ISO 9000

What is ISO 9000?

The objective of ISO is to standardize certain things about the world to make life easier for everyone. Standards allow us to communicate about the world. For example, take the statement “It’s 18 centimeters long.” This expressive, meaningful statement presupposes a standard, namely, a clearly quantified linear unit of measurement known as a centimeter. If there were no clear standard for what a centimeter is, this common expressive statement would be useless. If one person thinks of a centimeter as being the width of a coffee table, while another thinks of it as the width of a human hair, these two people would have difficulty understanding each other when discourse involves “centimeters.” ISO makes sure we’re all on the same page when qualify and quantify the material world.

But ISO standards go beyond the standardization of measurements, quantities and units. ISO standards provide consistency in the use of terminology, processing parameters, classifications of materials, and so on. For example, ISO standards tell us precisely what nickel is, and what zinc is, and what copper is, and what constitutes various alloys of these metals. ISO standards establish parameters for acceptability of boiler welds, gear ratios, etc. ISO standards apply to software development and engineering, nuclear processing, cinematography, fire safety, vacuum technology, and the list goes on.

ISO 9000 is that series of ISO documents that is concerned with quality assurance, specifically, the management of quality assurance. Three documents sharing the same root surname (“9000”) comprise the nuclear family of ISO 9000: ISO 9000, ISO 9001, and ISO 9004.

ISO 9000 itself is a guidance document. As a guidance document, it contains no requirements against which organizations can be audited. Instead, it lays out the fundamentals of systemic quality assurance management and provides vocabulary definitions for terms that are used within the other documents in the family.
ISO 9004 is also a guidance document. It provides tips and hints regarding improvement of quality management systems beyond the very basic requirements of ISO 9001.
ISO 9001 is a generic, general standard for quality assurance. It is applicable to any organization that satisfies customers for a living. To assure the quality of products supplied to customers, ISO 9001 requires organizations to control and improve organizational processes that affect the conformity of product to requirements, or, “realization processes”. The standard also requires control and improvement of support processes—some of which are required to be controlled via a documented procedure.

Unlike ISO 9000 and 9004, ISO 9001 is an actual standard and not a guidance document. ISO 9001 contains requirements against which organizations can be audited. Whereas ISO 9000 and 9004 use the word “should” to indicate best practices, ISO 9001 uses the word “shall”—meaning that if an organization’s quality management system is to achieve registration to ISO 9001, they must comply with the “shalls.”

A cousin to the ISO 9000 family is ISO 19011, which is a guidance document specifying best practices for assessing quality management systems against the requirements of ISO 9001 or ISO 14001 (which is an environmental standard, rather than a quality assurance standard). ISO 19011 applies to both quality and environmental management system auditing because it describes how to conduct a process audit. Process audits are the best way to determine conformity of a management system to the requirements of either ISO 9001 or ISO 14001.

Whereas ISO 9001 recommends a process approach to structuring and implementing a management system, ISO 19011 recommends a process approach to assessing management systems. Cavendish Scott has been using this approach since 1985 and fully understands the approach and requirements. Our approach focuses on the needs of the business rather than pandering to the requirements of the standard. It ensures that organizations get the maximum out of their ISO 9001 implementation. This approach requires organizations to define their processes, identify inputs, outputs and controls, define objectives and demonstrate improvement of those processes.

Need ISO 9000 Certification?

Cavendish Scott is a full-service ISO management system consulting, auditing and training organization with decades of experience in international management system standards. Whether you need a quick and simple ISO certificate, cost effective internal auditing or a complicated process improvement program – we are right for your project. We’re right for you.

From ISO 9001:2008, 0.1, General:

“The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by its organizational environment, changes in that environment, and the risks associated with that environment, its varying needs, its particular objectives, the products it provides, the processes it employs, its size and organizational structure.

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

The quality management system requirements specified in this International Standard are complementary to requirements for products.

This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, statutory and regulatory requirements applicable to the product, and the organization's own requirements.

The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.”