the documented quality system should be continuously monitored through internal and external audits, and updated when required.

ISO 9001 ensures quality assurance in design, production, installation and servicing for manufacturing businesses that design and make their own products. ISO 9002 is employed in contractual arrangements when specified needs are declared in terms of established design or specifications. ISO 9003 needs a dealer to demonstrate its capability to detect and control the disposition of any product nonconformity during final check and testing. ISO 9004 sets a standard for an organization's internal quality management.

ISO 9000 production standards consist of a total of 20 elements (sections) that explain what a company has to do in order to show that it is abiding by ISO 9000 rules. Each element should be clearly and completely documented.

Many company owners find that ISO 9000 production is an invaluable marketing tool to alleviate the problems of TQM (total quality management). But a very few also see it as an unnecessary bureaucratic boondoggle.

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ISO 9000 Quality Assurance

ISO 9000 is a set of standards developed by the ISO (international organization for standardization) for quality assurance systems. It was first published in 1987 and the standards were modified in 1994. ISO 9000 serves as a true base for organizations to improve their quality assurance systems.

A quality assurance system involves the organizational structure, duties, procedures, processes, and materials for applying quality management. It is designed to help businesses assure their services and products, and please customer hopes by meeting their specifications. Quality assurance covers all activities of a product?s life cycle, including planning, controlling, measuring, testing and reporting, and improving quality levels.

ISO 9000 quality assurance models view an enterprise as a network of interconnected processes. For a quality system to be ISO-compliant, the processes should address areas known in the standard and should be documented and practiced as described. Documenting a process gives an organization the opportunity to understand, control, and improve its process network.

ISO quality assurance is a management activity that contains auditing and reporting actions. These two functions assist the manager to verify the efficiency of the quality system. ISO 9000 expresses quality assurance resources in general terms that can be used by any organization irrespective of the products or services provided. However, ISO 9000 does not explain how a business should apply these quality system elements.

Most companies first attempt to get certified to one of the quality assurance system models in the ISO 9000 series. For this, the company?s quality system and actions are audited by third party auditors for conformity to the standard and for effective operation. Upon successful certification, the company obtains a certificate from a certification body represented by the auditors.

ISO 9000 provides detailed information on ISO 9000, ISO 9000 Standards, ISO 9000 Software, ISO 9000 Consulting and more. ISO 9000 is affiliated with Home Inspections.

ISO 9000 Services

Designing a quality management system that fulfills the requirements of ISO 9000 is not a difficult task. Many ISO 9000 services help businesses build up systems that obey the requirements of the ISO 9000 series of international standards.

ISO 9000 is a complete quality control system recognized and respected throughout the world. It applies to all types of businesses irrespective of their size and final outcome. ISO 9000 now includes three quality standards, namely, ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000. The first one introduces requirements and other two present guidelines.

These services assist business organizations to attain ISO 9000 knowledge, implement the standard, and prepare for registration with the least time, in the most convenient way, and cost-effectively too. Both product and service oriented businesses seek the assistance of ISO 9000 services to improve their productivity and customer happiness through reduced waste and rework, shortened cycle times, superior supplier relations, and improved problem tracking. Most ISO 9000 services are customized to your organization?s particular needs.

Their auditor team of these ISO 9000 services consists of experienced professionals who are qualified to evaluate companies pursuing all variations of certification under the ISO 9000 standard. The audits done by such professionals provide public recognition that your business is dedicated to producing quality products or services, and giving prompt delivery.

With many years of experience, ISO 9000 services can prepare your organization to implement standards and avoid unforeseen casualties. They offer assistance through unique services, tools, and workshops and training events such as facilitator training, internal audit training, and documentation training.

Many ISO 9000 services also offer project planning with senior management, compliance reviews and gap analyses, quality manual/procedure review, writing and organizing procedures and other documentation, assistance with supplier development, and liaison with third-party assessors.

ISO 9000 provides detailed information on ISO 9000, ISO 9000 Standards, ISO 9000 Software, ISO 9000 Consulting and more. ISO 9000 is affiliated with Home Inspections.

ISO 9000 Training

ISO 9000 training is the process of training individuals for the purpose of attaining ISO certification. ISO 9000 is a set of standards implemented by organizations for quality management systems that control the fabrication of a product or service. Perhaps today?s most popular generic international standard, it guarantees first-rate quality at all stages of design, development, manufacturing and delivery.

ISO 9000 training enables an individual to understand various quality standards as well as how they are basically planned. That is, it provides a clears idea about the interrelationship of ISO 9000, ISO 9001 and ISO 9004. The training program is also good for understanding ISO requirements and various ISO clauses. Most ISO 9000 training courses also include introduction to the ISO 9000 quality management system (QMS), process documentation, implementing an efficient QMS, and process auditing.

Process documentation workshops help you learn how to document your management system. This includes detailed methods for developing, documenting and implementing your business and quality processes. These programs also help you gain practical experience.

Before receiving ISO 9000 certification, businesses conduct an audit of documents and methods. An auditor training course help you train your own auditors to conduct process audits. These courses explain how to carry out a process audit and how to audit documented and undocumented processes.

