Auditors look for objective data associated with each the 20 elements specified by the ISO 9001 standard:
define, document, and implement a policy for quality.
Included in this element are requirements for periodic management review of Business Plans (4.1.4), Data Analysis (4.1.5), and Customer satisfaction (4.1.6).
establish, document, and maintain a quality system which includes a
quality manual, system procedures, and quality planning.
establish and maintain documented procedures for controlling the scope of contracts and subsequent amendments.
establish and maintain documented procedures to control and verify the
design of the product to ensure conformance to specified requirements.
Document and data control:
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. This includes the scope of documents, other procedures referenced, and change control procedures.
establish and maintain documented procedures to ensure that purchased
product, associated documents and data conform to requirements.
The standard includes the evaluation of sub-contractors based on their ability to meet subcontract requirements and the type and extent of control exercised by the supplier over sub-contractors.
Control of customer-supplied product:
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.
Product identification and traceability:
where appropriate, establish and maintain documented procedures for
identifying the product from receipt and during all stages of production,
delivery and installation.
identify and plan the production, installation and servicing processes
which directly affect quality, and to ensure these processes are carried
out under controlled conditions.
Inspection and testing:
establish and maintain documented procedures for inspection and testing
activities, in order to verify that the specified requirements for the
product are met.
Control of inspection, measuring and test equipment:
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
Inspection and test status:
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.
Control of non-conforming product:
establish and maintain documented procedures to ensure that product
that does not conform to specified requirements is prevented from un-intended
use or installation.
Corrective and preventive action:
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.
Handling, storage, packaging, preservation and delivery:
establish and maintain documented procedures to prevent damage or deterioration
Control of quality records:
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.
Internal quality audits:
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.
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.
where servicing is a specified requirement, establish and maintain documented
procedures for performing, verifying and reporting that the servicing meets
the specified requirements.
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.
The QS-9000 standard drafted by the Automotive Industry Action Group (AIAG)
extended ISO 9000 to include
Manufacturing Capability analysis.
- Production Part Approval Processes,
- Continuous Improvement,