The following application article is part of a larger set of articles
published under the title ISO 9000 in Scientific
Computing as a special supplement to Scientific Computing & Automation
magazine.
While ISO 9000 defines what a quality system should do, it does not define
how to do it. That's up to the individual company. Each company does, however,
need to meet certain requirements. Just seven pages long, Section Four contains
the meat of the standard -- the quality system requirements -- which spell
out the 20 areas of required conformance, labeled 4.1 through 4.20.
4.1 Management Responsibility - Requires that management define,
implement, communicate, and maintain quality objectives, and assign personnel
at all levels of the organization to be responsible for verifying the company's
quality system. Periodic management reviews are required.
4.2 Quality System - Requires the creation and implementation of
a quality manual, including documented procedures and instructions.
4.3 Contract Review - Requires the company to document customer orders,
and to verify that it can meet customer requirements.
4.4 Design Control - Requires the documentation of quality measures
in design, including design planning, input, output, verification, and changes.
4.5 Document Control - Requires procedures for creating, distributing,
and tracking all documents, including changes, related to ISO 9000 activities
to ensure the use of only the latest revisions.
4.6 Purchasing - Establishes procedures for supplier assessment,
selection, review, and monitoring, as well as verification of purchased
product quality.
4.7 Purchaser Supplied Product - Stipulates how a company should
handle, store, and maintain customer-supplied materials.
4.8 Product Identification and Traceability - Specifies how the company
should identify products through all stages of production, delivery, and
installation.
4.9 Process Control - Formalizes and ensures controlled conditions
for production and installation processes that affect quality. Requires
document controls and maintenance.
4.10 Inspection and Testing - Establishes procedures for inspection
and testing of incoming, in-process, and out-going products.
4.11 Inspection, Measuring, and Test Equipment - Defines the requirements
for equipment maintenance and calibration.
4.12 Inspection and Test Status - Establishes a system for identifying
the status of products as they move through the facility.
4.13 Control of Nonconforming Product - Ensures that products not
conforming to requirements are prevented from inadvertent use or installation.
4.14 Corrective Action - Establishes, documents, and maintains procedures
for investigating nonconforming products and initiating preventive action.
4.15 Handling, Storage, Packaging and Delivery - Formalizes procedures
for product handling, storage, packaging, and delivery.
4.16 Quality Records - Establishes procedures for identifying, collecting,
indexing, filing, storing, maintaining, and disposition of quality records.
4.17 Internal Quality Audits - Requires regular internal quality
audits to ensure compliance with ISO standards. Requires corrective action
of deficiencies.
4.18 Training - Identifies and provides training for all personnel
performing activities that affect quality. Requires training records for
verification.
4.19 Servicing - Where servicing is specified in a contract, requires
procedures for performing and verifying service activities.
4.20 Statistical Techniques - Specifies the use of appropriate statistical
techniques for verifying process capability.