ISO 9000 -- A MARKETING TOOL FOR U.S. AGRIBUSINESS

Clause

Title and description

4.1

Management responsibility: Defines the firm’s quality policy, organization, and
management review. This step ties that part of management with ‘executive
responsibility’ to the quality system.

4.2

Quality system: Defined as the combination of organizational structure, procedures,
process and resources, the quality system must be fully documented and maintained
to meet all ‘specified requirements’. This step involves the preparation of a quality
manual.

4.3

Contract review: Addresses the capabilities of the firm to meet its contractual
requirements.

4.4

Design control: Reviews the design of the product to ensure that all specified
requirements can be met. This step follows each stage of the process through design
review, verification, validation, and changes.

4.5

Document and data control: Linking with other clauses, this is the commitment the
firm makes to maintain all documents and data and guarantee these records reflect
up-to-date practices.

4.6

Purchasing: Sets-up checks that all products purchased from subcontractors
conform to their specified requirements.

4.7

Control of customer-supplied product: Firms that incorporate customer-supplied
ingredients or packaging materials into their end-products should establish and
maintain documented procedures for the verification, storage, and maintenance of
products.

4.8

Product identification and traceability: A system that follows the product through
each stage of production, delivery, and installation should be implemented. This
‘trace-back’ capability is essential for product recalls.

4.9

Process control: That all aspects of the production process (e.g., buildings, plant,
equipment, personnel, etc.) must be carried out under controlled conditions. Further
“where the results of processes cannot be fully verified by subsequent inspection
and testing of the product and where, for example, processing deficiencies may
become apparent only after the product is in use, the processes shall be carried out
by qualified operators and/or shall require continuous monitoring and control of
process parameters to ensure that the specified requirements are met (ISO 9001
1994, p. 6).’’

4.10

Inspection and testing: Procedures to verify that the specific requirements of the
inputs, intermediate, and final product are being met should be initiated.

4.11

Control of inspection, measuring, and test equipment: Those instruments required to
comply with 4.10 should be periodically calibrated.

4.12

Inspection and test status: Some system of identification of the product that
indicates if it is in compliance with the tests performed must be in place.

4.13

Control of nonconforming product: This is then followed-up with an assurance that
nonconforming product is not inadvertently used (such may be reworked and then
reinspected depending upon the details of the quality system).

4.14

Corrective and preventative action: There must be an effective system that
implements both corrective and preventative action when required.

4.15

Handling, storage, packaging, preservation, and delivery: The quality of the
product should be maintained during the post-production stages.

4.16

4.17

Control of quality records: All quality records should be readily available.

Internal quality audits: The quality system should undergo periodic internal reviews
to determine its effectiveness.