The 20 ISO 9000 quality assurance system elements
The 20 ISO 9000 quality
assurance system elements
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An ISO 9000 compliant quality
assurance system includes up to 20 system elements documented in a pyramid of
inter‑connected policies, procedures and work instructions. Of the three
system models (ISO 9001, 9002, and ISO 9003), ISO 9001 requires all 20 system
elements. The following summary is condensed from the International Standard
document ISO 9001, second edition, reference number ISO 9001:1994(E).
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1. Management responsibility:
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to
define, document, and implement a policy for quality.
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2. Quality system:
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to
establish, document, and maintain a quality system which includes a quality
manual, system procedures, and quality planning.
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3. Contract review:
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to
establish and maintain documented procedures for contract review.
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4. Design control:
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to
establish and maintain documented procedures to control and verify the design
of the product to ensure conformance to specified requirements.
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5. Document and data control:
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to
establish and maintain documented procedures to control all documents and data
(including hard copy and electronic media) including such documents as
standards and customer drawings.
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6. Purchasing:
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to
establish and maintain documented procedures to ensure that purchased product,
associated documents and data conform to requirements. Sub‑contractors
are to be evaluated and selected on their ability to meet subcontract
requirements and the type and extent of control exercised by the supplier over
sub‑contractors is to be defined.
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7. Control of customer‑supplied
product
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to
establish and maintain documented procedures for the control of verification,
storage and maintenance of customer‑supplied product provided for
incorporation into the supplies or for related activities.
8. Product identification and
traceability:
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where
appropriate, to establish and maintain documented procedures for identifying
the product from receipt and during all stages of production, delivery and
installation.
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9. Process control:
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to
identify and plan the production, installation and servicing processes which
directly affect quality, and to ensure these processes are carried out under
controlled conditions.
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10. Inspection and testing:
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to
establish and maintain documented procedures for inspection and testing
activities to in order to verify that the specified requirements for the
product are met.
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11. Control of inspection,
measuring and test equipment:
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to
establish and maintain documented procedures to control, calibrate and maintain
inspection, measuring and test equipment (including test software) used by the
supplier to demonstrate the conformance of product to the specified
requirements.
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12. Inspection and test
status:
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the
inspection and test status of product shall be identified and maintained
throughout the production, installation and servicing of the product to ensure
that only product that has passed the required inspections and tests (or
released under an authorized concession) is dispatched, used or installed.
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13. Control of non‑conforming
product:
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to
establish and maintain documented procedures to ensure that product that does
not conform to specified requirements is prevented from un‑intended use
or installation.
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14. Corrective and preventive
action:
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to
establish and maintain documented procedures for implementing corrective action
in the handling of customer complaints, product non‑conformities, and the
application of controls to ensure corrective action is taken and that it is
effective. Preventive action procedures will detect, analyze, and eliminate
potential causes of non‑conformities.
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15. Handling, storage,
packaging, preservation and delivery:
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to
establish and maintain documented procedures to prevent damage or deterioration
of product.
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16. Control of quality records:
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to
establish and maintain documented procedures for identification, collection,
indexing, access, filing, storage, maintenance and disposition of quality
records. Quality records shall be maintained to demonstrate conformance to
specified requirements and the effective operation of the quality system.
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17. Internal quality audits:
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to
establish and maintain documented procedures for planning and implementing
internal quality audits to verify whether quality activities and related
results comply with planned arrangements and to determine the effectiveness of
the quality system.
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18. Training:
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to
establish and maintain documented procedures for identifying training needs and
provide for the training of all personnel performing activities affecting
quality. Appropriate records of training shall be maintained.
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19. Servicing:
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where
servicing is a specified requirement, to establish and maintain documented
procedures for performing, verifying and reporting that the servicing meets the
specified requirements.
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20. Statistical techniques:
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the
supplier identify the need for statistical techniques required for
establishing, controlling and verifying process capability and product
characteristics, and shall establish and maintain documented procedures to
implement and control their application.
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The ISO 9000 documentation
pyramid
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The 20 quality assurance
elements (or fewer elements in the case of ISO 9002 and ISO 9003), are
incorporated in an interconnected documentation pyramid. The documents are
indexed such that changes at one particular level do not require changes at a
higher level, but may require changes at a lower level.
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Level 1: the quality manual
and quality system elements
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At
the top of the pyramid is the quality assurance manual which contains the
corporate policy and statement on quality. Also included are brief statements
describing how each of the applicable system elements are implemented in
accordance with the company quality policy. The primary function of the 40 to
50 page quality manual is to succinctly define the company’s quality assurance
system to employees, management, and the ISO 9000 Registrar. It also acts as an
excellent sales tool. The quality manual can be included with responses to
proposals and other sales initiatives. It clearly confirms to the prospective
client that they will be dealing with a quality organization which can provide
goods or services in conformance with the clients specified requirements.
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Level 2: quality assurance
procedures
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The
second level of the documentation pyramid contains quality assurance procedures
which describe how, when, and where the quality system element activities are
conducted, along with who is responsible for conducting them. Typically, each
procedure is a few pages long.
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Level 3: quality assurance
work instructions
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The
third documentation level includes the detailed instructions for the
performance of the work done by the company or organization. The work
instructions include design specifications, drawings, service instructions,
operating procedures, process sheets etc.
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Service companies and
organizations
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The staff effort and expense
involved in creating and documenting an ISO 9000 compliant quality assurance
system can be prohibitive. Service companies and organizations in particular
can have difficulty in translating how they deliver their services into terms
required by a quality assurance standard which was initially developed for
manufacturers. However, it is possible for service companies and organizations
to minimize the effort and expense involved .
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