Functional Requirement: 2a
Citation Quality systems - Model for quality assurance in design/development, production, installation and
servicing. IS0 9001: 1987.
Pages 4.16
Extract The supplier shall establish and maintain procedures for identification, collection, indexing, filing,
storage, maintenance and disposition of quality records.
Functional Requirement: 2b
Citation Johnson, P.L. ISO 9000: meeting the new international standards. 1993.
Pages 46
Extract Management Responsibility: ISO 9001, 4.1; ISO 9004-2, 5.2. Checklist of requirements. *
Management designates a representative with authority and responsibility for implementing and
maintaining the requirements of the standard.
Functional Requirement: 6c
Citation Johnson, P.L. ISO 9000: meeting the new international standards. 1993.
Pages 65-66
Extract The standard [ISO 9000] outlines a few guidelines for the facility's document control scheme: ... *
Documentation and records should be ... dated [and] identifiable ...
Functional Requirement: 7c
Citation Quality systems - Model for quality assurance in design/development, production, installation and
servicing. IS0 9001: 1987.
Pages 4.16
Extract All quality records shall be legible and identifiable to the product involved.
Citation Rabbitt, J.A. The ISO 9000 book : a global competitor's guide to compliance and certification.
1993.
Pages 133
Extract They [records] should identify the process and products involved.
Functional Requirement: 8
Citation United States. General Services Administration. Information Resources Management Service.
Electronic forms systems analysis and design. 1993.
Pages 15
Extract One of the major concerns of electronic forms system analysts is the authentication of the data or
information on electronic forms (including electronic signature in many cases). To be effective,
authentication programs must be part of an overall security program. An agency must ensure that only
persons who have a need to know and have proper delegations of authority and clearances can complete
and "sign" electronic forms.
Functional Requirement: 8b
Citation United States. General Services Administration. Information Resources Management Service.
Electronic forms systems analysis and design. 1993.
Pages 16
Extract Safeguards must be installed ... to assure that only authorized persons have access to the
forms.
Functional Requirement: 9
Citation Quality systems - Model for quality assurance in design/development, production, installation and
servicing. IS0 9001: 1987.
Pages 4.16
Extract Quality records shall be maintained to demonstrate achievement of the required quality and
effective operation of the quality system.
Functional Requirement: 9a
Citation Johnson, P.L. ISO 9000: meeting the new international standards. 1993.
Pages 65-66
Extract The standard [ISO 9000] outlines a few guidelines for the facility's document control scheme: ... *
Quality records and documentation should be stored in a way to prevent damage, loss and
deterioration.
Functional Requirement: 10
Citation Johnson, P.L. ISO 9000: meeting the new international standards. 1993.
Pages 65-66
Extract The standard [ISO 9000] outlines a few guidelines for the facility's document control scheme: ... *
To prevent obsolete editions from being used, a procedure must ensure that outdated documents are
promptly discarded.
Functional Requirement: 10a
Citation Quality systems - Model for quality assurance in design/development, production, installation and
servicing. IS0 9001: 1987.
Pages 4.5.1
Extract The supplier shall establish and maintain procedures to control all documents and data that relate
to the requirements of this International Standard. These documents shall be reviewed and approved for
adequacy by authorized personnel prior to issue. This control shall ensure that... b) obsolete documents
are promptly removed from all points of issue or use.
Functional Requirement: 12
Citation Quality systems - Model for quality assurance in design/development, production, installation and
servicing. IS0 9001: 1987.
Pages 4.5.1
Extract The supplier shall establish and maintain procedures to control all documents and data that relate
to the requirements of this International Standard. These documents shall be reviewed and approved for
adequacy by authorized personnel prior to issue. This control shall ensure that a) the pertinent issues of
appropriate documents are available at all locations where operations essential to the effective
functioning of the quality system are performed
Citation Quality systems - Model for quality assurance in design/development, production, installation and
servicing. IS0 9001: 1987.
Pages 4.16
Extract Quality records shall be stored and maintained in such a way that they are readily retrievable that
they are readily retrievable in facilities that provide a suitable environment to minimize deterioration or
damage and to prevent loss.
Last Modified: 7/3/96 [kjb]
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