ISO Standards

The single critical problem area in ISO implementation is traceability. In the case of product deficiency or non-meeting of standards a Non-Conformance Report is completed. This report is a tracking mechanism to identify the cause and cost of non-conformity, and remedial actions and their costs.

Traceability to batch number/operator/supplier etc is fundamental to the success and implementation of ISO and is where most reporting/recording systems fail. With PRO$IT you can trace back any level you require, through all levels of build and to any supplier/sub-contractor.

A Brief Overview of ISO

The vast majority of ISO standards are highly specific to a particular product, material, or process (eg film speeds), however, ISO 9000 and ISO 14000 are generic management system standards that can be applied to any organization, large or small, whatever its product - including services - in any sector of activity, and whether it is a business enterprise or a government department.

"ISO 9000" and "ISO 14000" are families of standards which are referred to under these generic titles for convenience. Both families consist of standards and guidelines relating to management systems, and related supporting standards on terminology and specific tools, such as auditing. ISO 9000 is primarily concerned with "quality management".

The standardized definition of "quality" in ISO 9000 refers to all those features of a product (or service) which are required by the customer. "Quality management" means what the organization does to ensure that its products conform to the customer's requirements.

An organization chooses that its quality system be certified against ISO 9001, ISO 9002 or ISO 9003 according to the business processes covered by the quality system. There is no difference of quality ranking between the three standards. Most mid-size businesses choose to qualify to ISO 9002 standards and ISO 9003 is not found that much. ISO 9001 generally is used where businesses do a lot of design. An organisation can implement ISO in one division/branch/department alone, can be ISO 9001 in one division and ISO 9002 in another, etc.

ISO 14000 is primarily concerned with "environmental management", i.e. what the organization does to minimize harmful effects on the environment caused by its activities. Both ISO 9000 and ISO 14000 concern the way an organization goes about its work, and not directly the result of this work, i.e. they concern processes, and not products directly. However the way in which the organization manages its processes is obviously going to affect its final product. In the case of ISO 9000, it is going to affect whether or not everything has been done to ensure that the product meets the customer's requirements. Neither ISO 9000 nor ISO 14000 are product standards.