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.

ISO 9001 Software

Companies that need quality management systems realize that products like ISO 9001 software are important tools to insure their product safety, consistency and profitability. Using ISO 9001 software can help guarantee that any company can monitor productivity, customer satisfaction and product quality with reports that contain solid information. This information is now vital to management in order for maximum efficiency in any industry. This is why ISO 9001 software is vital to any sized company. Continuous improvement means continuous profitability. Here are just a few reasons why:

o Companies increase sales because of better performance, quality, and delivery. This propels you ahead of your competition.

o ISO 9001 software helps retain employees and attract more highly qualified employees because they are assured of a controlled and consistent work environment.

o The experience of a more professional workplace boosts employee morale.

o Reduced operating costs dramatically increase your company's productivity, leading to higher profitability.

o Customer satisfaction and higher profitability expand your market share and demand for your consistently higher product quality.

o When you're compliant or certified to the appropriate standard, the businesses that work with you know that quality objectives, continuous improvement, and customer satisfaction are your goals. Many companies require that their suppliers are ISO 9001 compliant; therefore, once you're certified, your opportunities increase.

ISO 9001 software has be utilized and has developed experience of helping manufacturing, service, and distribution organizations to be more efficient and more profitable through continuous improvement programs. We help you to implement the time-tested methods of continuous improvement to measure performance, analyze data, and apply the appropriate process changes. This includes using ISO 9001 software.

ISO 9001 software also offers a suite of modules to enable you to manage the document management and ISO 9001 Compliance Management process. These modules enable complete transparent system measurement with targeted action items ensuring all persons are notified of tasks and carry them out in a prompt and efficient manner.

ISO 9001 software provides training in there software and also bring extensive experience in implementing the ISO 9001 software in various environments.

Training Options There are also three other ways ISO delivers training to help companies comply with industry standards:

1. Full training program help for administrators of our ISO 9001 software program at your location this training includes full orientation to our document management, corrective action calibration records , training records and numerous other features of our software 2. General users training to assist users in the company in utilizing the ISO 9001 software system in there day to day environment for document management and responding to action items. 3. Upgrade training program help for companies who experience personnel turnover to bring the new person up to speed on the ISO 9001 software system. 4. Overview seminars providing orientation sessions for those new employees or those new to the software

The ISO 9001 software comes from extensive experience introducing effective and affordable quality management systems to a wide variety of industries and service organizations. Numerous companies who have worked with us reap the benefits of increased profitability, enhanced customer relations, elevated employee morale, and increased sales. Clients enjoy our flexibility in organizing the process around their needs and their schedules. We have a proven track record of success and customer satisfaction.

Learn More at: www.interaxgrp.com

Becky King is a well respected software reviewer who lives in California with her family and two dogs.

Photography A - Z the Easy Way: I - ISO Setting

Do you know what ISO is? Perhaps not. And, in fact, you don’t need to know what it is – just how to use it. In very simple terms, the ISO setting is a measure of how sensitive your camera sensor is to light. A low ISO (e.g. 100) will not be very sensitive to light whereas a high setting (e.g. 1600) will be very sensitive.

How does this affect you?

It’s simple, and don’t let others tell you otherwise. If you have plenty of light around – say on a sunny day or if it is bright but overcast, use ISO setting 100 or 200. In fact, keep it at that setting for most of your shots. Then just take your pictures as normal.

If however, you are in low light levels, you may wish to use flash (keep the same ISO setting) OR use a higher ISO without flash.

Here is an example of practical use:

You want to take a picture of your friend. Normally, on a normal bright day, you would use programme mode or a semi-automatic mode which will select an aperture of 5.6 and shutter speed of 1/250. No problem.

But if the light is fading and you don’t want to use flash, then the shutter speed for the same aperture might reduce to 1/30 or 1/15. At slow speeds like this you will find your shots are not as sharp due to camera shake. Here, you can switch to a higher ISO setting – for every doubling of the ISO you can halve the shutter speed. Therefore you will be able to use a faster shutter speed in low light conditions with a higher ISO.

That’s it really.

There are two drawbacks. First, you will get a “noisier” image at a higher ISO setting (more grainy – but this can often create a nice effect) and secondly you must remember to switch back to your usual ISO after the shots have been taken (so that your usual images have the optimum ISO setting).

Eric Hartwell runs the photography resource site http://www.theshutter.co.uk and the associated discussion forums as well as the regular weblog at http://thephotographysite.blogspot.com.

ISO 9001, What Next?

