ISO 9000 

ISO 9000 certification is a growing trend as customers require it.  Companies also are beginning to realize that the process it represents is an excellent way to assure their products will be of high quality and that their customers will be satisfied.  Limited resources prevent many small businesses from establishing a quality system.  Part of the problem is not knowing what is really required.  Quality Systems Innovations, Inc. can help.  We offer a full range of consulting services and specialize in helping you to install the right quality system for your business.  Indeed, we are prepared to help you implement your quality system in manageable steps as your needs and budget may dictate.

 

ISO 9000 for Small Businesses

It is not necessary for you to install a cumbersome quality system in your company.  Implementation of a quality system which was designed for larger organizations, is a common mistake that paralyzes many small businesses.  Our documented quality systems free you from the layers of unnecessary personnel and paperwork frequently associated with larger quality systems and are designed for self implementation.

We will tailor an ISO 9001:2000 compliant quality system to your business' needs.  Your unique quality system will be provided quickly and at a reasonable price. You receive only what you need, and you can install the system at your convenience.  Full implementation will help you meet ISO 9001:2000 requirements, whether or not you choose to register.

How do we do it?

We have developed a quality system which is easily customized for small businesses in a broad range of industries.  We have eliminated the bureaucratic approach commonly found in many large companies.

We save you time and money in developing your quality system with focused questionnaires, mail, and e-mail instead of on-site visits.  Of course, we are available to respond to your questions by phone and e-mail.  We will provide on-site visits if required, but find that they are not necessary in most cases.

 

Our ISO 9001:2000 quality system is sensible and flexible, and is an excellent fit in today's continuously changing business environment. The quality system is designed around your needs - not the other way around!

Let our experience help you!

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If you prefer to document an ISO 9001:2000 quality system yourself, you may purchase our  "Customize It Yourself" Quality Manual starting at $249.  This manual was designed for small businesses, and will save you months of documentation time,  significantly reducing your costs.

ISO 9001 Quality Manual Table of Contents


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Developing New Products?

 Quality Systems Innovations Inc. offers a New Product Development and Introduction Manual to help you to succeed with your new products while complying with ISO 9000 requirements.  You will save time and money in the process by developing the right product in the minimum time while maintaining control of your costs.  As always with QSI's products, the manual is tailored to your needs, and we guide you every step of the way.

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What is ISO 9000?

In 1987, the Geneva-based International Organization for Standardization (ISO) published the ISO 9000 series international standards to serve as the basis for a quality management system.  It is the descendant of British standard BS-5750.  The American equivalent is Q9000.  Since the original release, the standards have been revised in 1994 and in 2000.

Registration is granted by accredited organizations called registrars, who review the company’s quality manual and procedures to ensure that they meet the requirements of the applicable standard, and audit the processes to ensure that the documented system is implemented and effective.  Once registration is granted, the registrar conducts surveillance audits once to twice per year to ensure that the system continues to be implemented and meets the requirements of the applicable standard.

ISO 9000, which couples a total quality management approach with documentation methodology to create an internal auditing system, is also the first-ever attempt to create an international quality assurance standard to cover all industries and the service sector.

The so-called ISO 9000 standard is actually comprised of a series of standards. 

The three new standards that were released on December 15, 2000 are:

ISO 9000:2000 Quality Management Systems — Fundamentals and Vocabulary

ISO 9001:2000 Quality Management Systems — Requirements

ISO 9004:2000 Quality Management Systems — Guidance for Performance Improvement

ISO 9000:2000 describes underlying concepts and approaches for the new ISO 9000:2000 family, and provides definitions for the vocabulary.  ISO 9000 is not a specification, however, it is named in ISO 9001 as a normative reference and thus can be used by auditors to support their interpretation of ISO 9001 requirements — in particular in reference to the vocabulary.

ISO 9001:2000 is the actual requirements for the quality management system.  Its requirements define the criteria for the quality system.  The role of this standard in the series has not changed, but its content and organization are completely revised.

ISO 9004:2000 describes a quality system that goes beyond the basic requirements specified in ISO 9001.  It is intended as a guide for organizations that want to further expand and improve the quality system after implementing ISO 9001 (i.e., in the post-certification phases).  ISO 9004 is not a requirement and should not b e used by third-party auditors for registration audits. 

What is an ISO 9001 Compliant Quality System?

An ISO 9001 compliant quality system satisfies the requirements of the ISO 9001 standard but has not been formally assessed and registered by a third party registrar. This means that you could enjoy the benefits of an ISO 9001 Compliant Quality System without going through the expense normally associated with registration. You would be in a position to register at anytime should the need arise.


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