Special Report: ISO 9000

Manufacturers, especially those who sell products and services internationally, are taking a very serious look at becoming ISO 9000 compliant. According to the British Standards Institute, 47% of ISO certification failures are due to poor documentation control. Without ISO 9000, companies will have restricted global opportunities.

ISO 9000 is a set of internationally accepted standards on quality systems for companies with design, manufacture and service capabilities. They were first developed by the International Organization for Standardization (ISO) and a similar approach was adopted by the American National Standards Institute (ANSI) and the American Society of Quality Control (ASQC).

When an organization is audited for ISO 9000 compliancy, many aspects of their business practices are assessed. A key part of the quality audit is determining if company records are current and readily available. In a nutshell, ISO 9000 is a records- based compliance system. A successful assessment depends on how well records are managed and whether components of records management are included in their quality operations.

Although ISO 9000 certification is not a stamp of product approval, the end result of the process often leads companies to develop higher levels of consistent product output--yielding more uniform product quality for the consumer. Increasingly, customers and governments request their suppliers to comply with ISO 9000 standards.

In an ISO 9000 environment, all activities that affect quality must be recorded--from the development of a quality plan, to the design of the product, through the processing of materials that comprise the product, to the fabrication/assembly of the completed products, through shipment.

A physical examination of a product will not determine whether the product has the level of quality that is required by the customer or what was promised or intended by the manufacturer. The only evidence that confirms product quality resides in the information contained in company records.

The Company seeking compliancy is required to establish and maintain documented procedures for identification, collection, indexing, access, filing, storage, maintenance and disposition of quality records. All records must be legible and should be stored and retained in such a way that they are readily retrievable, and should reside in a suitable environment to prevent damage or deterioration and loss of data. Retention times of records must be established and recorded.

With areas of greatest failure centering around record and document control, for many companies, this task can only be managed by electronic solutions. In a design and manufacturing environment , CAD drawings and paper archives are essential documentation. These documents graphically describe each process of design, production, and assembly, as well as provide a good foundation for document management.

Scanning technology provides a sound method of protecting paper drawings from damage or deterioration. With an electronic archive in place, a company can view, edit, retrieve and safely store CAD and raster files.

Another requirement of ISO 9000 is accessibility. By implementing viewing technology, CAD records can be reviewed "on-demand" by CAD operators, as well as by non-technical personnel.

Workflow management adds another element of discipline to the quality process. With the ability to add change notes that reflect the intent of modifications to a CAD drawing, the manufacturer is getting much more than the history of a project. This information provides vital tracking of the quality procedure and offers pertinent data for decision making down the road.