The overriding goal of ISO-14000. (History 1995)

As ISO-9000 becomes a way of life for the global business community, ISO-14000 is almost ready to debut with its own set of standards for voluntary environmental compliance.

Much has been heard recently about the antiregulation sentiment sweeping across the country. Lawmakers in Washington have responded with talk of "regulatory reform" and programs aimed at "re-inventing government."

One of the targets of this regulatory backlash has been the ever-burgeoning flood of environmental laws and regulations continuing to impose burdens on corporate America. A common thread running throughout this rhetoric has been a perception that government is too big and that corporate self-policing and self-management can achieve far greater benefits at far less cost.

It is unlikely that meaningful relief from environmental regulations will come any time soon. However, a major step in the direction of voluntary corporate initiatives in this area is on the horizon.

Getting Ready for 14000

The Geneva-based International Standards Organization, with the assistance of representatives from over 40 countries, is in the final stages of developing ISO-14000, a set of voluntary international environmental quality standards designed to promote sound corporate management of environmental compliance matters.

When fully adopted in early 1996, the standards will allow companies to obtain ISO-14000 certification of their operations in recognition of the development of these comprehensive environmental quality standards.

ISO-14000 is the second major undertaking of the International Standards Organization in developing international quality management systems for business enterprises. In the mid-1980s the Organization adopted its ISO-9000 series of standards for corporate quality management. The ISO-9000 program provided a formal mechanism for certifying that a company had developed and integrated certain quality management principles into its business operations.

While initially slow to gain acceptance in the business community, ISO-9000 certification is fast becoming a necessary part of standard business practices, both in the US and abroad. It is estimated that by 1996, 12,000 US companies will be ISO-9000-certified, up from only 100 in 1990. Internationally, more than 50,000 companies have received ISO-9000 certification.

The idea behind extending the ISO quality management principles into the environmental arena arose out of the historic United Nations Conference on Environment and Development held in Rio de Janeiro in 1992.

Joe Cascio, IBM program director/environmental, health and safety standardization, and chairman of one of the ISO technical advisor groups, reports that the Rio conference discussions produced "a proliferation of national and regional environmental management, labeling and audit schemes that could have impacted international trade in a very severe way." The need to bring some standardization to these conflicting programs ultimately provided the impetus for the formation of ISO-14000.

What IS0-14000 is - and isn't - About

What, then, is ISO-14000 all about? The overriding goal of ISO-14000 is to develop a comprehensive system of universally accepted corporate standards to ensure that companies will be in a position to successfully manage their environmental compliance matters.

ISO-14000 is not about developing regulations to attain certain pollution standards. Instead, the focus is on the management of environmental issues or the development of internal corporate management programs ultimately leading to responsible and verifiable operating strategies that will result in the efficient use of natural resources and the protection of the environment.

ISO-14000 calls for the development of corporate Environmental Management Systems (EMSs) to guide not only the environmental performance of a company's industrial operations but also the potential environmental impact of the goods or services produced.

As envisioned by ISO-14000, an effective corporate EMS requires that a company review the environmental issues and challenges confronting the organization and ultimately develop policies, objectives, target strategies and production processes to meet and properly manage these challenges.

ISO-14000 spells out in detail the guiding principles for the development of effective EMS programs:

First and foremost, ISO-14000 acknowledges that environmental management must be among the highest corporate priorities. ISO-14000 also acknowledges that a company and its highest levels of management must demonstrate their commitment to the EMS process.

Additionally, for effective implementation of EMS programs, ISO-14000 recognizes the importance of adequate resources, including proper employee training, to the success of any EMS.

Finally, ISO-14000 recognizes that standardized and comprehensive procedures must be in place in order to correctly assess the effectiveness of these EMS programs and ensure the accountability of responsible corporate managers for the success or failure of these endeavors.

Moving beyond philosophical principles, ISO-14000 also details the critical elements of an effective EMS. It requires companies to perform an "Initial Environmental Review" of their operations. This review will include an identification of all regulatory obligations and potentially significant environmental impacts of a company's operations. This initial review must also include an honest assessment of the company's compliance status and the extent to which the company is meeting its regulatory obligations.

Once this review is completed and a company understands the status of its environmental compliance efforts, it can then move on to the EMS planning process. ISO-14000 states as one of its guiding principles that "an organization should focus on what needs to be done - it should have a purpose and a plan."

For the implementation of an EMS, the purpose and plan includes the development of overriding environmental policies, the establishment of environmental objectives and targets to meet these policy goals, and the preparation of a strategic plan and management program aimed at implementing these identified policies and objectives through scheduled action items.

