ISO 9001

ISO 9001 is one of a series of three international standards for quality systems that can be used for external quality assurance purposes. These standards specify quality system requirements for use where a contract between two parties requires the demonstration of a supplier's capability. Quality system requirements are defined for three types of supplier activity:
ISO 9001 is applicable when the contract between the two parties specifically requires design and/or development effort and the product requirements are stated principally in performance terms or they need to be established, and confidence in product conformance can be attained by adequate demonstration of some of the supplier's capabilities in design, development, production, installation, and servicing. The quality system requirements of ISO 9001 are aimed at preventing nonconformity at all phases of the product life cycle from design and/or development through servicing. These requirements are complementary to the technical specifications of the product. They do not replace the technical requirements, and are not an alternative to them.

When an organization's quality system has been assessed against ISO 9001, ISO 9002 or ISO 9003 by an accredited independent certification body, then the quality system is registered, and can be used as evidence of quality assurance in tendering for contracts. Quality systems produced in accordance with these quality system requirements are subject to regular third party assessment based on documented, objective evidence of compliance.

The ISO 9000 series of standards, and their European equivalent (EN 29000), are derived from the British quality management standard (BS 5750) which was built on a military standard, the UK Ministry of Defence's Def Stan 0521.

Increasingly, large companies are insisting that suppliers should be accredited. Dealing with accredited suppliers provides them with a sense of security, and reduces the effort required to control the supplier's products. From the supplier's point of view, accreditation provides a quality image, customer confidence, and access to markets where quality certification is obligatory. In addition, the introduction of a quality management system may have a major effect on internal performance. The accreditation process usually takes between one and two years.

ISO 9001 quality system requirements are detailed in the standard in the following sections:

Management responsibility
Quality system
Contract review
Design control
Document control
Purchaser supplied product
Product identification and traceability
Process control
Inspection and testing
Inspection, measuring and test equipment
Inspection and test status
Control of nonconforming product
Corrective action
Handling, storage, packaging and delivery
Quality records
Internal quality audits
Statistical techniques

Within each of these sections, there are generally several sub-sections. For example, the section on Management responsibility has the following sub-sections - Quality policy, Organization, and Management review. Within the sub-section on Quality policy, the standard states that the supplier's management shall define and document its policy and objectives for quality and its commitment to quality, and that the supplier shall ensure that this policy is understood, implemented and maintained at all levels in the organization.

Within the section on Design control, there are sub-sections entitled General, Design and development planning, Design input, Design output, Design verification, and Design changes. Within the section on Document control, there are sub-sections entitled Document approval and issue, and Document changes/modifications.

Within the sub-section Document approval and issue, the standard states that the supplier shall establish and maintain procedures to control all documents and data that relate to ISO 9001 requirements. Much of this information is made up of engineering documents and data - precisely the data that an EDM/PDM system manages.

Within the sub-section Document changes/modifications, the standard states that changes to documents shall be reviewed and approved by the same functions/organizations that performed the original review and approval unless specifically designated otherwise. Again, there is a connection to EDM/PDM systems, this time to the workflow control functions.

An EDM/PDM system can provide rapid, secure and accurate availability, access and dissemination of engineering information to support ISO 9001 requirements. It can manage the changes to this information, and ensure application of procedures.


Copyright 1998 by John Stark