Stat-A-Matrix in New Jersey, Management Systems International in California, and ISO 9000 Network in Massachusetts are some of the leading companies offering ISO 9000 training and consulting. They provide on-site seminars and help organizations achieve ISO 9000 registration. Their training covers the most up-to-date information, process mapping, and project management. Their classes are developed and delivered by ISO 9000 experts.

ISO 9000 provides detailed information on ISO 9000, ISO 9000 Standards, ISO 9000 Software, ISO 9000 Consulting and more. ISO 9000 is affiliated with Home Inspections.

ISO 9000 Vicarious Liability

ISO 9000 is an enormously successful international quality management system set by the international standards organization. Apart from helping in designing a quality assurance system, ISO 9000 also imposes many liabilities and responsibilities on the part of business organizations.

ISO certification can guard organizations against corporate vicarious liability. Vicarious liability refers to the legal responsibility (accountability) of an employer for the actions, crime or injury done by one of his employees in the course of discharging duties. Crimes that come under the purview of vicarious liability include fraud and theft, defamation, breach of confidence and data protection, and discrimination based on race and gender.

ISO 9000 vicarious liability processes help firms reduce risks. The extent of liability depends upon the relation between the nature of the employment and the crime that has been committed. When the two are connected closely enough, the employer can be held liable.

Common forms of vicarious liabilities include employers' vicarious liability, principals' vicarious liability, and the liability of corporations in tort. Consider, for example, principals? liability. In this case, the owner of a car is vicariously liable for the rash and negligent driving of the driver. The owner is the principal and the driver is his employee. Laws have been reluctant to extend this liability to the owners of some other kinds of chattel. For instance, the owner of an airplane is not vicariously liable for a pilot?s misdeeds.

A business can operate only through the actions and deeds of its employees and agents. Therefore, it is important to decide to what extend vicarious liability will apply to hold a business liable for the frauds of its directors or other officers. ISO 9000 certification provides a clear description of such situations.

ISO 9000 provides detailed information on ISO 9000, ISO 9000 Standards, ISO 9000 Software, ISO 9000 Consulting and more. ISO 9000 is affiliated with Home Inspections.

What is ISO 9000

ISO 9000 is a set of international standards that ensure product and service quality. In 1987, International Organization for Standardization (ISO) created the ISO 9000 standards providing guidelines to implement and operate quality management systems.

The ISO revised the standards in 1994, and again reorganized the standards and published an updated version in December 2000. The revised version includes three quality standards, namely, ISO 9000:2000, ISO 9001:2000, and ISO 9004:2000. The first one presents requirements, while the last two present guidelines.

ISO 9000 standards help businesses create in-house quality systems and monitor their existing quality systems. To develop quality systems, businesses should first identify areas in which quality control is required. Next step is to recognize what changes are to be made. After that, they should implement the standards by updating and managing their new quality processes.

ISO 9000 certification provides several benefits that can influence almost all activities of a company. The advantages range from increased stature to bottom-line operational saving. Of the numerous benefits include increased marketability, reduced operational expenses, better management control, improved internal communication, reduction of product-liability risks, and improved customer service.

For quality management, ISO 9000 standards require a total of twenty elements (sections.) They include management responsibility, quality management system, order entry, design control, document and data control, purchasing, control of customer supplied products, product identification and tractability, and process control.

ISO 9000 standards are generic as they can apply to any business, service or product, regardless of the industry. Businesses that employ these standards include manufacturing, processing, servicing, printing, forestry, electronics, steel, computing, legal services, financial services, accounting, trucking, and banking.

ISO 9000 is of great importance owing to its worldwide orientation. It has become the logical selection of all organizations that do business internationally, and for customers who want an international standard of quality. At present, national standards bodies from more than 120 nations support ISO 9000 quality standards.

ISO 9000 provides detailed information on ISO 9000, ISO 9000 Standards, ISO 9000 Software, ISO 9000 Consulting and more. ISO 9000 is affiliated with Home Inspections.

ISO 9001: A Brief Explanation on ISO 9001 Quality Procedure

When our company intend to implement Quality Management System (ISO 9001:2000), we should prepare quality management system documentation that includes documented statement of quality policy and quality objectives, a quality manual, quality procedures and workplace references or work instructions to ensure the effective planning, operation, and control of company processes.

In regard with quality procedure, it should be established, documented, implemented and maintained. The documented ISO 9001:2000 procedure may be different from one company to another because of the size of company and type of activities, the complexity of processes and their interactions and the competence of their personnel.

In practice, format of ISO 9001:2000 quality procedures may also differ from one company to another. For a company that is trying to make their own ISO 9001: 2000 quality procedures for the first time, using ISO 9001:2000 procedure examples can be very helpful. It does not mean duplicating the ISO 9001:2000 procedure example for the company own use.

An ISO 9001:2000 quality procedure may consist of cover sheet, flow diagram, and procedure in detail. The cover sheet contains Company name, title of ISO 9001:2000 procedure, sheet number, document number and revision record (revision number, description of revision, date of revision and signature of the person in charge.

The flow diagram explains step by step from the beginning how the ISO 9001:2000 procedure flows. And the procedure its self should at least have an objective, scope, general explanation, definitions used in the procedure, content of the procedure, records used, related documents and important attachments. The contents of ISO 9001:2000 procedure is a text description of the work flow or instructions based on its flow diagram. The description is started with the persons in charge and followed by explanation of their tasks or jobs as specified in the flow diagram.

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