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ARCHIVE OF OBSOLETE
ISO 9001:1994 MATERIAL
ISO 9001 is for
Organizations that Design,
Produce, Install, and Service Products
ISO
9001 is a Quality Assurance Model
made up of Quality System Requirements
ISO 9001 is
a quality assurance model made up of 20 sets of quality system
requirements.
This model applies to organizations that design,
develop, produce, install, and service
products. ISO expects
organizations to apply this model, and to meet these
requirements,
by developing a quality system.
ISO
9001 4.1 - Management responsibilities
Define a quality policy. Your policy
should describe your organization's attitude towards
quality.
Define the organizational structure
that you will need in order to manage your quality
system.
Define a procedure that your senior
managers can use to review the effectiveness of your
quality system.
ISO
9001 4.2 - Quality system requirements
Develop
a quality system and a manual that describes it.
Develop
and implement quality system procedures that are
consistent with your quality policy.
Develop
quality plans which show how you intend to fulfill
quality system requirements. You are expected to develop
quality plans for products, processes, projects, and
customer contracts.
ISO
9001 4.3 - Contract review requirements
Develop and document procedures to
coordinate the review of sales orders and customer
contracts. Make sure you include the customer in the
process of review.
Your contract review procedures
should ensure that all contractual requirements are
acceptable before you agree to provide products or
services to your customers.
Develop procedures which specify how
customer contracts are amended, and which ensure that
changes in contracts are communicated throughout the
organization.
Develop a record keeping system that
you can use to document the review of customer orders and
contracts.
ISO
9001 4.4 - Product design requirements
Develop and document procedures to
control the product design and development process. These
procedures must ensure that all requirements are being
met.
Develop product design and
development planning procedures.
Identify the groups that should be
routinely involved in the product design and development
process, and ensure that their design input is properly
documented, circulated, and reviewed.
Develop procedures to ensure that
all design input requirements are identified, documented,
and reviewed; and that all design flaws, ambiguities,
contradictions, and deficiencies are resolved.
Develop procedures to control design
outputs.
Develop procedures which specify how
product design reviews should be planned and performed.
Develop procedures which specify how
design outputs, at every stage of the product design and
development process, should be verified.
Develop procedures which validate
the assumption that your newly designed products will
meet customer needs.
Develop procedures to ensure that
all product design modifications are documented,
reviewed, and formally authorized before the resulting
documents are circulated and the changes are implemented.
ISO
9001 4.5 - Document and data control
Develop procedures to control
quality system documents and data.
Develop procedures to review,
approve, and manage all of your quality system documents
and data.
Develop procedures to control
changes to documents and data.
ISO
9001 4.6 - Purchasing requirements
Develop procedures to ensure that
purchased products meet all requirements. These
procedures should control the selection of
subcontractors, the use of purchasing data, and the
verification of purchased products.
Develop procedures to select,
evaluate, monitor, and control your subcontractors (your
suppliers). Make sure that quality records are kept which
chronicle the performance of all your subcontractors.
Your records should identify the acceptable
subcontractors and the products and services they
provide.
Develop procedures to ensure that
your purchase order documents precisely describe what you
want to buy.
Develop procedures that allow you or
your customers to verify the acceptability of products
you have purchased.
ISO
9001 4.7 - Customer-supplied products
ISO
9001 4.8 - Product identification and tracing
ISO
9001 4.9 - Process control requirements
Develop and document procedures to
plan, monitor, and control your production, installation,
and servicing processes.
Design a record keeping system that
monitors and controls process personnel and equipment.
Make sure that all important process qualities are
monitored and recorded.
ISO
9001 4.10 - Product inspection and testing
- Develop procedures to
inspect, test, and verify that incoming, in-process, and
final products meet all specified requirements. Also
ensure that appropriate product inspection and testing
records are developed, and that your procedures ensure
that these records are properly maintained.
Develop
procedures which ensure that incoming products are not
used until you have verified that they meet all specified
requirements.
Develop
procedures which ensure that work-in-process meets all
requirements before work is allowed to continue.
Develop
procedures which ensure that final products meet all
requirements before they are made available for sale.
Develop
a record keeping system that your staff can use to
document all product testing and inspection activities.
ISO
9001 4.11 - Control of inspection equipment
Develop
procedures to control, calibrate, and maintain
inspection, measuring, and test equipment used to
demonstrate that your products conform to specified
requirements (the term equipment includes both hardware
and software).
Develop
procedures to ensure that your measurement equipment is
appropriate, effective, and secure.
Develop
procedures to calibrate all of your quality oriented
inspection, measuring, and test equipment.
ISO
9001 4.12 - Inspection and test status of products
ISO
9001 4.13 - Control of nonconforming products
Develop procedures to prevent the
inappropriate use of nonconforming products. Also make
sure that everyone is notified when your products do not
conform to specified requirements.
Develop procedures to control how
your nonconforming products are reviewed, reworked,
regraded, re-tested, recorded, and discussed.
ISO
9001 4.14 - Corrective and preventive action
Develop
procedures to correct or prevent nonconformities.
Develop
procedures to ensure that nonconformities are identified
and corrected without delay.
Develop
procedures to ensure that potential nonconformities are
routinely detected and prevented.
ISO
9001 4.15 - Handling, storage, and delivery
Develop
and document procedures to handle, store, package,
preserve, and deliver your products.
Develop
product handling methods and procedures that prevent
product damage or deterioration.
Designate
secure areas to store and protect your products.
Develop
procedures which specify how your products will be placed
into storage and removed from storage.
Develop
procedures which specify how your products will be
protected from damage or deterioration during storage.
Develop
procedures which specify how your products will be
monitored and evaluated to detect damage or deterioration
while in storage.
Develop
packing, packaging, and marking methods and procedures to
protect and control the quality of products and packaging
materials.
Develop
methods and procedures to protect and preserve product
quality prior to delivery and while the product is still
under your control.
Develop
procedures to protect your products after final testing
and inspection, and during product delivery.
ISO
9001 4.16 - Control of quality records
Identify
and define the quality information that should be
collected.
Develop
a quality record keeping system, and develop procedures
to maintain and control it.
ISO
9001 4.17 - Internal quality audit requirements
ISO
9001 4.18 - Training requirements
ISO
9001 4.19 - Servicing requirements
ISO
9001 4.20 - Statistical techniques
Select
the statistical techniques that you will need in order to
establish, control, and verify your process capabilities
and product characteristics.
Develop
procedures to explain how your techniques should be
applied.
Develop
procedures to monitor and control how techniques are
used.
Make
sure that all statistical procedures are documented.
Make
sure that proper statistical records are kept.
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