The remaining critical component of an effective EMS, as recognized in ISO-14000, is the development of procedures to measure and monitor a company's success in carrying out its EMS and achieving its environmental policy and performance goals.

Critical components of ISO-14000 are the development of standardized performance evaluation and auditing procedures. Once completed, these procedures will be used as benchmarks to assess the true effectiveness of any EMS.

The EMS program outlined in ISO-14000 is by no means revolutionary. In fact, critics of ISO-14000 argue the program is nothing more than a paperwork exercise with few benefits and many burdens. Proponents offer that evaluating existing compliance, documenting findings and actively attempting to manage the environmental impact of one's operation is a challenge for even the most e nvironmentally responsible of corporate citizens.

The corresponding benefits to be gained from this process, say these proponents, include the fostering of good public relations and community and consumer support, the simplification of the compliance challenge through an understandable and orderly EMS implementation process, and the opportunity for cost savings and increased profits resulting from proactive management of environmental liabilities and the thoughtful development of pollution prevention and resource conservation strategies.

What Will the Impact Be?

At this early stage in the ISO-14000 development process, it is hard to predict the exact impact these new standards will have on the industrial community, including the converting industry. Many observers are predicting the impact to be significant and pervasive. In part, this view is bolstered by the dramatic integration of the ISO-9000 standards into the industrial community.

It is expected that companies with substantial international operations will be obligated to pursue ISO-14000 certification as this program continues to gain momentum abroad.

For US operations the impact is a little less certain. The Environmental Protection Agency (EPA) has adopted a "wait and see" attitude on ISO-14000. To date, the Agency has resisted programs that have strayed too far from traditional "command and control" regulatory schemes. Recently, though, with its Common Sense Initiatives and Environmental Leadership Program, EPA appears to be moving in the direction of affirming, if not promoting, ISO-14000-styled programs.

In order for ISO-14000 to truly catch on in the US, however, EPA must move beyond merely a tacit recognition of the program and provide tangible benefits to the regulated community for achieving ISO-14000 recognition.

Driso provide ISO 9001 2000 consultancy, auditing, software, and training Services. They also supply Easy ISO 9001 2000® software for initially setting up an ISO 9001 2000 compliant Quality Management System or improving upon an existing one.

To contact Driso Consultancy Services visit the web site below and see what they can do for you and your business. Contact: http://www.driso.co.uk for more details.

Steps to Build ISO 9001 Compliant Program

Implementing an ISO 9001 system represents a major effort. However, all of that effort can represent a significant shift for a business - from quantity to quality. And this could make sure your business gets the desired results.

Shift Policy and Procedures Focus to Performance

Developing, implementing and maintaining your ISO 9001 program can be crucial to the core issues of a business. The focus is designed to help:

• Satisfy customer requirements for compliance

• Increase profits with more contracts

• Save money through efficiency

But to do this you need to put a framework in place that spotlights performance and performance improvement.

Get Management System Support

To effectively build a program and meet the requirements, your organization should carry out a strong process:

• Management Decision and Commitment

• Adequate Training and Evaluation

• Compliance with Appropriate Standards

• Audit and Registration

Once you’ve identified your company’s need for compliance, it is essential for top management to get on board. Management can ensure that quality is documented, demonstrable, effective and maintained.

Quality Systems and Procedures

The appropriate personnel should then review the standards for their industry and work to meet those requirements with organized documentation. Personnel can then develop, implement and maintain a set of quality systems and procedures to satisfy the ISO 9001 requirements.

Operations Training and Well-defined Processes

To build a program and meet the requirements, your organization should begin with effective training for how to create well-defined processes. You will first want to learn how to identify the objectives necessary to deliver top results. And then you will be ready to put those processes to work.

Internal Auditor Training

After you’ve implemented the ISO program, you should monitor and measure the processes against your own objectives. You can build an effective management system that objectively shows what you’re doing right and wrong. To learn how, you can take advantage of an Internal Auditor skills class and learn how to bridge the gap and move toward continual performance improvement.

Improve Business Process Performance

With ISO 9001 compliance you can improve the overall process performance of your business. And this can save money while satisfying your customers and increasing profit.

Chris Anderson is currently the managing director of Bizmanualz, Inc. and co-author of policies and procedures manuals, producing the layout, process design and implementation to increase performance. To learn how to increase your business performance, visit: Bizmanualz, Inc.